INFRARED LIGHT THERAPY FOR TREATMENT OF NEUROPATHY AND PAIN Protocol: PAI013 Effective Date: April 11, 2011 Table of Contents Page DESCRIPTION ........................................................................................................................................ 1 COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE......................................... 1 BACKGROUND ...................................................................................................................................... 2 CLINICAL EVIDENCE........................................................................................................................... 3 U.S. FOOD AND DRUG ADMINISTRATION (FDA) .......................................................................... 7 APPLICABLE CODES ............................................................................................................................ 8 REFERENCES ......................................................................................................................................... 9 PROTOCOL HISTORY/REVISION INFORMATION ........................................................................ 12 INSTRUCTIONS FOR USE This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC)) may differ greatly. In the event of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute medical advice. DESCRIPTION This policy describes the use of infrared light therapy for neuropathy and pain. The goal of infrared light therapy is to reduce or reverse nerve damage and associated symptoms such as pain and loss of sensation. COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE Infrared light therapy is not medically necessary for the management of pain or neuropathy including conditions such as diabetic neuropathy, osteoarthritis, rheumatoid arthritis, ankle sprains, plantar fasciitis, chondromalacia patellae, myofascial pain, musculoskeletal pain, fibromyalgia, tendonitis, epicondylitis, and temporomandibular joint disorder due to inadequate clinical evidence of safety and/or efficacy in published, peer-reviewed medical literature. Infrared Light Therapy for Treatment of Neuropathy and Pain Page 1 of 12 Medicare has a National Coverage Determination for Infrared Therapy Devices (270.6). There is no Local Coverage Determination for Nevada for Infrared Therapy Devices. (accessed Feb 2011) The Medicare NCD is as follows: Effective for services performed on and after October 24, 2006, the Centers for Medicare & Medicaid Services has determined that there is sufficient evidence to conclude the use of infrared therapy devices and any related accessories is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act (the Act). The use of infrared and/or near-infrared light and/or heat, including monochromatic infrared energy, is non-covered for the treatment, including the symptoms such as pain arising from these conditions, of diabetic and/or non-diabetic peripheral sensory neuropathy, wounds and/or ulcers of the skin and/or subcutaneous tissues. For Medicare and Medicaid Service Determinations Related to States Outside of Nevada: Please review Local Coverage Determinations that apply to other states outside of Nevada. http://www.cms.hhs.gov/mcd/search. BACKGROUND Infrared light therapy involves the treatment of damaged tissues with light from a low-intensity infrared laser. Since it is a noninvasive treatment, the applied light must travel through the skin and any other overlying tissues to reach the site of damage. The infrared light must then be absorbed to cause a biostimulatory, healing effect. Although the mechanism or mechanisms by which infrared light therapy might reduce pain and promote healing have not been established, this modality has been investigated as a treatment for a wide range of neuropathic, arthritic, and orthopedic disorders including diabetic neuropathy, osteoarthritis, rheumatoid arthritis, ankle sprains, plantar fasciitis, chondromalacia patellae, myofascial pain, musculoskeletal pain, fibromyalgia, tendonitis, epicondylitis, and temporomandibular joint disorder. In contrast to more powerful surgical lasers, low level laser light is low power, usually 5-500 milliwatts with wavelengths of 600-1000 nm. Infrared light therapy treatment protocols vary in many respects. One significant aspect of variation is the light source, which is usually a single-beam infrared laser. The light source could also be a cluster of laser sources or an array of infrared light-emitting diodes. When performed with an array of light-emitting diodes, this procedure has been referred to as monochromatic near-infrared photoenergy (MIRE) therapy. These light sources usually emit light at a single wavelength. An example of MIRE therapy is the Anodyne® Therapy release, cause local vasodilation, improve circulation, and heal damaged nerves. Infrared Light Therapy for Treatment of Neuropathy and Pain Page 2 of 12 CLINICAL EVIDENCE Diabetic Neuropathy: In an RCT in which patients served as their own controls, Leonard et al. examined whether treatments with the Anodyne® Therapy System would decrease pain or improve sensation in 27 patients with diabetic peripheral neuropathy. Each lower extremity was treated with sham (heat only) or active monochromatic near-infrared photoenergy (MIRE) treatments for 2 weeks, followed by 2 weeks of active treatment for all patients. After both 6 and 12 active MIRE treatments, the 18 patients who were able to sense the 6.65 Semmes-Weinstein monofilament test (SWM) but not the 5.07 SWM at baseline had improved sensation to the 5.07 SWM. Sham treatments did not improve sensation. Significant reductions in neuropathic symptoms were also reported, as well as improvement in balance and reduced pain. The 9 patients with greater sensory impairment measured by insensitivity to the 6.65 SWM at baseline, had no significant improvement in sensation, neuropathic symptoms, or pain reduction. Study limitations included small sample size and the design did not measure pain reduction or balance improvement in active compared to sham treatment of individual limbs. There was a lack of objective measurement for balance impairment, and follow-up was limited to evaluation after 12 treatments, with no analysis of long-term durability. Clift et al. (2005) conducted a randomized, double-blinded, placebo-controlled study of 39 subjects with diabetic peripheral neuropathy (defined as the inability to detect the 5.07 monofilament at any of the four test sites on the plantar surface of the foot). The purpose of the study was to determine if the number of sites that could sense the 5.07 monofilament on the plantar region of the foot would increase after treatments with MIRE. Subjects were assigned randomly to an active MIRE group or a placebo group. Subjects received 30 minutes of active MIRE or placebo three times a week for four weeks. The subjects’ plantar sensation was tested before treatment, after four weeks of treatment/placebo and again after four weeks of nontreatment. The average number of sties with increased sensation increased in both groups during the treatment phase, but neither group demonstrated any improvement during the nontreatment phase. There were no significant differences reported between the active and placebo groups at any measurement. The authors concluded that the active MIRE treatment was no more effective than the placebo MIRE. Lavery et al. (2008) conducted a double-blind, randomized, sham-controlled clinical trial to determine he efficacy of anodyne MIRE in-home treatments over a 90 day period to improve peripheral sensation and self-reported quality of life in patients with diabetes. Sixty-nine patients with diabetes and a vibration perception threshold (VPT) between 20 and 45V were randomized to an active or sham treatment group. Sixty patients completed the study. The Anodyne units were used at home every day for 40 minutes over 90 days. No significant differences in measures for were found in quality of life, the Michigan Neuropathy Screening Instrument (MNSI), VPT, SWM, or nerve conduction velocities in the active or sham groups (p>0.05). Franzen-Korzendorfer et al. (2008) reported on a controlled, double-blind, randomized clinical study that examined the effect of MIRE on transcutaneous oxygen measurement and protective sensation. The study included 18 patients with diabetes and loss of protective sensation. Patients served as their own control by having each leg randomly assigned to either the sham or active treatment group. Sensation, pain and transcutaneous oxygen measurements were taken on two sites per foot pre and post Infrared Light Therapy for Treatment of Neuropathy and Pain Page 3 of 12 treatment. A series of 30-minute monochromatic infrared energy treatments (one foot active treatment, one foot sham) were delivered. Monochromatic infrared energy was provided a the manufacturer preset level of energy of 1.5 J/cm(2)/min at a wavelength of 890 nm; sham units delivered no energy. There were no significant differences observed between the active and sham treatments for transcutaneous oxygen values, pain or sensation. Significantly improved sensation when compared to pretest baseline scores (p<0.05) was noted in both active and sham MIRE-treated feet. There was no statistical relationship found between transcutaneous oxygen and sensation. MIRE treatment did not appear to have an effect on transcutaneous oxygen measurements, pain or sensation in adults with diabetes and loss of protective sensation. There have been small case studies published that examined the Anodyne® Therapy System (ATS) for various uses (Kochman, et al., 2022) and Kochman (2004). These studies have been limited by small size, as well as by a lack of control group, randomization, blinding and long-term follow-up. DeLessis et al. (2005) and Harkless et al. (2006) reported on larger case series that examined MIRE for peripheral neuropathy. These studies were limited by lack of randomization, a control group and blinding. In addition, Harkless et al. (2006) a retrospective review of 2239 patient records, utilized the records of patients who, after being treated with MIRE, had all exhibited improvement in their symptoms. Musculoskeletal Conditions: A randomized, double-blind, placebo-controlled study of 40 patients found no significant differences between four treatment groups with respect to all outcome parameters (p>0.05 and there were no differences between laser and placebo laser treatments on pain severity and functional capacity in patients with acute and chronic low back pain caused by lumbar disk herniation (Ay, et al., 2010). In 2008, Oken et al. reported on a randomized, controlled, single-blind trial of 59 patients that evaluate the efficacy of light therapy compare to effects of brace or ultrasound (US) in lateral epicondylitis. No significant difference was noted between the groups in terms of visual analog scale (VAS), grip strength and global assessment at baseline and at follow-up assessments (p>.05). Limitations of the study included the relatively small study size, lack of long-term follow-up and that activities of daily living were not evaluated. Djavid et al. (2007) conducted a randomized, controlled trial of 61 patients to evaluate light therapy for chronic low back pain. There was no between-group difference for any outcome measure immediately after the six-week intervention. At 12 weeks, there was no difference in the light therapy plus exercise compared with exercise group, while there was improvement noted that in the light therapy plus exercise group when compared to the placebo laser therapy plus exercise group—pain was reduced by 1.8 cm (95% CI 0.1 to 3.3, p=0.03), lumbar range of movement increased by 0.9 cm (95% CI, 0.2 to 1.8, p<0.01) on the Shober Test and by 15 degrees (95% CI5 to 25, p<0.01) of active flexion and disability reduced by 9.4 points (95% CI 2.7 to 16.0, p=0.03) on the Oswestry Disability Index. There are several systematic and technical reviews published regarding the use of light therapy for musculoskeletal conditions. Bjordal et al. conducted a systematic review with meta-analysis of light therapy in lateral elbow tendinopathy, with primary outcome measures of pain relief and/or global improvement and subgroup analyses of methodological quality, wavelengths and treatment procedures. The review included 13 randomized controlled trials (730 patients). The weighted mean difference for pain relief was 10.2 mm (95% CI: 3.0 to 17.5). Trials which targeted acupuncture points reported negative results, as did trials with wavelengths 820, 830 and 1064 nm. In a subgroup of five trials with Infrared Light Therapy for Treatment of Neuropathy and Pain Page 4 of 12 904 nm lasers and one trial with 632 nm wavelength where the lateral elbow tendon insertions were directly irradiated, the weighted mean difference for pain relief was 17.2 mm (95% CI: 8.5 to 25.9) and 14.0 mm (95% CI: 7.4 to 20.6) respectively. The light therapy doses in this subgroup ranged between 0.5 and 7.2 Joules. In the secondary outcome measures of pain free grip strength, pain pressure threshold, sick leave, the follow-up data from 3 to 8 weeks after the end of treatment showed consistently significant results in favor of the same light therapy subgroup (p < 0.02). Yousefi-Nooraie et al. (2008) conducted a Cochrane review that included seven studies and examined light therapy for nonspecific low-back pain. The authors concluded that based on the heterogeneity of the populations, interventions and comparison groups, “that there are insufficient data to draw firm conclusion on the clinical effect of light therapy for low-back pain.” In addition the authors note that there is a need for further methodologically rigorous randomized, controlled trials to evaluate the effects of light therapy compared to other treatments, different lengths of treatment, wavelengths and dosage. A review of evidence was conducted for the development of an American Pain Society /American College of Physicians clinical practice guideline for diagnosis and treatment of low back pain (Chou and Huffman, 2007). The review examined nonpharmacologic therapies for acute and chronic low back pain and included only systematic reviews and randomized trials, with seven trials that included light therapy, Four trials found laser therapy superior to sham for pain or functional status up to one year after treatment, but another higher-quality trial found no differences between laser and sham in patients receiving exercise. One lower-quality study reported found similar results for laser, exercise and the combination of laser plus exercise for pain and back-specific functional status. It was noted that optimal treatment parameters, wavelength, dosage, dose intensity are uncertain Osteoarthritis: There is inconclusive evidence that infrared light therapy is effective for osteoarthritis of the knee and either insufficient evidence or lack of evidence of efficacy for osteoarthritis of the hands, fingers, and neck. Gur et al. found that at 3 months follow-up, infrared laser treatment produced moderate, statistically significant reductions in pain and improvements in mobility for patients with osteoarthritic knees. Two other RCTs of infrared light therapy for knee osteoarthritis did not demonstrate a treatment effect. These studies may have failed to reproduce the benefits obtained by Gur et al. due to differences in the infrared light exposure protocol. Ozdemir et al. randomized 60 patients to ten sessions of true or placebo infrared laser therapy for cervical osteoarthritis. Infrared light treatment was associated with statistically and clinically significant reductions in pain, range of motion, and Neck Pain Disability Scale scores relative to baseline; however, in addition to lack of follow-up, the statistical significance of differences in outcomes between the treatment and control groups was not reported. A study of infrared light therapy for osteoarthritis of the fingers and hand reported that treatment did not produce any statistically significant improvements in most of the measures of pain and function. Rheumatoid Arthritis: Infrared Light Therapy for Treatment of Neuropathy and Pain Page 5 of 12 A Cochrane systematic review (Brosseau, et al., 2005) was performed for the purpose of reviewing literature regarding the use of LLLT as treatment for rheumatoid arthritis (RA). Six studies with 220 patients with rheumatoid arthritis were included in the review. The main limitation with the studies is the heterogeneity of clinical application. In addition, the results are subject to publication bias, if negative trials have not been published. It was concluded in this review that “this meta-analysis found that pooled data gave some evidence of a clinical effect, but the outcomes were in conflict, and it must therefore be concluded that firm documentation of the application of LLLT in RA is not possible. Conversely, a possible clinical benefit in certain subgroups cannot be ruled out from the present metaanalysis and further large scaled studies are recommended with special attention to the findings in this meta-analysis (e.g., low versus high dose wavelength, nerve versus joint application, and treatment duration).” A Cochrane systematic review (Brosseau, et al., 2004) was performed for the purpose of reviewing the literature regarding LLLT as treatment for osteoarthritis. The review included seven controlled clinical trials, with 184 patients randomized to laser and 161 to an inactive laser probe. It was noted that the “main limitation of this systematic meta-analyses is the heterogeneity of clinical application, including different dosages, wavelengths, and types of LLLT. “ The authors summarized the implications for its practice as “there is insufficient evidence to draw any firm conclusions regarding the use of LLLT for treatment of osteoarthritis.” Lateral Epicondylitis: The available studies do not present sufficient evidence to conclude that infrared light therapy is effective for lateral epicondylitis. In one RCT, Haker and Lundeberg reported that infrared laser treatment accelerated recovery of grip strength, with statistically significant improvements at 3 months follow-up; however, these improvements were matched by spontaneous improvements in the control group at 1 year follow-up. Moreover, at 3 months and 1 year follow-up, this study found that infrared laser therapy had not reduced pain or improved outcomes in several other measures of function. Similar results were obtained by Vasseljen et al. who found that at 4 weeks follow up, infrared laser therapy was associated with statistically significant improvements in pain and grip strength; however, the treatment group did not experience any statistically significant improvements in weight lifting or flexion tests. Basford et al. reported that infrared light therapy failed to significantly reduce pain or improve function for patients with lateral epicondylitis. Temporomandibular Joint Disorder: There is inconclusive evidence concerning the efficacy of infrared light therapy for temporomandibular joint disorder. One study found that infrared light treatment was associated with modest, statistically significant improvements in range of motion, a substantial reduction in number of tender sites, and no significant improvement in pain. The efficacy of infrared light therapy for temporomandibular joint disorder was also addressed in two placebo-controlled randomized trials that were not reviewed in detail due to lack of follow-up. One of these studies enrolled 48 patients who were randomized to true infrared laser treatment, placebo infrared laser treatment, or microcurrent electrical stimulation. Both active treatments were associated with statistically significant improvements in pain and range of motion. However, the other placebo-controlled randomized trial came to the opposite conclusion. Conti enrolled 20 patients who were randomized to true or placebo infrared laser therapy and reported that, compared with the control group, patients who underwent true therapy did not have any statistically significant improvements in pain or range of motion. Another RCT of 30 patients with Infrared Light Therapy for Treatment of Neuropathy and Pain Page 6 of 12 temporomandibular joint disorder randomly assigned patients to low intensity laser therapy or a placebo group. The therapy was evaluated 15, 30, and 60 days following therapy. The groups did not have a statistically significant difference in improvements in pain and range of motion. Myofascial Pain: The available RCTs of infrared light therapy present promising but inconclusive evidence that it is an effective treatment for myofascial and musculoskeletal pain. Gur et al. performed a study and reported that for patients with chronic myofascial pain of the neck and shoulder girdle, infrared laser therapy produced moderate, statistically significant reductions in number of trigger points and Neck Pain Disability Scale scores; however, improvements in pain scores were not significant and this study involved only 10 weeks of follow-up. Two other placebo-controlled randomized trials of infrared laser therapy have reported that infrared laser therapy reduces neck and shoulder pain. Significant shortcomings of these RCTs are their small size and lack of follow-up. Fibromyalgia: Another study evaluated infrared light therapy for fibromyalgia. Although this trial reported that the treatment group had statistically significant improvements in pain, morning stiffness, fatigue, depression, and Fibromyalgia Impact Questionnaire scores, the magnitude of these improvements was relatively small, the study did not involve any follow-up, and there were no significant improvements in muscle spasm, number of tender points, skinfold tenderness, or sleep disturbance. Bingol et al. studied 40 patients with shoulder pain. Twenty patients were randomly assigned to lowpower laser treatment and 20 patients were part of the control group. The study results demonstrated better results in palpation sensitivity and passive extension for the group treated with laser, but no significant improvement in pain or active range in the laser treatment group compared to the control group. Summary: Overall, studies do not provide sufficient evidence to conclude that infrared light therapy is effective treatment for pain or neuropathy. Although some of these studies suggest that infrared light therapy is relatively safe and might improve symptoms of neuropathy, limitations in study design hamper interpretation of the evidence and therefore, no definitive conclusions can be drawn about long-term health outcomes. Further study using randomized controlled clinical trials is needed. Professional Societies/Organizations MIRE for the treatment of peripheral neuropathy is not recognized as a standard of care by the American Association of Clinical Endocrinologists, the American Diabetes Association, the American Academy of Neurology, the American Medical Association, the American Orthopedic foot and Ankle Society or the American Podiatric Medical Association. U.S. FOOD AND DRUG ADMINISTRATION (FDA) U.S. Food and Drug Administration (FDA): Infrared lamps to perform phototherapy are regulated by the FDA as Class II devices. A number of infrared light phototherapy devices have been approved by the FDA through the 510(k) approval process (Searchable 510(k) database scanned for infrared lamp product code ILY. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm). Infrared Light Therapy for Treatment of Neuropathy and Pain Page 7 of 12 The Anodyne Therapy System received 510(k) approval in March 1994. At that time, the device was named the Spectropad System (Spectromed Inc., Lakewood, CO). (510(k) approvals. K931261. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?) An FDA warning letter to the manufacturer indicated that the manufacturer's promotion of Anodyne (for use to treat wounds, ulcers, diabetic neuropathy, soft tissue injury, and carpel tunnel syndrome) is in violation of federal law since the FDA has not cleared Anodyne for these promoted uses. (Warning letter for Anodyne. December 2005. Available at: http://www.fda.gov/foi/warning_letters/g5660d.htm.) Currently, the manufacturer's website indicates that the Anodyne Therapy System is approved for increasing circulation and reducing pain. APPLICABLE CODES The codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit document. This list of codes may not be all inclusive. CPT® Codes 97026 97039 Description Application of a modality to one or more areas; infrared Unlisted modality (specify type and time if constant attendance) CPT® is a registered trademark of the American Medical Association. HCPCS Code S8948 ICD-9 Diagnosis Codes 250.60 250.61 250.62 357.2 357.4 Description Application of a modality (requiring constant provider attendance) to one or more areas; low-level laser; each 15 minutes Description Diabetes with neurological manifestations, type II or unspecified type, not stated as uncontrolled Diabetes with neurological manifestations, type I [juvenile type], not stated as uncontrolled Diabetes with neurological manifestations, type II or unspecified type, uncontrolled Polyneuropathy in diabetes Polyneuropathy in other diseases classified elsewhere Infrared Light Therapy for Treatment of Neuropathy and Pain Page 8 of 12 REFERENCES American Diabetes Association (ADA). Standards of medical care in diabetes (position statement). Diabetes Care. 2004 Jan; 27, supplement 1. Anodyne Therapy LLC [Web site]. Anodyne Therapy for Healthcare Professionals. Available at http://www.anodynetherapy.com/Professionals.htm. Accessed August 22, 2006. Ay S, Doğan SK, Evcik D. Is low-level laser therapy effective in acute or chronic low back pain? Clin Rheumatol. 2010 Apr 23. Basford JR, Sheffield CG, Cieslak KR. Laser therapy: a randomized, controlled trial of the effects of low intensity Nd:YAG laser irradiation on lateral epicondylitis. Arch Phys Med Rehabil. 2000;81(11):1504-1510. Bertolucci LE, Grey T. Clinical comparative study of microcurrent electrical stimulation to midlaser and placebo treatment in degenerative joint disease of the temporomandibular joint. Cranio. 1995;13(2):116-120. Bingol U, Altan L, Yurtkuran M. Low-power laser treatment for shoulder pain. Photomed Laser Surg. 2005 Oct;23(5):459-64. Bjordal JM, Lopes-Martins RA, Iversen VV. A randomised, placebo controlled trial of low level laser therapy for activated Achilles tendinitis with microdialysis measurement of peritendinous prostaglandin E2 concentrations. Br J Sports Med. 2006 Jan;40(1):76-80; discussion 76-80. Bjordal JM, Couppe C, Chow RT, et al. A systematic review of low level laser therapy with locationspecific doses for pain from chronic joint disorders. Aust J Physiother. 2003;49(2):107-116. Bjordal JM, Lopes-Martins RA, Joensen J, Couppe C, Ljunggren AE, Stergioulas A, Johnson MI. A systematic review with procedural assessments and meta-analysis of low level laser therapy in lateral elbow tendinopathy (tennis elbow). BMC Musculoskelet Disord. 2008 May 29;9:75. Brosseau L, Robinson V, Wells G, Debie R, Gam A, Harman K, Morin M, Shea B, Tugwell P. Low level laser therapy (Classes I, II and III) for treating rheumatoid arthritis. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD002049. Brosseau L, Wells G, Marchand S, et al. Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand. Lasers Surg Med. 2005;36(3):210-219. Bulow PM, Jensen H, Danneskiold-Samsoe B. Low power Ga-Al-As laser treatment of painful osteoarthritis of the knee. a double-blind placebo- controlled study. Scand J Rehabil Med. 1994;26 (3):155-159. Infrared Light Therapy for Treatment of Neuropathy and Pain Page 9 of 12 Ceylan Y, Hizmetli S, Silig Y. The effects of infrared laser and medical treatments on pain and serotonin degradation products in patients with myofascial pain syndrome. A controlled trial. Rheumatol Int. 2004;24(5):260-263. Chou R, Huffman LH; American Pain Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):492-504. Chow RT, Barnsley L, Heller GZ, Siddall PJ. A pilot study of low-power laser therapy in the management of chronic neck pain. J Musculoskeletal Pain. 2004;12(2):71-81. Clifft JK, Kasser RJ, Newton TS, Bush AJ. The effect of monochromatic infrared energy on sensation in patients with diabetic peripheral neuropathy: a double-blind, placebo-controlled study. Diabetes Care. 2005 Dec;28(12):2896-900. Conti PC. Low level laser therapy in the treatment of temporomandibular disorders (TMD): a doubleblind pilot study. Cranio. 1997;15(2):144-149. DeLellis SL, Carnegie DH, Burke TJ. Improved sensitivity in patients with peripheral neuropathy. J Am Podiatr Med.2005;95(2):143-7. Djavid GE, Mehrdad R, Ghasemi M, Hasan-Zadeh H, Sotoodeh-Manesh A, Pouryaghoub G. In chronic low back pain, low level laser therapy combined with exercise is more beneficial than exercise alone in the long term: a randomised trial. Aust J Physiother. 2007;53(3):155-60. Franzen-Korzendorfer H, Blackinton M, Rone-Adams S, McCulloch J. The effect of monochromatic infrared energy on transcutaneous oxygen measurements and protective sensation: results of a controlled, double-blind, randomized clinical study. Ostomy Wound Manage. 2008 Jun;54(6):16-31. Gur A, Cosut A, Sarac AJ, et al. Efficacy of different therapy regimes of low-power laser in painful osteoarthritis of the knee: a double-blind and randomized-controlled trial. Lasers Surg Med. 2003;33(5):330-338. Gur A, Sarac AJ, Cevik R, et al. Efficacy of 904 nm gallium arsenide low level laser therapy in the management of chronic myofascial pain in the neck: a double-blind and randomized-controlled trial. Lasers Surg Med. 2004;35(3):229-235. Gur A, Karakoc M, Nas K, et al. Effects of low power laser and low dose amitriptyline therapy on clinical symptoms and quality of life in fibromyalgia: a single-blind, placebo-controlled trial. Rheumatol Int. 2002;22(5):188-193. Gur A, Karakoc M, Nas K, et al. Efficacy of low power laser therapy in fibromyalgia: a single-blind, placebo-controlled trial. Lasers Med Sci. 2002;17(1):57-61. Infrared Light Therapy for Treatment of Neuropathy and Pain Page 10 of 12 Haker E, Lundeberg T. Is low-energy laser treatment effective in lateral epicondylalgia? J Pain Symptom Manage. 1991;6(4):241-246. Harkless LB, DeLellis S, Carnegie DH, Burke TJ. Improved foot sensitivity and pain reduction in patients with peripheral neuropathy after treatment with monochromatic infrared photo energy--MIRE. J Diabetes Complications. 2006 Mar-Apr;20(2):81-7. Kochman AB. Monochromatic infrared photo energy and physical therapy for peripheral neuropathy: Influence on sensation, balance, and falls. J Geriatr Phys Ther. 2004;27(1):16-9. Kochman AB. Monochromatic infrared photo energy and physical therapy for peripheral neuropathy: Influence on sensation, balance, and falls. J Geriatr Phys Ther. 2004;27(1):16-9. Kulekcioglu S, Sivrioglu K, Ozcan O, Parlak M. Effectiveness of low-level laser therapy in temporomandibular disorder. Scand J Rheumatol. 2003;32(2):114-118. Lavery LA, Murdoch DP, Williams J, Lavery DC. Does anodyne light therapy improve peripheral neuropathy in diabetes? A double-blind, sham-controlled, randomized trial to evaluate monochromatic infrared photoenergy. Diabetes Care. 2008 Feb;31(2):316-21. Epub 2007 Oct 31. Leonard DR, Farooqi MH, Myers S. Restoration of sensation, reduced pain, and improved balance in subjects with diabetic peripheral neuropathy: a double-blind, randomized, placebo-controlled study with monochromatic near-infrared treatment. Diabetes Care. 2004;27(1):168-172. Oken O, Kahraman Y, Ayhan F, Canpolat S, Yorgancioglu ZR, Oken OF. The short-term efficacy of laser, brace, and ultrasound treatment in lateral epicondylitis: a prospective, randomized, controlled trial. J Hand Ther. 2008 Jan-Mar;21(1):63-7. Ozdemir F, Birtane M, Kokino S. The clinical efficacy of low-power laser therapy on pain and function in cervical osteoarthritis. Clin Rheumatol. 2001;20(3):181-184. Tascioglu F, Armagan O, Tabak Y, et al. Low power laser treatment in patients with knee osteoarthritis. Swiss Med Wkly. 2004;134(17-18):254- 258. Vasseljen O Jr, Hoeg N, Kjeldstad B, et al. Low level laser versus placebo in the treatment of tennis elbow. Scand J Rehabil Med. 1992;24(1):37-42. Venancio Rde A, Camparis CM, Lizarelli Rde F. Low intensity laser therapy in the treatment of temporomandibular disorders: a double-blind study. J Oral Rehabil. 2005 Nov;32(11):800-7. Yousefi-Nooraie R, Schonstein E, Heidari K, Rashidian A, Pennick V , Akbari-Kamrani M, et al. Low level laser therapy for nonspecific low-back pain. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD005107. Zinman LH, Ngo M, Ng ET, et al. Low-intensity laser therapy for painful symptoms of diabetic sensorimotor polyneuropathy: a controlled trial. Diabetes Care. 2004;27(4):921-924. Infrared Light Therapy for Treatment of Neuropathy and Pain Page 11 of 12 PROTOCOL HISTORY/REVISION INFORMATION Date 10/28/2010 07/24/2009 Action/Description Corporate Medical Affairs Committee The foregoing Health Plan of Nevada/Sierra Health & Life Healthcare Operations protocol has been adopted from an existing UnitedHealthcare coverage determination guideline that was researched, developed and approved by the UnitedHealthcare Coverage Determination Committee. Infrared Light Therapy for Treatment of Neuropathy and Pain Page 12 of 12
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