Physiotherapy ELECTROPHYSICAL AGENTS CANADA Contraindications and Precautions: An Evidence-Based Approach to Clinical Decision Making in Physical Therapy VOLUME 62 NUMBER 5 SPECIAL ISSUE 2010 ISSN-0300-0508 E-ISSN-1708-8313 TABLE OF CONTENTS 1 Foreword Sandy Rennie 4 Authors and Contributors 1 5 Introduction: Purpose, Methodology, and Definition of Terms 2 11 Summary of Recommendations 3 13 Continuous and Pulsed Ultrasound 4 26 Electrical Stimulation Therapy (TENS, NMES, and HVPC) 5 39 Low-Level Laser Therapy and Non-coherent Light 6 47 Superficial Heating Agents 7 55 Cryotherapy 8 63 Short-Wave Therapy: Thermal and Non-thermal 9 74 Guide to Safe Practice APPENDIX 1 76 Summary of Consensus by Experts APPENDIX 2 77 Textbook Resources Considered INDEX 78 Index of Recommendations, Rationales, and References Key Words: adverse effects, adverse reaction, cold, complication, contraindications, cryotherapy, electrical stimulation, electrophysical agents (EPAs), heat, HVPC, IFC, low-level laser therapy, physical therapy, precautions, rehabilitation, risk, safety, side effect, TENS, therapeutic ultrasound, US DOI:10.3138/ptc.62.5 •JW^L* Canadian Association »•21 !»*•' Physiotherapy canadienne de Association Physiotherapie • • • • • • • Scientific Editor Dina Brooks, BSc(PT), MSc, PhD Associate Professor Department of Physical Therapy University of Toronto Toronto, ON Associate Editors Christine Carpenter, PT, PhD Reader in Physiotherapy Faculty of Health and Life Sciences Coventry University Coventry, UK Jerome Frenette pht, PhD Professeur titulaire, Programme de Physiothérapie Departement de Réadaptation Pavilion Ferdinand-Vandry Universitě Laval Quebec, QC Tania Lam, BSc(PT), PhD Assistant Professor School of Human Kinetics University of British Columbia Vancouver, BC Marilyn MacKay-Lyons, BSc(PT), MSc(PT), PhD Associate Professor School of Physiotherapy Dalhousie University Halifax, NS Christine B. Novak, BSc(PT), MSc, PhD Research Associate University Health Network Toronto, ON Tom Overend, PhD, BSc(PT) Associate Professor School of Physical Therapy University of Western Ontario London, ON Marco Pang, BScPT, PhD Assistant Professor Department of Rehabilitation Sciences The Hong Kong Polytechnic University Kowloon, Hong Kong W. Darlene Reid, BMR(PT), PhD Professor, Department of Physical Therapy Director, Muscle Biophysics Laboratory, VCHRI University of British Columbia Vancouver, BC Ted Stevenson, MSc(PT) Physiotherapist Rehabilitation Services St. Boniface General Hospital Winnipeg, MB International Advisory Board Bastiaan R. Bloem, MD, PhD Professor, Department of Neurology Chair in Movement Disorders Radboud University Nijmegen Medical Center The Netherlands Rik Gosselink, PhD, PT Professor, Department of Rehabilitation Sciences Katholieke Universiteit Leuven Leuven University Belgium Karen Grimmer-Somers, PhD, MMedSci, BPhty, CertHealthEc, LMusA Professor, School of Health Sciences Director, Centre for Allied Health Evidence University of South Australia Australia Suh-Fang Jeng, ScD, PT Professor School and Graduate Institute of Physical Therapy College of Medicine National Taiwan University Taiwan Meg E. Morris, BAppSc(Physio), MAppSc, Grad Dip(Geron), PhD, FACP Professor & Chair, School of Physiotherapy University of Melbourne Australia Kenneth J. Ottenbacher, OT, PhD Russell Shearn Moody Distinguished Chair in Neurological Rehabilitation Senior Associate Dean for Graduate Research Education School of Allied Health Sciences University of Texas Medical Branch USA Carol L. Richards, PhD, PT, FCAHS Professor & Canada Research Chair in Rehabilitation Department of Rehabilitation Medicine Laval University Quebec City, QC Peter Rosenbaum, MD, CM, FRCP(C) Professor, Department of Pediatrics McMaster University Hamilton, ON Julius Sim, BA, MSc(Soc), MSc(Stat), PhD Primary Care Musculoskeletal Research Centre Keele University, UK Statistical Consultants Paul Stratford, PT, MSc Professor School of Rehabilitation Science & Associate Member Department of Clinical Epidemiology and Biostatics McMaster University Hamilton, ON David L. Streiner, PhD, CPsych Professor, Department of Psychiatry University of Toronto Assistant V.P. 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Publications Mail PM40600510 Return Undeliverable Items to: University of Toronto Press, 5201 Dufferin Street, North York, ON, M3H 5T8 PRINTED IN CANADA ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS Foreword Sandy Rennte The importance of the guideline "Electrophysi-cal Agents—Contraindications and Precautions: An Evidence-Based Approach to Clinical Decision Making in Physical Therapy" by Houghton, Nussbaum, and Hoens simply cannot be overstated. This excellent work is timely, relevant, and important both clinically and educationally; it could well become a seminal guide to contraindications and precautions in the use of electrophysical agents (EPAs) not only in Canada but internationally. While Houghton et al. point out that their primary references were not acquired through a rigorous systematic review process, the thoroughness of the literature review is impressive. It provides a sound basis for examining why certain contraindications and precautions are still viable and appropriate in today's clinical practice. In addition to a comprehensive list of scientific articles, the authors consulted 17 textbooks that address contraindications and precautions for the EPAs; they examined and interpreted guidelines produced by the Chartered Society of Physiotherapy (UK) and the Australian Physiotherapy Association; and, perhaps most importantly from an academic perspective, they conducted a consensus exercise among North American (Canadian and US) and international experts through a direct survey, requesting their recommendations on contraindications and precautions for commonly used EPAs. The authors' purpose in developing this document was to provide a resource that could guide clinical decision making for the safe and effective use of EPAs; evidence-based practice was at the forefront of their approach. Their purpose was not to address indications for the use of EPAs, but rather to describe the evidence and prevailing opinions on the most common contraindications to and precautions for the effective use of EPAs, and specifically six commonly used EPAs: cold (cryotherapy), heat (superficial thermal agents), electrical stimulation (TENS, NMES, HVPC), low-level laser therapy, short-wave diathermy, Sandy Rennte, PT, PhD: Associate Professor and Director, School of Physiotherapy, Dalhousie University, Halifax, Nova Scotia. Address correspondence to Dr. Sandy Renne, School of Physiotherapy, Dalhousie University, Halifax, NS B3H 355 Canada; E-mail: sandy.rennie@dal.ca. and therapeutic ultrasound. Unfortunately, not all examples of the agents used in these groupings are discussed; however, there is enough information that the reader can safely draw conclusions for the EPAs not described, with a few exceptions. These exceptions are discussed below. ULTRASOUND In the section on effective duration of ultrasound, the authors describe using pulsed ultrasound for a minimum of 10 minutes, based on good evidence. However, they do not mention that continuous ultrasound should also be used for a minimum of 10 minutes (as described by Draper et al.)1 in order to produce the tissue-temperature rise of 4°C required to achieve a thermal impact on the tissues. ELECTRICAL STIMULATION Houghton et al. have included several types of electrical stimulation in this section: transcutaneous electrical nerve stimulation (TENS), high-voltage pulsed current (HVPC), interferential current (IFC), and neuromuscular electrical stimulation (NMES). It might have been prudent to separate these currents according to their primary uses in physiotherapy practice, rather than combining them together. TENS and IFC are used primarily for pain relief; HVPC is used for wound care and sometimes for pain relief; and NMES is used for muscle-fibre recruitment. Therefore, while the majority of contraindications and precautions are similar, there are some exceptions. Another precaution should be noted for the use of IFC with suction-cup application. Whether the suction is vacuum or positive pressure (Venturi system), the risk of skin damage is increased when this method of application is used. Therefore, it is important to ensure that the patient's skin condition is appropriately safe for IFC suction application. Houghton et al. indicate that NMES is contrain-dicated "anywhere" on pregnant women; however, there appears to be no evidence for this. NMES is an effective tool for muscle recruitment, muscle strengthening, and functional activity.24 Although it should not be used on the abdomen or lumbar spine, 1 2 Physiotherapy Canada, Volume 62, Number 5 NMES should be safe and effective for other situations when motor-unit recruitment (particularly peripherally) would be beneficial for pregnant women. The authors dismiss myths around the use of electrical stimulation on patients with certain medical conditions, acknowledging that NMES can be used safely and effectively in patients with cancer, chronic obstructive pulmonary disease, and heart disease. Recent research58 has shed more light on the use of electrical stimulation in these situations. SUPERFICIAL HEATING AGENTS In this section, the primary electrophysical agents discussed by Houghton et al. are those that fall into the category of superficial heating agents—that is, agents that heat tissues within 3 cm of the skin surface. These agents typically include paraffin wax baths, hydrocollator hot packs, and hydrotherapy. In recent years, another superficial heating agent has appeared on the over-the-counter market for consumers: the heat wrap. Commercially available, wearable heat wraps are air activated and can be worn for up to 8 hours at a time; they consist of cloth embedded with multiple discs made of iron powder, activated charcoal, sodium chloride, and water. These discs are spaced throughout the cloth's application surface; when the wrap is removed from its sealed pouch and exposed to air, the discs oxidize, undergoing an exothermic reaction and thus producing heat. These wearable heat wraps maintain a temperature of about 40°C (104°F), elevate tissue temperature, and can be worn during activities of daily living, at work, and during sleep. They are available in different sizes and shapes to accommodate body size and contour and location of application. Several studies have examined the effectiveness of these heat wraps.912 While practising physiotherapists may not use heat wraps in a clinic or department, they should be aware of these products and their risks for skin damage through burns and/or blisters. Since these products are being used more and more by patients, it is imperative that we understand their mechanism of use and the safety concerns around them, as patients will undoubtedly ask for our advice with respect to their use. Another concern we often have with the use of superficial heating agents is the impact the heat may have on subcutaneous fatty tissue. In two recent articles, Petrofsky et al.1314 examined the effects of superficial heat on subjects with a high body mass index (BMI). In their experiments using hydrocollator hot packs on overweight subjects, they found that the change in muscle temperature was reduced, while the change in skin temperature was increased, relative to non-overweight patients. This temperature accumulation in the skin is potentially dangerous, particularly for obese patients who are older, have diabetes, or have impaired circulation and/or reduced skin thickness, as it may result in burns or skin damage. SUPERFICIAL COOLING AGENTS A hierarchy of cooling agents is provided by Houghton et al. Missing from their list, however, are combined cold and compression units such as the Cryo/Cuff. These units are designed to provide both cold and compression simultaneously, and they have been shown to be both safe and effective.1518 The authors' list of general contraindications and precautions for the use of cryotherapy would certainly also apply to these cold/compression units; however, an additional relevant precaution is that too much combined cold and compression can compromise tissues even more. The use of these devices is common in acute joint injuries, such as ankle sprains, to help control swelling and possible bleeding in the region. However, caution is advised when adding compression to a cryotherapy application to ensure that circulation and nerve(s) are not compromised. SHORT-WAVE THERAPY A primary concern raised by Houghton et al. about the use short-wave therapy (SWT) is that there should be no metal furniture within a 2 m distance of the operating SWT unit, nor should any items of furniture being used by the patient have any metal parts. While this safety approach seems plausible, it may not be possible in today's clinics and hospital physiotherapy departments. The majority of treatment plinths in current use are adjustable in height, with moveable parts to accommodate patients in various positions of support. These modern plinths are designed not only for better patient accessibility and comfort but also for the comfort and safety of the physiotherapist: because they can change the height and configuration of the plinth, physiotherapists are less likely to sustain joint, muscle, or back injuries. These plinths, which are adjustable manually (hydraulic) or electrically (footswitch), have metal frames and parts, and this, according to Houghton et al, makes them unusable for SWT. We may need to rethink this application restriction and find ways of applying SWT safely and effectively using adjustable treatment plinths. If precautions are taken to ensure that the patient is not touching any metal and that the SWT leads and electrode^) are properly attached and not touching the plinth, treatment may be considered safe. Rennie Foreword 3 PROCEDURES FOR ALL ELECTROPHYSICAL AGENT TREATMENTS A systematic and common-sense approach to the use of EPAs is described by Houghton et al: ensuring patient safety through explanation, informed consent, sensation testing, and patient monitoring during treatment; reassessment using valid outcome measures; and ensuring completion of appropriate documentation. CONCLUSION "Electrophysical Agents—Contraindications and Precautions: An Evidence-Based Approach to Clinical Decision Making in Physical Therapy" is a much-needed resource for physiotherapists in Canada and abroad and should be part of the education of future physiotherapists. REFERENCES 1. Draper DO, Castel JC, Castel D. Rate of temperature increase in human muscle during 1 MHz and 3 MHz continuous ultrasound. J Orthop Sport Phys Ther. 1995;22:142-50. 2. Dehail P, Duclos C, Barat M. Electrical stimulation and muscle strengthening. Ann Readapt Med Phys. 2008;51:441-51. doi:10.1016/j.annrmp.2008.05.001 3. Gorgey AS, Dudley GA. The role of pulse duration and stimulation duration in maximizing the normalized torque during neuromuscular electrical stimulation. J Orthop Sport Phys Ther. 2008;38:508-16. doi:10.2519/jospt.2008.2734 4. Paillard T. Combined application of neuromuscular electrical stimulation and voluntary muscular contractions. Sports Med. 2008;38;161-77. doi:10.2165/00007256-200838020-00005 5. Maddocks M, Lewis M, Chauhan A, Manderson C, Hocknell J, Wilcock A. Randomized controlled pilot study of neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer. J Pain Symptom Manag. 2009;38:950-6. doi:10.1016/j.jpainsymman.2009.05.011 6. Dal Corso S, Napolis L, Malaguti C, Gimenes AC, Alburquerque A, Nogueira CR, et al. Skeletal muscle structure and function in response to electrical stimulation in moderately impaired COPD patients. Respir Med. 2007;101:1236-43. doi:10.1016/j.rmed.2006.10.023 7. Dobsak P, Novakova M, Siegelova J, Fiser B, Vitovec J, Nagasaka M, et al. Low-frequency electrical stimulation increases muscle strength and improves blood supply in patients with chronic heart failure. Circ J. 2006;70:75-82. doi:10.1253/circj.70.75 8. Bennett M, Johnson M, Brown S, Radford H, Brown J, Searle D. Feasibility study of transcutaneous electrical nerve stimulation (TENS) for cancer bone pain. J Pain. 2010;11:351-9. doi:10.1016/ j.jpain.2009.08.002 9. Trowbridge CA, Draper DO, Freland JB, Jutte LS, Eggett DL. Paraspinal musculature and skin temperature changes: comparing the ThermaCare HeatWrap, the Johnson & Johnson Back Plaster, and the ABC Warme-Pflaster. J Orthop Sport Phys Ther. 2004;34:549-58. doi:10.2519/jospt.2004.1168 10. Mayer JM, Ralph L, Look M, Erasala GN, Verna JL, Matheson LN, et al. Treating acute low back pain with continuous low-level heat wrap therapy and/or exercise: a randomized controlled trial. Spine. 2005;5:395-403. doi:10.1016/j.spinee.2005.03.009 11. Nadler SF, Steiner DJ, Petty SR, Erasala GN, Hengehold DA, Weingand KW. Overnight use of continuous low-level heat wrap therapy for relief of low back pain. Arch Phys Med Rehabil. 2003;84:335-42. 12. Michlovitz S, Hun L, Erasala GN, Hengehold DA, Weingand KW. Continuous low level heat wrap is effective for wrist pain. Arch Phys Med Rehabil. 2004;85:1409-16. 13. Petrofsky JS, Laymon M. Heat transfer to deep tissue: the effect of body fat and heating modality. J Med Eng Technol. 2009;33:337-48. doi:10.1080/03091900802069547 14. Petrofsky J, Bains G, Prowse S, Gunda L, Berk L, Raju C, et al. Dry heat, moist heat and body fat: are heating modalities really effective in people who are overweight? J Med Eng Technol. 2009;33:361-9. doi:10.1080/03091900802355508 15. Kullenberg B, Ylipaa S, Soderlund K, Resch S. Postoperative cryotherapy after total knee arthroplasty. J Arthroplasty. 2006;21:1175-9. doi:10.1016/j.arth.2006.02.159 16. Holmstrom A, Hardin B. Cryo/Cuff compared to epidural anesthesia after knee unicompartmental arthroplasty. J Arthroplasty. 2005;20:316-21. doi:10.1016/j.arth.2004.09.043 17. Singh H, Osbahr D, Holovacs T, Cawley P, Speer K. The efficacy of continuous cryotherapy on the postoperative shoulder: a prospective, randomized investigation. J Shoulder Elbow Surg. 2001;10:522-5. doi:10.1067/mse.2001.118415 18. Knobloch K, Grasemann R, Jagodzinski M, Richter M, Zeichen J, Krettek C. Changes in Achilles midportion tendon microcirculation after repetitive simultaneous cryotherapy and compression using a Cryo/Cuff. Am J Sport Med. 2006;34:1953-9. doi:10.1177/0363546506293701 Authors and Contributors ABOUT THE AUTHORS Pamela £ Houghton, PhD, BScPT: Associate Professor, School of Physical Therapy, Faculty of Health Sciences, University of Western Ontario, London, Ontario; Chair of Graduate Program in Health and Rehabilitation Sciences, Faculty of Health Sciences, University of Western Ontario, London, Ontario. Ethne L Nussbaum, PhD, MEd, BScPT: Associate Professor, Department of Physical Therapy, University of Toronto, Toronto, Ontario; Research Physiotherapist, Mount Sinai Hospital, Toronto, Ontario. Alison M. Hoens, MSc, BScPT, PG Sports PT: Clinical Associate Professor and Physical Therapy Knowledge Broker, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia; Research, Education and Practice Coordinator, Physiotherapy, Providence Health Care, Vancouver, British Columbia. Address correspondence to Pamela £ Houghton, School of Physical Therapy, University of Western Ontario, London, ON N6G 1H1 Canada. Tel.: 519-661-3360; Fax: 519-661-3866; E-mail: phoughto@uwo.ca. ACKNOWLEDGEMENTS The authors wish to thank the following contributors: Alain-Yvan Belanger, PhDPT, MSc, BSc: Professor, Programme de Physiotherapie, Departement de Readaptation, Faculte de Medicine, Universite Laval, Quebec (Quebec). Susan L. Michlovitz, PhDPT, CHT: Professor, Department of Physical Therapy, Temple University, Philadelphia, Pennsylvania, USA. Sandy Rennie, PhD, MSc, BPT: Director and Associate Professor, School of Physiotherapy, Faculty of Health Professions, Dalhousie University, Halifax, Nova Scotia. Barbara Shay, PhD: Associate Professor, Department of Physical Therapy, School of Medical Rehabilitation, University of Manitoba, Winnipeg, Manitoba. Joseph Anthony, PhD, PT: Clinician, Providence Health Care Vancouver, British Columbia; Sessional Instructor, Department of Physical Therapy, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia. 4 ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS 1. Introduction This document was developed by three physical therapists dedicated to evidence-based practice in the use of electrophysical agents (EPAs), with the intent to provide a resource to guide safe practice using EPAs. IMPETUS This project began when the authors taught a workshop on EPAs prior to the 2007 World Congress of Physiotherapy in Vancouver, Canada. The workshop revealed considerable discrepancy between instructors and participants in terms of what was considered safe practice with respect to EPA contraindications and precautions. Furthermore, the authors found that they were frequently being contacted for guidance on EPA safety issues, yet their attempts to provide answers were complicated by conflicting or inadequate evidence in the literature. It was clear that there was a need for a resource to guide this important area of physiotherapy practice. The authors therefore sought to capture traditional EPA safe practice by examining the consensus of opinion among selected EPA experts and authors of recent book chapters and monographs, and to review the literature for evidence to support or refute the common view, with the goal of developing evidence-based recommendations for safe practice in the use of EPAs. PURPOSE The authors' intent in developing this resource was to provide the physical therapy community with a resource that could guide clinical decision making for safe practice in the use of EPAs, thereby reducing the incidence of adverse reactions. This resource was developed with the following objectives: 1. To provide a compilation and synthesis of information from original research articles, reviews, and textbook resources about contraindications and precautions for EPAs. 2. To summarize expert opinion (North American and international, as represented by EPA guidelines of the Australian Physiotherapy Association and the UK Chartered Society of Physiotherapy) in order to highlight the degree of consensus with respect to contraindications and precautions for EPAs. 3. To make clear recommendations on EPA contraindications and precautions based on scientific evidence, physiological rationale, and/or ethical reasoning. 4. To provide a rationale for each recommendation to enable physiotherapists to make informed clinical decisions. SCOPE It is important to note that our focus here is restricted to the evidence and prevailing opinions for EPA contraindications and precautions; it does not address their indications (i.e., their clinical effectiveness). Accordingly, this guide should be used in conjunction with the three critical components of evidence-based practice: (1) best research evidence (i.e., clinical effectiveness studies), (2) clinical expertise, and (3) patient values.1 This resource focuses on the following commonly used electrophysical agents (EPAs): • Superficial heat (hot packs, wax, and hydrotherapy) • Cryotherapy (ice, ice baths, and cold packs) • Therapeutic ultrasound (pulsed and continuous mode) • Short-wave therapy (pulsed and continuous mode) • Light therapy (low-level laser therapy and noncoherent light) • Electrical stimulation therapy (E-stim) using surface electrodes: transcutaneous electrical stimulation (TENS), neuromuscular electrical stimulation (NMES), high-voltage pulsed current (HVPC), and interferential current (IFC) The use of these energies (electrical, light, sound, and thermal) for diagnostic, medical, or surgical applications is not considered. Microwave diathermy, low-frequency pulsed electromagnetic fields (PEMFs), iontophoresis, electromyography (EMG) biofeedback, compression therapy, ultraviolet irradiation, and radiant heat are not included. This guide considers commonly encountered clinical conditions or patient scenarios 5 6 Physiotherapy Canada, Volume 62, Number 5 associated with the use of EPAs, rather than rare conditions and circumstances. PROVISOS The information provided here should be used in conjunction with the standards mandated by professional associations and regulatory bodies (e.g., Health Canada, the US Food and Drug Administration, provincial physiotherapy regulatory organizations). Contraindications and precautions are also listed in the operating manuals provided by equipment manufacturers, as required by Health Canada, although Health Canada does not vet these listings. In the event of a discrepancy between the information provided in this document and that provided by a manufacturer, the clinician is not bound by the manufacturer's recommendation. Although this resource provides a review of the evidence, an expression of popular views, and informed recommendations for practice, it is ultimately the clinician who is responsible for making decisions about EPA application in a specific clinical situation. Clinical decisions should be based on weighing the evidence supporting use or non-use of a device and on an appreciation of the unique characteristics of the individual patient. In the absence of clear or substantive evidence of efficacy, and in the presence of potential adverse effects, it is recommended that clinicians err on the side of caution and avoid the use of the EPA. METHODOLOGY Consensus among North American and international experts was established by surveying experts within Canada and the United States, reviewing textbook resources, and interpreting guidelines from the Chartered Society of Physiotherapy in the United Kingdom and the Australian Physiotherapy Association. The findings are summarized in Appendix 1. Canadian/US Expert Consensus Eight physical therapists who instruct students on the use of EPAs within physical therapy programs in Canada and the United States and who are experienced in EPA practice were surveyed for their recommendations on commonly cited EPA contraindications. Many of these individuals are independent investigators with active research programmes in the field of EPA use, and their work is published in peer-reviewed journals. These eight individuals were invited to respond to a given list of conditions for the selected EPAs (see Appendix 1). For some conditions or specific body areas, fewer than eight responses were received. For the purposes of the present discussion, consensus among these experts is expressed as percent (raw) agreement that the particular EPA should not be used on patients with a given condition (i.e., that it is contraindicated). Raw percent agreement was determined by dividing the number of experts who stated that a condition was contraindicated by the total number of experts who provided a response. Experts were encouraged to give no response when they were unsure, rather than making an uninformed decision. When an expert did not register a response, the denominator and raw percent agreement were adjusted accordingly. Thus, higher percent agreement in this consensus process was considered stronger support for a recommendation that the EPA should be contraindicated for the given condition. Resources A total of 17 textbooks that included contraindications and precautions for one or more of the six EPAs addressed in this document were identified by reviewing the reference lists of English-language journal articles and by contacting academic and clinical colleagues. The most recent edition of each text was obtained by contacting publishers (see Appendix 2). Using these resources, a list was compiled of all medical conditions, scenarios, and body areas mentioned as contraindications. Percent (raw) agreement of contraindications for text resources was calculated as the number of resources listing the condition as a contraindication divided by the total number of resources that included a section on contraindications and precautions for the particular EPA. Where a textbook did not mention a particular condition or recommend treating the condition with caution (a precaution), it was assumed that the authors considered the condition safe to be treated (i.e., not contraindicated). Higher raw percentage values were considered to indicate stronger agreement among textbook resources that the EPA is contraindicated for a given condition. Overall, the consensus among authors of textbooks was quite low for most EPAs. Guidelines of the Australian Physiotherapy Association (APA) and the Chartered Society of Physiotherapy (CSP) Similar documents addressing this topic have been produced by Robertson et al. in Australia2 and by the Chartered Society of Physiotherapy (CSP) in the United Kingdom.3 These guidelines were reviewed by the present authors, and an interpretation of their recommendations is included here in order to give the reader an appreciation of the degree of international agreement on contraindications and precautions for the various EPA modalities. However, 1. Introduction 7 caution is advised when comparing recommendations, as the differences in Australian, UK, and Canadian approaches to the topic required a degree of subjective interpretation. For example, the CSP guidelines do not consider TENS, NMES, IFC, and HVPC separately; therefore, the present authors have necessarily assumed that the list of contraindications and precautions pertains to all types of low-frequency E-stim. The APA guidelines group various conditions together (e.g., acute infection, malignancy, tuberculosis, and osteomyelitis are grouped in the category "risk of dissemination"), which likewise requires an assumption that each of these conditions is a contraindication. In addition, terminology varies between the documents. For example, the CSP guidelines include a category termed "local circulatory insufficiency," which was assumed to denote arterial insufficiency and to be similar to the category here termed "impaired circulation"—and, moreover, to exclude other circulatory disturbances such as deep vein thrombus, venous congestion, and edema. RECOMMENDATIONS Within this document, clear recommendations are provided for the safe use of EPAs in specific conditions, together with a rationale and supporting literature for each condition. Tables at the beginning of each section summarize these recommendations. These tables are not meant to stand alone; rather, users of this resource are strongly encouraged to refer to the text, where recommendations are clarified, the rationale underlying the recommendation is provided, and the level of evidence supporting the recommendation is evaluated. Rationale A key feature of these guidelines is a discussion of the underlying biophysical mechanisms and concerns related to each recommendation. When adverse reactions are theorized but no evidence of such an adverse effect could be found in the literature, the rationale is hypothesized based on known physical principles and biological effects of the relevant EPA. In cases of controversy as to the relative risks and benefits of using an EPA, alternative viewpoints are presented. It is hoped that this information will assist clinicians in making their own decisions about EPA use in particular circumstances. Research Evidence Original articles addressing contraindications, precautions, and adverse reactions related to use of EPAs were identified by searching several electronic databases (CINAHL, Medline, and PubMed) for papers published between 1966 and January 2007. A secondary search of all references in book chapters, review articles, and articles located via the database search was also performed. An updated search was performed in March 2008 using the CINAHL, EMBASE, EBM Reviews, and PubMed databases and the following search terms: contraindication, adverse reaction, side effect, complication, safety, rehabilitation, physical therapy, physiotherapeutic, ultrasound, therapy, laser, LLLT, LILT, light, heat, cold, cryotherapy, electrical stimulation, TENS, EMS, high voltage pulsed current, HVPC, interferential current, IFC, and electrotherapy. The studies included in the literature review were original research articles, experimental research (animal models, cell culture studies, and trials using healthy human subjects), and clinical reports (case reports, Phase I clinical trials that reported adverse reactions as a primary outcome) published in English. Primary sources are referred to whenever possible in these guidelines to support or refute the suggested contraindication, precaution, or recommendation for safe practice. Recommendations The authors have made a clear recommendation for each condition considered here. These recommendations are based on specific criteria that have been applied consistently across all EPAs and all conditions considered (see chart below). Criteria include the seriousness of the potential adverse reaction, the level of research evidence supporting the recommendation, and the degree of consensus among North American and international experts. Because consensus among experts and resources was generally poor, however, the consensus data seldom informed the authors' recommendation for practice. Note that the authors have chosen to consider any condition that has the potential for a serious adverse reaction as a contraindication, regardless of the research evidence. Summaries Table 1 summarizes the authors' recommendations for the six EPAs discussed here. Thereafter, each EPA-specific section begins with a list that summarizes all recommendations specific to that EPA. This is followed by a table providing the percent (raw) agreement on contraindications among the North American experts and the authors of the textbook chapters consulted, an interpretation of the recommendations found in the APA and CSP guidelines, the seriousness of potential adverse reactions, the level of research evidence, and the authors' recommendations. For the rationale and supporting evidence for these recommendations, the reader is 8 Physiotherapy Canada, Volume 62, Number 5 Symbol Definition Criteria • CONTRAINDICATION DO NOT use the EPA with this condition or in this body location. • Potential for serious adverse reaction • Moderate to strong research evidence • Consensus among experts and resources /P\ PRECAUTION Experienced clinicians may elect to treat this condition/location with extra caution (e.g., using lower intensities and/or more frequent monitoring). • Potential for moderate to minor adverse reaction • Low to moderate research evidence © SAFE This condition or body location is NOT contraindicated. • Potential for minor adverse reaction • Absent to low research evidence (no adverse reactions have been reported with clinical use) strongly urged to consult the detailed condition-specific discussions presented under the heading "Recommendation, Rationale, and References" in each section. These detailed discussions may include a few conditions not covered in the summary of recommendations or in the tables. Each section concludes with recommendations for safe practice (under the heading "Safe Practice"), followed by a list of references cited in the text and tables. Throughout this document, the above symbols are used in summary tables and detailed recommendations. CRITERIA FOR ASSIGNING THE SERIOUSNESS OF ADVERSE REACTION AND LEVEL OF RESEARCH EVIDENCE Seriousness of Adverse Reaction Serious Potential adverse reaction could be catastrophic, is potentially life threatening, or could result in permanent deformity, discomfort, or disability (e.g., cardiac dysfunction, coma, fetal abnormality). Moderate Potential adverse reaction could be a major inconvenience for the individual and could require medical attention; however, the reaction is temporary and not likely to compromise the individual's overall medical health (e.g., deep skin burn, systemic infection, tissue necrosis). Minor Potential adverse reaction could be a minor inconvenience to the patient and would resolve spontaneously (e.g., increased pain, superficial burn). Level of Research Evidence Strong Clinical reports are consistent and suggest a potential for adverse reactions should the EPA be used in the presence of this condition or on this body area. These clinical reports are supported by experimental evidence and/or by a strong biophysical rationale for the adverse reaction. Moderate The potential harmful effect has been demonstrated in experimental research using appropriate cell culture or animal models or when applied to healthy human subjects; however, clinical evidence is either lacking or conflicting. Low There is a sound biophysical rationale to explain how the EPA might cause an adverse reaction; however, there is no research evidence, either animal or clinical, to substantiate this response, or the existing evidence is contradictory. Absent No research, either experimental or clinical, has been found, and there is no known biophysical rationale to explain how the adverse reaction might occur. LIMITATIONS 1. Primary resources included in this document were retrieved up to September 2009. It is probable that more current information is available. This document will need to be updated frequently (at least every 5 years). 1. Introduction 9 2. The primary references included in this document were not acquired through a rigorous systematic review process; it is possible, therefore, that other pertinent evidence was overlooked. Moreover, there was no concomitant systematic evaluation of the methodological quality of the cited studies. 3. The recommendations for each condition and EPA considered in this document are the opinions of the authors. Bias on the part of the authors and contributors was not rigorously controlled; however, given that one of the objectives was to provide readers with information on the degree of consensus of opinion, the authors considered it important not to control for bias. With respect to author bias in formulating the recommendations, it should be noted that consensus was reached by discussion and only after review of the literature. 4. International opinion was taken into account by reviewing guidelines published by Australian and UK physiotherapy societies/associations. The authors also recorded contraindications and precautions listed in textbook chapters written by international experts. However, the authors did not contact the individual authors of these documents directly to gather their opinions. 5. Not all recommendations are based on strong clinical evidence. However, the authors of this document maintain that this is necessary practice when, in the absence of strong clinical evidence (especially where there are ethical issues that preclude undertaking a clinical trial), pre-clinical evidence (e.g., animal studies) or common sense must be relied upon.4 DEFINITION OF TERMS Adverse reaction: an undesirable response that is potentially harmful to the patient or that could delay recovery from his or her condition. Active deep vein thrombosis (DVT): For the purpose of this document, a deep vein thrombosis is considered "active" during its early development (i.e., thrombus is recent and not completely organized), when there is greater risk of embolization. Following anticoagulation therapy, a DVT is considered to have dissolved and been reabsorbed. Contraindication: a specific situation in which a drug, procedure, or surgery should not be used because it may be harmful to the patient. Contraindication (local): a situation in which application of the EPA over a specific location or region of the body could be harmful and thus the EPA should not be used at this location/region. Cryotherapy: the use of a cold conductive agent that is applied, directly or through an insulating layer, to the skin. Ice packs, ice baths, cold gel packs, and ice massage are included in this category. Electrical stimulation therapy (E-stim): E-stim includes forms of electrical energy that are applied via surface electrodes to stimulate superficial nerves or tissues in order to promote healing, reduce pain, or activate muscles. This category includes TENS, IFC, HVPC, and NMES (see definitions below). Direct current, defined as unidirectional flow of current for at least 1 second, typically used only for the delivery of drugs across the skin (iontophoresis), is not addressed in this document. Electrophysical agent (EPA): physical energy (electrical, electromagnetic, thermal, light, or sound) used in a therapeutic manner to reduce impairments or promote recovery of function. EPAs are sometimes referred to as "modalities," "thermal agents," or "electrotherapy." Experts: the three authors plus five North American physical therapists who provided their opinions on contraindications for EPAs. Authors of chapters in EPA textbooks consulted by the authors are termed "international experts." High-voltage pulsed current (HVPC): also called "pulsed galvanic current" and properly named "twin-peaked monophasic pulsed current." For the purpose of this document, HVPC is considered as it is used to reduce edema, improve perfusion, promote tissue repair, and treat chronic wounds. Typically, it is applied locally over the target site (e.g., wound) at a sensory or submotor level of intensity. Interferential current (IFC): the use of medium-frequency (1,000-10,000 Hz) alternating current. Application can be via two independent channels using four electrodes (quadripolar) arranged around the target site in a crossfire pattern to produce an amplitude-modulated interference pattern of electrical energy in the tissues. Alternatively, IFC devices can deliver an amplitude-modulated alternating current via a single channel (bipolar, premodulated). Low-level laser therapy/non-coherent light (LILT): photoirradiation that includes Class II and III lasers and other non-coherent light sources used to stimulate or promote biological function (500 mW or less power). Other terms used for this therapy are photon therapy or phototherapy, low-intensity laser therapy {LILT), cold laser therapy, laser irradiation, and low-intensity laser irradiation ÍLILI). High-power medical lasers are excluded. Therapies using invisible radiation, specifically ultraviolet and radiant heat, are also excluded. Neuromuscular electrical stimulation (NMES): the use of pulsed currents to stimulate motor nerves, which in turn produce a fused tetanic muscle contraction with or without joint movement. Precaution: a situation in which a patient is at some risk of experiencing an adverse event. In this case treatment should proceed with caution. Proactive measures should be taken to reduce the risk of harm; such measures might include adjusting treatment parameters (lower intensity) or treatment schedule (treatment duration or frequency of application) and/or closer monitoring of patient response to the treatment. Resources: chapters written by international experts for EPA textbooks or monographs that were consulted in the development of this document (see Appendix 2). Risk: an unwanted response that may occur but that could not be predicted prior to commencing the treatment. Although safe practices help to reduce the likelihood of such events, there are some risks that can never be entirely eliminated (e.g., consequences of equipment malfunction). Short-wave therapy (SWT): the use of electromagnetic fields at a radio frequency of 27.12 MHz. Thermal SWT: For the purposes of this document, thermal SWT means that perceptible skin warming is produced and subcutaneous or deep tissue temperature is increased at least 1°C; this is considered likely at mean power output in the range of 35-40 W or higher. Thermal SWT can be produced using continuous-mode SWT or pulsed short wave (PSW), including PSW treatments often referred to as "pulsed radiofrequency energy" (PRFE). Non-thermal SWT: For the purposes of this document, nonthermal SWT means that perceptible skin warming is not produced, although subcutaneous/deep tissue temperature may be slightly increased; this is considered likely at mean power output in the range 10 Physiotherapy Canada, Volume 62, Number 5 of 32-34 W or lower. Non-thermal SWT can be produced using continuous-mode SWT or PSW (including PRFE). Temperature change in an electromagnetic field depends on mean power of the treatment rather than on the use of continuous or pulsed mode. The authors recognize that the estimated mean power outputs for producing thermal versus non-thermal effects used in this document may be considerably different in persons of very low body mass index (BMI) and in obese persons, depending also on size and spacing of electrodes. Pulsed electromagnetic fields (PEMFs) using low-energy magnetic fields alternating at frequencies in the range of 1-100 Hz are not addressed in this manual. Superficial heating agents: the use of a hot conductive agent applied to the skin to temporarily increase temperature of skin and subcutaneous structures. Hot packs, paraffin wax, and hydrotherapy tanks are included in this category. These heating agents typically increase the temperature of skin and of subcutaneous structures within 3 cm of the skin surface. Transcutaneous electrical nerve stimulation (TENS): the use of electrical currents to produce analgesia or hypoalgesia. A variety of pulsed waveforms are used, with frequencies typically in the range of 1-100 Hz. Intensities are set to produce sensory stimulation alone or combined with motor stimulation to produce muscle twitches (acupuncture-like TENS). Tuberculosis (TB): is considered "active" when there is no immune control over the disease process and the patient manifests signs and symptoms. In "latent" TB, the person is infected but there are no signs or symptoms, as the immune system is able to control the disease. In active TB, the infection may be isolated or walled off in a specific location (loculated or encapsulated) or may be widely distributed (disseminated). Risk of exacerbation of the disease process is greatest when there is active TB that is not being medically managed. The effect of EPAs on either latent or active forms of TB is not known, and the potential to spread or activate the TB lesions is considered serious. Therefore, throughout this document, the application of EPAs over tissues affected by TB (latent or active) is specified as contraindicated. Ultrasound: therapeutic ultrasound at high frequency (0.5-3 MHz) and low intensity (0.1-3.0 W/cmz) used to induce or promote tissue processes. Both continuous- and pulsed-mode ultrasound are considered in this document. Diagnostic ultrasound, low-frequency kHz ultrasound, and diathermy ultrasound used for tissue ablation are not included. REFERENCES 1. Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine: how to practice and teach EBM. 2nd ed. Toronto: Churchill Livingstone; 2000. 2. Robertson VJ, Chipchase LS, Laakso EL, Whelan KM, McKenna LJ. Guidelines for the clinical use of electrophysical agents. Camberwell, VIC: Australian Physiotherapy Association; 2001. 3. Guidance for the clinical use of electrophysical agents. London: Chartered Society of Physiotherapy; 2006. 4. Smith CS, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. Brit Med J. 2003;327:1459-61. ABBREVIATIONS APA Australian Physiotherapy Association guidelines A-TENS acupuncture-like TENS C contraindication (EPA should not be used) C-local EPA should not be used directly over the involved area Cold cryotherapy (ice, cold gel packs, etc.) Cont continuous CSP Chartered Society of Physiotherapy guidelines DVT deep vein thrombosis ECG electrocardiogram EPA electrophysical agent E-stim electrical stimulation considered generically, including TENS, NMES, HVPC, IFC and Russian current but excluding electrical stimulation for wound healing, direct current and iontophoresis FDA US Food and Drug Administration Heat superficial heating agents (wax, hot packs, etc.) HVPC high-voltage pulsed current NA Not addressed because the resource or experts did not give an opinion NMES neuromuscular electrical stimulation P precaution (EPA can be applied with caution) PRFE pulsed radio-frequency energy PSW pulsed short wave S safe (no individual considered this a contraindication or precaution) SWT short-wave therapy TB tuberculosis (including active and latent forms of the disease) TENS transcutaneous electrical nerve stimulation US Cont continuous-mode ultrasound (i.e., 100% duty cycle) likely to produce tissue heating US Pulsed pulsed-mode ultrasound (20-50% duty cycle) with minimal tissue heating ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS 2. Summary of Recommendations Table 1 Summary of Authors' Recommendations for Use of EPAs in the Presence of Certain Conditions or Over Specific Body Areas Ultrasound Electrical Stimulation LLLT Light Heat Cold SWT Therm SWT Non Cont Pulsed TENS NMES HVPC Conditions Active deep vein thrombosis or thrombophlebitis C-local C-local C C C C-local C C C C Active epiphysis P P P P P S P s P P Acute injury / inflammation C-local P s s s S C-local s C-local s Cardiac failure S S C-local C-local C-local S P p P s Chronic wound P S S S S S S c P s Cold hypersensitivity (e.g. Raynaud's, cryoglobulinemia, hemoglobulinemia) S S S S S S S c S s Cold urticaria S S S S S S S c S s Damaged or at-risk skin P P C-local C-local C-local S C-local p P s Haemorrhagic conditions c C C C C C C c C c Hypertension s S S S S S S p S s Impaired circulation C-local P P C-local P S C-local C-local C-local p Impaired sensation C-local P C-local P P S C-local P C-local s Impaired cognition or communication C P C P P P C C C p Infection C-local P C-local C-local C-local P C-local P C-local p Malignancy C-local C-local C-local C-local C-local C-local C-local S C-local C-local Photosensitivity or systemic lupus erythematosis S S S S S P S S S S Pregnancy C-local C-local C-local C C-local C-local P S C C Recently radiated tissue C-local C-local C-local C-local C-local P C-local S C-local C-local Skin disease (e.g., eczema) C-local P P P P S C-local S C-local P Tuberculosis C-local C-local C-local C-local C-local C-local C-local C-local C-local C-local continued on page 12 11 12 Physiotherapy Canada, Volume 62, Number 5 continued from page 11 Ultrasound Electrical Stimulation LLLT Heat Cold SWT SWT Cont Pulsed TENS NMES HVPC Light Therm Non Implants Electronic device C-local C-local C-local C-local C-local S S S C C Metal implant S S S S S S S s C S Plastic, cement implant C-local P S S S S s s c s Local Areas Eyes C C C C C c p p c p Anterior neck, carotid sinus C C C C C p p c c c Chest, heart S S P C P s s s c c Head S S C C C s s s s s Regenerating nerves P P C P P s s c c p Reproductive organs C C C C C c c s c s Note: This table is not meant to be used in isolation. Readers should consult sections 3-8. A comprehensive list of contraindications and precautions for each EPA is provided at the beginning of each of these sections, which also provide specific details about the authors' recommendations. C = contraindication; C-local = contraindication over the site; P = precaution; S = safe; Ultrasound Cont = continuous-mode ultrasound (has 100% duty cycle and may produce perceptible skin warming); Ultrasound Pulsed = pulsed-mode ultrasound (has duty cycle less than 50% and usually does not produce perceptible skin warming); HVPC = high-voltage pulsed current (electrical stimulation used to stimulate healing of chronic wounds, applied in the area of affected tissues at a subsensory or sensory level of stimulation); NMES = neuromuscular electrical nerve stimulation (electrical stimulation applied using stimulus parameters sufficient to produce a tetanic muscle contraction); TENS = transcutaneous electrical nerve stimulation (electrical stimulation applied at sensory levels [produces pins-and-needles sensation]) to produce analgesia or hypoalgesia (includes interferential current [IFC]); LLLT/Light = low-level laser therapy (includes all Class II and III lasers and non-coherent light sources); Heat = hot packs, wax, and other superficial conductive heating agents that heat tissues within 3 cm of the skin surface; Cold = all forms of cryotherapy (cold packs, ice bags, ice bath, ice massage, etc.); SWT = short-wave therapy; Therm = Thermal SWT (produces perceptible skin warming and tissue temperature increases at least 1°C); Non = Non-thermal SWT (does not produce perceptible warmth but may increase tissue temperature slightly) ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS 3. Continuous and Pulsed Ultrasound SUMMARY OF RECOMMENDATIONS 3 Do NOT use the EPA to treat in the presence of this condition or in this body location. Neither continuous nor pulsed ultrasound should be applied • to the low back or abdomen of pregnant women • to regions of known or suspected malignancy • over electronic devices • to actively bleeding tissue or persons with untreated haemorrhagic disorders • to regions with active deep vein thrombosis or thrombophlebitis • over recently radiated tissues • to areas with myositis ossificans • to eyes • to anterior neck or carotid sinus • to reproductive organs (testes) • over tissues infected with tuberculosis In addition, continuous ultrasound that produces tissue heating should not be applied • to persons with cognition or communication impairments sufficient to prevent them from giving accurate and timely feedback • to infected tissues that are under tension (abscess) • to tissues inflamed as result of recent injury or exacerbation of chronic inflammatory condition • to areas with impaired circulation • to areas of impaired sensation that prevent persons from giving accurate and timely feedback • over areas affected by heat-sensitive skin diseases (e.g., eczema) • to intact skin overlying implants containing cement or plastic components /P\ Pulsed or continuous ultrasound may be applied with caution to • spinal cord or superficial peripheral nerves • regenerating nerves • active epiphysis • "at risk" or fragile skin Pulsed ultrasound may be applied with caution • to intact skin overlying implants containing cement or plastic components • to areas of impaired sensation that prevent patients from giving accurate and timely feedback • to patients with cognition or communication impairments sufficient to prevent them from giving accurate and timely feedback • to areas with impaired circulation, provided pain is not exacerbated • over areas affected by heat-sensitive skin diseases (e.g., eczema) • to infected tissues with open drainage • to areas with regenerating nerves • to tissues inflamed as result of recent injury or exacerbation of chronic inflammatory condition Experienced clinicians may elect to treat this condition/location with caution (e.g., lower intensity, more frequent monitoring) © This condition/scenario or body location is NOT contraindicated. Pulsed or continuous ultrasound can be used on • intact skin overlying metal implants • the head • the chest wall, provided the ribcage is intact • persons with cardiac failure or hypertension Pulsed ultrasound can be used on • areas near or over chronic wounds Continuous ultrasound has 100% duty cycle and may produce perceptible skin warming; pulsed ultrasound has duty cycle less than or equal to 50% and usually does not produce perceptible skin warming. 13 14 Physiotherapy Canada, Volume 62, Number 5 Table 2a Consensus and Recommendations on Continuous Ultrasound* Resources %(n = 12) Can/US % APA CSP Adverse Reaction** Research Evidence** Recommendation For Details See Conditions Pregnancy 100 100 (n = 8) c C- local Serious Moderate © 3-1 Malignancy 83 100 (n = 8) c C-local Serious Strong © 3-2 Active epiphysis 50 N/A N/A C- local Moderate Moderate © 3-3 Myositis ossificans S N/A N/A N/A Moderate Absent © 3-3 Deep vein thrombosis Thrombophlebitis 75 100 (n = 8) N/A P Serious Low © 3-7 Infection Tuberculosis 75 100 (n = 8) C C Moderate Moderate © 3-8 Acute injury Inflammation 25 100 (n = 8) C N/A Minor Low © 3-9 Haemorrhagic conditions 58 75 (n = 8) C C Serious Moderate © 3-10 Recently radiated tissue 42 88 (n = 8) C P Serious Low © 3-11 Impaired sensation 58 63 (n = 8) S P Moderate Absent © 3-12 Impaired cognition or communication S 63 (n = 8) C C Moderate Absent © 3-13 Impaired circulation 50 88 (n = 8) C P Moderate Moderate © 3-14 Skin disease Damaged or at-risk skin 8 86 (n = 7) C P Minor Absent © 3-15 Implants Plastic/cement implant 42 50 (n = 8) N/A N/A Moderate Moderate A 3-4 Metal implant S p (n = 8) N/A C Minor Strong © 3-5 Electronic implant Cardiac pacemaker 83 88 (n = 8) C-Iocal C-local Serious Low © 3-6 continued on page 15 3. Continuous and Pulsed Ultrasound 15 continued from page 14 Resources %(n = 12) Can/US % APA CSP Adverse Reaction** Research Evidence** Recommendation For Details See Local Areas Reproductive organs 92 75 (n = 8) C C-local Serious Absent © 3-16 Eyes 100 100 (n = 8) C C-local Serious Absent © 3-17 Neck S N/A N/A N/A Serious Strong © 3-18 Spinal cord Superficial/regenerating nerves 75 N/A N/A N/A Minor Low A 3-19 3-20 Chest, heart Head 58 N/A N/A N/A Moderate Low © 3-21 APA = Australian Physiotherapy Association guideline; Can/US = results of survey of North American experts; CSP = Chartered Society of Physiotherapy guideline (UK); C = contraindication; C-local = contraindication over the site; N/A = not addressed; P = precaution; S = safe * This table shows the percent (raw) agreement of commonly cited contraindications for continuous ultrasound (duty cycle = 100%) by North American experts (Can/US; n < 8) and authors of textbooks (Resources; n = 12). An interpretation of the Australian (APA) and UK Chartered Society of Physiotherapy (CSP) guidelines is shown. A recommendation is given for each condition based on an interpretation of the risk of adverse reactions and the strength of the supporting evidence. ** Readers should consult the Introduction for criteria used to rank adverse reactions, research evidence, and recommendations. Table 2b Consensus and Recommendations on Pulsed Ultrasound* Resources %(n = 12) Can/US % APA CSP Adverse Reaction** Research Evidence** Recommendation For Details See Conditions Pregnancy 100 100 C = 8) C-local C-local Serious Moderate © 3-1 Malignancy 83 88 (n = 8) P C-local Serious Strong © 3-2 Active epiphysis 50 N/A N/A C-local Moderate Moderate A 3-3 Myositis ossificans S N/A N/A N/A Moderate Absent © 3-3 Deep vein thrombosis Thrombophlebitis 67 100 (n = 8) N/A P Serious Low © 3-7 Infection 75 75 (n = 8) P C Moderate Moderate A 3-8 Acute injury Inflammation 11 P (n = 8) P N/A Minor Low A 3-9 Haemorrhagic conditions 58 63 (n = 8) P C Serious Moderate © 3-10 Recently radiated tissue 42 75 (n = 8) P P Serious Low © 3-11 continued on page 16 16 Physiotherapy Canada, Volume 62, Number 5 continued from page 15 Resources %(n = 12) Can/US % APA CSP Adverse Reaction** Research Evidence** Recommendation For Details See Impaired cognition or communication S P (n = 8) P C Minor Absent A 3-13 Impaired sensation 42 P (n = 8) P P Minor Absent A 3-12 Impaired circulation 50 P (n = 8) P P Minor Moderate A 3-14 Skin disease Damaged or at-risk skin 8 57 (n = 7) P P Minor Absent A 3-15 Implants Plastic/cement implant 33 38 (n = 8) N/A N/A Moderate Moderate A 3-4 Metal implant S S (n = 8) N/A S Minor Strong © 3-5 Electronic implant 83 88 (n = 8) C-Iocal C-local Serious Low © 3-6 Local Areas Reproductive organs 92 75 (n = 8) C C-local Serious Absent © 3-16 Eyes 100 100 (n = 8) C C-local Serious Absent © 3-17 Spinal cord Superficial/regenerating nerves 75 N/A N/A N/A Minor Low A 3-19 3-20 Chest, heart Head 58 N/A N/A N/A Moderate Low © 3-21 Anterior neck Carotid sinus S N/A N/A C Serious Absent • 3-18 APA = Australian Physiotherapy Association guideline; Can/US = results of survey of North American experts; CSP = Chartered Society of Physiotherapists (UK) guideline; C = contraindication; C-local = contraindication over the site; N/A = not addressed; P = precaution; S = safe. * This table shows the percent (raw) agreement of commonly cited contraindications for pulsed ultrasound (duty cycle < 50%) by North American experts (Can/US; n < 8) and authors of textbooks (Resources; n = 12). An interpretation of the Australian (APA) and Chartered Society of Physiotherapy (CSP) guideline is shown. A recommendation is given for each condition based on an interpretation of the risk of adverse reactions and the strength of the supporting evidence. ** Readers should consult the Introduction for criteria used to rank adverse reactions, research evidence, and recommendations. 3. Continuous and Pulsed Ultrasound 17 ULTRASOUND: RECOMMENDATIONS, RATIONALE, AND REFERENCES 3-1 Pregnancy Recommendation d Continuous and pulsed ultrasound should not be used over the low back, abdomen, or uterus. High-intensity, lower-frequency waves administered in continuous mode are potentially the most dangerous because they produce the greatest penetration and tissue heating. Rationale Sound waves transmit through amniotic fluid and could cause fetal malformations, including growth retardation, micropthalmia, exencephaly, microencephaly, neural tube defects, and myelodyplasia. Teratogenic effects of ultrasound are greater if tissue heating occurs or if maternal core temperature is elevated. Research Evidence MODERATE Diagnostic ultrasound is thought to be safe for human fetal development at levels below 0.1 W/cm2 spatial average temporal peak (SATP) and at increases in temperature of embryonic and fetal tissue of no more than 1.5°C above normal physiological levels (37°C).1-5 However, therapeutic ultrasound has produced malformations in fetal tissue models.6-8 3-2 Malignancy Recommendation © Pulsed and continuous ultrasound should not be used over suspected or confirmed malignancy. Abnormal growth should be regarded as malignant until diagnosis has been confirmed. Use caution when a patient with a history of cancer within the last 5 years has pain of undiagnosed origin. Rationale Sound waves applied to tumour cells can stimulate growth and induce new blood-vessel growth, which helps provide fuel for further tumour growth and potentially promotes metastases. Research Evidence MODERATE Ultrasound increased tumour growth and the incidence of metastases in animal models; effects were thought to be due to ultrasound-enhanced angiogenesis.9-16 The literature is not consistent in these findings. Therapeutic ultrasound equipment should not be used to induce hyperthermia for the purpose of tumour ablation.17-18 3-3 Active Epiphysis, Myositis Ossificans Recommendation /\ Active / P\ Epiphysis /T\ Myositis v_/ Ossificans Continuous and pulsed ultrasound can be used over bone-growth plates in adolescents using low intensities. There should be no discomfort during or after treatment. Continuous and pulsed ultrasound should not be applied in the vicinity of myositis ossificans. Rationale Ultrasound over unfused epiphyseal growth plates may alter bone growth. About 75% of ultrasound energy is reflected at tissue/bone interfaces, and the transmitted portion is largely absorbed by periosteum. Intensities that could produce unwanted bone growth are likely to cause pain as a result of the periosteal absorption. Therefore, ultrasound over bone using parameters and techniques that avoid painful stimulation is unlikely to produce adverse effects. Ultrasound over ectopic bone (myositis ossificans, hypertropic ossification) could stimulate further bone growth and exacerbate impairments. Research Evidence MODERATE Early studies in animal models that demonstrated abnormal bone growth following ultrasound used extraordinarily high ultrasound intensity and a stationary sound head.19-26 The pre-clinical research is therefore not relevant to normal clinical practice. Ultrasound stimulates osteoblast function and has been shown to promote repair of bone fractures. However, the effective parameters (1.5 MHz, 0.15 W/cm2, SATP, and a mark:space ratio of 1:4) are different from those typically used with therapeutic ultrasound.27 18 Physiotherapy Canada, Volume 62, Number 5 3-4 Plastic and Cement Implants Recommendation © USCont /p\ US Pulsed Continuous ultrasound should be avoided directly over joint replacements or prostheses constructed of cement or plastic. Low-intensity pulsed ultrasound may be used with caution over areas containing plastic/cement implants. Rationale Most plastic materials have a high coefficient of ultrasound absorption. Methyl methacrylate cement and plastic are rapidly heated by ultrasound. Water-saturated acrylic bone cement used to fixate endoprostheses becomes rubbery and soft if heated to 60-70°C. However, this degree of heating would never occur using typical therapeutic ultrasound. Research Evidence MODERATE Therapeutic ultrasound applied to animal models has been shown to alter the mechanical properties of plastic and cement components of surgical implants.28-31 3-5 Metal Implants Recommendation ® Continuous and pulsed ultrasound are not contraindicated over metal implants. Application requires precautions to avoid standing waves and unstable cavitation. Rationale Metal reflects about 90% of incident ultrasound—slightly more than is reflected by bone. Research Evidence STRONG Metal is not heated by ultrasound, and sound waves do not loosen screws or plates.31-36 3-6 Electronic Devices Recommendation © Continuous and pulsed ultrasound should not be applied directly over the site of implanted pacemakers or other electronic devices (defibrillators, neuromuscular devices). This means that ultrasound should be used only when the exact location of device components is known. This contraindication applies regardless of whether or not the device is in use. Monitor patients closely when applying ultrasound at sites remote from the components of implanted systems. Rationale Sound waves reflected at a device-tissue interface could possibly cause tissue heating; the risk of an adverse effect would depend on the location of the implanted components and the intensity and duration of the exposure. The CSP guidelines recommend that only thermal ultrasound (continuous mode) be avoided over electronic implants. Research Evidence LOW The effect of therapeutic ultrasound waves on function of pacemakers and electronic stimulators is not known. No adverse effects have been reported in the literature. Various organizations have issued alerts about the definite risk of serious injury or death if patients with implanted electrical leads are exposed to ultrasound diathermy;37-39 however, ultrasound diathermy is not a device used by physiotherapists. 3-7 Active Deep Vein Thrombosis, Thrombophlebitis Recommendation © Continuous and pulsed ultrasound should not be applied over the area of an active deep vein thrombus (DVT). The area overlying a previous DVT that has been treated with anticoagulant therapy can be treated with caution. Rationale Ultrasound could dislodge or cause partial disintegration of a thrombus, potentially blocking circulation to vital organs. Mechanisms by which this may occur include disintegration of existing blood clots induced by mechanical effects of ultrasound and possible increased local blood flow. There is no risk of ultrasound-induced emboli when anticoagulative therapy has resolved the clot(s). Research Evidence LOW Ultrasound caused red blood cell stasis in a chick embryo model and has also been shown to cause partial disintegration of a thrombus.4041 Studies that examined the effects of continuous and pulsed ultrasound on local blood flow produced inconsistent and inconclusive findings.42-44 3. Continuous and Pulsed Ultrasound 19 3-8 Infection, Tuberculosis (TB) Recommendation © USCont /p\ US Pulsed • IB Ultrasound heat should not be applied to infected tissue that is under tension (e.g., abscess). However, infection with open drainage can be treated using very low intensity pulsed ultrasound. Ultrasound should be discontinued if an increase in any signs of inflammation (redness, heat, pain, and swelling) occurs. Tuberculous lesions should not be treated with either pulsed or continuous ultrasound. Rationale Heating may lead to increased swelling in closed spaces and, therefore, to increased pain. In diffuse infection that has no open drainage, heat may cause further spread of infection via increased circulation. This would be particularly undesirable in cases of TB. Research Evidence LOW It is uncertain whether pulsed or continuous ultrasound can increase regional blood flow and thereby spread infection.42-44 The effect of ultrasound on bacterial growth is unknown. Pro-inflammatory effects of ultrasound may assist in the defence against infection.45-49 3-9 Acute Injury, Inflammation Recommendation © USCont /p\ US Pulsed Continuous-mode ultrasound that might increase tissue temperature should not be applied to already inflamed tissue. Pulsed ultrasound can be applied to inflamed tissues provided that cardinal signs of inflammation (redness, swelling, heat, pain) are not exacerbated. Rationale Metabolic and vascular changes are induced by local heat that may exacerbate inflammation and increase swelling. Research Evidence LOW Pulsed ultrasound is purported to activate cellular processes of inflammation, without heating and without increasing swelling, to promote faster resolution of the inflammatory phase of healing and, overall, to speed repair of injury.45-4750-53 Pulsed ultrasound has been used in several clinical studies to treat acute injuries; no adverse reactions have been reported.50-53 3-10 Haemorrhagic Conditions Recommendation © Neither continuous nor pulsed ultrasound should be applied to actively bleeding tissues. Ultrasound can be used to help resolve bruising following haemostasis. Ultrasound can be used on persons with bleeding disorders (haemophilia) after replacement factor has been administered and coagulopathy has resolved. Rationale Mechanical vibration produced by ultrasound can disrupt platelet plug formation and cause uncontrolled blood loss or bleeding into surrounding tissues. Heating-induced increase in local blood flow (continuous ultrasound) may also interfere with haemostasis. Some resources suggest that ultrasound applied over the pelvic region of menstruating women may increase blood loss. Research Evidence MODERATE Ultrasound is known to alter platelet degranulatjon and aggregation.42 The literature is inconclusive with respect to the effects of ultrasound on local blood flow.42-44 Ultrasound appears to have resolved haematoma formation.54 20 Physiotherapy Canada, Volume 62, Number 5 3-11 Recently Radiated Tissue Recommendation © Continuous and pulsed ultrasound should not be applied to tissues that have received radiation therapy within the previous 6 months. Rationale There is a potential risk of stimulating growth of any remaining malignant cells. Recently radiated tissues may respond atypically to ultrasound because of the presence of radiation-induced inflammation or scar tissue or cellular and circulatory effects. Research Evidence LOW The ability of ultrasound to stimulate the growth of cancer cells is well established.9-18 There is little information on how previous radiation therapy might affect tissue response to ultrasound.55 3-12 Impaired Sensation Recommendation © usCont /p\ US Pulsed Avoid using continuous thermal ultrasound or high-temporal-peak-intensity pulsed ultrasound (>2.0 W/cm2, SATP, 1:4) on body areas with impaired pain or heat sensation or with patients who cannot provide appropriate and timely feedback due to an altered level of consciousness or impaired cognition. Perform a sensory discrimination test (refer to the section on US safe practice). Rationale When adjustment of ultrasound parameters requires feedback from the client, it must be confirmed that the client can perceive heat and pain and is able to communicate appropriately. Communication between therapist and client is most often required when adjusting continuous-mode ultrasound intensity and rate of applicator movement to produce a moderate, comfortable level of tissue heating, or when insonating over superficial bone. Tissue heating depends on a number of factors specific to the individual client (e.g., tissue perfusion, body type, proximity of bone). Therefore, use of standard ultrasound heating protocols without patient feedback is associated with a significant risk of burns or unstable cavitation, both of which can result in significant tissue damage. Research Evidence ABSENT No reference found. 3-13 Impaired Cognition or Communication For recommendation see Impaired Sensation (above) 3-14 Impaired Circulation Recommendation © usCont /p\ US Pulsed Avoid tissue heating through use of continuous ultrasound or high-temporal-peak-intensity pulsed ultrasound. Ultrasound should be discontinued if pain increases during or following treatment. Continuous and pulsed ultrasound should not be used when arterial circulation is severely compromised. Rationale Adequate circulation is required to dissipate heat produced by both continuous and pulsed ultrasound. Incapacity of the arterial system to dissipate heat produced by ultrasound may lead to further ischemia, pain, and possibly blister formation. There is evidence that pulsed ultrasound is safe when circulation is somewhat compromised. Research Evidence LOW Low-intensity pulsed ultrasound has been used without adverse effect on venous ulcers.56-58 3. Continuous and Pulsed Ultrasound 21 3-15 Skin Disease, Damaged or "At Risk" Skin, Chronic Wounds Recommendation © USCont /p\ US Pulsed Continuous- and pulsed-mode ultrasound should not be applied using a gel-coupling in-contact method to areas of skin loss or skin at risk of breakdown. Continuous ultrasound producing heat should not be applied over dermatological conditions (eczema, psoriasis, or other heat sensitive skin disorders). Pulsed ultrasound can be used to treat open wounds. Rationale Transducer contact may further irritate or traumatize at-risk skin. Ultrasound delivered using a water bath is a safe alternative method of application to avoid physical trauma to skin. Research Evidence ABSENT Ultrasound has been applied using a water-immersion method to chronic venous leg ulcers without adverse reactions.57-59 3-16 Reproductive Organs Recommendation © Continuous and pulsed ultrasound should not be applied directly over the reproductive organs. Rationale Ultrasound may contribute to infertility by affecting gamete production, especially heat-sensitive spermatogenesis in the testes. Research Evidence ABSENT No reference found. 3-17 Eyes Recommendation © Continuous and pulsed ultrasound should not be applied directly to eyes. Rationale Unstable cavitation could occur in ocular fluid as a result of standing wave formation, leading to retinal damage. Research Evidence ABSENT No reference found. 3-18 Anterior Neck, Carotid Sinus Recommendation © Continuous- and pulsed-mode ultrasound should not be applied to anterior neck region over carotid sinus. Rationale The effects of ultrasound on these excitable tissues are unknown. Research Evidence ABSENT No reference found. 22 Physiotherapy Canada, Volume 62, Number 5 3-19 Spinal Cord Recommendation A Continuous- and pulsed-mode ultrasound should be used with caution following recent laminectomy above L2 level and in individuals with spina bifida, and should be avoided directly over the area where the spinal cord might be exposed to ultrasound waves. Rationale Unstable cavitation may occur in cerebrospinal fluid. Normally, however, the central nervous system elements (brain and spinal cord) are protected by bone and are therefore unlikely to be affected by ultrasound waves. Research Evidence LOW Ultrasound may alter nerve conduction (see below).60-65 3-20 Peripheral and Regenerating Nerves Recommendation /P\ Monitor patients for discomfort when applying ultrasound directly over large superficial peripheral or regenerating nerves. Ultrasound can produce the sensation of "pins and needles" at or distal to the treatment site (sometimes reported by patients when ultrasound is applied over the carpal tunnel area). Rationale There appears to be no clear rationale for avoiding ultrasound over large peripheral nerves. Some discomfort may be experienced by patients when superficial nerves are heated. This sensation is likely to be associated with continuous-mode ultrasound and to be due to heating of the nerve. Research Evidence LOW There is some evidence that continuous and pulsed ultrasound can alter nerve-conduction velocity in large superficial nerves; however, there are also contradictory findings.60-65 In pre-clinical studies, pulsed ultrasound accelerated recovery after nerve injury, which suggests a potential clinical role for ultrasound after nerve injury. Adverse clinical outcomes have not been reported.66-68 3-21 Chest, Heart Recommendation Pulsed or continuous ultrasound applied to the chest wall is safe provided that the transducer head is not stationary and the rib cage is intact. Ultrasound used below the ribcage should not be directed toward the heart and/or lungs. Rationale Ultrasound could potentially alter cardiac conduction and cause arrhythmias. Research Evidence LOW Ultrasound at 0.1 W/cm2 spatial peak temporal average (SPTA) applied to the exposed thoracic cavity in small animals caused bleeding of the lungs and gut.142 The clinical relevance of this research in small animals is questionable. SAFE PRACTICE Perform a Sensory Discrimination Test Test sensory integrity by asking patients to differentiate between hot and cold stimuli or between light touch and painful stimulus. Temperature discrimination and pain (a sharp pricking quality) are conveyed by spinothalamic tracts, whereas light touch is conveyed mainly by dorsal columns; thus, it is not sufficient to test light touch only. This sensory test should always be performed when using continuous-mode ultrasound (refer to Impaired Sensation and Impaired Communication). Inspect Skin Area Avoid ultrasound on skin areas affected by psoriasis, eczema, and similar skin disorders. Ultrasound to open skin requires judicious use of universal precautions to ensure that infectious agents are not transferred between patients by the therapist or through contaminated ultrasound couplants. Avoid Transfer of Infectious Agents Ultrasound gel dispensers can become contaminated when exposed to an infected individual, and the bacterial agent can spread to subsequent patients 3. Continuous and Pulsed Ultrasound 23 through exposure to the contaminated gel or equipment. Single-use gel containers can be used when treating open skin areas or infected individuals. Non-sterile gel applications to intact skin should include procedures that prevent contamination of stock solutions of gel (bottles) that are used for multiple patients. Preheating bottled ultrasound gel may increase patient comfort, but it provides no therapeutic benefit and may promote microbial growth.39'6970 Ultrasound transducers are a source of contamination and should therefore be cleaned before and after each use with an alcohol wipe or alternative sanitizer.69 Avoid Pre-treatment of the Area with Superficial Heating or Cooling Agents Altering tissue temperature prior to ultrasound application modifies the amount of tissue heating produced by the ultrasound. The cumulative effect of a hot pack followed by thermal ultrasound can lead to skin damage.71-73 Avoid Unsupervised Self-Treatment by Clients or Treatment by Unqualified Persons Inappropriate use of ultrasound may lead to severe pain, tissue damage, or bleeding in the treated area. Inappropriate technique may severely compromise delivery of ultrasound to the target tissues and therefore limit clinical effectiveness.74 Use Appropriate Ultrasound Couplants Some couplants do not transmit, or reduce transmission of, ultrasound. For example, gel- or water-filled latex gloves interfere with transmission, as do certain creams, oils, and lotions.7577 In addition, inappropriate products may damage the ultrasound transducer. For example, gels used for electrode stimulation (electrode gels) may damage the transducer because of their high salt concentration. Limit Thermal Ultrasound Treatment to Surface Areas < 10 cm2 Treating areas more than two times the effective radiating area (ERA) of the ultrasound transducer (about 10 cm2) significantly reduces the thermal effectiveness of ultrasound because of continuing heat loss to adjacent cooler tissue.7880 Pulsed ultrasound can be applied to areas two to three times the ERA, but treatment time should be increased. Apply Ultrasound Using Effective Treatment Duration (>10 minutes) Clinical trials of pulsed ultrasound have usually not shown benefit when treatment duration was less than 10 minutes. Pulsed ultrasound is delivered intermittently; using an on:off cycle of 1:4 or 1:1 (mark: space ratio) results in an 80% or 50% reduction, respectively, in total energy delivered relative to the same intensity delivered for the same duration in continuous mode. Therefore, it is recommended that pulsed ultrasound treatments be applied for a minimum of 10 minutes.70'8182 Adjust Parameters When Applying Ultrasound in Water Water temperature should be as close as possible to normal skin temperature. Ultrasound intensity should be increased when ultrasound is applied in water to achieve tissue temperatures similar to those produced when ultrasound is applied using a gel couplant.76 In addition, ultrasound intensity should be increased whenever treatment is applied under water with the transducer at a distance > 1 cm from the treated surface.83 There is some controversy about the type of basin that should be used for ultrasound in water. Historically, a metal basin was considered to be contraindicated; however, a recent study showed that use of a metal basin produces more efficient heating, since metal reflects about 99% of incident ultrasound energy back into the water, where it can be absorbed by the tissues. By contrast, plastic absorbs ultrasound, decreasing the energy available for tissue absorption. Use of a metal basin requires careful monitoring of patient response in order to achieve a sensation of mild skin warmth while avoiding periosteal pain, which would indicate too much heating.31 Ensure Regular Maintenance and Calibration of Machines (every 6 months recommended) Ultrasound units should be checked regularly for malfunction. In addition, systems require calibration to ensure that the delivered intensity coincides with the displayed intensity. Previous studies have found that between 10% and 90% of clinical ultrasound units assessed were not functioning at acceptable levels.84-86 REFERENCES 1. Barnett SB, ter Haar GR, Ziskin MC, Rott HD, Duck FA, Maeda K. International recommendations and guidelines for the safe use of diagnostic ultrasound in medicine. Ultrasound Med Biol. 2000;26:355-66. doi:10.1016/S0301-5629(00)00204-0 2. National Institutes of Health. Consensus statement: diagnostic ultrasound imaging in pregnancy. Washington, DC: The Institutes; 1984. 3. 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Aust J Physiother. 2004;50:147-51. 82. Ebenbichler GR, Resch KL, Nikolakis P, Wiesinger GF, Uhl F, Ghanem AH, et al. Ultrasound treatment for treating the carpal tunnel syndrome: randomised sham controlled trial. Brit Med J. 1998;316:731-5. 83. Robertson V, Ward A. Limited interchangeability of methods of applying 1 MHz ultrasound. Arch Phys Med Rehabil. 1996;77:379-84. 84. Artho PA, Thyne JG, Warring BP, Willis CD, Brismee JM, Latman NS. A calibration study of therapeutic ultrasound units. Phys Ther. 2002;82:257-63. 85. Guirro R, Serrao F, Elias D, Bucalon A. Calibration of therapeutic ultrasound equipment. Physiotherapy. 1997;83:419-22. doi:10.1016/S0031-9406(05)65725-2 86. Hekkenberg RT. Characterizing ultrasonic physiotherapy systems by performance and safety now internationally agreed. Ultrasonics. 1998;36:713-20. ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS 4. Electrical Stimulation SUMMARY OF RECOMMENDATIONS (J Do NOT use the EPA to treat in the presence of this condition or in this body location. Electrical stimulation (all forms) should not be applied • to areas where it could cause malfunction of electronic devices, including cardiac pacemakers • to the low back or abdomen of pregnant women • to acupuncture points of pregnant women • to regions of known or suspected malignancy • to persons with active deep vein thrombosis or thrombophlebitis • to actively bleeding tissue or to persons with untreated hemorrhagic disorders • to infected tissues, tuberculosis, or wounds with underlying osteomyelitis • to recently radiated tissues • to the chest in persons with cardiac disease, arrhythmias, or heart failure • to the neck or head region of persons known to have seizures • transcranial^ without specialized training • to areas near reproductive organs or genitalia without specialized training • to areas near or over eyes • to anterior neck or carotid sinus • to damaged or at-risk skin areas that would result in uneven conduction of current (excluding open wounds where the specific intent is to use electrical stimulation for tissue healing) TENS should not be applied to • areas that have impaired sensory awareness • persons with cognition or communication impairments sufficient to prevent them from giving accurate and timely feedback NMES should not be applied to • pregnant women (anywhere) • areas with impaired circulation • any area unstable due to recent surgery, bone fracture, or osteoporosis • the chest or the intercostal muscles • the lower abdomen /P\ Electrical stimulation (all forms) can be applied with caution to • active epiphysis • persons with skin diseases (e.g., eczema, psoriasis) HVPC can be applied with caution to • persons with cognition or communication impairments sufficient to prevent them from giving accurate and timely feedback • areas of impaired sensation that prevent people from giving accurate and timely feedback • areas with impaired circulation, provided that pain is not exacerbated • superficial regenerating nerves • the chest wall or lower abdomen NMES can be applied with caution to • persons with cognition or communication impairments sufficient to prevent them from giving accurate and timely feedback • areas of impaired sensation that prevent accurate and timely feedback TENS can be applied with caution to • areas with impaired circulation, provided that pain is not exacerbated • the anterior chest wall or lower abdomen Experienced clinicians may elect to treat this condition/location with caution (e.g., at lower intensities and/or with more frequent monitoring). continued on page 27 26 4. Electrical Stimulation 27 continued from page 26 Electrical stimulation (all forms) can be used on ( s ) • intact skin overlying implants containing metal, plastic, or cement • tissues inflamed as a result of recent injury or exacerbation of a chronic inflammatory v— condition This condition/scenario or body TENS and HVPC can be used on location is NOT contraindicated. • any area unstable due to recent surgery, bone fracture, or osteoporosis • areas around or within chronic wounds of known etiology or open wounds with localized infection EPA = electrophysical agent; HVPC = electrical stimulation used to stimulate healing of chronic wounds (applied in the area of affected tissues at a sub-sensory or sensory level of stimulation); NMES = electrical stimulation applied using stimulus parameters sufficient to produce a tetanic muscle contraction; TENS = electrical stimulation applied at sensory levels (produces pins-and-needles sensation) to produce analgesia/hypoalgesia (includes interferential current (IFC)). Table 3 Consensus and Recommendations on Electrical Stimulation (TENS, NMES, HVPC)* Resources % (n= 11) Can/US % APA CSP Adverse Reaction** Research Evidence** Recommendation For Details See Conditions Pregnancy 82 86 (n = 7) C-local C-local Serious Moderate © 4-2 Malignancy 45 100 (n = 7) P C-local Serious Low © 4-3 Deep vein thrombosis 27 100 (n = 7) N/A P Serious Moderate © 4-4 Haemorrhagic conditions 18 100 (n = 7) P C Serious Moderate © 4-5 Infection Tuberculosis Osteomyelitis 9 86 (n = 7) P N/A Moderate Low 4-6 Recently radiated tissue 9 86 (n = 7) P P Serious Moderate © 4-7 Skin disease Damaged or at-risk skin 27 71 (n = 6) P P Minor Strong © 4-8 Impaired circulation 9 43 (n = 7) P P Minor Low © NMES A TENS/HVPC 4-9 Impaired sensation 18 57 (n = 7) P P Minor Moderate © TENS A NMES/HVPC 4-10 continued on page 28 28 Physiotherapy Canada, Volume 62, Number 5 continued from page 27 Resources %(n= 11) Can/US % APA CSP Adverse Reaction** Research Evidence** Recommendation For Details See Impaired cognition or communication 9 57 (« = 7) P C Minor Moderate © TENS A NMES/HVPC 4-11 Recent fracture or suture Osteoporosis 18 N/A N/A N/A Moderate Moderate © NMES CD HVPC/TENS 4-13 Seizure/epilepsy 9 N/A N/A C Moderate Moderate © 4-14 Implants Electronic implant 100 86 (« = 7) C-local C Serious Moderate © 4-1 Metal implant S 29 (« = 7) N/A S Minor Low © 4-12 Local Areas Anterior neck Carotid sinus region 91 N/A N/A C Serious Low © 4-15 Chest Intercostal muscles Heart 18 N/A C P Minor Moderate © NMES A TENS/HVPC 4-16 Head, transcranially S N/A S C Serious Moderate © 4-17 Reproductive organs S 29 (« = 7) S C Moderate Absent © 4-18 Eyes S 86 (« = 7) S C Serious Absent © 4-19 Lower abdomen S N/A N/A N/A Moderate Moderate © NMES A TENS/HVPC 4-20 APA = Australian Physiotherapy Association guidelines; Can/US = results of survey of North American experts; CSP = Chartered Society of Physiotherapy guidelines; C = contraindication; C-local = contraindication over the site; N/A = not addressed; P = precaution; S = safe; HVPC = electrical stimulation used to stimulate healing of chronic wounds (applied to the area of affected tissues at a sub-sensory or sensory level of stimulation); NMES = electrical stimulation applied using stimulus parameters sufficient to produce a tetanic muscle contraction; TENS = electrical stimulation applied at sensory levels (produces pins-and-needles sensation) to produce analgesia/hypoalgesia (includes interferential current (IFC)). * This table shows the percent (raw) agreement of commonly cited contraindications for electrical stimulation (TENS, NMES, HVPC, IFC) by North American experts (Can/US; n < 8) and authors of textbooks (Resources; n = 11). An interpretation of the Australian (APA) and Chartered Society of Physiotherapy (CSP) guideline is shown. A recommendation is given for each condition based on an interpretation of the risk of adverse reactions and the strength of the supporting evidence. ** Readers should consult the Introduction for criteria used to rank adverse reactions, research evidence, and recommendations. 4. Electrical Stimulation 29 ELECTRICAL STIMULATION (E-STIM): RECOMMENDATIONS, RATIONALE, AND REFERENCES 4-1 Electronic Devices Recommendation © E-stim should not be applied in a location where it may cause malfunction of implanted electronic devices (e.g., pacemakers, cardioverter defibrillator, neurostimulators implanted in spinal cord or brain, bone-growth stimulators). Malfunction of these devices could be life threatening or require surgical replacement of the device. An ECG should be obtained during E-stim to determine whether there is interference with the cardiac pacemaker function and whether E-stim affects the patient's heart rate or other vital signs. Whenever an ECG is recorded during E-stim treatment, the relevant physicians should be advised so that stimulus artefacts produced by TENS do not result in misinterpretation of the ECG findings, leading to the patient undergoing unnecessary assessments or treatments. Rationale E-stim applied over the chest wall or near leads connected to electronic devices could cause fibrillation; changes in heart rate, cardiac output, and blood pressure; and perfusion of vital organs, including the brain. Demand-type pacemakers, the type most commonly implanted, pace heart rate based on feedback from the patient's own heart and are therefore more susceptible to external stimuli produced by E-stim. Less commonly used fixed-rate cardiac pacemakers pace heart rate continuously and are less likely to be influenced by external E-stim such as TENS. Some cardiac pacemakers can be filtered to block interference by external electronic devices such as TENS. Research Evidence MODERATE There are documented cases in which E-stim application caused atrial fibrillation and alterations in heart function.1-11 Some authors recommend that E-stim not be applied directly over implanted devices (C-local), whereas others suggest that E-stim is contraindicated in any body location for people with implanted electronic devices. The literature is not clear on whether these advisories pertain to TENS treatments only or to all types of electrical currents. E-stim has produced ECG artefacts in persons with cardiac pacemakers, and in one case this resulted in unnecessary treatment.12-15 However, when 20 different TENS models, representing five different manufacturers, were evaluated on 51 patients using demand-type pacemakers, with four or more body sites tested on each patient, the TENS produced no episodes of pacemaker interference, inhibition, or reprogramming.16 4-2 Pregnancy Recommendation © Avoid any type of E-stim over the low back, pelvis, or abdomen during pregnancy. Sensory-level TENS is safe during labour to help alleviate mild to moderate pain. Avoid use of E-stim on acupuncture points (A-TENS) or NMES activation of large muscle groups during pregnancy. Rationale E-stim applied directly over the lower abdomen may lead to unwanted uterine contractions and, potentially, to miscarriage or premature labour when applied during the first and third trimesters respectively. A majority of resources state that TENS can safely be applied to body sites remote from the uterus. Some suggest that E-stim is safe even when applied to surface areas overlying the uterus, since the current does not penetrate to the depth of uterine muscle. The direct effects of electrical current on fetal development are not clear. However, because any fetal effects could potentially be devastating, extra caution is required. Research Evidence MODERATE A-TENS significantly increased frequency and intensity of uterine contractions during labour.17 Endogenous opiates, which can be released with electrically induced muscle contractions, are potent stimulators of myometrial contractions.18-20 E-stim increased uterine contractility and uterine pressures in non-pregnant women.17 TENS has been used successfully to treat LBP during pregnancy, and no adverse effects on the newborn were reported.18-20 A document published by the Chartered Society of Physiotherapy in the UK (2007) states that it is permissible to apply TENS to the low back during pregnancy in certain circumstances.21 30 Physiotherapy Canada, Volume 62, Number 5 4-3 Malignancy Recommendation © E-stim should be avoided over a confirmed or suspected malignancy. Abnormal growth should be regarded as malignant until it has been diagnosed. Caution is advisable in the presence of undiagnosed pain in patients with a history of cancer within the last 5 years. TENS may be used for pain management for patients in palliative care. NMES may improve quality of life in end-stage malignant and non-malignant diseases. Rationale E-stim may stimulate growth and promote spread of cancer cells. Bone is a common metastatic site for many types of cancer; the analgesic effects of TENS may mask pain and early signs of metastatic disease. Research Evidence LOW E-stim can stimulate DNA synthesis and cell replication and, therefore, potentially increase tumour cell growth. Angiogenic effects of E-stim may promote the spread of tumours. However, application of direct current to animal models has also been shown to reduce tumour growth. This inhibition has been attributed to interference with mitotic spindle formation during cell division.22 Thus, E-stim does influence cancer cell growth; however, whether this influence will promote or inhibit tumour growth is not clear. In advanced disease, improvements in quality of life afforded by E-stim may outweigh any possible risks associated with treatment. TENS has been used to help ameliorate pain, and NMES has relieved breathlessness and improved strength for the use of walking aids in persons with advanced malignancy.22-26 4-4 Active Deep Vein Thrombosis (DVT), Thrombophlebitis Recommendation © All forms of E-stim are contraindicated, both locally and at remote sites, in cases of active or suspected DVT and thrombophlebitis. E-stim can be applied with caution to persons with a past history of DVT treated with anticoagulant therapy. Rationale Muscle contraction induced by NMES applied near a DVT could dislodge a thrombus that could then embolize a vital organ, causing infarction, shortness of breath, stroke, or major organ failure. Reflex vasodilatation and increased blood flow to contralateral limbs and/or peripheral sites induced by E-stim could also embolize a blood clot. The CSP guidelines and many of the resources suggest that E-stim is safe provided that treatment of the DVT affected limb is avoided (C-local). Although the risk of E-stim's dislodging a thrombus is low, the consequences of a thrombus's travelling to a vital organ could be catastrophic. Research Evidence MODERATE E-stim applied to remote acupuncture points has been shown to significantly increase blood flow to the feet.27 Research has demonstrated that electrically induced muscle contractions increased blood flow, while sensory-level IFC had no effects on blood flow.28-32 Research has suggested that NMES may be beneficial for preventing DVT when applied prophylactically prior to clot formation.33 4-5 Haemorrhagic Conditions Recommendation d E-stim should not be applied to areas of uncontrolled bleeding or after recent injuries or surgeries that resulted in blood loss. E-stim can be used on persons with bleeding disorders (haemophilia) after replacement factor has been administered and coagulopathy has resolved. Rationale E-stim applied in haemorrhagic conditions may cause uncontrolled bleeding. Research Evidence MODERATE E-stim stimulates regional blood flow, causes release of inflammatory mediators and vasoactive substances, and reduces platelet aggregation.34 These effects could exacerbate bleeding when haemostasis has not been established.27 TENS and NMES have been used to decrease pain and improve muscle strength, respectively, without increased bleeding in people with haemophilia.35'36 4. Electrical Stimulation 31 4-6 Infection, Osteomyelitis, Tuberculosis Recommendation © Do not apply E-stim in the presence of localized abscess formations, tuberculosis, or chronic wounds with possible underlying osteomyelitis. E-stim may be applied in conjunction with antimicrobial therapy to superficially infected open wounds; however, in treating infected lesions, care must be taken to reduce the risk of cross-contamination through equipment or therapist contact (see "Safe Practices" below). Rationale E-stim may result in the spread of compartmentalized infections (abscess, TB). E-stim should not be used to promote skin closure in wounds with underlying osteomyelitis, because an exit site is required for drainage. CSP guidelines state that E-stim treatment should not be applied in cases of TB. Research Evidence LOW In vitro studies show that E-stim may inhibit bacterial growth.37-39 HVPC increases local blood flow, which may improve defence against infection in persons with impaired circulation. Electrically induced improvements in regional blood flow have been documented in people with diabetes, spinal-cord injury, and chronic wounds.2740-44 Therefore, it is possible that E-stim may be beneficial when applied to infected open wounds. Laboratory study has demonstrated that bacteria are readily transferred from contaminated skin to areas of sterile skin through inadequately cleaned IFC sponges.45 4-7 Recently Radiated Tissue Recommendation d Do not apply E-stim to tissues that have received radiation therapy within the previous 6 months. Rationale E-stim could possibly stimulate growth of remaining malignant cells. Recently radiated tissue may respond atypically because of the presence of radiation-induced inflammation or scar tissue and/or because of the cellular or circulatory effects of radiation therapy. Research Evidence MODERATE E-stim can stimulate DNA synthesis and cell replication and, therefore, could potentially increase tumour-cell growth. However, application of direct current in animals has also resulted in reduced tumour growth. This inhibiting effect has been attributed to interference with mitotic spindle formation during cell division.22 E-stim-induced increases in angiogenesis and local blood flow would promote the spread of tumours.27'40-44 4-8 Skin Disease, Damaged or At-Risk Skin Recommendation © E-stim should be applied only over healthy skin; therefore, the intended electrode application area should be examined for lesions, signs of irritation, and/or allergic reactions. Monitor patients with skin diseases for exacerbation of symptoms following E-stim application. Rationale Intact skin offers greater resistance to current flow than does broken skin. Uneven current flow under electrodes as a result of skin damage increases the risk of tissue burns. E-stim could stimulate inflammatory processes associated with dermatitis (eczema, contact dermatitis). Using self-adhesive electrodes on compromised skin or grossly edematous tissue could result in skin loss. Research Evidence STRONG Skin disorders are the most common adverse effect of E-stim.46-50 See "Safe Practices" below for guidance on reducing the risk of E-stim-induced skin allergy or burn. 32 Physiotherapy Canada, Volume 62, Number 5 4-9 Impaired Circulation Recommendation © NMES /p\ HVPC/TENS E-stim may be beneficial in the presence of moderate arterial disease. In the presence of severe arterial disease, however, electrical current can induce ischemia, exacerbate pain, and potentially damage fragile tissue. HVPC/TENS can be applied by experienced clinicians to improve wound healing and reduce claudication in people with arterial disease. Rationale Increasing cellular activity increases metabolic demand; in cases of severely compromised circulation, the demand may exceed oxygen supply, resulting in increased pain. Continued treatment may lead to tissue ischemia and necrosis. Deficiency in either arterial or venous circulation is associated with skin deterioration and edema. Applying E-stim electrodes over compromised skin may cause skin breakdown, which is difficult to heal and can potentially lead to chronic wounds. Intact skin offers greater resistance to current flow than does broken skin; uneven current flow under electrodes as a result of skin loss or damage increases the risk of tissue burns. Research Evidence LOW Electrically induced improvements in regional blood flow and tissue oxygenation have been documented in people with diabetes, spinal-cord injury, and chronic wounds.2740-44 NMES applied to calf muscles improved functional capacity of people with claudication due to advanced arterial disease. HVPC and A-TENS have been used safely to treat patients with arterial insufficiency.41-44 4-10 Impaired Sensation Recommendation (Č) TENS /p\ NMES, HVPC TENS and IFC should not be applied when impaired sensation (touch or pain) interferes with the patient's ability to appreciate the prescribed and/or maximum safe level of current intensity. Experienced therapists may apply E-stim (HVPC or NMES) to anaesthetic areas to improve healing and/or increase muscle strength in persons with neurological injuries (e.g., spinal-cord injury, stroke). In these instances, stimulus parameters should be tested on an area of the body with intact sensation if possible; stimulus parameters should be carefully selected and patients closely monitored for early signs of adverse reactions. Types of electrical currents that are associated with greater risk of skin burns (direct current) should not be applied to anaesthetic areas. Rationale Impaired sensation interferes with E-stim that requires patient feedback to set treatment intensity (TENS, IFC, NMES) and thus increases the risk of an E-stim-induced adverse event.51 Analgesic effects of TENS and IFC require intact afferent nerves. Research Evidence MODERATE Peripheral nerve block is known to abolish the analgesic effects of TENS. Ice applied concomitantly with IFC abolishes perception of IFC within 2-8 minutes of ice application.52 Conversely, HVPC and NMES have been used successfully in individuals with neurological conditions that interfere with sensory awareness (e.g., spinal-cord injury).53-55 4-11 Impaired Cognition or Communication Recommendation (Č) TENS /p\ HVPC, NMES TENS and IFC should not be applied when altered consciousness or other cognitive impairment could interfere with the patient's ability to appreciate the prescribed and/or maximum safe intensity of current. Provided that informed consent is obtained, experienced therapists may elect to apply HVPC or NMES to patients who are unable to provide reliable feedback, using carefully selected stimulus parameters and closely monitoring the person for early signs of adverse reactions. Rationale When feedback is required to set stimulus parameters, misunderstood instructions may result in ineffective treatment and increased risk of a skin burn. Application of E-stim for wound healing (HVPC) or muscle re-education (NMES) often involves using preset protocols that do not require patient feedback. Research Evidence MODERATE E-stim is commonly used to treat wounds (HVPC) and to stimulate muscle contraction (NMES) in patients who are unable to perceive the stimulation (e.g., in cases of spinal-cord injury).51'52'5455 4. Electrical Stimulation 33 4-12 Metal Implants Recommendation ® Tissues overlying metal implants can be treated with all forms of E-stim. However, E-stim should not be applied over skin staples or to tissues treated with dressings or topical agents containing metal ions (silver, zinc). Rationale Some experts suggest that applying E-stim to skin overlying superficial implanted metal creates a risk of burn. However, there is little consensus among experts on how near the skin the metal must be in order to influence current flow. Resources generally agree that the conduction of electrical current is not likely to be affected by most metal components, including surgical implants of the type used in joint-replacement surgery. Research Evidence LOW Persons with joint replacements that include metal components have been treated with E-stim with benefit and without adverse reactions.56-58 4-13 Recent Surgery, Unstable Fracture, Osteoporosis Recommendation (Č) TENS (J) HVPC, TENS High-intensity NMES should not be used on recent postoperative ligament or tendon repairs, skin flaps, joint replacements, or fracture stabilization. Consult with the surgeon to determine the safety of NMES in the presence of injured or recently repaired tissue. Rationale Forceful muscle contraction produced by NMES could cause fracture displacement, tear recent tendon or skin sutures, disrupt staples, or disturb an incision site or graft. Research Evidence MODERATE In one study, electrically induced high-force muscle contractions produced an avulsion fracture.59 4-14 Seizure Disorders, Epilepsy Recommendation (J) head, trunk /p\ neck, limbs Avoid neck and transcranial placement of electrodes in individuals with epilepsy; apply E-stim cautiously to the trunk and limbs in persons who are known to have seizures. Rationale E-stim may induce seizures. CSP guidelines state that electrodes placed on the neck are contraindicated in patients with epilepsy. Research Evidence MODERATE Epileptic seizures have occurred following TENS treatment in a person post stroke and in a boy known to have seizures.6061 In contrast, research using an animal model of epilepsy suggests that A-TENS applied to a limb may help reduce epileptic activity.62 4-15 Anterior Neck, Carotid Sinus Recommendation © Direct application of any type of E-stim using surface electrodes over the anterior neck is not advisable. Rationale Stimulation in this area may reflexively stimulate the vagus or phrenic nerves, which may induce a rapid fall in blood pressure, causing the patient to faint. Stimulation may also cause laryngeal spasm. Resources generally recommend that this body region should be avoided. Research Evidence LOW The FDA advises that E-stim is contraindicated in this region. CSP guidelines state that electrodes placed on the neck are contraindicated in patients with epilepsy. 34 Physiotherapy Canada, Volume 62, Number 5 4-16 Chest, Heart, Cardiac Failure Recommendation © NMES /p\ HVPC, TENS TENS should be applied cautiously over the anterior chest and heart (using low-intensity and sensory-level stimulation only). This location should be avoided in patients with cardiac disease, arrhythmias, or a cardiac pacemaker. It is not advisable to apply NMES to intercostal muscles of the anterior chest wall. However, lower-extremity E-stim appears to be safe in patients with cardiac failure. Rationale Stimulation using relatively high current amplitude over the anterior chest area may cause heart arrhythmias or fibrillation. NMES of intercostal muscles may interfere with breathing. CSP guidelines suggest that electrical current be applied to the anterior chest area with great caution. Research Evidence MODERATE Development of respiratory distress has been reported as a result of applying E-stim to intercostal muscles.63 However, TENS applied to the chest wall has been shown to significantly reduce mild to moderate postoperative pain following thoracotomy.64 NMES applied to lower-limb muscles has been shown to benefit persons with advanced chronic obstructive pulmonary disease.65-70 4-17 Head, Transcranial Application Recommendation © Only therapists who have attained an advanced skill level should apply E-stim transcranial^. Careful monitoring of patients after treatment is recommended. Rationale The risks of treating this body region are not fully understood. Transcranial application should be avoided in persons with epilepsy. Research Evidence MODERATE Epileptic seizures have occurred following TENS treatments, especially when electrical current was applied using electrodes placed transcranial^.6061 However, TENS has been used transcranials to reduce tension headaches, with 10% of patients experiencing minor adverse reactions.71 4-18 Reproductive Organs Recommendation © E-stim near reproductive organs or genitalia requires specialized training and otherwise should be avoided. Rationale The risks of E-stim for gametogenesis are not known. Research Evidence ABSENT E-stim has been used successfully for electroejaculation in patients with spinal-cord injury with no serious adverse effects72 NMES is also successfully used to treat urinary incontinence, using conventional electrodes or specialized rectal or vaginal probes to activate pelvic floor muscles.73'74 4-19 Eyes Recommendation © Avoid applying E-stim to areas near or over the eyes. Rationale The risks of treating this body area are not known. There is no known clinical indication that requires eye stimulation. Research Evidence ABSENT No reference found 4. Electrical Stimulation 35 4-20 Lower Abdomen and Internal Organs Recommendation © NMES /p\ HVPC, TENS Avoid high-intensity stimulation (NMES) or treatment using large electrodes over lower abdominal muscles. Rationale E-stim reaching intestines may stimulate smooth muscle surrounding gastrointestinal (Gl) tract and increase Gl motility. Research Evidence MODERATE Ischemic colitis has been reported in association with inappropriate self-applied NMES to the lower abdomen.75 SAFE PRACTICE Perform a Sensory Discrimination Test Test sensory integrity by asking patients to differentiate between hot and cold stimuli or between light touch and painful stimuli. Temperature discrimination and pain (a sharp pricking quality) are conveyed by spinothalamic tracts, whereas light touch is conveyed mainly by dorsal columns; thus, it is not sufficient to test light touch only. Check and Prepare Skin Before Starting Ensure that skin is intact at the intended electrode site. Wipe the skin surface with an alcohol swab and allow it to dry prior to applying electrodes. Cleaning the skin using warm water is also acceptable. Reduced skin impedance means that lower amplitude is required for effective treatment, which in turn increases patient comfort. Monitor Skin for Signs of Irritation Skin irritation is the most frequent complication of electrical stimulation treatment; it may develop gradually, and commonly occurs when self-adhesive electrodes are used, as a result of an allergic reaction to the self-adhesive gel.47>76~82 Avoid Repeated Use of Self-Adhesive Electrodes Electrical conductivity is significantly reduced with successive uses of self-adhesive electrodes. This can cause uneven distribution and inadvertent concentration of current over the electrode area. Self-adhesive electrodes also have a limited lifespan and should be discarded when the adhesive surface is dry. Self-adhesive electrodes should not be shared among patients. Monitor, Regulate, and Document Medication and Caffeine Consumption When Using E-stim for Pain Management Opioid drugs and caffeine may interfere with the analgesic effects of E-stim. Repeated opioid medication can lead to opioid tolerance. High caffeine intake (200 mg/day, or three cups of coffee) blocks adenosine receptors; adenosine is thought to be a neurotransmitter in the C-fibre pathway.8385 Monitor Patients Receiving IFC A variety of adverse effects have been associated with E-stim, including fainting, nausea, burns, rashes, increased swelling, and pain. These effects occur more frequently with application of IFC than with other types of E-stim, such as TENS. Ice reduces, then abolishes, the sensation of IFC. Therefore, applying IFC in combination with ice increases the likelihood of an adverse effect, and particularly the risk of an electrical burn. Do not use small electrodes combined with high-amplitude current when applying IFC. Using high-intensity (high-concentration) IFC may lead to skin and tissue burns.51'52'75'8688 Maintain a Regular Protocol for Disinfection of Sponges Sponges and electrodes used for E-stim are commonly contaminated with microorganisms.45 Soaking electrodes and/or sponges in a solution of dimethyl-benzyl ammonium chloride diluted with water for 20 minutes, followed by 5 minutes of tap-water rinsing, removes about 95% of bacteria. Ensure a sufficient sponge supply to permit complete drying between uses.89 Use Suction Electrodes with Care Carefully increase the amount of negative pressure used to hold electrodes in place in order to avoid 36 Physiotherapy Canada, Volume 62, Number 5 bruising the skin. Do not use suction electrodes over areas of pain or gross edema or on damaged skin. For patients on anticoagulant therapy, there may be added risk of causing bruising as a result of vigorous mechanical effects on skin capillaries. Secure Electrodes with Even Pressure Distribution and Full Contact Patients should be instructed prior to treatment about any need to maintain a particular position during the treatment. Electrodes coupled to the skin using electroconductive gel can be moved during NMES to search for the optimal location of a motor point. To ensure patients' comfort during this procedure, use sufficient gel, move the electrodes slowly, and keep the full surface of the carbon electrode in even contact with the skin. Adjust Stimulus Parameters and Intensity with Care At the end of treatment, slowly reduce stimulus intensity and then turn the machine off. E-stim machines that allow stimuli to be turned off without reducing intensity should be used with extreme caution. Check that the intensity dial registers zero current flow before turning the E-stim machine back on. Advise patients not to adjust the intensity or parameters of E-stim treatment without consulting a professional. Excessive duration or intensity of treatment can lead to injury.7588 Maintain and Replace Carbon Electrodes Carbon-impregnated rubber electrodes have a limited lifespan. Discard electrodes when the surface appears dull, because the impedance is likely too high for safety, effectiveness, and patient comfort (impedance should not exceed 300 ohms). When conductivity is low or uneven, there is a greater risk of skin burn. Protect the surface of conductive electrodes by avoiding abrasive materials, alcohol-based cleansers, and rough cleaning. Needles for intramuscular stimulation should be sterilized between uses according to the manufacturer's directions. Maintain a Safe Distance between Electrical Stimulation Units and Short-Wave Equipment High-frequency electromagnetic radiation, such as that produced by short-wave and microwave diathermy, can purportedly induce current flow in medium-frequency stimulators such as interferential devices, even when the power control in the medium-frequency device is set at zero. Electrical stimulators and diathermy units should operate at least 3 m from each other. Where space is limited, IFC and SWD devices should not be operated simultaneously.90 Observe the Special Requirements for E-stim Treatment of Wounds Current should be delivered uniformly to the wound bed. Advanced training, appropriate techniques, and specialized equipment may be required. Aseptic technique (antibacterial hand wash, gloves, sterile supplies) should be employed to prevent cross-contamination between patients as well as between patients and therapists. REFERENCES 1. Chen D, Philip M, Philip PA, Monga TN. Cardiac pacemaker inhibition by transcutaneous electrical nerve stimulation. Arch Phys Med Rehabil. 1990;71:27-30. 2. Crevenna R, Mayr W, Keilani M, Pleiner J, Nuhr M, Quittan M, et al. Safety of a combined strength and endurance training using neuron-muscular electrical stimulation of thigh muscles in patients with heart failure and bipolar sensing cardiac pacemakers. Wien Klin Wochenschr. 2003;115:710-4. 3. Crevenna R, Wolzt M, Fialka-Moser V, Keilani M, Nuhr M, Paternostro-Sluga T, et al. Longterm transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. Artif Organs. 2004;28:99-102. 4. Eriksson M, Shuller H, Sjorland B. Hazard from transcutaneous nerve stimulation in patients with pacemakers. Lancet. 1978;311:1319. doi:10.1016/S0140-6736(78)91312-0 5. Glotzer TV, Gordon M, Sparta M, Radoslovich G, Zimmerman J. Electromagnetic interference from a muscle stimulation device causing discharge of an implantable cardioverter defibrillator: epicardial bipolar and endocardial bipolar sensing circuits are compared. Pacing Clin Electrophysiol. 1998;21:1996-8. doi:10.1111/j.1540-8159.1998.tb00021.x 6. Glotzer TV. Reply to the editor. Pacing Clin Electrophysiol. 1999;22:693. doi:10.1111/j.l540-8159.1999.tb00522.x 7. Jones SL. Electromagnetic field interference and cardiac pacemakers. Phys Ther. 1976;56:1013-8. 8. La Ban M, Petty D, Hauser A, Taylor R. Peripheral nerve conduction stimulation: its effect on cardiac pacemakers. Arch Phys Med Rehabil. 1988;69:358-62. 9. Philbin DM, Schabrun S. Inappropriate shocks delivered by an ICD as a result of sensed potentials from a trancutaneous electrical nerve stimulation unit. Pacing Clin Electrophysiol. 1998;10:2010-1. 10. Nagele H, Azizi M. Inappropriate ICD discharge induced by electrical interference from a physio-therapeutic muscle stimulation device. Herschrittmacherther Elektrophysiol. 2006;17:137-9. doi:10.1007/s00399-006-0527-8 11. Weitz SH, Tunick PA, McElhinney L, Mitchell T, Kronzon I. Pseudatrial flutter: artifact simulating atrial flutter caused by transcutaneous electrical nerve stimulation (TENS). Pacing Clin Electrophysiol. 1997;20:3010-1. doi:10.1111/j.1540-8159.1997.tb05478.x 12. Hauptman PJ, Raza M. Electrocardiographic artifact with a transcutaneous electrical nerve stimulation unit. Int J Cardiol. 1992;34:110-2. doi:10.1016/0167-5273(92)90093-I 13. Kimberley AP, Soni N, Williams TR. Transcutaneous nerve stimulation and the electrocardiograph. Anaesth Intens Care. 1987;15:358-9. 14. Marples IL. Transcutaneous electrical nerve stimulation (TENS): An unusual source of electrocardiogram artifact. Anaesth. 2000;55:719-20. doi:10.1046/j,1365-2044.2000.01557-39x. 15. Sliwa JA, Marinko MS. Transcutaneous electrical nerve 4. Electrical Stimulation 37 stimulation-induced electrocardiogram artifact: a brief report. Am J Phys Med Rehabil. 1996;75:307-9. 16. Rasmussen MJ, Hayes DL, Vlietstra RE, Thorsteinsson G. Can transcutaneous electrical nerve stimulation be safely used in patients with permanent cardiac pacemakers? Mayo Clin Proc. 1988;63:443-5. 17. Dunn P, Rogers D, Halford K. Transcutaneous electrical nerve stimulation at acupuncture points in the induction of uterine contractions. Obstet Gynecol. 1989;73:286-90. 18. Belanger AY. Physiological evidence for an endogenous opiate-related pain-modulating system and its relevance to TENS: a review. Physiother Can. 1985;37:163-8. 19. Chapman CR, Benedetti C. Analgesia following transcutaneous electrical stimulation and its partial reversal by a narcotic antagonist. Life Sci. 1977;21:1645-8. doi:10.1016/0024-3205(77)90243-0 20. Gabis L, Shklar B, Geva D. Immediate influence of transcranial electrostimulation of pain and I5-endorphin blood levels: an active placebo-controlled study. Am J Phys Med Rehabil. 2003;82:81-5. 21. Coldron Y, Crothers E, Haslam J, Notcutt W, Sidney D, Thomas R, et al. ACPWH guidance on the safe use of Transcutaneous Electrical Nerve Stimulation (TENS) for musculosketal pain during pregnancy. London, UK: Edited/written by the ACPWH and published by the Chartered Society of Physiotherapists, 2007. 22. Schaefer N, Schafer H, Maintz D, Wagner M, Overhaus M, Hoelischer AH, et al. Efficacy of direct electrical therapy and laser induced interstitial thermotherapy in local treatment of hepatic colorectal metastases: an experimental model in the rat. J Surg Res. 2008;146:230-40. doi:10.1016/j.jss.2007.03.084 23. Bauer W. Electrical treatment of severe head and neck cancer pain. Arch Otolaryngol. 1983;109:382-3. 24. Bausewein C, Booth S, Gysels M, Higginson I. Non-pharmacological interventions for breathlessness in advanced stages of malignant and non-malignant diseases. Cochrane Db Syst Rev.;2008:2. doi:10.1002/14651858.CD005623.pub2 25. Crevenna R, Marosi C, Schmidinger M, Fialka-Moser V. Neuromuscular electrical stimulation for a patient with metastatic lung cancer—a case report. Support Care Cancer. 2006;14:970-3. doi:10.1007/s00520-006-0033-x 26. Reuss R, Meyer SC. The use of TENS in the management of cancer pain. Clin Manag Phys Ther. 1985;5:26-8. 27. Kaada B. Vasodilatation induced by transcutaneous nerve stimulation in peripheral ischemia (Raynaud's phenomenon and diabetic polyneuropathy). Eur Heart J. 1982;3:303-14. 28. Lamb S, Mani R. Does interferential therapy affect blood flow? Clin Rehabil. 1994;8:213-8. doi:10.1177/026921559400800305 29. Nussbaum EL, Rush P, Disenhaus L. The effects of interferential therapy on peripheral blood flow. Physiotherapy. 1990;76:803-7. doi:10.1016/S0031-9406(10)63186-0 30. Levine SP, Kett RL, Gross MD, Wilson BA, Cederna PS, Juni JE. Blood flow in the gluteus maximus of seated individuals during electrical muscle stimulation. Arch Phys Med Rehabil. 1990;71:682-6. 31. Liu HI, Currier DP, Threlkeld AJ. Circulatory response of digital arteries associated with electrical stimulation of calf muscle in healthy subjects. Phys Ther. 1987;67:340-5. 32. Mohr T, Akers TK, Wessman HC. Effect of high voltage stimulation on blood flow in the rat hind limb. Phys Ther. 1987;67:526-33. 33. Lindstrom B, Korsan-Bengtsen K, Jonsson O, Petrusson B, Pettersson S, Wikstrand J. Electrically induced short-lasting tetanus of the calf muscles for prevention of deep vein thrombus. Brit J Surg. 1982;69:203-6. 34. Aquejouf O, Doutremepuich F, Doutremepuich C. Effects of electrical stimulation on laser beam induced experimental thrombus. Pathophysiol Haemost Thromb. 2006;35:364-9. 35. Querol F, Gallach JE, Toca-Herrera JL, Gomis M, Gonzalez LM. Surface electrical stimulation of the quadriceps femoris in patients affected by haemophilia A. Haemophilia. 2006;12:629-32. doi:10.1111/j.l365-2516.2006.01356.x 36. Roche PA, Gijsbers K, Belch JJ, Forbes CD. Modification of haemophiliac haemorrhage pain by transcutaneous electrical nerve stimulation. Pain. 1985;21:43-8. doi:10.1016/0304-3959(85)90075-2 37. Kincaid CB, Lavoie KH. Inhibition of bacterial growth in vitro following stimulation with high voltage, monophasic, pulsed current. Phys Ther. 1989;69:651-5. 38. Rowley BA. Electrical current effects on E. coli growth rates. Proc Soc Exp Biol Med. 1972;139:929-34. 39. Szuminsky N, Albers AC, Unger P, Eddy JG. Effect of narrow, pulsed high voltages on bacterial viability. Phys Ther. 1994;74:660-7. 40. Gilcreast D, Stotts NA, Froelicher E, Baker L, Moss K. Effect of electrical stimulation on foot skin perfusion in persons with or at risk for diabetic foot ulcers. Wound Repair Regen. 1998;6:434-41. doi:10.1046/j,1524-475X.1998.60505.x 41. Anderson SI, Whatling P, Hudlicka O, Gosling P, Simms M, Brown MD. Chronic transcutaneous electrical stimulation of calf muscles improves functional capacity without inducing systemic inflammation in claudicants. Eur J Vase Endovasc Surg. 2004;27:201-9. doi:10.1016/j.ejvs.2003.10.003 42. Im MJ, Lee WPA, Hoopes JE. Effect of electrical stimulation on survival of skin flaps in pigs. Phys Ther. 1990;70:37-40. 43. Peters EJ, Armstrong DG, Wunderlich RP, Bosma J, Stacpoole-Shea S, Lavery LA. The benefit of electrical stimulation to enhance perfusion in persons with diabetes mellitus. J Foot Ankle Surg. 2001;37:396-400. doi:10.1016/S1067-2516(98)80048-3 44. Goldman R, Brewley B, Zhou L, Golden M. Electrotherapy reverses inframalleolar ischemia: a retrospective, observational study. Adv Skin Wound Care. 2003;16:79-89. doi:10.1097/ 00129334-200303000-00009 45. Lambert I, Tebbs SE, Hill D, Moss HA, Davies AJ, Elliot TS. Interferential therapy machines as a possible vehicle for cross-infection. J Hosp Infect. 2000;44:59-64. doi:10.1053/jhin,1999.0647 46. Al'Ajlan A, Thestrup-Pedersen K, Al'Eisa A. Contact leukoderma following nickel dermatitis elicited by TENS electrode plates. Contact Dermatitis. 2000;42:172-3. 47. Dwyer CM, Chapman RS, Forsyth A. Allergic contact dermatitis from TENS gel. Contact Dermatitis. 1994;30:305. doi:10.1111/ j,1600-0536.1994.tb00608.x 48. Oyibo SO, Breislin K, Boulton AJM. Electrical stimulation therapy through stocking electrodes for painful diabetic neuropathy: a double blind, controlled crossover study. Diabetic Med. 2004;21:940-4. doi:10.1111/j.l464-5491.2004.01243.x 49. Stecker MM, Patterson T, Netherton BL. Mechanisms of electrode induced injury, part 1: theory. Am J Electroneurodiagnostic Technol. 2006;46:315-42. 50. Weber-Muller F, Reichert-Penetrat S, Schmutz JL, Barbaud A. Contact dermatitis from polyacrylate in TENS electrode. Ann Dermatol Vener. 2004;131:478-80. 51. Ford KS, Shrader MW, Smith J, McLean TJ, Dahm DL. Full thickness burn formation after the use of electrical stimulation therapy for rehabilitation of unicompartmental knee arthroplasty. J Arthroplasty. 2005;20:950-3. 52. Tsang KKW, Morris LM, Hand JW. Ice bag application may negate the effects of interferential electrical stimulation. J Athl Training. 2008;43(3 Supp):S84. 53. Dudley-Javoroski S, Shields RK. Muscle and bone plasticity after spinal cord injury: review of adaptations to disuse and to electrical muscle stimulation. J Rehabil Res Dev. 2008;45:283-96. doi:10.1682/JRRD.2007.02.0031 54. Richardson RR, Meyerjr PR, Cerullo LJ. Transcutaneous electrical 38 Physiotherapy Canada, Volume 62, Number 5 neurostimulation in musculoskeletal pain of acute spinal cord injuries. Spine. 1980;5:42-5. doi:10.1097/00007632-198001000-00008 55. Loeser JD, Black RG, Christman A. Relief of pain by transcutaneous stimulation. J Neurosurg. 1975;42:308-14. doi:10.3171/ jns.1975.42.3.0308 56. Stevens JE, Mizner RL, Snyder-Mackler L. Quadriceps strength and volitional activation before and after total knee arthroplasty for osteoarthritis. J Orthop Res. 2003;21:775-9. doi:10.1016/ S0736-0266(03)00052-4 57. Stevens JE, Mizner RL, Snyder-Mackler L. Neuromuscular electrical stimulation for quadriceps muscle strengthening after bilateral total knee arthroplasty: a case series. J Orthop Sport Phys Ther. 2004;34:21-9. doi:10.2519/jospt.2004.0947 58. Avramidis K, Strike PW, Taylor PN, Swain ID. Effectiveness of electrical stimulation of the vastus medialis muscle in the rehabilitation of patients after total knee arthroplasty. Arch Phys Med Rehabil. 2003;84:1850-3. doi:10.1016/S0003-9993(03)00429-5 59. Ansari A, Ramsey KW, Floyd DC. Rupture of a flexor pollicis longus repair in a body builder through the use of an electronic muscle stimulator. Brit J Sports Med. 2006;40:1009-10. doi:10.1136/bjsm.2006.026591 60. Rosted P. Repetitive epileptic fits—a possible adverse effect after TENS. Acupuncture Med. 2001;19:46-9. doi:10.1136/aim.l9.1.46 61. Scherder E, Someren EJV, Swaab D. Epilepsy: a possible contraindication for transcutaneous electrical nerve stimulation. J Pain Symptom Manage. 1999;17:152-3. 62. Guo J, Lui J, Fu W, Ma W, Xu Z, Yuan M, et al. Effect of electro-acupuncture stimulation of hindlimb on seizure incidence and supragranular mossy fibre sprouting in a rat model of epilepsy. J Physiol Sei. 2008;58:309-15. 63. Mann JC. Respiratory compromise: a rare complication of transcutaneous electrical nerve stimulation for angina pectoris. J Accid Emerg Med. 1996;13:68. doi:10.1136/emj.l3.1.68 64. Benedetti F, Amanzio M, Casadio C, Cavallo A, Cianci R, Giobbe R, et al. Postthoracoscopy pain: is TENS the answer? Ann Thorac Surg. 1997;64:608-10. 65. Bourjeily-Habr G, Rochester CL, Palermo F, Snyder P, Mohsenin V. Randomised controlled trial of transcutaneous electrical muscle stimulation of the lower extremities in patients with chronic obstructive pulmonary disease. Thorax. 2002;57:1045-9. doi:10.1136/thorax.57.12.1045 66. Dal Corso S, Näpolis L, Malaguti C, Gimenes AC, Albuquerque A, Nogueira CR, et al. Skeletal muscle structure and function in response to electrical stimulation in moderately impaired COPD patients. Respir Med. 2007;101:1236-43. doi:10.1016/j.rmed.2006.10.023 67. Neder JA, Sword D, Ward SA, Mackay E, Cochrane LM, Clark CJ. Home based neuromuscular electrical stimulation as a new rehabilitative strategy for severely disabled patients with COPD. Thorax. 2002;57:333-7. doi:10.1136/thorax.57.4.333 68. Quittan M, Wiesinger GF, Sturm B. Improvement of thigh muscles by neuromuscular electrical stimulation in patients with refractory heart failure. Am J Phys Med Rehabil. 2001;80:206-14. doi:10.1097/00002060-200103000-00011 69. Vivodtzev I, Lacasse Y, Maltais F. Neuromuscular electrical stimulation of the lower limbs in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil. 2008;28:79-91. 70. Zanotti E, Felicetti G, Maini M, Fracchia C. Peripheral muscle strength training in bed-bound patients with COPD receiving mechanical ventilation. Chest. 2003;124:292-6. doi:10.1378/ chest.124.1.292 71. Solomon S, Elkind A, Freitag F, Gallagher RM, Moore K, Swerdlow B, et al. Safety and effectiveness of cranial electro- therapy in the treatment of tension headache. Headache. 1989;29:445-50. doi:10.1111/j.1526-4610.1989.hed2907445.x 72. Engin-Ustiin Y, Korkmaz C, Duru NK, Baser I. Comparison of three sperm retrieval techniques in spinal cord injured men: pregnancy outcome. Gynecol Endocrinol. 2006;22:252-5. doi:10.1080/09513590600647326 73. Mariotti G, Sciarra A, Salciccia S, Alfarone A, Pierro GD, Gentile V. Early recovery of urinary incontinence after prostatectomy using early pelvic floor electrical stimulation and biofeedback associated treatment. J Urol. 2009;181:1788-9. 74. Gilling PJ, Wilson LC, Westenberg AM, McAllister WJ, Kennett KM, Frampton CM, et al. A double blind randomized controlled trial of electromagnetic stimulation of the pelvic floor versus sham therapy in the treatment of women with stress urinary incontinence. Brit J Urol. 2009;103:1386-90. 75. Tsujimoto T, Takano M, Ishikawa M, Tsuruzono T, Matsumura Y, Kitano H, et al. Onset of ischemic colitis following use of electrical muscle stimulation (EMS) exercise equipment. Int Med. 2004;43:693-5. doi:10.2169/internalmedicine.43.693 76. Bolton L. TENS electrode irritation. J Am Acad Dermatol. 1983;8:134-5. doi:10.1016/S0190-9622(83)80304-l 77. Castelain PY, Chabeau G. Contact dermatitis after transcutaneous electric analgesia. Contact Dermatitis. 1986;15:32-5. doi:10.1111/j.l600-0536.1986.tb01258.x 78. Fisher AA. Dermatitis associated with transcutaneous electrical stimulation current. Cutis. 1978;21:24-47. 79. Fisher AA, Brancaccio RR. Allergic contact sensitivity to propylene glycol in a lubricant jelly. Arch Dermatol. 1979;115:1451. doi:10.1001/archderm.H5.12.1451 80. Marren P, De Berker D, Powell S. Methacrylate sensitivity and transcutaneous electrical nerve stimulation (TENS). Contact Dermatitis. 1991;25:190-1. doi:10.1111/j.l600-0536.1991.tb01828.x 81. Morris SD, McGibbon DH, Rycroft RJ. Dermatitis caused by electromagnetic radiations. Contact Dermatitis. 2001;45:188. doi:10.1034/j,1600-0536.2001.045003188.x 82. Zugerman C. Dermatitis from transcutaneous electrical nerve stimulation. J Am Acad Dermatol. 1982;6:936-9. doi:10.1016/ S0190-9622(82)70082-9 83. Frasson E, Priori A, Ruzzante B, Didone G, Bertolasi L. Nerve stimulation boosts Botulinum toxin action in spasticity. Mov Disord. 2005;20:624-9. doi:10.1002/mds.20395 84. Marchand S, Li J, Charest J. Effects of caffeine on analgesia from transcutaneous electric nerve stimulation. N Engl J Med. 1995;333:325?326. doi:10.1056/NEJM199508033330521 85. Sluka K, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain Symptom Manage. 2003;4:109-21. doi:10.1054/jpai.2003.434 86. Kitchen S. Audit of the unexpected effects of electrophysical agents. Physiotherapy. 2000;86:152-5. 87. Partridge CJ, Kitchen SS. Adverse effects of electrotherapy used by physiotherapists. Physiotherapy. 1999;85:298-303. doi:10.1016/S0031-9406(05)67133-7 88. Guarascio P, Lusi EA, Soccorsi F. Electronic muscle stimulators: a novel unsuspected cause of rhabdomyolysis. Brit J Sport Med. 2004;38:505-7. 89. Kalinowski D, Brogan M, Sleeper M. A practical technique for disinfecting electrical stimulation apparatuses used in wound treatment. Phys Ther. 1996;76:1340-7. 90. Shields N, O'Hare N, Boyle G, Gormley J. Development and application of a quality control procedure for short-wave diathermy units. Med Biol Eng Comp. 2003;41:62-8. doi:10.1007/BF02343540 ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS 5. Low-Level Laser Therapy (LLLT) / Non-coherent Light SUMMARY OF RECOMMENDATIONS (J Do NOT use the EPA to treat in the presence of this condition or in this body location. LLLT/non-coherent light should not be applied to • tissues infected with tuberculosis or other forms of virulent bacteria • the low back or abdomen of pregnant women • regions of known or suspected malignancy • actively bleeding tissue or persons with untreated haemorrhagic disorders • regions with active deep vein thrombosis or thrombophlebitis • eyes • reproductive organs (testes) /P\ LLLT/non-coherent light can be applied with caution to • recently radiated tissues • persons with photosensitivity disorders (xeroderma pigmentosum) or systemic lupus erythematosus • persons with infections who have a compromised immune function • persons with cognition or communication impairments sufficient to prevent them from giving accurate and timely feedback • active epiphysis • anterior neck and carotid sinus Experienced clinicians may elect to treat this condition/location with caution (e.g., at lower intensities and/or with closer monitoring). © This condition/scenario or body location is NOT contraindicated. LLLT/non-coherent light can be used on • tissues infected with non-virulent bacteria • areas with impaired circulation • areas of impaired sensation that prevents patients from giving accurate and timely feedback • areas overlying regenerating nerves • persons with hypertension or cardiac failure • areas overlying electronic devices • intact skin overlying implants composed of metal, plastic, or cement • tissues inflamed as result of recent injury or exacerbation of chronic inflammatory condition • areas of damaged or "at risk" skin, areas affected by skin diseases, and chronic wounds • skin overlying active epiphysis EPA = electrophysical agent; LLLT = low-level laser therapy including all Class II and III lasers and non-coherent light sources 39 40 Physiotherapy Canada, Volume 62, Number 5 Table 4 Consensus and Recommendations on Low-Level Laser Therapy / Non-coherent Light* Resources % (n= 11) Can/US % APA CSP Adverse Reaction** Research Evidence** Recommendation For Details See Conditions Pregnancy 91 86 (n = 7) C-local C-local Serious Low © 5-2 Malignancy 82 100 (n = 7) P C-local Serious Moderate © 5-3 Haemorrhagic conditions 46 33 (n = 6) P C Serious Low © 5-4 Recently radiated tissue 18 86 (n = 6) P P Moderate Low A 5-5 Infection Tuberculosis 9 71 (n = 7) P N/A Serious Moderate © TB A Other 5-6 Impaired communication 9 P (n = 7) P C Minor Absent A 5-7 Impaired sensation 9 S (n = 7) S P Minor Absent © N/A Deep vein thrombosis Thrombophlebitis 9 43 (n = 7) N/A P Serious Absent © 5-8 Impaired circulation 9 14 (n = 7) S S Minor Low CD 5-9 Acute injury Inflammation S 14 (n = 7) P N/A Minor Moderate GD 5-10 Photosensitivity Systemic lupus erythematosus 27 N/A N/A C Serious Absent A 5-11 Skin disease Damaged or at-risk skin Chronic wounds S S N/A NA Minor Absent © 5-12 Active epiphysis 36 N/A N/A C-local Moderate Absent © N/A Local Areas Eyes 100 100 (n = 7) C C Serious Strong © 5-1 Reproductive organs (testes) 9 29 (n = 6) S C Serious Absent • 5-13 APA = Australian Physiotherapy Association guidelines; Can/US = results of survey of North American experts; CSP = Chartered Society of Physiotherapy guidelines; C = contraindication; C-local = contraindication over the site; N/A = not addressed; P = precaution; S = safe; LLLT = low-level laser therapy, including Class II and III lasers and non-coherent light sources * This table shows the percent (raw) agreement of commonly cited contraindications for low-level laser therapy / non-coherent light by North American experts (Can/US; n < 8) and authors of textbooks (Resources; n = 11). An interpretation of the Australian (APA) and Chartered Society of Physiotherapy (CSP) guideline is shown. A recommendation is given for each condition based on an interpretation of the risk of adverse reactions and the strength of the supporting evidence. ** Readers should consult the Introduction for criteria used to rank adverse reactions, research evidence, and recommendations. 5. Low-Level Laser Therapy (LLLT) / Non-coherent Light 41 LOW-LEVEL LASER THERAPY/NON-COHERENT LIGHT (LLLT): RECOMMENDATIONS, RATIONALE, AND REFERENCES 5-1 Eyes Recommendation © LLLT should not be applied to the orbital area. Rationale Approximately 1 second of coherent light passing through the pupil and striking the retina can cause permanent visual defects. Research Evidence STRONG In rhesus monkeys, the threshold for retinal damage (50% probability of detecting a lesion) was about 5.52 mJ of intra-ocular energy.1-3 5-2 Pregnancy Recommendation © LLLT should be avoided over the low back, abdomen, and pelvic region during the first 35 weeks of pregnancy. Rationale Recommendations are based on possible light-induced effects on fetal growth and/or fetal malformations. CSP guidelines also recommend using caution during pregnancy even when the target tissue is not in the pelvic region. Research Evidence LOW Adverse effects of LLLT on the fetus have not been shown. It is also not known whether LLLT applied to the pelvic region will reach the fetus. Most resources recommend that LLLT be avoided over the pregnant uterus because any fetal malformation could have long-term and devastating effects.4 The types of lasers that are used for prenatal tissue coagulation/ablation should not be confused with low-intensity lasers used by physiotherapists. 5-3 Malignancy Recommendation © LLLT should not be used over confirmed or suspected malignancy. Abnormal growth should be regarded as malignant until diagnosis has been confirmed. Use caution when a patient with a history of cancer within the last 5 years has pain of undiagnosed origin. Rationale Applying LLLT directly to malignant cells may stimulate cancerous cell activity and growth; light-enhanced angiogenesis may play a role in sustaining tumour growth. Research Evidence MODERATE In cell-culture studies, LLLT has been shown to alter DNA synthesis and ATP production and to stimulate protein synthesis.5 Dermal angiogenesis has been demonstrated after laser treatment.6 These stimulating effects of light have not been studied in the context of tumour growth. There is no indication that LLLT could transform normal cells into malignant cells; on the contrary, the literature suggests that LLLT may promote repair of DNA.4'78 5-4 Haemorrhagic Conditions Recommendation © LLLT should not be applied to actively bleeding tissue. It can be used to promote resolution of haematoma once bleeding has ceased. LLLT can be used on persons with bleeding disorders (haemophilia) after replacement factor has been administered and coagulopathy has resolved. Rationale Although the risk of LLLT-induced exacerbation and/or prolongation of bleeding is probably minimal, the safe approach is not to irradiate, since the consequences of haemorrhage are potentially life threatening. Research Evidence LOW It is uncertain whether therapeutic light has adverse effects on coagulation.910 42 Physiotherapy Canada, Volume 62, Number 5 5-5 Recently Radiated Tissue Recommendation A LLLT may be used to treat tissues that have been treated with radiation therapy. Careful monitoring for signs of abnormal growth or tissue damage is recommended. Rationale Skin ulcers usually develop as an acute complication of ionizing irradiation, but they may persist for months or even years post radiation. LLLT has been used to promote healing of acute and chronic radiation ulcers; however, some authors suggest avoiding LLLT for 6 months following radiation therapy. Research Evidence LOW No evidence was found for adverse effects of using light to promote ulcer healing in radiation-damaged skin. In 5 patients 3 to 7 months post radiation therapy, radiogenic mastitis resolved,11 and in one patient, a skin ulcer healed following laser therapy.612 LLLT safely reduces duration and symptoms of chemotherapy-induced oral mucositis; however, this particular use of LLLT does not involve applying LLLT to previously radiated tissue.13 5-6 Infection, Tuberculosis Recommendation © TB /p\ Other LLLT should not be used in persons with tuberculosis; other less virulent soft-tissue infections may be treated with caution. Bacterial growth should be analyzed at baseline and biweekly when treating infected open wounds. Patients who are immunocompromised should be closely monitored for spread of infection. Rationale LLLT is known to modulate the growth of some bacterial species; its effects on TB are not known. LLLT produces some effects via systemic mechanisms; thus, the safe approach is not to use LLLT at any location in persons with TB until it becomes clear whether LLLT can increase or spread TB infection. All patients should be monitored for signs of increased bacterial concentration or advancing infection when LLLT is used on infected tissues. Research Evidence MODERATE LLLT modulates in vitro growth of bacteria, depending on laser parameters as well as on the bacterial species.14-19 Blue light has been shown to kill methicillin-resistant Staphylococcus aureus (MRSA); however, this wavelength is not commonly available in clinical practice at present.19 Pre-clinical research shows that clearing wounds of all bacteria, including normal flora, does not necessarily produce improved wound healing. 808 nm light increased S. aureus growth in animal wounds.20 Laser irradiation has been used with apparent effectiveness in cases of tissue gangrene and osteomyelitis.21 5-7 Impaired Cognition or Communication Recommendation A LLLT should be used cautiously if a patient is unable to understand treatment explanations or to follow instructions and warnings. Rationale LLLT is commonly used to treat conditions involving absent or reduced sensation in the treatment area. Although communication is not essential for the purpose of giving immediate sensory feedback, the patient must be able to comply with safety procedures. Research Evidence ABSENT LLLT has been used without reports of adverse effects in very elderly institutionalized persons and in individuals with diabetic neuropathy or sensory loss in the treatment area.22-26 5. Low-Level Laser Therapy (LLLT) / Non-coherent Light 43 5-8 Active Deep Vein Thrombosis, Thrombophlebitis Recommendation O LLLT should not be applied directly over an active or suspected DVT. The area overlying a previous DVT treated with anti-coagulant therapy can be treated with caution. Rationale The effects of LLLT on a thrombus are not known. LLLT has a modest effect on capillary blood flow, and thus the risk that LLLT will dislodge a thrombus is minimal. However, should a clot embolize, a vital organ could be compromised, with devastating results. Research Evidence ABSENT LLLT increased capillary blood flow in persons with diabetic microangiopathy and also in persons with Buerger's disease.2627 There appear to be no studies on LLLT's effects on the formation or dissolution of blood clots. 5-9 Impaired Circulation Recommendation LLLT may be used to treat areas of impaired circulation (arterial disease or venous insufficiency). Rationale There is an extensive literature supporting the safe use of laser therapy in patients with circulatory impairment and no evidence that increasing cellular activity could increase existing ischemia. Research Evidence LOW Advantageous cellular effects of LLLT have been established, although there are some conflicting findings.28 LLLT has been used safely to treat skin ulcers in individuals with diabetes and severe arterial insufficiency.6'2229 There is some evidence that episodic-type ischemia associated with connective tissue diseases or Raynaud's phenomenon improves after laser treatment of the hands.30 5-10 Acute Injury, Inflammation Recommendation 0 LLLT appears safe to use in the management of acute injury. Monitor the patient for exacerbation of symptoms after each treatment. Rationale It is prudent to monitor the response following each application, since the literature shows that results on acute injury are variable. Research Evidence MODERATE LLLT is known to attenuate the release of inflammatory mediators, including TNF-a, IL-1, and other cytokines, following acute soft-tissue injury.3132 Reducing such mediators may lead to less inflammation.33'34 LLLT's effects on the development and resolution of inflammation may be wavelength and dose dependent.35-37 5-11 Photosensitivity, Systemic Lupus Erythematosus Recommendation A LLLT should be used cautiously in patients with diseases known to be light sensitive, including xeroderma pigmentosum, polymorphic light eruption (PLE), and systemic lupus erythematosus (SLE). It is advisable to use LLLT at low irradiance (power density) and low radiant exposure (energy density), to follow up with patients after the first application, and to allow a 2- to 3-day interval between applications. Rationale LLLT does not induce tissue heating or erythema and can therefore be used safely with persons who sunburn easily. For certain diseases of the skin, however, a cautious approach is advisable because of a potential atypical response to LLLT (SLE affects capillary blood flow, and microvasculitis is common). Research Evidence MODERATE Exposures to ultraviolet radiation (UV) and visible light sufficient to produce erythema are known to exacerbate skin lesions in individuals with SLE38-40 and PLE.4142 Conversely, repeated low doses of UV (A1, A, and B wave bands) are used to reduce symptoms of SLE. No reports were found on the use of LLLT in persons with light-sensitivity conditions or SLE. 44 Physiotherapy Canada, Volume 62, Number 5 5-12 Skin Disease, Damaged or At-Risk Skin Recommendation (Š LLLT may be used over open wounds or damaged skin, provided that treatment parameters are appropriately adjusted. Rationale Light absorption will be altered based on a number of factors, including absence of skin, skin thickness, skin pigmentation, and skin perfusion (because red light is strongly absorbed by haemoglobin and melanin). Therefore, LLLT should be adjusted based on anticipated changes to light absorption. Monitoring patient response is important. Research Evidence STRONG LLLT has been used safely to treat many types of open wounds. Adverse effects have not been documented.2343 The effects of skin characteristics on light transmission have been established.44 5-13 Reproductive Organs (Testes) Recommendation LLLT should not be applied to the testes. Rationale The effects of LLLT on reproductive organ function and spermatogenesis are not known. Research Evidence ABSENT No references found. SAFE PRACTICE Apply LLLT in a Safe Environment Apply treatment in a separate cubicle to protect other persons in the area from unintended irradiation. Patients and therapists should use protective goggles specific to the wavelength of light in use. Notwithstanding the use of goggles, the laser applicator should be activated only when the probe tip or array surface is applied to the tissue surface. In some countries, users of LLLT are required to attend appropriate training in the safe use of lasers in health care. Many safely measures are recommended in the resources.13 It has been said, however, that "laser safety has more to do with good operating procedure than with door interlocks and panic buttons. Almost without exception, the only item of protection required is eyewear." 3(P.17S7) Restrict Use of Laser Devices to Qualified Personnel Safety should be assured by providing only approved operators with a key to access Class II and III laser devices. Clean and Disinfect Laser Applicators Regularly Dust and skin debris accumulated at the laser tip may interfere with emission. Disinfect the applicator (using 70% alcohol) between patients. Plastic wrap can be applied to the applicator when treating open wounds (note that this produces a light-transmission loss of about 8%).45 Other types of semi-transparent dressings can block up to 48% of incident light, and exposure duration should be increased to compensate for such loss.45'46 Plan Regular Equipment Maintenance and Calibration (every 6 months recommended) Laser diodes are easily damaged, and their emission should be checked if the applicator is dropped. Laser output decreases over time. Output must be measured using a light meter of the appropriate wavelength. Treatment dosage should be calculated using actual output rather than the estimated output at the time of equipment purchase. Poor performance of laser diodes has been demonstrated: in one study, clinical devices emitted, on average, between 31% and 60% of manufacturers' rated output, and a few devices emitted no light at all.47 Monitor and Document Adverse Events Resulting from LLLT Some individuals report feeling nauseated following light treatment; however, nausea appears to affect individuals receiving active LLLT and those receiving a placebo treatment at an equal rate. Increased pain, tingling, and numbness have also been reported following real and placebo LLLT.4852 5. Low-Level Laser Therapy (LLLT) / Non-coherent Light 45 REFERENCES 1. AFOSH (Air Force Occupational Safety and Health Standard). Laser radiation protection program (Report No. Standard 48-139). Washington, DC: Department of the Air Force; 1999. 2. American National Standards Institute. American national standard for safe use of lasers (Report No.: ANSI Standard Z136.1). New York: The Institute; 2000. 3. Moseley H. Ultraviolet and laser radiation safety. Phys Med Biol. 1994;39:1765-99. 4. Navrátil L, Kymplova K. Contraindications in noninvasive laser therapy: truth and Action. J Clin Laser Med Surg. 2002;20:341-3. doi:10.1089/104454702320901134 5. Lubart R, Lavi R, Friedmann H, Rochkind S. Photochemistry and photobiology of light absorption by living cells. Photomed Laser Surg. 2006;24:179-85. doi:10.1089/pho.2006.24.179 6. Schindl A, Schindl M, Schindl L, Jurecka W, Honigsmann H, Breier F. Increased dermal angiogenesis after low-intensity laser therapy for a chronic radiation ulcer determined by a video measuring system. J Am Acad Dermatol. 1999;40:481-4. doi:10.1016/ S0190-9622(99)70503-7 7. Carmeliet P, Jain RK. Angiogenesis in cancer and other diseases. Nature. 2000;407:249-57. 8. Logan ID, McKenna PG, Barnett YA. An investigation of the cytotoxic and mutagenic potential of low intensity laser irradiation in Friend Erythroleukemia cells. Mutat Res Lett. 1995;347(2):67-71. 9. Liu XC, Lyon R, Meier HT, Thometz J, Haworth ST. Effect of lower-level laser therapy on rabbit tibial fracture. Photomed Laser Surg. 2007;25:487-94. doi:10.1089/pho.2006.2075 10. Aimbire F, Lopes-Martins RAB, Albertini R, Pacheco MTT, Castro-Faria-Neto HC, Martins PSLL, et al. Effect of low-level laser therapy on hemorrhagic lesions induced by immune complex in rat lungs. Photomed Laser Surg. 2007;25:112-7. doi:10.1089/pho.2006.1041 11. Schaffer M, Bonel H, Sroka R, Schaffer PM, Busch M, Sittek H, et al. Magnetic resonance imaging (MRI) controlled outcome of side effects caused by ionizing radiation, treated with 780 nm-diode laser—preliminary results. J Photochem Photobiol B. 2000;59:1-8. doi:10.1016/S1011-1344(00)00134-2 12. Schindl A, Schindl M, Pernerstorfer-Schon H, Mossbacher U, Schindl L. Low intensity laser irradiation in the treatment of recalcitrant radiation ulcers in patients with breast cancer— long term results of 3 cases. Photodermatol Photoimmunol Photomed. 2000;16:34-7. doi:10.1034/j.1600-0781.2000.160109.x 13. Corti L, Chiarion-Sileni V, Aversa S, Ponzoni A, D'Arcais R, Pagnutti S, et al. Treatment of chemotherapy-induced oral mucositis with light-emitting diode. Photomed Laser Surg. 2006;2:207-13. doi:10.1089/pho.2006.24.207 14. Hamblin MR, Zahra T, Contag CH, McManus AT, Hasan T. Optical monitoring and treatment of potentially lethal wound infections in vivo. J Infect Dis. 2003;187:1717-25. doi:10.1086/375244 15. Nussbaum EL, Lilge L, Mazzulli T. Effects of laser irradiation on in vitro growth of bacteria: comparison of continuous wave and frequency modulated light. Lasers Surg Med. 2002;31:343-51. doi:10.1002/lsm,10121 16. Nussbaum EL, Lilge L, Mazzulli T. The effects of 630, 660, 810 and 905 nm laser irradiation delivering radiant exposures of 1-50 J/cmz on three species of bacteria in vitro. J Clin Laser Med Surg. 2002;20:325-33. doi:10.1089/104454702320901116 17. Nussbaum EL, Lilge L, Mazzulli T. Effects of low-level laser therapy (LLLT) of 810 nm upon in vitro growth of bacteria: relevance of irradiance and radiant exposure. J Clin Laser Med Surg. 2003;21:283-90. 18. Enwemeka CS, Williams D, Enwemeka SK, Hollosi S, Yens D. Blue 470-nm light kills methicillin-resistant Staphylococcus aureus (MRSA) in vitro. Photomed Laser Surg. 2009;27:221-6. doi:10.1089/pho.2008.2413 19. Enwemeka CS, Williams D, Hollosi S, Yens D, Enwemeka SK. Visible 405 nm SLD light photo-destroys methicillin-resistant Staphylococcus aureus (MRSA) in vitro. Lasers Surg Med. 2008;40:734-7. doi:10.1002/lsm.20724 20. Nussbaum EL, Mazzulli T, Pritzker KPH, Las Heras F, Jing F, Lilge L. Effects of low intensity laser irradiation during healing of skin lesions in the rat. Lasers Surg Med. 2009;41:372-81. doi:10.1002/lsm.20769 21. Schindl M, Schindl A, Polzleitner D, Schindl L. Healing of bone affections and gangrene with low-intensity laser irradiation in diabetic patients suffering from foot infections. Forsch Komple-mentarmed. 1998;5:244-7. doi:10.1159/000021113 22. Zinman LH, Ngo M, Ng ET, Nwe KT, Gogov S, Bril V. Low-intensity laser therapy for painful symptoms of diabetic sensorimotor polyneuropathy. Diabetes Care. 2004;27:921-4. doi:10.2337/diacare.27.4.921 23. Lucas C, Stanborough R, Freeman C, De Haan R. Efficacy of low-level laser therapy on wound healing in human subjects: a systematic review. Lasers Med Sei. 2000;15:84-93. doi:10.1007/ S101030050053 24. Nussbaum EL, Biemann I, Mustard B. Comparison of ultra-sound/ultraviolet-C and laser for treatment of pressure ulcers in patients with spinal cord injury. Phys Ther. 1994;74:812-23. 25. Taly AB, Nair KPS, Murali T, John A. Efficacy of multiwavelength light therapy in the treatment of pressure ulcers in subjects with disorders of the spinal cord: a randomized double-blind controlled trial. Arch Phys Med Rehabil. 2004;85:1657-61. doi:10.1016/j.apmr.2004.03.028 26. Schindl A, Schindl M, Schon H, Knobler R, Havelec L, Schindl L. Low intensity laser irradiation improves skin circulation in patients with diabetic microangiopathy. Diabetes Care. 1998;21:580-4. doi:10.2337/diacare.21.4.580 27. Schindl L, Kainz A, Kern H. Effect of low level laser irradiation on indolent ulcers caused by Buerger's disease: literature review and preliminary report. Laser Therapy. 1992;4:25-9. 28. Sobanko JF, Alster TS. Efficacy of low-level laser therapy for chronic cutaneous ulceration in humans: a review and discussion. Dermatol Surg. 2008;34:991-1000. doi:10.1111/j.l524-4725.2008.34197 .x 29. Schindl A, Schindl M, Pernerstorfer-Schon H, Kerschan K, Knobler R, Schindl L. Diabetic neuropathic foot ulcer: successful treatment by low-intensity laser therapy. Dermatology. 1999;198:314-6. doi:10.1159/000018140 30. Al-Awami M, Schillinger M, Maca T, Pollanz D, Minar E. Low level laser therapy for treatment of primary and secondary Raynaud's phenomenon. VASA-J Vascular Dis. 2004;33:25-9. doi:10.1024/0301-1526.33.1.25 31. Aimbire F, de Oliveira APL, Albertini R, Correa JC, de Campos CBL, Lyon JP, et al. Low level laser therapy (LLLT) decreases pulmonary microvascular leakage, neutrophil influx and IL-1 beta levels in airway and lung from rat subjected to LPS-induced inflammation. Inflammation. 2008;31:189-97. 32. Aimbire F, Santos FV, Albertini R, Castro-Faria-Neto HC, Mittmann J, Pacheco-Soares C. Low-level laser therapy decreases levels of lung neutrophils anti-apoptotic factors by a NF-kB dependent mechanism. Int Immunopharmacol. 2008;8:603-5. 33. Qadri T, Bohdanecka P, Tuner J, Miranda L, Altamash M, Gustafsson A. The importance of coherence length in laser phototherapy of gingival inflammation—a pilot study. Lasers Med Sei. 2007;22:245-51. doi:10.1007/sl0103-006-0439-l 34. Roynesdal AK, Bjornland T, Barkvoll P, Haanaes HR. The effect of soft-laser application on postoperative pain and swelling. Oral Maxillofacial Surg. 1993;22:242-5. 35. Bjordal J, Couppe C, Ljunggren A. Low level laser therapy for tendinopathy: evidence of a dose-response pattern. Phys Ther Rev. 2001;6:91-9. 36. Bjordal JM, Lopes-Martins RAB, Iversen W. A randomised, 46 Physiotherapy Canada, Volume 62, Number 5 placebo controlled trial of low level laser therapy for activated Achilles tendinitis with microdialysis measurement of peritendinous prostaglandin E2 concentrations. Brit J Sport Med. 2006;40:76-80. doi:10.1136/bjsm.2005.020842 37. Gabel P. Does laser enhance bruising in acute sporting injuries? Aust J Physiother. 1995;41:273-5. 38. Orteu CH, Sontheimer RD, Dutz JP. The pathophysiology of photosensitivity in lupus erythematosus. Photodermatol Photo-immunol Photomed. 2001;17:95-113. doi:10.1034/j.1600-0781.2001.170301.x 39. Sanders CJ, Van Weelden H, Kazzaz GA, Vigurdsson S, Toonstra J, Bruijnzeel-Koomen CA. Photosensitivity in patients with lupus erythematosus: a clinical and photo biological study of 100 patients using a prolonged phototest protocol. Brit J Dermatol. 2003;149:131-7. doi:10.1046/j,1365-2133.2003.05379.x 40. Sanders CJG, Lam HY, Bruijnzeel-Koomen CAFM, Sigurdsson V, Van Weelden H. UV hardening therapy: a novel intervention in patients with photosensitive cutaneous lupus erythematosus. J Am Acad Dermatol. 2006;54:479-86. doi:10.1016/j.jaad.2005.10.046 41. Mastalier U, Kerl H, Wolf P. Clinical, laboratory, phototest and phototherapy findings in polymorphic light eruptions: a retrospective study of 133 patients. Eur J Dermatol. 1998; 8:554-9. 42. Szegedi A, Simics E, Aleksza M, Horkay I, Gaal K, Sipka S, et al. Ultraviolet-Al phototherapy modulates Thl/Th2 and Tcl/Tc2 balance in patients with systemic lupus erythematosus. Rheumatology. 2005;44:925-31. doi:10.1093/rheumatology/keh643 43. Franek A, Chmielewska D, Brzezinska-Wcislo L, Slezak A, Blaszczak E. Application of various power densities of ultrasound in the treatment of leg ulcers. J Dermatol Treatment. 2004;15:379-86. doi:10.1080/09546630410023593 44. Nussbaum EL, Zuylen JV. Transmission of light through human skinfolds: effects of physical characteristics, irradiation wavelength and skin-diode coupling relevant to phototherapy. Physiother Can. 2007;59:194-207. 45. Chen C, Diven DG, Lockhart S, Bell B. Laser transmission through transparent membranes used in cutaneous laser treatment. J Am Acad Dermatol. 2001;45:919-23. doi:10.1067/ mjd.2001.116221 46. Lilge L, Tierney K, Nussbaum E. Low-level laser therapy for wound healing: feasibility of wound dressing transillumination. J Clin Laser Med Surg. 2000;18:235-40. 47. Nussbaum EL, Van Zuylen J, Baxter GD. Specification of treatment dosage in laser therapy: unreliable equipment and radiant power determination as confounding factors. Physiother Can. 1999;51:159-67. 48. Chow RT, Heller GZ, Barnsley L. The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. Pain. 2006;124:201-10. 49. Laakso E, Richardson C, Cramond T. Pain scores and side effects in response to low level laser therapy (LLLT) for myofascial trigger points. Laser Therapy. 1997;9:67-72. 50. Thorsen H, Gam AN, Svensson BH, Jess M, Jensen MK, Schack LK, et al. Low level laser therapy for myofascial pain in the neck and shoulder girdle: a double-blind, cross-over study. Scand J Rheumatol. 1992;21:139-42. doi:10.3109/03009749209095086 51. Walker J. Relief from chronic pain by low power laser irradiation. Neurosci Lett. 1983;43:339-44. doi:10.1016/0304-3940(83)90211-2 52. Waylonis GW, Wilke S, O'Toole D, Waylonis DA, Waylonis DB. Chronic myofascial pain: management by low-output helium-neon laser therapy. Arch Phys Med Rehabil. 1988;69:1017-20. ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS 6. Superficial Heat SUMMARY OF RECOMMENDATIONS 3 Do NOT use the EPA to treat in the presence of this condition or in this body location. Superficial heat should not be applied to • large areas, or at sufficient intensity to raise core temperature, in pregnant women • regions of known or suspected malignancy • infected tissues or persons with tuberculosis • persons with active deep vein thrombosis or thrombophlebitis • areas of impaired sensation that prevent the patient from giving accurate and timely feedback • actively bleeding tissue or persons with untreated haemorrhagic disorders • recently radiated tissues • large areas, or at sufficient intensity to raise core temperature, in persons with severe cardiac disease or in cardiac failure • persons with cognition or communication impairments sufficient to prevent them from giving accurate and timely feedback • areas with impaired circulation • tissues inflamed as result of recent injury or exacerbation of chronic inflammatory condition • areas affected by heat-sensitive skin diseases (e.g., eczema) • areas of skin breakdown or damage producing uneven heat conduction across the skin • areas of severe edema • reproductive organs (testes) /P\ Superficial heat can be applied with caution to • areas near or over eyes • anterior neck and carotid sinus • pregnant women • people with cardiac failures Experienced clinicians may elect to treat this condition/location with caution. © This condition/scenario or body location is NOT contraindicated. Superficial heat can be used on • intact skin overlying implants containing metal, plastic, or cement • areas over electronic devices • areas near chronic wounds • superficial or regenerating nerves • the head, chest, or heart • areas over active epiphysis • persons with hypertension EPA = electrophysical agent; superficial heating agents include hot packs, wax, and other conductive agents that heat tissues within 3 cm of the skin surface. 47 48 Physiotherapy Canada, Volume 62, Number 5 Table 5 Consensus and Recommendations on Superficial Heating Agents* Resources % (n = 9) Can/US % (n = 8) APA CSP** Adverse Reaction*** Research Evidence*** Recommendation For Details See Conditions Impaired sensation 89 88 P p Minor Strong © 6-1 Impaired cognition or communication 67 50 P c Minor Absent © 6-2 Acute injury Inflammation 78 88 C NA Moderate Moderate © 6-3 Haemorrhagic conditions 78 100 C C Serious Moderate © 6-4 Impaired circulation 78 63 c C Minor Strong © 6-5 Malignancy 78 100 c C-local Serious Moderate © 6-6 Infection Tuberculosis 33 100 c C Serious Moderate © 6-7 Deep vein thrombosis Thrombophlebitis 33 100 c C Serious Strong © 6-8 Pregnancy 22 13 s S Serious Moderate © Systemic A Local 6-9 Skin disease Damaged or at-risk skin 33 100 c C Minor Strong © 6-10 Cardiac failure 22 NA c NA Serious Low © Systemic A Local 6-11 Recently radiated tissue 22 75 c P Serious Low © 6-13 Severe edema 22 75 c P Minor Low © N/A continued on page 49 6. Superficial Heat 49 continued from page 48 Resources % (n = 9) Can/US % (n = 8) APA CSP** Adverse Reaction*** Research Evidence*** Recommendation For Details See Implants Metal implants 11 S NA p Minor Absent CD 6-12 Local Areas Reproductive organs 11 38 C s Serious Low © 6-14 Eyes 11 50 C c Moderate Absent A 6-15 APA = Australian Physiotherapy Association guidelines; Can/US = results of survey of North American experts; CSP = Chartered Society of Physiotherapy guidelines; C = contraindication; C-local = contraindication over the site; N/A = not addressed; P = precaution; S = safe; Systemic = the heating agent is applied in a manner that results in raising of core body temperature (sweating); Local = the superficial heating agent is applied to a relatively small, local area that is not likely to elevate core temperature (no sweating); Superficial Heating Agents include hot packs, wax, and other conductive agents that heat tissues within 3 cm of the skin surface. * This table shows the percent (raw) agreement of commonly cited contraindications for superficial heating agents (e.g., hot packs, wax) by North American experts (Can/US; n = 8) and authors of textbooks (Resources; n = 9). An interpretation of the Australian (APA) and Chartered Society of Physiotherapy (CSP) guidelines is shown. A recommendation is given for each condition based on an interpretation of the risk of adverse reactions and the strength of the supporting evidence. ** The CSP guidelines address different types of heating agents. The following tables provide more specific information on use of hot packs and wax. *** Readers should consult the Introduction for criteria used to rank adverse reactions, research evidence, and recommendations. SUPERFICIAL HEAT: RECOMMENDATIONS, RATIONALE, AND REFERENCES 6-1 Impaired Sensation Recommendation © Avoid use of superficial heat when the patient cannot provide appropriate and timely feedback. Normal skin sensation means that the patient can reliably discriminate between mild and moderate warmth (refer to the section on safe practice). Rationale It is important for the clinician to understand the degree of heat experienced by the patient. In the absence of appropriate feedback, a patient can easily be burned before the clinician realizes that there is a problem. Research Evidence STRONG There are several reports of skin burns' occurring during the use of superficial heating agents.1-4 6-2 Impaired Cognition or Communication See explanation for Impaired Sensation (above) 6-3 Acute Injury, Inflammation Recommendation © Avoid heating acutely inflamed tissue. Rationale Inflammation occurs soon after injury (within 3 days) and can persist or reappear with exacerbation of chronic conditions. Therefore, the area should be examined regardless of time post injury to look for signs of inflammation: redness, heat, swelling, pain, and loss of function. Heat exacerbates inflammatory processes, which may extend the area of injury and prolong the recovery period. Research Evidence MODERATE Metabolic and vascular changes are induced by local heat, which perpetuates many inflammatory processes (increased blood perfusion, release of local inflammatory mediators, formation of tissue edema).5 There is a risk of secondary hypoxic injury when the supply of oxygen is inadequate to meet tissue demands. 50 Physiotherapy Canada, Volume 62, Number 5 6-4 Haemorrhagic Conditions Recommendation © Avoid local use of superficial heat until haemorrhage has ceased. Avoid using heat anywhere on the body that is sufficient to cause a systemic response (sweating and general vasodilatation) in an individual who is at risk of haemorrhage. In persons with bleeding disorders (haemophilia), superficial heat can be used after replacement factor has been administered and coagulopathy has resolved. Rationale Heat-induced increase in local blood flow may prolong bleeding. Research Evidence MODERATE Tissue heating is known to cause vasodilatation and increased local and limb blood flow.6 6-5 Impaired Circulation Recommendation © Avoid heating tissues with circulatory insufficiency. Do not apply heating agents at an intensity sufficient to change core body temperature in persons with peripheral vascular disease (PVD). Examine distal extremities for signs of peripheral arterial disease prior to applying heating agents. Reduce dosage of heat to hands and feet. Rationale Adequate blood circulation is needed to avoid excessive heat accumulation in areas treated with superficial heating agents. Increasing the core body temperature in persons with PVD may lead to thrombus formation and can potentially compromise vital organs and cause heart attack or stroke. Distal extremities are most affected by arterial disease; therefore, it is important to check hands and feet for signs of arterial disease (thin, shiny, pale skin; cold to touch; thickened, brittle nails). Hands and feet are particularly susceptible to applied heat because their skin surface area is large in relation to the volume of tissue, which results in very efficient heat transfer. The CSP guidelines advise avoiding the use of hot packs over areas of impaired circulation and using wax with caution. Research Evidence STRONG There is a risk of burns if local circulation is insufficient to dissipate applied heat.3'78 Increasing core body temperature to 39°C leads to haemoconcentration, an increase in platelet count, and a reduction in anti-thrombotic processes. This core temperature could be achieved with full-body immersion in 40°C water for about 50-60 min. At this temperature, the risk of a thrombotic event may be elevated in individuals with PVD.9 6-6 Malignancy Recommendation © Avoid using superficial heating agents on persons with cancer. Abnormal growth should be regarded as malignant until diagnosis has been confirmed. Use caution when a patient with a history of cancer within the last 5 years has pain of undiagnosed origin. Rationale Some sources advise not using superficial heat anywhere on the body for an individual with confirmed or suspected malignancy; the CSP guidelines, however, advise avoidance only over the malignant tissue. Local heat can increase tumour growth and increase incidence of metastases by increasing blood flow and/or by increasing metabolic rate. Applying heat anywhere on the body is a potential risk, according to some experts, because heating large surface areas may produce a systemic response (i.e., sweating and general vasodilatation) and because heating one limb may produce a reflex increase in blood flow in the contralateral limb. Research Evidence MODERATE Increasing tissue temperature stimulates metabolic activity of all types of cells. Heat-induced vasodilatation increases tissue perfusion.6'1011 The effects of superficial heat on tumour growth and metastatic processes have not been examined directly. 6. Superficial Heat 51 6-7 Infection, Tuberculosis Recommendation © Avoid applying heat directly over infected tissue (e.g., abscess, septic arthritis, TB, infected open wounds) or to large areas of the trunk or limbs remote from the infected site. When an individual's body temperature is higher than the physiological norm, avoid applying heat to large surface areas, as this may produce a further rise in core temperature. Rationale Applying heat to an area of tissue that is hot, red, and swollen as a result of infection can exacerbate swelling and pain. However, when a localized infection such as an abscess has an opening for drainage, mild local heat may help to resolve the infection by increasing blood flow. The CSP guidelines specifically recommend avoiding wax treatment. Research Evidence MODERATE There are clinical reports of heat-induced changes in limb blood flow.6 The effects of applying heating agents to infected tissues have not been documented. 6-8 Active Deep Vein Thrombosis, Thrombophlebitis Recommendation © Avoid use of superficial heat directly over the site of an active DVT and to large surface areas of the trunk or to the unaffected contralateral limb of individuals with an active DVT. Individuals with a previous DVT that was successfully treated with anti-coagulant therapy can be treated with caution. Rationale Application of heat to large surface areas sufficient to produce sweating can produce generalized vasodilatation and increased blood flow at remote sites, which may dislodge a thrombus. The consequences of a thrombus travelling to a vital organ can be catastrophic. The CSP guidelines recommend that use of a hot pack is contraindicated, whereas the use of wax requires precautions. Application of wax to the hand is unlikely to cause general vasodilatation; as a precaution, however, the patient should be monitored during treatment for generalized increased body temperature (general sweating response), particularly when both hands are treated simultaneously. Research Evidence STRONG There are clinical reports of heat-induced changes in limb blood flow.6 Experimental studies using healthy human subjects have shown that heating one hand produces reflex changes in blood flow in the contralateral limb.1011 6-9 Pregnancy Recommendation (J) Systemic /p\ Local Avoid applying heat that could elevate core temperature in pregnant women. Application of hot packs to the trunk or other surface areas or full-body immersion in hot water (hydrotherapy tanks) should be avoided. Heat can be safely applied to small areas of the extremities (e.g., wax to the hand). The patient should be monitored, and treatment should be discontinued if there is any sign of body-temperature elevation (central erythema, generalized sweating, etc.). Rationale Applying superficial heat to the low back is not likely to heat fetal tissues directly. However, increasing maternal body temperature could have devastating consequences. Although teratogenic effects of heat on the fetus are worst during the first trimester, heating fetal tissues later in pregnancy can also alter fetal growth and development. CSP guidelines recommend avoiding superficial heat until week 35 of pregnancy. Applying wax to hands or feet is unlikely to raise either maternal core temperature or fetal temperature. Research Evidence MODERATE Elevation of maternal body temperature (hyperthermia) is known to cause fetal malformations.1213 Whether or not superficial heating agents can induce changes in maternal and fetal temperature has not been established. 52 Physiotherapy Canada, Volume 62, Number 5 6-10 Skin Diseases, Damaged or At-Risk Skin, Chronic Wounds Recommendation (J) Diseases (^) Damaged skin (J) Wounds Heat (hot packs and wax) should not be applied over heat-sensitive skin diseases (e.g., eczema, psoriasis, vasculitis, dermatitis). Conductive heating agents should not be applied to damaged skin that would alter heat transfer. Tissues surrounding chronic wounds may be treated with mild heat, provided there is adequate local circulation. Rationale Heat exacerbates certain inflammatory-type skin diseases (e.g., eczema, psoriasis). The conductive property of skin should be consistent across the surface area that is in contact with the heating agent; heat conduction is uneven over damaged skin, which can potentially result in tissue burns. Heating skin that is poorly perfused (e.g., vasculitis, arterial ulcers) increases the risk of tissue burn. The CSP guidelines recommend not applying wax to diseased skin and using hot packs with caution. Applying heat to early-stage skin grafts before circulation is well established may cause graft failure. Research Evidence MODERATE Heat is known to exacerbate certain skin conditions.1 Tissue heating also increases many inflammatory processes.5 Increasing tissue temperature increases cell activity and the demand for oxygen and other nutrients, which may exacerbate tissue hypoxia. It should be noted that controlled warming that raises wound temperature by 1-2°C, but not above physiological temperature (37°C), may be an effective treatment for venous ulcers.14 Wax has been used safely to reduce skin contractures after burn injury and once tissues have healed.15"17 6-11 Cardiac Failure, Hypertension Recommendation (^) Systemic /p\ Local Applying superficial heat over the trunk or large surface areas sufficient to cause a systemic response to heat (sweating) is not recommended. Full-body heating (hydrotherapy tanks) should be avoided. Rationale Generalized peripheral vasodilatation is produced by heating a large surface area of the body or in response to an increase in core body temperature. This elevation in skin blood flow requires more cardiac output in order to maintain blood pressure. People with impaired heart function may not tolerate the increased cardiac demand. Research Evidence LOW No reference found. 6-12 Metal Implants Recommendation CD Avoid use of heat directly over very superficial metal implants (e.g., staples in skin) or over metal jewellery. Rationale Metals have high thermal conductivity; therefore, there is high potential for thermal injury of tissues surrounding heated metal implants. Metal implants underlying thick subcutaneous or muscular layers pose a negligible risk, since superficial thermal agents are unlikely to raise resting temperature at such depths. The CSP advisory applies only to hot packs. Research Evidence ABSENT No reference found. 6. Superficial Heat 53 6-13 Recently Radiated Tissues Recommendation © Avoid heating tissues that have received radiation therapy during the last 6 months. Rationale Heat could stimulate growth of any residual malignant cells. Radiation alters cell metabolism, including that of endothelial cells and fibroblasts. The presence of radiation-induced inflammation, scar tissue, or circulatory effects may adversely affect tissue response, especially the ability to dissipate heat. Research Evidence LOW Increasing tissue temperature stimulates metabolic activity in all types of cells. The effects of heat therapy on radiated tissues have not been examined. 6-14 Reproductive Organs Recommendation © Heat should not be applied directly to testes. Rationale Heat is known to affect spermatogenesis and reduce fertility. Research Evidence LOW No references have examined the effect of physiotherapeutic heating agents on male reproductive function. 6-15 Eyes Recommendation A Heat application in the vicinity of the eyes should be undertaken with caution. Rationale There is no literature to guide practice in this area. Facial skin is normally highly sensitive; therefore, it is likely that potentially damaging heat would cause discomfort, prompting a patient to ask for treatment to be terminated. Research Evidence ABSENT No reference found. SAFE PRACTICE Perform a Sensory Discrimination Test Test sensory integrity by asking patients to differentiate between hot and cold stimuli or between light touch and painful stimuli. Temperature discrimination and pain (a sharp pricking quality) are conveyed by spinothalamic tracts, whereas light touch is conveyed mainly by dorsal columns; thus, it is not sufficient to test light touch only. Check Skin Integrity Inspect target area for presence of skin disease and open lesions. Remove jewellery and clothing. Wash skin before applying wax. Monitor for Systemic Temperature Change An increase in core temperature is indicated by generalized sweating. Significant changes in core temperature may affect treatment effectiveness and/ or compromise patient safety, especially in the frail elderly. Check Skin Response under Heating Agents Check skin a few times during the application and as frequently as every 5 minutes if a patient is receiving a particular treatment for the first time.18 It may be unsafe to apply superficial heat to obese individuals. The risk of a burn increases with the amount of subcutaneous fat, because fat is an insulator, retaining heat rather than transferring (conducting) it to adjacent tissue layers. Patients should not lie on 54 Physiotherapy Canada, Volume 62, Number 5 top of hot packs or pads, as pressure sufficient to compress skin capillaries (>32 mmHg) compromises the normal protective reflex vasodilatation response, a mechanism that protects skin from thermal injury. Monitor Vital Signs and Watch for Sudden Changes in Blood Pressure and Syncope Persons with orthostatic hypotension, recent traumatic injury, or history of cardiovascular deficiency are particularly susceptible to heat treatments that cause a sudden change in surface temperature (intense heat) and to applications that involve large areas of the body surface (hydrotherapy tanks). Use a Bell and Timer Provide enough instruction for the patient to understand the expected thermal sensation and how an unwanted response might manifest or feel. A bell that is sufficiently loud to attract your attention should be left within the patient's reach, with specific instructions as to when the bell should be used. A timer will remind you to return and check on the patient regularly. Take the timer with you if you are not likely to hear it when you leave the patient. Observe Precautions When Treating Open Wounds Discharge from open wounds can contaminate heating agents designed for multi-patient use. Opportunistic bacteria such as Pseudomonas aeruginosa inhabit hot tubs and may pose a risk to some individuals.19 Avoid immersing hands and feet with open skin lesions in paraffin wax baths; instead, wax can be ladled over affected limbs once skin lesions have been covered with protective barriers. Avoid Pre-treatment of the Area with Superficial Liniments Monitor use of liniments before applying superficial heat. Many topical agents produce vasodilatation, and in such instances adding heat could lead to a burn. Wash skin before treatment, especially prior to applying paraffin wax. REFERENCES 1. Nadler SF, Prybecien M, Malanga GA, Sicher D. Complications from therapeutic modalities: results from a national survey of athletic trainers. Arch Phys Med Rehabil. 2003;84:849-53. doi:10.1016/S0003-9993(02)04955-9 2. Barillo DJ, Coffey EC, Shirani KZ, Goodwin CW. Burns caused by medical therapy. J Burn Care Rehabil. 2000;21:269-73. doi:10.1097/00004630-200021030-00016 3. Balakrishnan C, Rak TP, Melinger MS. Burns of the neuropathic foot following use of therapeutic footbaths. Burns. 1995;21:622-3. doi:10.1016/0305-4179(95)00045-D 4. Gosselin TK. Thermal wounds following heat pad use. Clin J Oncol Nurs. 2003;7:1-2. doi:10.1188/03.CJON.87-88 5. Schmidt KL. Heat, cold, and inflammation. Rheumatology. 1979;38:391-404. doi:10.1111/j.l471-4159.2007.04698.x 6. Fiscus KA, Kaminski TW, Powers ME. Changes in lower-leg blood flow during warm-, cold- and contrast-water therapy. Arch Phys Med Rehabil. 2005;86:1404-10. doi:10.1016/j.apmr.2004.11.046 7. Shalom A, Friedman T, Wong L. Burns and diabetes. Ann Burns Fire Disasters. 2005;18:1-6. 8. Petrofsky JS, Besonis C, Rivera D. Circulatory response to hydrotherapy and dry heat in individuals with type 2 diabetes. Int J Ther Rehabil. 2005;12:491-7. 9. Boldt LH, Fraszl W, Rocker L, Schefold JC, Steinach M, Noack T, et al. Changes in the haemostatic system after thermoneutral and hyperthermic water immersion. Eur J Applied Physiol. 2008;102:547-54. doi:10.1007/s00421-007-0620-7 10. Astrup A, Simonsen L, Bulow J, Christensen NJ, Am J. Measurement of forearm oxygen consumption: role of heating the contralateral hand. Am J Physiol. 1988;255:E572-8. 11. Marshall JM, Stone A, Johns EJ. Analysis of the responses evoked in the cutaneous circulation of one hand by heating the contralateral hand. J Auton Nerv Syst. 1991;32:91-9. doi:10.1016/ 0165-1838(91)90059-C 12. Shiota K, Orpitz JM. Neural tube defects and maternal hyperthermia in early pregnancy: epidemiology in a human embryo population. Am J Med Genet. 1982;12:281-8. doi:10.1002/ajmg,1320120306 13. Kalter H, Warkany J. Congenital malformations: etiological factors and their role in prevention. N Engl J Med. 1983;308:424-31. doi:10.1056/NEJM198302243080804 14. Santilli SM, Valusek PA, Robinson C. Use of a non-contact radiant heat bandage for the treatment of chronic venous stasis ulcers. Adv Wound Care. 1999;12:89-93. 15. Burns SP, Conin TA. The use of paraffin wax in the treatment of burns. Physiother Can. 1987;39:258-60. 16. Head MD, Helm PA. Paraffin and sustained stretching in the treatment of burn contractures. Burns. 1977;4:136-9. doi:10.1016/0305-4179(77)90131-0 17. Helm PA, Kevorkian CG, Lushbaugh M. Burn injury: rehabilitation management in 1982. Arch Phys Med Rehabil. 1982;63:6-16. 18. Fyfe M. Skin temperature, color, and warmth felt, in hydrocolla-tor pack applications to the lumbar region. Aust J Physiother. 1982;28:12-6. 19. Speert DP. Molecular epidemiology of Pseudomonas aeruginosa. Front Biosci. 2002;7:354-61. doi:10.2741/speert ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS 7. Cryotherapy SUMMARY OF RECOMMENDATIONS (J Do NOT use the EPA to treat in this condition or body location. Superficial cold should not be applied • to persons with cold urticaria (also called cold allergy or cold hypersensitivity) • to persons with Raynaud's disease • to persons with cryoglobulinemia • to persons with hemoglobulinemia • to areas of impaired circulation • to areas near chronic wounds • over regenerating nerves • to tissues affected by tuberculosis • to haemorrhaging tissue or in persons with untreated haemorrhagic disorders • to areas with impaired circulation • to persons with active deep vein thrombosis or thromophlebitis • to anterior neck and carotid sinus Home cold-therapy programmes should NOT be prescribed for • persons with cognition or communication problems that interfere with their ability to follow directions. /P\ Superficial cold can be applied with caution to • areas of impaired sensation that prevent people from giving accurate and timely feedback • infected tissues • tissue near or over eyes • damaged or at-risk skin Cold therapy that is intense or applied to a large surface sufficient to produce generalized peripheral vasoconstriction should be applied with caution to • people with hypertension • people with cardiac failure Experienced clinicians may elect to treat this condition/location with caution (e.g., at lower intensities and/or with more frequent monitoring). © This condition/scenario or body location is NOT contraindicated. Superficial cold can be used on • tissues over active epiphysis • intact skin overlying implants containing metal, plastic, or cement • skin overlying electronic devices • regions of known or suspected malignancy • the low back and abdomen of pregnant women • recently radiated tissues • reproductive organs • areas affected by skin diseases • the chest, heart, and head • tissues inflamed as result of recent injury or exacerbation of chronic inflammatory condition EPA = electrophysical agent; Cryotherapy includes all forms of cold conductive agents. 55 56 Physiotherapy Canada, Volume 62, Number 5 Table 6 Consensus and Recommendations on Cryotherapy* Resources % (n= 11) Can/US % (n = 8) APA CSP Adverse Reaction** Research Evidence** Recommendation For Details See Conditions Cold urticaria or hypersensitivity 100 75 N/A c Serious Strong © 7-1 Raynaud's disease/vasospasm 100 75 N/A c Serious Strong © 7-2 Cryoglobulinemia 82 75 N/A c Serious Strong © 7-3 Hemoglobulinemia 64 75 N/A N/A Serious Strong © 7-4 Impaired circulation 82 75 C C Minor Moderate © 7-5 Haemorrhagic conditions S 13 C C Moderate Moderate © 7-6 Chronic wounds 27 N/A C P Minor Moderate © 7-7 Impaired sensation 36 63 P P Minor Moderate A 7-8 Superficial regenerating nerve 27 N/A N/A N/A Minor Strong © 7-9 Impaired cognition or communication 11 38 P C Minor Strong © 7-10 Hypertension N/A N/A N/A N/A Moderate Strong © Systemic A Local 7-11 Infection Tuberculosis 9 25 S P Moderate Moderate © Systemic A Local • TB 7-12 Deep vein thrombosis Thrombophlebitis S N/A c P Serious Absent • N/A continued on page 57 7. Cryotherapy 57 continued from page 56 Resources % (n= 11) Can/US % (n = 8) APA CSP Adverse Reaction** Research Evidence** Recommendation For Details See Implants Metal implant S 25 N/A N/A Minor Absent © N/A Local Areas Eyes S 25 S C Moderate Absent A 7-13 Anterior neck Carotid sinus S N/A N/A P Serious Absent © N/A APA = Australian Physiotherapy Association guideline; Can/US = results of survey of North American experts; CSP = Chartered Society of Physiotherapy guideline; C = contraindication; C-local = contraindication over the site; NA = not addressed; P = precaution; S = safe; Systemic = cold therapy is applied in a manner that lowers body temperature (causes shivering); Local = cold is applied to a small localized area of the body not likely to produce changes to core body temperature; Cryotherapy includes all forms of cold conductive agents * This table shows the percent (raw) agreement of commonly cited contraindications for cryotherapy (e.g., ice, cold packs) by North American experts (Can/US; n < 8) and authors of textbooks (Resources; n = 11). An interpretation of the Australian (APA) and Chartered Society of Physiotherapy (CSP) guidelines is shown. A recommendation is given for each condition based on an interpretation of the risk of adverse reactions and the strength of the supporting evidence. ** Readers should consult the Introduction for criteria used to rank adverse reactions, research evidence, and recommendations. SUPERFICIAL COLD: RECOMMENDATIONS, RATIONALE, AND REFERENCES 7-1 Cold Urticaria/Hypersensitivity Recommendation © Avoid applying superficial cold to persons who are known to have this relatively rare condition. Patients who develop an allergic-type reaction (weals, swelling, erythema) after cold therapy should be advised to consult a physician. Rationale Affected individuals usually develop local reactions to ice application (weals, swelling, and erythema). In severe cases, the condition causes a systemic histamine response (sneezing, bronchospasm, and dysphasia) that may progress to anaphylaxis. Loss of consciousness can occur due to a large drop in blood pressure as a result of generalized vasodilatation. Research Evidence STRONG Cold urticaria produced by ice application has been reported in the literature.1-9 7-2 Raynaud's Disease, Raynaud-Like Phenomenon Recommendation © Avoid applying cold to hands and feet that show signs of cyanosis and/or pallor or to individuals with a history of vascular hyperactivity to cold (i.e., reversible vasospasm disproportionate to the triggering event in terms of its duration, diffusion, and intensity). Rationale In Raynaud's disease, the blood vessels are commonly in a state of vasospasm, which would be exacerbated by applying cold. Prolonged vasoconstriction can lead to thrombus formation, tissue ischemia, and necrosis. Research Evidence STRONG Application of cold to distal extremities can trigger vasospasm in digital arteries.1011 58 Physiotherapy Canada, Volume 62, Number 5 7-3 Cryoglobulinemia Recommendation © Cryotherapy should not be used on persons who are known to have this condition. Rationale Cryoglobulins are serum proteins that precipitate at 4°C (39.2°F) and redissolve after warming to 37°C (98.6°F). The condition may occur in the absence of any other disease but is commonly associated with hepatitis C virus and with collagen-vascular disorders. Mononeuropathy or symmetric polyneuropathy occurs in 7-15% of individuals. Research Evidence STRONG Cooling tissues causes aggregation of serum proteins, which can obstruct blood vessels (thrombosis) and cause tissue ischemia and necrosis.1213 7-4 Haemoglobulinemia (Cold Agglutinin Syndrome) Recommendation © Cryotherapy should not be used on persons who are known to have this autoimmune haemolytic disease. If a patient experiences a first occurrence of symptoms during or following cryotherapy, he or she should be referred to a physician for assessment. Rationale Affected persons are typically middle-aged or elderly. Symptoms include fatigue; shortness of breath and weakness with exertion; dark urine (especially in cold weather); and severe pallor of fingers, toes, ears, and nose when exposed to cold. Individuals may report haematuria (red-purple urine) after cryotherapy treatment. Research Evidence STRONG The symptoms are due to chronic haemolytic anaemia. Haemoglobin is released into the urine as a result of cold-induced haemolysis of red blood cells.14 7-5 Impaired Circulation Recommendation d Avoid using cryotherapy on ischemic tissues. Rationale Poorly perfused tissues appear cyanotic, mottled or pale, shiny, hairless, and cold to touch. The distal lower extremities are usually the most affected by arterial disease. Research Evidence MODERATE Thermoregulation is impaired when circulation is compromised (e.g., in diabetes), and the distal extremities become highly susceptible to temperature extremes. Cold-induced vasoconstriction may compromise tissues already deprived of oxygen and thus increase the risk of tissue damage.15 Hypoxia may alter the coagulation cascade, which may precipitate a thrombotic event.16 7-6 Haemorrhagic Conditions Recommendation Systemic Avoid reducing core body temperature (indicated by shivering) via excessive duration or extent of ice application. Cold therapy alone is not sufficient to stop uncontrolled bleeding (e.g., post surgery or trauma, or in patients with coagulopathy or uncontrolled haemophilia) and is always applied in conjunction with other measures. In cases of haemophilia, cold can be applied after the patient has received replacement factor. Rationale Hypothermia can interfere with platelet function. Therefore, prolonged cold can have the unintended effect of delaying haemostasis and increasing bleeding. Intermittent cold therapy (e.g., applied for 10-20 minutes and repeated every 2 hours) is not likely to alter core temperature. Research Evidence MODERATE Perioperative reduction in core body temperature impairs platelet activation.16-18 7. Cryotherapy 59 7-7 Chronic Wounds Recommendation © Prolonged ice treatment should be avoided in areas of surgical wounds for all persons immediately post surgery or post injury. Cryotherapy treatments should be avoided in the vicinity of a chronic non-healing wound. Rationale Reduction in tissue temperature impairs wound-healing processes, reduces tissue perfusion, and increases susceptibility to infection. Intermittent cryotherapy treatments are advisable post surgery and following acute injuries to help with symptom management while allowing tissue to return to normal physiological temperature between applications. Hypothermia-induced impairment of healing further compromises the closure of chronic non-healing wounds. Research Evidence MODERATE Cold induces vasoconstriction, decreases collagen synthesis, and compromises wound strength. Healing is arrested during and for 1 to 2 hours following tissue hypothermia induced by wound dressing changes.17'1920 Some wound applications have been developed expressly to maintain wound tissues at normal physiological temperature (37°C) in order to promote healing.21 Hypothermia following surgery reduces resistance to infection by impairing neutrophil function; conversely, maintaining normal physiological temperature after surgery is associated with lower incidence of infection.18 7-8 Impaired Sensation Recommendation A Use cryotherapy cautiously in patients who have a sensory disturbance (e.g., diabetes, post stroke). Monitor skin very closely when electing to treat in the presence of such conditions. Excessive or prolonged changes in skin colour are a sign of frostbite. Rationale In normally innervated skin, cryotherapy slows nerve-conduction velocity and ultimately blocks all sensation. Therefore, intact sensation should not be a prerequisite for cryotherapy. Importantly, patient feedback should not be the only information used to gauge the safe intensity or duration of treatment. Monitor skin changes frequently during treatments; marked skin pallor or blue-black colouring is an adverse sign and may indicate the development of frostbite. In persons with underlying loss of neurogenic control of the vascular system (e.g., diabetes, spinal-cord injury) the response to cold therapy can be highly atypical; the main concern is excessive vasoconstriction. Research Evidence STRONG Patients who are post stroke or who have diabetes or Complex Regional Pain Syndrome may experience a paradoxical burning sensation (allodynia) from cryotherapy.22 It has been hypothesized that cold can accelerate the progression of diabetic polyneuropathy by enhancing neuronal ischemia.23 There are many reported cases of skin injury (frostbite) as a result of cryotherapy.23-35 7-9 Regenerating Nerve Recommendation © Avoid applying cold directly over regenerating superficial nerves (e.g., peroneal, ulnar). Rationale Cold-induced neuronal ischemia may delay regeneration. Research Evidence MODERATE Cold can cause allodynia (burning sensation) after peripheral nerve injury.22 Applying cold to superficial nerves reduces nerve-conduction velocity, and excessive cooling has resulted in nerve injury.24-33 60 Physiotherapy Canada, Volume 62, Number 5 7-10 Impaired Cognition or Communication Recommendation © Ensure that patients understand the appropriate use of cold therapy and the risks of adverse reactions, particularly for patients using cold therapy as a home treatment (see "Safe Practice" below). Self-treatment should be discouraged in patients with an impaired ability to follow instructions. Rationale Tissue damage is a latent effect of excessive cooling. The evolving injury is seldom appreciated during treatment because of reduced pain awareness (numbness). Ice is readily accessible and inexpensive, and it may be used with no appreciation of its potential adverse effects. Research Evidence STRONG Adverse reactions (frostbite and nerve injuries) appear to be strongly associated with inappropriate techniques and prolonged or excessively cold applications.34-37 Many instances of cryotherapy-induced injury are associated with self-treatment. 7-11 Hypertension Recommendation Systemic Monitor vital signs when treating individuals with known cardiovascular disease. /p\ Local Rationale Cooling a large surface area may cause widespread peripheral vasoconstriction, leading to increased mean arterial blood pressure. In hypertensive individuals, cryotherapy should be discontinued if blood pressure becomes elevated. Research Evidence STRONG Cold increases sympathetic tone and produces peripheral vasoconstriction, which increases blood pressure.38-40 7-12 Infection, Tuberculosis Recommendation (J) Systemic • TB /P\ Local Monitor signs of advancing infection when treating individuals with localized infection. Avoid cooling a large body region to the point of lowering core body temperature. Do not apply cold to areas affected by tuberculosis. Rationale Although reducing tissue temperature limits bacterial growth, local tissue vasoconstriction reduces tissue oxygenation and polymorphonuclear leukocyte infiltration, which impairs host phagocytic activity against bacteria. Core hypothermia reduces defence against infection. Research Evidence MODERATE Cold increases sympathetic tone and produces peripheral vasoconstriction.38-40 Perioperative hypothermia is associated with greater incidence of postoperative wound infections.18 7-13 Eyes Recommendation A Application of cold in the vicinity of the eyes should be undertaken with caution. Rationale There is no literature to guide practice in this area. Facial skin is normally highly sensitive; therefore, it is likely that potentially damaging cold would cause discomfort, prompting a patient to ask for treatment to be terminated. Research Evidence ABSENT No reference found. 7. Cryotherapy 61 SAFE PRACTICE Prescribe Safe Treatment Schedules Recommended temperature of the cooling agent, method of application, and duration of treatment are specific to location and patient and should account for both volume and depth of target tissue. For example, 5 minutes might be appropriate for a hand injury but inadequate for a hamstring injury. Modest cooling may improve outcomes in acute injury; however, excessive cooling may cause greater damage.7 Generally, longer applications are associated with reports of frostbite and nerve injury. The re-warming period should be at least twice as long as the treatment time (1:2 ratio), although a 1:6 ratio is preferred (20 min on, 120 min off). Too-frequent application of cryotherapy increases the likelihood of frostbite.4144 Application of ice should be restricted to 10-15 minutes over areas of minimal subcutaneous fat and over superficial nerves. Decreased nerve-conduction velocity leading to transient and reversible nerve block occurs if nerve temperature is brought within —5°C to 0°C (23-32°F). Cryotherapy-induced nerve injuries are most common when cold is applied in conjunction with compression. For this reason, blood-flow restriction rather than cold-induced effects is believed by some to be the causative factor. Check capillary refill during application of ice combined with compression therapy to ensure that blood flow to the extremity is not limited.24-33"45-47 Prescribe Safe Treatment Methods The hierarchy of cooling, from most to least efficient, is as follows: ice-water immersion, crushed ice, frozen peas, gel pack. If a patient has risk factors for an adverse reaction to cooling (e.g., impaired sensation, advanced age), then the clinician should select a mode with less cooling potential. The rate of skin cooling is reduced by placing a layer of dry towel between the cooling agent and the skin.47 49 An insulating layer should always be used when applying ice over wound staples or recent surgical wounds. Prevent Skin Burn When Using Commercial Cold Gel Packs Cold gel packs stored in a freezer have a surface temperature below 0°C (32°F). An insulating layer should be used between the cold pack and the patient's skin. Commercial gel packs should not be secured against the skin using elastic wraps.46 Longer application times may be required when a cooling agent is applied over an insulating layer (e.g., dry towel, dressing, or plaster cast).31 Monitor for Physiological Signs of General Body Cooling Shivering and piloerection are signs of generalized cooling and a decrease in core temperature, which may compromise patient safety. The application of therapeutic cryotherapy should produce only local effects. General cooling effects are more likely to occur in elderly patients, who have difficulty regulating body temperature, and in persons with elevated temperature (fever). Adequate draping of patients may be used to offset generalized effects.47 Avoid Cooling the Skin Prior to or During Electrical Stimulation Therapy Cryotherapy induces vasoconstriction and transient nerve block. There is a risk of thermal burn when electrical current, particularly interferential current, is applied in areas of reduced sensation and circulation. Awareness of increasing temperature and pain is a protective mechanism against thermal damage.50 Consider the Effect of Cold on Patient Performance Cryotherapy application slows conduction velocity, affecting sensory, motor, and autonomic nervous systems. As a result, local pain awareness, proprioception, muscle strength, agility, and dexterity are reduced immediately after cold application. Clinicians should use caution in prescribing activity immediately post cryotherapy because of the increased risk of injury or re-injury.5152 Sensory loss also counteracts potential effects of pain treatments that depend on intact sensory systems, such as TENS, IFC, and other pain-modulating currents.53 Avoid Prolonged Ice or Iced-Water Application after Burn The immediate application of cool water to a burn provides prompt relief of pain. However, excessive cooling of burned tissue can increase the severity of the injury by increasing tissue hypoxia.15 REFERENCES 1. Austen KF. Chapter 311. Allergies, anaphylaxis, and systemic mastocytosis. In: Fauci AS, Braunwald EB, Kasper DL, Hauser SL, Longo DL, Jameson JL, et al., editors. Harrison's principles of internal medicine. 17th edition. New York: McGraw-Hill; 1998. 2. Claus-Walker J, Halstead LS, Carter RE, Campos RJ, Spencer WA, Canzoneri J. Physiological responses to cold stress in healthy subjects with cervical cord injuries. 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Peroneal nerve palsy induced by cryotherapy. Phys Sport Med. 1989;17:63-70. 30. Malone TR, Englehardt DL, Kirkpatrick JS, Basset FH. Nerve injury in athletes caused by cryotherapy. J Athl Training. 1992;27:235-7. 31. Metzman L, Gamble JG, Rinsky LA. Effectiveness of ice packs in reducing skin temperatures under casts. Clin Orthop. 1996;330:217-21. doi:10.1097/00003086-199609000-00029 32. Moeller JL, Monroe J, McKeag DB. Cryotherapy-induced common peroneal nerve palsy. Clin J Sport Med. 1997;7:212-6. doi:10.1097/00042752-199707000-00011 33. Parker JT, Small NC, Davis DG. Cold-induced nerve palsy. Athl Training. 1983;18:76. 34. O'Toole G, Rayatt S. Frostbite at the gym: a case report of an ice pack burn. Brit J Sport Med. 1999;33:278-9. doi:10.1136/bjsm.33.4.278 35. Proulx RP. South Carolina frostbite. J Am Coll Emerg Phys. 1976;5:618. 36. Quist LH, Peltier G, Lundquist KJ. Frostbite of the eye lids following inappropriate applications of ice compresses. Arch Ophthamol. 1996;114:226. 37. Stevens DM, D'Angelo JV. Frostbite due to improper use of frozen gel pack. N Engl J Med. 1978;299:1415. doi:10.1056/NEJM197812212992516 38. Boyer JT, Fraser JRE, Doyle AE. The haemodynamic effects of cold immersion. Clin Sci. 1960;19:539. 39. Kim JY, Jung KY, Hong YS, Kim JI, Jang TW, Kim JM. The relationship between cold exposure and hypertension. J Occup Health. 2003;45:300-6. doi:10.1539/joh.45.300 40. Waylonis GW. The physiological effect of ice massage. Arch Phys Med Rehabil. 1967;48:37-42. 41. Bassett FH, Beal Covington D. When cryotherapy injures: the danger of peripheral nerve damage. Physician SportsMed. 1993;21:78-93. 42. Graham C, Stevenson J. Frozen chips: an unusual cause of severe frostbite injury. Brit J Sport Med. 2000;34:382-4. doi:10.1136/ bjsm.34.5.382 43. Karunakara RG, Lephart SM, Pincivero DM. Changes in forearm blood flow during single and intermittent cold application. J Orthop Sport Phys Ther. 1998;29:177-80. 44. Selfe J, Hardaker N, Whitaker J, Hayes C. Thermal imaging of an ice burn over the patella following clinically relevant cryotherapy application during a clinical research study. Phys Ther Sport. 2007;8:153-8. doi:10.1016/j.ptsp.2007.04.001 45. Barlas D, Homan CS, Thode HC Jr. In vivo tissue temperature comparison of cryotherapy with and without external compression. Ann Emerg Med. 1996;28:436-9. doi:10.1016/S0196-0644(96)70011-2 46. Cuthill JA, Cuthill GS. Partial-thickness burn to the leg following application of a cold pack: case report and results of a questionnaire survey of Scottish physiotherapists in private practice. Physiotherapy. 2006;92:61-5. doi:10.1016/j.physio.2005.06.004 47. Collins KJ, Dore C, Exton-Smith AN, Fox RH, MacDonald IC, Woodward PM. Accidental hypothermia and impaired temperature homeostasis in the elderly. Brit Med J. 1977;1:353-6. doi:10.1136/bmj.1.6057.353 48. Kennet J, Hardaker N, Hobbs S, Selfe J. Cooling efficiency of four common cryotherapeutic agents. J Athl Training. 2007;42:343-8. 49. Tsang KKW, Buxton BP, Guion WK, Joyner AB, Browder KD. The effect of cryotherapy applied through various barriers. J Sport Rehabil. 1997;6:343-54. 50. Satter EK. Third-degree burns incurred as a result of interferential current therapy. Am J Dermatopathol. 2008;30:281-3. doi:10.1097/DAD.0b013e31816a9d4f 51. Hatzel B, Kaminski T. The effects of ice immersion on concentric and eccentric isokinetic muscle performance in the ankle. Isokinet Exerc Sci. 2000;8:103-7. 52. Tremblay F, Estephan L, Legendre M, Sulpger S. Influence of local cooling on proprioceptive acuity in the quadriceps muscle. J Athl Training. 2001;36:119-23. 53. Newing AB, Tsang KKW, Thomas KE, Hand JW. Concomitant application of ice and electrical stimulation does not improve pain threshold. J Athl Training. 2008;43:S-85. ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS 8. Short-Wave Therapy SUMMARY OF RECOMMENDATIONS r7> All forms of short-wave therapy (thermal or non-thermal) should not be applied to l c J • persons with known or suspected malignancy • pregnant women (anywhere) • persons with electronic implants Do NOT use the EPA to treat • persons with active deep vein thrombosis or thrombophlebitis person with this condition or in • persons with tuberculosis this body location. • recently radiated tissues • heart, anterior neck region, or carotid sinus • actively bleeding tissue or persons with untreated hemorrhagic disorders Thermal doses of short-wave therapy (including PSW) should not be applied [in addition to those listed above] • to areas of impaired circulation • to areas of impaired sensation that prevent the patient from giving accurate and timely feedback • to areas with ceramic-, plastic-, or cement-containing implants • to persons with metal implants • to persons with heat-sensitive skin diseases (e.g., eczema) • to persons with a fever • to areas of skin damage or severe edema • to infected tissues • to tissues inflamed as result of recent injury or exacerbation of chronic inflammatory condition • over areas of the body covered with a thick layer of adipose tissue (obesity) • to eyes • to persons with cognition or communication impairments sufficient to prevent them from giving accurate and timely feedback • over lung fields • to reproductive organs • to areas with regenerating nerves A Thermal short-wave can be applied with caution to / P\ • persons with cardiac disease or cardiac failure / r \ • areas of damaged or at-risk skin or chronic wounds • active epiphysis Experienced clinicians may elect Non-thermal short-wave therapy can be applied with caution to treat this condition/location • to areas with impaired circulation with caution (e.g., at lower • to infected tissues intensities or with more frequent • in persons with cognitive or communication impairments sufficient to prevent them from giving monitoring). accurate and timely feedback • to areas with regenerating nerves • to persons with heat-sensitive skin diseases (e.g., eczema) • to eyes continued on page 64 63 64 Physiotherapy Canada, Volume 62, Number 5 continued from page 63 Non-thermal short-wave therapy can be used on ( s ) • areas overlying metal implants VaA • tissues inflamed as result of recent injury or exacerbation of chronic inflammatory condition v— • areas of damaged or at-risk skin, chronic wounds This condition/scenario or body location is NOT contraindicated. • areas with a thick layer of adipose tissue (obesity) • areas of impaired sensation that prevent the patient from giving accurate and timely feedback • reproductive organs • lung fields • areas with ceramic-, plastic-, or cement-containing implants EPA = electrophysical agent; PSW = pulsed short-wave; SWT = short-wave therapy, including all forms of short-wave; Thermal Short-Wave Therapy = SWT producing perceptible skin warming and subcutaneous/deep tissue temperature increases of at least 1°C (using continuous-mode short-wave, pulsed short-wave, or pulsed radiofrequency energy); Non-thermal Short-Wave Therapy = SWT that does NOT produce perceptible skin warming but may slightly increase subcutaneous/deep-tissue temperature (using continuous-mode short-wave, pulsed short-wave, or pulsed radiofrequency energy) Table 7 Consensus and Recommendations on Thermal and Non-thermal Short-Wave Therapy (SWT)* Resources % (n = 12) Can/US % (n < 8) APA CSP Adverse Reaction** Research Evidence** Recommendation For Details See SWT Thermal SWT Nonthermal SWT SWT SWT SWT/PSW SWT/PSW Thermal SWT Nonthermal SWT Conditions Pregnancy 83 100 (n = 8) 100 (77=7) C c Serious Strong © © 8-1 Malignancy 67 100 (n = 8) 100 (77=7) c C-local Serious Moderate © © 8-3 Acute inflammation 75 100 (77=8) S (77=7) c P Minor Moderate © © 8-7 Infection Tuberculosis 42 100 (n = 8) 100 (77=6) c C Serious Low © A 8-8 Recently radiated tissue 17 88 (n = 7) 83 (77=6) c P Serious Absent © © 8-9 Impaired sensation 67 100 (77=8) 29 (77=7) c P Serious Low © © 8-12 Impaired cognition or communication 42 88 (77=8) 14 (77=7) c C Moderate Absent © A 8-13 Superficial regenerating nerve S N/A N/A N/A N/A Minor Low © A 8-14 Deep vein thrombosis Thrombophlebitis 33 100 (77=8) 57 (77=7) C N/A Serious Low © © 8-15 Haemorrhagic conditions 83 100 (77=8) 50 (77=6) C C Serious Low © © 8-16 Impaired circulation 75 100 (77=8) 33 (77=6) C C Serious Moderate © A 8-17 Obesity P N/A N/A N/A N/A Minor Low © © 8-18 continued on page 65 8. Short-wave Therapy 65 continued from page 64 Resources % (n = 12) Can/US % (n < 8) APA CSP Adverse Reaction** Research Evidence** Recommendation For Details See SWT Thermal SWT Nonthermal SWT SWT SWT SWT/PSW SWT/PSW Thermal SWT Nonthermal SWT Skin disorders Severe edema 50 88 (n = 7) 33 (n = 6) N/A N/A Minor Absent © A 8-20 8-7 Chronic wounds S N/A N/A N/A N/A Minor Low A 8-20 Fever 25 N/A N/A C N/A Moderate Absent © © N/A Active epiphysis 42 N/A N/A N/A C Moderate Absent A A N/A Implants Plastic/cement implants Synthetic materials 25 45 (n = 7) S (n = 6) N/A N/A Minor Low © © 8-4 Metal implants 83 88 (n = 8) 29 (n = 7) C C Moderate Low © © 8-5 Electronic implants 92 100 (n = 8) 71 (n = 7) C C Serious Strong © © 8-6 Local Areas Reproductive organs 67 100 (n = 8) 67 (n = 6) C C Serious Low © © 8-2 Heart Neck region S N/A N/A N/A P Serious Low © © 8-10 Chest Lungs S N/A N/A N/A N/A Moderate Absent A © 8-11 Eyes 58 100 (n = 8) 86 (n = 7) C C Moderate Absent © A 8-19 APA = Australian Physiotherapy Association guidelines; Can/US = results of survey of North American experts; CSP = Chartered Society of Physiotherapy guidelines; C = contraindication; C-local = contraindication over the site; N/A = not addressed; P = precaution; S = safe; PSW = pulsed short-wave; SWT = short-wave therapy (including all forms of short-wave); Thermal = Thermal SWT (produces perceptible skin warming and tissue temperature increases of at least 1°C); Non-thermal = Non-thermal SWT (does NOT produce perceptible warmth but may increase tissue temperature slightly) * This table shows the percent (raw) agreement of commonly cited contraindications by North American experts (Can/US; n < 8) and authors of textbooks (Resources; n = 12). An interpretation of the Australian (APA) and Chartered Society of Physiotherapy (CSP) guidelines is shown. A recommendation is given for each condition based on an interpretation of the risk of adverse reactions and the strength of the supporting evidence. Readers should consult the Introduction for criteria used to rank adverse reactions, research evidence, and recommendations. 66 Physiotherapy Canada, Volume 62, Number 5 SHORT-WAVE THERAPY (SWT): RECOMMENDATIONS, RATIONALE, AND REFERENCES 8-1 Pregnancy Recommendation © Thermal and non-thermal forms of SWT should not be applied to pregnant women. Rationale Hyperthermia and electromagnetic fields are known to have negative effects on fetal development. Research Evidence STRONG Adverse birth outcomes have occurred in women who received pelvic SWT treatment during early pregnancy. A negative association between exposure to SWT in the workplace and birth outcomes for physiotherapists has been reported but has not been clearly substantiated.1-4 Embryolethal effects of non-thermal SWT have been reported in animal studies5 and teratogenic effects have been demonstrated in guinea pigs using SWT at intensities that produced significant maternal hyperthermia. 8-2 Reproductive Organs Recommendation (^) Thermal (j^) Non-thermal Thermal SWT should not be directed at the testes of men or the pelvic region of menstruating women. Rationale It is known that hyperthermia can cause sterility in men; local heat may increase menstrual flow. The APA and CSP guidelines do not differentiate between thermal and other forms of SWT. Research Evidence LOW Historically, infections of the female reproductive tract were treated using a minimally perceptible dose of SWT. There are no reports of this treatment's having produced adverse effects.6 Other gynaecological and obstetric conditions causing lower-abdominal or perineal pain have been treated using non-thermal SWT (7.4 W mean power), and some authors have reported a benefit from this treatment.7-9 8-3 Malignancy Recommendation O All forms of SWT should be avoided in persons with known or suspected malignancy. Abnormal growth should be regarded as malignant until the diagnosis has been confirmed. Rationale Tumour growth can increase as a result of enhanced circulation associated with an increase in tissue temperature and of up-regulation (increase) of cellular activity associated with non-thermal SWT. Research Evidence LOW No reference found. 8. Short-Wave Therapy 67 8-4 Plastic Implants Recommendation (^) Thermal (j^) Non-thermal Do not apply thermal SWT over implants fixed with acrylic bone cement. Do not apply thermal SWT over metal-plastic implants until further research is performed. Non-thermal SWT can safely be applied in the vicinity of metal-plastic implants. Rationale Plastic is an inert substance. However, plastic implants (e.g., stents, joint replacements) are commonly constructed of plastic polymers with added conductive materials (e.g., carbon-fibre-reinforced plastic), and such implants are affected by electromagnetic fields (e.g., development of radiofrequency eddy currents; distortion, depending on the shape of the implant and whether it is tubular). Until more information is available, thermal effects should be avoided. Plastic (non-conductive) materials and materials used to fix plastic prostheses are affected by high temperatures. Although SWT sufficient to produce these effects would not likely be tolerated by conscious individuals, safe practice suggests not using thermal SWT around these materials. Research Evidence LOW Electromagnetic field effects have been shown for some metal-plastic materials.10 Water-saturated acrylic bone cement becomes rubbery and soft at temperatures of 60-70°C.11 Some thermoplastic material (e.g., materials used in oral surgery) must be heated to 63°C to attain moldability.12 8-5 Metal Implants Recommendation (J) Thermal (jT) Non-thermal Thermal SWT should not be used in the vicinity of implanted metal until further research is performed. Non-thermal SWT can safely be applied in the vicinity of implanted metal. Thermal and non-thermal SWT are likely safe in women fitted with copper-bearing intrauterine devices (lUDs). Rationale Metal is readily polarized in an electromagnetic field and, therefore, distorts the electrical field. Although the metal itself does not heat, a soft-tissue burn could potentially occur at each end of an implanted metal rod as a result of intensification of the electrical field. The CSP guidelines suggest that SWT can be applied over metal provided that mean power output does not exceed 5 W. However, there is not 100% consensus on this issue. Research Evidence MODERATE Pulsed SWT using mean power of 48 W has been used with benefit and without adverse effects over implanted metal involving elbow and ankle joints in a few patients; placement of the implants was examined radiographically in each patient to determine safety.2'13-15 The effects of SWT directed at the uterus appear very similar in the presence of copper-bearing versus non-copper-bearing lUDs: intrauterine temperature increased less than 1°C following a 20-minute application.1617 8-6 Electronic Devices Recommendation © No form of SWT should be used in any circumstance within 3 m of a person wearing an electronic implant. This contraindication applies regardless of the body site or the type of implanted device. Hearing aids and any externally worn medical device should be removed prior to treatments involving SWT. Rationale Some types of pacemaker are not affected by operating SWT units. However, because of the diversity of pacemaker and cardiac defibrillator devices, it is safest that persons with any type of pacemaker never be treated with or permitted within 3 m of an operating SWT unit. Research Evidence STRONG Not all types of pacemakers are affected by short-wave treatments.18 The FDA Centre for Devices and Radiological Health reported that brain damage occurred in two patients with implanted deep brain stimulators who were directly exposed to SWT.19-23 68 Physiotherapy Canada, Volume 62, Number 5 8-7 Acute Injury, Inflammation, Edema Recommendation (^) Thermal (j^) Non-thermal Avoid thermal SWT in cases of acute swelling. PSW treatment is safe in acute inflammation (e.g., sprains, strains, tendonitis). In cases of severe swelling, treatment should be started using low mean power output, approximately 24 W, and increased gradually up to 32 W at follow-up treatments as the condition improves. Rationale Adding heat to already inflamed tissue (indicated by redness, swelling, heat, and pain) may further increase the inflammatory response and exacerbate pain. Excessive swelling can cause ischemia and tissue necrosis. Tissues of high water content heat relatively more than drier tissues; heating may therefore be atypically high in the presence of gross edema. Research Evidence MODERATE PSW applied at intensities below 32 W has been used safely to treat acute injuries.2425 8-8 Infection, Tuberculosis Recommendation (J) Thermal © TB /p\ Non-thermal Thermal SWT should not be used on persons with a body temperature above the physiological norm (37°C) or directly targeted at infected tissue. Non-thermal SWT can be applied to treat low-grade chronic infection (e.g., salpingitis). Patients should be monitored closely to check for exacerbation of symptoms. Thermal and non-thermal SWT should not be used on persons with tuberculosis. Rationale Bacterial growth increases with a modest rise in host tissue temperature. The CSP guidelines specifically recommend avoiding thermal SWT for persons with TB. Research Evidence LOW Historically, infections of the female reproductive tract were treated using a minimally perceptible dose of SWT. There are no reports of this treatment's having produced adverse effects.6 The specific effects of SWT on TB have not been studied. 8-9 Recently Radiated Tissue Recommendation O Avoid all forms of SWT over recently radiated tissue. Rationale There may be a risk of stimulating growth of any remaining malignant cells. Recently radiated tissue may respond atypically because of the presence of radiation-induced inflammation, scar tissue, and the cellular or circulatory effects of radiation therapy. The APA recommends avoiding treatment for 3 to 6 months after radiation. Research Evidence ABSENT No reference found. 8-10 Heart, Anterior Neck Recommendation © Thermal SWT should not be directed at the heart or major blood vessels in the anterior neck region. Rationale There is a risk of increasing blood volume to the head. Research Evidence ABSENT The effects of SWT directed at the heart and major blood vessels in the neck have not been studied. 8. Short-Wave Therapy 69 8-11 Chest/Lungs Recommendation Thermal (j^) Non-thermal Experienced clinicians may elect to apply mild thermal SWT or PSW to lung fields; however, further research is needed to substantiate the safety of this treatment. Rationale The effects of applying strong warmth through the chest and lungs are unknown. Research Evidence LOW Clinical application of mild thermal SWT accelerated resolution of small spontaneous pneumothoraces; no adverse effects were reported.26 8-12 Impaired Sensation Recommendation (J) Thermal (j^) Non-thermal Thermal SWT should not be used on patients who cannot detect changes in skin temperature. Non-thermal SWT can be safely applied at a mean power that does not produce visible skin erythema during treatment. Rationale Because subjective skin warmth is used as a guide for treatment intensity, accurate patient feedback is necessary to prevent tissue burn. In the absence of intact skin sensation, PSW should be restricted to applications using mean power <32 W. Research Evidence LOW In one study, healthy subjects on average reported perceptible skin warmth at mid-thigh using a drum electrode and PSW at a mean power of approximately 21 W. It is not clear why this low-power treatment produced perceptible warmth; the skin-electrode distance was not described.27 Non-thermal PSW has been used in persons with spinal-cord injury, with no adverse effects reported2829 8-13 Impaired Cognition or Communication Recommendation Thermal /p\ Non-thermal Avoid thermal SWT when a person cannot reliably follow instructions or give appropriate feedback. Experienced clinicians may elect to apply non-thermal PSW to patients who cannot communicate or follow instructions; continuous close monitoring of the patient is advised. Rationale Safety and efficacy may be compromised by applying heat to a patient who cannot report his or her perception of heat. Monitoring is necessary when using PSW to ensure that there is no tampering with equipment or moving of a body part in relation to electrodes. Research Evidence ABSENT PSW has been used to treat pressure ulcers in elderly institutionalized persons, some of whom were confused and unaware of the treatment; no adverse effects were reported.28 8-14 Regenerating Nerves Recommendation (J) Thermal /p\ Non-thermal Thermal SWT should be avoided over regenerating nerves. Non-thermal PSW can be applied with caution. Rationale There appears to be no literature on the effects of thermal SWT on peripheral nerve injury, and only pre-clinical research supporting non-thermal PSW treatment of peripheral nerves. Research Evidence ABSENT In an animal model, PSW accelerated regeneration following a crush injury to peripheral nerve; there was no effect on healthy nerves.3031 70 Physiotherapy Canada, Volume 62, Number 5 8-15 Active Deep Vein Thrombosis, Thrombophlebitis Recommendation © All forms of SWT should be avoided over the area of an active or suspected DVT. The area overlying a previous DVT that was treated using anti-coagulant therapy can be treated with caution. Rationale Thermal SWT can change regional blood flow, which in turn may dislodge or cause disintegration of a thrombus and potentially restrict circulation to vital organs. Possible effects of non-thermal PSW on platelet function and thrombus formation, or on absorption of a dissolving thrombus, have not been established. Research Evidence LOW Heat-induced changes in local blood flow have been demonstrated using other thermal agents.32 8-16 Haemorrhagic Conditions Recommendation All forms of SWT should be avoided over actively bleeding tissue. Application of non-thermal SWT should be delayed until haemostasis is established. SWT can be applied in persons with haemophilia after replacement factor has been administered. Rationale Heat causes local vasodilatation and increased blood flow, which can delay haemostasis and prolong bleeding. Possible effects of PSW on platelet function and blood clots have not been established. Research Evidence LOW Heat-induced changes in local blood flow have been demonstrated using other thermal agents.32 8-17 Impaired Circulation Recommendation (J) Thermal /p\ Non-thermal Thermal SWT should not be applied over areas where arterial supply is poor. Non-thermal SWT at low mean power can be applied with caution. Rationale There is an increased risk of skin burn when blood flow is compromised, because the vascular system is unable to dissipate the mounting heat. Distal extremities are most affected by arterial disease; therefore, it is important to check hands and feet for signs of arterial disease (thin, shiny, pale skin; cold to touch; thickened brittle nails). There is no literature on the use of PSW in persons with diabetic or venous ulcers; however, PSW has been used safely on pressure ulcers associated with spinal-cord injury. Although relief of pressure may reduce or eliminate the ischemic factor, applied heat will not be dissipated efficiently because of impaired vasodilator response. Research Evidence MODERATE PSW using average powers in the 6 W to 38 W range has been used with benefit on chronic Stage II and III pressure ulcers. Although tissue temperature would likely have increased slightly at average powers around 30 W, no adverse effects were reported.2833 8-18 Obesity Recommendation (J) Thermal (jT) Non-thermal In obese individuals, avoid applying thermal SWT to body regions with high fat content. Distal joints, such as foot/ankle and hand/wrist, can be treated safely. Non-thermal PSW is safe over regions with high fat content, but a thick layer of fat reduces the depth of the short-wave field. Rationale Adipose tissue retains heat. The intensity of an electric field is strongest closer to the source; thus, the field will be more intense in the subcutaneous fat layer than in underlying muscle. Research Evidence LOW The risk of burn is greater when thermal SWT is applied using capacitor- rather than inductive-type electrodes.2 8. Short-wave Therapy 71 8-19 Eyes Recommendation (^) Thermal /p\ Non-thermal Avoid thermal SWT near the eyes. Rationale Theoretically, heat could accumulate in the fluid-filled chamber of the eye, causing injury. Research Evidence ABSENT Barely perceptible thermal SWT was a popular treatment for sinusitis in the past; however, this practice was based on anecdotal evidence. Applications to treat frontal and nasal sinuses included the eye in the field. There appear to be no reports in the literature of adverse effects using this dated but purportedly effective treatment. 8-20 Skin Disease, Damaged or At-Risk Skin, Open Wounds Recommendation (J) Thermal (j^) Non-thermal Avoid thermal SWT in the presence of heat-sensitive skin lesions (e.g., eczema). PSW can safely be used to treat damaged skin or open wounds. Rationale Heat may exacerbate the intensity and extent of skin lesions in cases of eczema and dermatitis. Research Evidence LOW PSW using average powers in the 6 W to 38 W range has been used with benefit to treat chronic Stage II and III pressure ulcers.2833 SAFE PRACTICE Prepare the Patient Prior to Treatment Undress the body part to be treated. When undressing is not suitable, the patient can wear dry, lightweight, all-cotton clothing. Avoid synthetic fibres, which trap sweat against the skin. Dry the skin of perspiration in the area of application. Remove jewellery, watches, body rings, and so on from the body part to be treated or from areas within the field. Remove hearing aids. Contact lenses should be removed whenever the eye region is within a short-wave field. Historically, barely perceptible thermal SWT was used to treat sinusitis, and treatment included the orbital region; there are no reports of adverse effects of this treatment. Perform a Sensory Discrimination Test Test sensory integrity by asking patients to differentiate between hot and cold stimuli or between light touch and painful stimuli. Temperature discrimination and pain (a sharp pricking quality) are conveyed by spinothalamic tracts, whereas light touch is conveyed mainly by dorsal columns; thus, it is not sufficient to test light touch only. This sensory test should always be performed when using thermal SWT. Temperature change in an electromagnetic field depends on mean power of the treatment rather than on the use of continuous or pulsed mode.27'3435 In the event of poor sensory discrimination in the treatment area, the short-wave output should be restricted to a maximum of approximately 38 W mean power.14 PSW (mean power 38 W) has been used under close observation in confused or unconscious patients without complications.28 Avoid Surface Moisture Thermal SWT must not be applied over damp or wet skin surfaces; there is a risk of burn due to field concentration on the moist surface relative to surrounding dry areas. Wet wound dressings must be removed for thermal treatments. PSW using low mean power (not greater than 30 W) can be applied without removal of wet dressings. Ensure a Safe Treatment Environment Items of furniture used for the patient (beds, chairs, tables, etc.) should have no metal parts, and metal furniture (cabinets, beds, etc.) should be at least 2 m away from the SWT unit. Other types of electrical equipment should be at least 3 m away from operating SWT units. Secure electrode cables a 72 Physiotherapy Canada, Volume 62, Number 5 safe distance from the patient's body and keep paired cables apart along their full length (equal to the distance between the cable sockets).23>36 Give Clear and Complete Patient Instructions Patients need to understand that they should not touch electrode leads while the unit is active because the body part in contact with the leads becomes part of the electromagnetic field and could heat to the point of a burn. Glass or plastic covers over disc electrodes are inert and will not hurt the patient if accidentally touched; however, shifting closer to one electrode during treatment concentrates the field at that surface and may result in overheating and a potential burn. Patients should remain awake and alert during treatment, regardless of the mode of SWT.3'36-39 Monitor Patients during Treatment Check periodically that the patient has not shifted position and that electrode arrangement remains optimal for the body part being treated. Check periodically for skin erythema and reduce intensity accordingly, or discontinue SWT if adequate reduction in intensity cannot be achieved. Monitor Proximity of Staff and General Public to Operating Short-Wave Equipment After setting up patients on SWT and adjusting output, personnel should remain at least 2 m away from the unit, electrodes, and cables of short-wave devices operating with capacitor-type electrodes, and 1 m away from short-wave devices operating with inductive-type electrodes (drum or cable), to avoid unnecessary exposure to electromagnetic energy. Members of the general public should be kept an additional 0.5-1.0 m away from operating short-wave units. Studies on pregnancy outcomes for physiotherapists exposed to electromagnetic energy on numerous occasions prior to becoming pregnant appear to show no evidence of adverse effects, with the exception of one study that found evidence of low birth weight. It is not advisable for pregnant clinicians to work in close proximity to active short-wave devices, despite the inconclusive evidence of fetal harm.2"4.38.40.41 REFERENCES 1. Guberan E, Campana A, Faval P, Guberan M, Sweetnam PM, Tuyn JW, et al. Gender ratio of offspring and exposure to shortwave radiation among female physiotherapists. Scand J Work Environ Health. 1994;20:345-8. 2. Delpizzo V, Joyner K. On the safe use of microwave and shortwave diathermy units. Aust J Physiother. 1987;33:152-61. 3. Shields N, O'Hare N, Gormley J. Contra-indications to shortwave diathermy: survey of Irish physiotherapists. Physiotherapy. 2004;90:42-53. doi:10.1016/S0031-9406(03)00005-l 4. Shields N, O'Hare N, Gormley J. Short-wave diathermy and pregnancy: what is the evidence? Adv Physiother. 2003;5:2-14. doi:10.1080/14038190310005753 5. Lieb RJ, Regelson W, West B. Effect of pulsed high frequency electromagnetic radiation on embryonic mouse palate in vitro. J Dent Res. 1980;59:1649-52. 6. Balogun JA, Okonofua FE. Management of chronic pelvic inflammatory disease with shortwave diathermy. Phys Ther. 1988;68:1541-5. 7. Grant A, Sleep J, Mcintosh J, Ashurst H. Ultrasound and pulsed electromagnetic energy treatment for perineal trauma: a randomized placebo-controlled trial. Brit J Obstet Gynaecol. 1989;96:434-9. doi:10.1111/j.l471-0528.1989.tb02419.x 8. Punnonen R, Grongroos M, Liukko P, Rauramo L, Virtavuo T. The use of pulsed high-frequency therapy (Curapuls) in gynecology and obstetrics. Acta Obstet Gynecol Scand. 1980;59:187-8. doi:10.3109/00016348009154639 9. Rozen D, Ahn J. Pulsed radiofrequency for the treatment of ilioinguinal neuralgia after inguinal herniorrhaphy. Mt Sinai J Med. 2006;73:716-8. 10. Graf H, Steidle G, Lauer UA, Schick F. rf enhancement and shielding in MRI caused by conductive implants: dependence on electrical parameters for a tube model. Med Phys. 2005;32:337-42. doi:10.1118/l.1843351 11. Volz RG, Gradillas EL. Thermal deformation of polyethylene in a total knee prosthesis. J Bone Joint Surg Am. 1978;60:662-3. 12. Eppley BL, Sclaroff A, Altshuler L. Thermoplastic material for intraoral stent fabrication. J Oral Maxil Surg. 1985;43:913-4. 13. Draper DO, Castel JC, Castel D. Low-watt pulsed shortwave diathermy and metal-plate fixation of the elbow. Athlet Ther Today. 2004;Sep:28-32. 14. Capulong ES, Friedman LW, Rivera LM, Ducommun EJ. Temperature difference between pulsed and continuous short wave diathermy of metal implants and surrounding tissues. Arch Phys Med Rehabil. 1983;64:519?520. 15. Seiger C, Draper DO. Use of pulsed shortwave diathermy and joint mobilization to increase ankle range of motion in the presence of surgical implanted metal: a case series. J Orthop Sport Phys Ther. 2006;36:669-77. doi:10.2519/jospt.2006.2198 16. Heick A, Espersen T, Pedersen H, Raahauge J. Is diathermy safe in women with copper-bearing IUD's? Acta Obstet Gynecol Scand. 1991;70:153-5. 17. Nielsen NC, Hansen R, Larsen T. Heat induction in copper-bearing intrauterine devices during shortwave diathermy. Acta Obstet Gynecol Scand. 1979;58:495. 18. Heath J. The effects of short wave diathermy, microwave and ultrasonics on demand pacemakers and ventrical inhibited pacemakers. Aust J Physiother. 1974;20:144-5. 19. US Food and Drug Administration [FDA], FDA public health notification: diathermy interactions with implanted leads and implanted systems with leads [Internet], Rockville, MD: The Administration; 2002 Dec 19 [updated 2009 Jun 24; cited 2010 Aug 3], Available from: http://www.fda.gov/MedicalDevices/ Safety/AlertsandNotices/PublicHealthNotifications/UCM062167 20. Medtronic Canada Ltd. Ultrasound diathermy alert. 2001. 21. Health Canada Health Products and Food Branch Inspectorate. Active implantable medical devices and systems—advisories, warnings and recalls for hospitals [Internet]. Ottawa: The Inspectorate; 2005 Dec 19 Available from: http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2005/interact_medic_dev-inst_3_nth-aah-eng.php 22. Roark C, Whicher S, Abosch A. Reversible neurological symptoms caused by diathermy in a patient with deep brain stimulators: case report. Neurosurgery. 2008;62:E256. 8. Short-Wave Therapy 73 23. Shields N, O'Hare N, Gormley J. An evaluation of safety guidelines to restrict exposure to stray radio frequency radiation from short-wave diathermy units. Phys Med Biol. 2004;49:2999-3015. doi:10.1088/0031-9155/49/13/016 24. Barclay V, Collier R, Jones A. Treatment of various hand injuries by pulsed electromagnetic energy (Diapulse). Physiotherapy. 1983;69:186-8. 25. Pennington GM, Danley DL, Sumko MH, Bucknell A, Nelson JH. Pulsed non-thermal high-frequency electromagnetic energy (Diapulse) in the treatment of Grade I and II ankle sprains. Mil Med. 1993;158:101-4. 26. Ma Y, Li J, Liu Y. Short wave diathermy for small spontaneous pneumothorax. Thorax. 1997;52:561-2. doi:10.1136/thx.52.6.561 27. Murray CC, Kitchen S. Effect of pulse repetition rate on the perception of thermal sensation with pulsed short wave diathermy. 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Arch Phys Med Rehabil. 2005;86:1404-10. doi:10.1016/j.apmr.2004.11.046 33. Itoh M, Montemayor JS, Matsumoto E, Eason A, Lee MHM, Folk FS. Accelerated wound healing of pressure ulcers by pulsed high peak power electromagnetic energy (Diapulse). Decubitus. 1991;4:24-34. 34. Draper DO, Knight K, Fujiwara T, Castel JC. Temperature change in human muscle during and after pulsed short-wave diathermy. J Orthop Sport Phys Ther. 1999;29:13-22. 35. Garrett CL, Draper DO, Knight KL. Heat distribution in the lower leg from pulsed short-wave diathermy and ultrasound treatments. J Athl Training. 2000;35:50-5. 36. Shah SGS, Farrow A. Investigation of practices and procedures in the use of therapeutic diathermy: a study from the physiotherapists' health and safety perspective. Physiother Res Int. 2007;12:228-41. doi:10.1002/pri.382 37. Shields N, Gormley J, O'Hare N. Short-wave diathermy: current clinical and safety practices. Physiother Res Int. 2002;7:191-202. doi:10.1002/pri.259 38. Shields N, O'Hare N, Boyle G, Gormley J. Developnment and application of a quality control procedure for short-wave diathermy units. Med Biol Eng Comp. 2003;41:62-8. doi:10.1007/ BF02343540 39. Shields N, Gormley J, O'Hare N. Physiotherapist's perception of risk from electromagnetic fields. Adv Physiother. 2005:170-5. doi:10.1080/14038190500431834 40. Li CY, Feng CK. An evaluation of radiofrequency exposure from therapeutic diathermy equipment. Ind Health. 1999;37:465-8. doi:10.1088/0143-0815/11/1/005 41. Lerman Y, Jacubovich R, Green MS. Pregnancy outcome following exposure to shortwaves among female physiotherapists in Israel. Am J Ind Med. 2001;39:499-504. doi:10.1002/ajim,1043 ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS 9. Safe Practice Procedures for All Electrophysical Agent Treatments This section offers suggestions for best practice in the clinical application of all types of electrophysical agents (EPAs). The emphasis is on procedures to ensure safe practice. These procedures should be used in conjunction with those mandated by local physiotherapy regulatory bodies. Following the normal introduction and patient interview process, your decision to use an EPA as part of patient management will depend on the results of detailed assessment findings, including • the patient's physical and functional impairment (e.g., pain, swelling, mobility, function, disability), determined using valid outcome measures • the desired physiologic response (e.g., to stretch soft tissue, reduce muscle spasm, improve blood flow, produce analgesia, facilitate muscle action) and treatment goal • the type, location, depth, and volume of the target tissue (e.g., muscle, nerve, tendon, ligament, capsule, subcutaneous tissue) Based on your preliminary decision regarding use of an EPA, • Select the most appropriate EPA to achieve the treatment goals, taking into account both indications and possible contraindications. Screen the patient to ensure that there are no contraindications to the selected treatment. • Choose an application technique that is optimal for the clinical scenario (including dose parameters, electrode type and placement, treatment time, and patient position). • Explain to the patient what is involved in the treatment, including why you chose the EPA, what sensation(s) to expect, the expected treatment duration, and when benefit can be expected. • Outline the benefits of the intended treatment. • Explain the short- and long-term risks of the treatment. There are some risks that can never be entirely eliminated, even in healthy persons and when there are no contraindications (e.g., equip- ment malfunction, atypical patient response). Therefore, clinicians using EPAs must always inform the patient of the severity and likelihood of relevant risks prior to starting the treatment. Safe practice should be directed at applying EPAs in a manner that reduces the risk of adverse reactions and reduces the severity of an adverse reaction should one occur. Communication with the patient throughout the treatment will also help to prevent any unwanted effects. • Confirm that the patient understands the treatment and respond to any questions or concerns he or she may have. • Obtain consent to proceed from the patient or substitute decision maker. Once you have obtained consent, • Position the patient comfortably and with optimal access to the target tissue. Advise the patient whether or not it is necessary to remain still during the treatment. • Examine integrity and condition of the skin at the intended treatment site; test sensation. • Prepare the treatment area according to best practice for application of the selected energy form (e.g., clean the skin of products that might reduce transmission of light energy). • Start the EPA device; confirm that it is working properly (check power metres, thermometers, etc.) and that output is at zero. Set parameters. • Apply the EPA while talking to the patient and describing what he or she should feel. Apply the modality in a manner that uses good body mechanics, preserves patient comfort and safety, and optimizes delivery of the sound, thermal, light, or electrical energy. • Monitor patient's response every 5 minutes during treatment (ask, look, or feel) and adjust parameters appropriately. Note: If you plan to move away during the treatment, advise what is not desirable and how you can be summoned (bell, etc.). 74 Safe Practice Procedures for All Electrophysical Agent Treatments 75 When treatment terminates (use a timer), Turn dose controls to zero and switch off the device. Examine the treated area and explain any reactions to the patient. Document whether treatment was well tolerated or whether adverse reactions were observed or reported. Explain to the patient whether after-effects should be expected (stiffness, erythema, return of pain, etc.). • Reassess impairment using valid outcome measures. Document both subjective and objective findings, the possible resolution of impairments, and attainment of patient goals. • Record all treatment parameters in sufficient detail to enable another individual to apply the treatment. • Sign and print your name on the record to permit clarification of treatment if required and for medico-legal purposes. ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS Appendix 1: Summary Table of Consensus by Experts Table A1 Percent (raw) agreement on commonly cited contraindications for selected electrophysical agents (EPAs) by North American experts (n = 8, unless otherwise specified). A higher percentage indicates greater consensus that the EPA should not be used for the given condition. US Cont US Pulsed E-stim LLLT Light Heat Cold SWT Therm SWT Non Conditions Active deep vein thrombosis, thrombophlebitis 100 100 100 (n = 7) 43 (n = 7) 100 25 100 57 (n = 7) Acute injury, inflammation 100 p 14 14 (n = 7) 88 S 100 S Haemorrhagic conditions 75 63 100 (n = 7) 33 (n = 6) 100 13 100 50 (n = 6) Impaired circulation 88 P 43 (n = 7) 14 (n = 7) 63 75 100 33 (n = 6) Impaired cognition/ communication 63 P 57 (n = 7) P 50 38 88 14 (n = 7) Impaired sensation 63 P 57 (n = 7) S 88 63 100 29 (n = 7) Infection (osteomyelitis, tuberculosis) 100 75 86 (n = 7) 71 (n = 7) 100 25 100 100 (n = 6) Malignancy 100 88 100 (n = 7) 100 (n = 7) 100 13 100 100 (n = 7) Pregnancy 100 100 86 (n = 7) 86 (n = 7) 13 13 100 100 (n = 7) Recently radiated tissue 88 75 86 (n = 7) 86 (n = 6) 75 13 88 (n = 7) 83 (n = 6) Severe edema 25 13 29 (n = 7) S 75 S 88 25 Skin diseases, damaged/ at-risk skin 86 (n = 7) 57 (n = 7) 71 (n = 7) S 100 38 88 33 (n = 6) Implants Metal P S 29 (n = 7) S S 25 88 29 (n = 7) Pacemaker, electronic device 88 88 86 (n = 7) 14 (n = 7) 13 13 100 71 (n = 7) Plastic, cement 50 38 S S 13 S 45 (n = 7) S Local Areas Eyes 100 100 86 (n = 7) 100 (n = 7) 50 25 100 86 (n = 6) Reproductive organs 75 63 50 (n = 7) 29 38 13 100 67 (n = 6) P = precaution (majority of experts considered the condition/body location a precaution); S = safe (none of the experts considered the condition/body location a precaution); US Cont = continuous-mode ultrasound (has 100% duty cycle and may produce perceptible skin warming); US Pulsed = pulsed-mode ultrasound (has duty cycle less than 50% and usually does not produce perceptible skin warming); E-stim = all forms of electrical stimulation including TENS, NMES, HVPC, and IFC; LLLT/Light = low-level laser therapy (includes all Class II and III lasers and non-coherent light sources); Heat = hot packs, wax, and other superficial conductive heating agents that heat tissues within 3 cm of the skin surface; Cold = all forms of cryotherapy (cold packs, ice bags, ice bath, ice massage, etc.); SWT = short-wave therapy; Therm = Thermal SWT (produces perceptible skin warming and tissue temperature increases at least 1°C); Non = Non-thermal SWT (does not produce perceptible warmth but may increase tissue temperature slightly) 76 ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS Appendix 2: Textbook Resources Considered Table A2 Texts reviewed for contraindications and precautions when using EPAs Author(s) Title Publisher ISBN Baxter GD Therapeutic Lasers: Theory and Practice Churchill Livingstone 0-443-04393-0 Behrens BJ, Michlovitz SL, editors Physical Agents: Theory and Practice (2nd ed.) F.A. Davis 0-8036-1134-X Belanger AY Evidence-Based Guide to Therapeutic Physical Agents Lippincott Williams & Wilkins 0-7817-2108-3 Cameron MH Physical Agents in Rehabilitation (2nd ed.) W.B. Saunders 0-7216-9378-4 Denegar CR Therapeutic Modalities for Athletic Injuries Human Kinetics 0-88011-838-5 Hecox B, Mehreteab TA, Weisberg MJ, editors Physical Agents: A Comprehensive Text for Physical Therapists Appleton & Lange 0-0385-8040-8 Kahn J Principles and Practice of Electrotherapy (4th ed.) Churchill Livingstone 0-443-06553-5 Kitchen S, Bazin S, editors Clayton's Electrotherapy (10th ed.) Churchill Livingstone 0-443-07216-7 Kitchen S, editor Electrotherapy: Evidence-Based Practice (11th ed.) Churchill Livingstone 0-443-07216-7 Michlovitz SL, Nolan T, editors Modalities for Therapeutic Intervention (4th ed.) F.A. Davis 0-8036-1138-2 NaltyT Electrotherapy: Clinical Procedures Manual McGraw-Hill 0-07-134317-2 Nelson RM, Hayes KW, Currier DP Clinical Electrotherapy (3rd ed.) Appleton & Lange 0-8385-1491-X Prentice WE Therapeutic Modalities in Rehabilitation (3rd ed.) McGraw-Hill 0-07-144123-9 Robertson V, Ward A, Low J, Reed A Electrotherapy Explained: Principles and Practice (4th ed.) Butterworth Heinemann 0-7506-8843-2 Robinson A, Snyder-Mackler L, editors Clinical Electrophysiology Lippincott Williams & Wilkins 0-683-07817-8 Shankar K, Randall KD, editors Therapeutic Physical Modalities Hanley & Belfus 1-56053-434-6 Starkey C Therapeutic Modalities for the Physical Therapist Assistant (2nd ed.) F.A. Davis 0-8036-0354-1 77 ELECTROPHYSICAL AGENTS: CONTRAINDICATIONS AND PRECAUTIONS Index of Recommendations, Rationales, and References Active Deep Vein Thrombosis Cold Hypersensitivity Electrical Stimulation 30 Cryotherapy 57 Low-Level Laser Therapy (LLLT) / Non-coherent Light 43 Cold Urticaria Short-Wave Therapy 70 Cryotherapy 57 Superficial Heat 51 Ultrasound 18 Cryoglobulinemia Active Epiphysis Cryotherapy 58 Ultrasound 17 Damaged or At-Risk Skin Acute Injury Electrical Stimulation 31 Low-Level Laser Therapy (LLLT) / Low-Level Laser Therapy (LLLT) / Non-coherent Light 44 Non-coherent Light 43 Short-Wave Therapy 71 Short-Wave Therapy 68 Superficial Heat 52 Superficial Heat 49 Ultrasound 21 Ultrasound 19 Edema Anterior Neck Short-Wave Therapy 68 Electrical Stimulation 33 Short-Wave Therapy 68 Electronic Devices/Implants Ultrasound 21 Electrical Stimulation 29 Cardiac Failure Short-Wave Therapy 67 Ultrasound 18 Electrical Stimulation 34 Superficial Heat 52 Epilepsy Electrical Stimulation 33 Carotid Sinus Electrical Stimulation 33 Eyes Ultrasound 21 60 Cryotherapy Chest Electrical Stimulation 34 Low-Level Laser Therapy (LLLT) / Electrical Stimulation 34 Non-coherent Light 41 Short-Wave Therapy 69 Short-Wave Therapy 71 Ultrasound 22 Superficial Heat Ultrasound 53 21 Chronic Wounds Cryotherapy 59 Haemoglobulinemia Superficial Heat 52 Cryotherapy 58 Ultrasound 21 Haemorrhagic Conditions Cold Agglutinin Syndrome Cryotherapy 58 Cryotherapy 58 Electrical Stimulation 30 Index of Recommendations, Rationales, and References 79 Low-Level Laser Therapy (LLLT) / Non-coherent Light 41 Short-Wave Therapy 70 Superficial Heat 50 Ultrasound 19 Head, Transcranial Application Electrical Stimulation 34 Heart Electrical Stimulation 34 Short-Wave Therapy 68 Ultrasound 22 Hypertension Cryotherapy 60 Superficial Heat 52 Impaired Circulation Cryotherapy 58 Electrical Stimulation 32 Low-Level Laser Therapy (LLLT) / Non-coherent Light 43 Short-Wave Therapy 70 Superficial Heat 50 Ultrasound 20 Impaired Cognition or Communication Cryotherapy 60 Electrical Stimulation 32 Low-Level Laser Therapy (LLLT) / Non-coherent Light 42 Short-Wave Therapy 69 Superficial Heat 49 Ultrasound 20 Impaired Sensation Cryotherapy 59 Electrical Stimulation 32 Short-Wave Therapy 69 Superficial Heat 49 Ultrasound 20 Infection Cryotherapy 60 Electrical Stimulation 31 Low-Level Laser Therapy (LLLT) / Non-coherent Light 42 Short-Wave Therapy 68 Superficial Heat 51 Ultrasound 19 Inflammation Low-Level Laser Therapy (LLLT) / Non-coherent Light 43 Short-Wave Therapy 68 Superficial Heat 49 Ultrasound 19 Internal Organs Electrical Stimulation 35 Lower Abdomen Electrical Stimulation 35 Lungs Short-Wave Therapy 69 Malignancy Electrical Stimulation 30 Low-Level Laser Therapy (LLLT) / Non-coherent Light 41 Short-Wave Therapy 66 Superficial Heat 50 Ultrasound 17 Metal Implants Electrical Stimulation 33 Short-Wave Therapy 67 Superficial Heat 52 Ultrasound 18 Myositis Ossificans Ultrasound 17 Obesity Short-Wave Therapy 70 Open Wounds Short-Wave Therapy 71 Osteomyelitis Electrical Stimulation 31 Osteoporosis Electrical Stimulation 33 Peripheral and Regenerating Nerves Ultrasound 22 Photosensitivity Low-Level Laser Therapy (LLLT) / Non-coherent Light 43 80 Physiotherapy Canada, Volume 62, Number 5 Plastic and Cement Implants Ultrasound 18 Plastic Implants Short-Wave Therapy 67 Pregnancy Electrical Stimulation 29 Low-Level Laser Therapy (LLLT) / Non-coherent Light 41 Short-Wave Therapy 66 Superficial Heat 51 Ultrasound 17 Raynaud-Like Phenomenon Cryotherapy 57 Raynaud's Disease Cryotherapy 57 Recent Surgery Electrical Stimulation 33 Recently Radiated Tissue Electrical Stimulation 31 Low-Level Laser Therapy (LLLT) / Non-coherent Light 42 Short-Wave Therapy 68 Superficial Heat 53 Ultrasound 20 Regenerating Nerve Cryotherapy 59 Short-Wave Therapy 69 Reproductive Organs Electrical Stimulation 34 Low-Level Laser Therapy (LLLT) / Non-coherent Light 44 Short-Wave Therapy 66 Superficial Heat 53 Ultrasound 21 Seizure Disorders Electrical Stimulation 33 Skin Disease Electrical Stimulation 31 Low-Level Laser Therapy (LLLT) / Non-coherent Light 44 Short-Wave Therapy 71 Superficial Heat 52 Ultrasound 21 Spinal Cord Ultrasound 22 Systemic Lupus Erythematosus Low-Level Laser Therapy (LLLT) / Non-coherent Light 43 Thrombophlebitis Electrical Stimulation 30 Low-Level Laser Therapy (LLLT) / Non-coherent Light 43 Short-Wave Therapy 70 Superficial Heat 51 Ultrasound 18 Tuberculosis (TB) Cryotherapy 60 Electrical Stimulation 31 Low-Level Laser Therapy (LLLT) / Non-coherent Light 42 Short-Wave Therapy 68 Superficial Heat 51 Ultrasound 19 Unstable Fracture Electrical Stimulation 33