Light Emitting Diode (LED) Therapy
Light emitting diode (LED) therapy is being proposed for the treatment of diabetic peripheral neuropathy, lymphedema, non-healing wounds and muscle pain. Treatment is based on the premise that LED therapy may cause an increase in nitric oxide concentrations that may lead to increased blood flow and promote vasodilatation.
LED therapy devices use one (monochromatic) or two wavelengths of infrared (invisible) light with or without red (visible) light. The light is measured in nanometers (880nm), with a higher nanometer number denoting a greater depth of tissue penetration. Treatment is administered several times a week over a period of weeks to months. LED therapy can be provided in an office or home setting.LED therapy utilizes a device (e.g., Anodyne Therapy System, Pain-X-2000, BioScan, Light Force Therapy) that delivers light to targeted tissue. This is done through multiple superluminous infrared diodes located on a flexible pad that is in contact with the skin. LED therapy may also be referred to as monochromatic infrared energy (MIRE™), infrared energy therapy, infrared light therapy or infrared heating pad system.
Light emitting diode therapy for the treatment of conditions / diseases, including but not limited to diabetic peripheral neuropathy, lymphedema, non-healing wounds, tendonitis, capsulitis, and pain is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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Scientific evidence in peer review literature is lacking regarding the use, safety, and effectiveness on health outcomes.
Association for the Advancement of Wound Care (AAWC). (2014). Venous and pressure ulcer guidelines. Retrieved September 14, 2018 from https://www.o-wm.com/article/association-advancement-wound-care-aawc-venous-and-pressure-ulcer-guidelines.
Center for Medicare & Medicaid Services. CMS.gov. (2007, January). National Coverage Determination (NCD): for Infrared Therapy Devices (270.6). Retrieved October 2, 2017 from https://www.cms.gov.
de Andrade, A., Bossini, P., and Parizotto, N. (2016). Use of low level laser therapy to control neuropathic pain: a systematic review. Journal of Photochemistry & Photobiology, 164, 36-42. Abstract retrieved October 2, 2017 from PubMed database.
De Barros, A., Gonzaga, I., Fernandes, G.A., Lima, A., Cortelazzi, P., de Oliveira, R., & Nicolau, R. (2018). Low-intensity LED therapy (Λ 640 ± 20 nm) on saphenectomy healing in patients who underwent coronary artery bypass graft: a randomized, double-blind study. Lasers in Medical Science, 33 (1), 103-109. Abstract retrieved September 14, 2018 from PubMed database.
Hsieh, R., Lo, M., Lee, W., & Liao, W. (2012). Therapeutic effects of short-term monochromatic infrared energy therapy on patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study. Journal of Orthopaedic & Sports Physical Therapy, 42 (11), 947-956. (Level 1 evidence)
Jagdeo, J., Austin, E., Mamalis, A., Wong, C., Ho, D., & Siegel, D.M. (2018). Light-emitting diodes in dermatology: A systematic review of randomized controlled trials. Lasers In Surgery and Medicine, 50 (6), 613-628. (Level 1 evidence)
Robinson, C., Klahr, P., Stein, C., Sbruzzi, G., & Plentz, R. (2015). Effects of monochromatic infrared energy in patients with diabetic peripheral neuropathy: a meta-analysis of randomized clinical trials. Eiabetology & Metabolic Syndrome, 2015, 7 (Suppl 1), A16. (Level 1 evidence)
U. S. Food and Drug Administration. (2006, December). Center for Devices and Radiological Health. 510(k) Premarket notification database K062635. Retrieved December 22, 2015 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2011, January). Center for Devices and Radiological Health. 510(k) Premarket notification database K101894. Retrieved December 22, 2015 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 12/1/2003
MOST RECENT REVIEW DATE: 10/10/2019
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