Light Emitting Diode (LED) Therapy
DESCRIPTION
Light emitting diode (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 LEDs located on a flexible pad that is in contact with the skin. LED therapy may also be referred to as infrared energy therapy, infrared light therapy or infrared heating pad system.
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, 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 is being proposed for the treatment of diabetic peripheral neuropathy, lymphedema, non-healing wounds and 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.
POLICY
Light emitting diode therapy for the treatment of conditions / diseases, including but not limited to diabetic peripheral neuropathy, lymphedema, non-healing wounds and pain is considered investigational.
ADDITIONAL INFORMATION
Scientific evidence in peer review literature is lacking regarding the use, safety, improvement or effectiveness on health outcomes for light emitting diode therapy.
Light emitting diode therapy does not meet the following technology evaluation criteria:
The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The technology must improve the net health outcome.
The technology must be as beneficial as any established alternatives.
The improvement must be attainable outside the investigational settings.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2005). Skin contact monochromatic infrared energy as a technique to treat cutaneous ulcers, diabetic neuropathy, and miscellaneous musculoskeletal conditions (1.01.22). Retrieved February 22, 2006 from BlueWeb.
Clifft, J. K., Kasser, R. J., Newton, T. S., Bush, A. J. (2005). The effect of monochromatic infrared energy on sensation in patients with diabetic peripheral neuropathy: A double-blind, placebo-controlled study. Diabetic Care, 28 (12), 2896-2900. Abstract retrieved February 22, 2006 from PubMed database.
Glasgow, P. D., Hill, I. D., McKevitt, A. M., Lowe, A. S. & Baxter, D. (2001). Low intensity monochromatic infrared therapy: a preliminary study of the effects of a novel treatment unit upon experimental muscle soreness. Lasers in Surgery and Medicine, 28 (1), 33-39.
Gupta, A. K., Filonenko, N., Salansky, N., & Sauder, D. N. (1998). The use of low energy photon therapy (LEPT) in venous leg ulcers: A double-blind, placebo-controlled study. Dermatologic Surgery, 24 (12), 1383-1386. Abstract retrieved June 5, 2003 from PubMed database.
Health Technology Assessment Information Service. Target database. (2006, January). Monochromatic infrared irradiation for peripheral neuropathic pain. Retrieved February 22, 2006 from ECRI HTAIS.
Horwitz, L. R., Burke, T. J., & Carngie, D. (1999). Augmentation of wound healing using monochromatic infrared energy. Advances in Wound Care, 12 (1), 35-40.
Kochman, A. B., Carnegie, D. H., & Burke, T. J. (2002). Symptomatic reversal of peripheral neuropathy in patients with diabetes. Journal of the American Podiatric Medical Association, 92 (3), 125-130.
U. S. Food and Drug Administration. (2005, August). Center for Devices and Radiological Health. Device listing database. Retrieved February 22, 2006 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?db=LST&ID=93425.
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EFFECTIVE DATE |
5/25/2006 |
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