DESCRIPTION
Electrical stimulation (ES) for the treatment of wounds involves the application of electrical current through electrodes applied directly to the skin in close proximity to the target wound. There is some evidence that the application of electrical stimulation may increase or accelerate the biological activities involved in wound healing,
including migration of neutrophils and macrophages, stimulation of fibroblasts, and improved blood flow. There are four types of electrical stimulation devices used in wound healing: low intensity direct current (LIDC), high voltage pulse current (HVPC), low voltage pulse micro-amperage alternating current (AC), and transcutaneous electrical nerve stimulation (TENS).
Electromagnetic therapy (e.g., Diapulse® Wound Treatment System™, PROVANT® Wound Closure System), also known as pulsed electromagnetic field stimulation (i.e., PEMF), does not involve the use of a current, as does electrical stimulation. Electromagnetic stimulators use generators that create energy in what is commonly referred to as the radio frequency or RF band. They typically deliver energy by non-contacting means (e.g., coils) rather than by leads and surface electrodes.
POLICY
Electrical stimulation using low-intensity, direct current, high-voltage pulsed current (HVPC), alternating current, or transcutaneous electrical nerve stimulation (TENS) for the treatment of wounds in any setting (i.e., home or treatment facility) is considered investigational.
Electromagnetic therapy for the treatment of wounds is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
At present no electrical stimulation or electromagnetic therapy devices have received approval from the U.S. Food and Drug Administration (FDA) specifically for the treatment of wound healing. A number of devices have been cleared for marketing for other indications. Use of these devices for wound healing is an off-label indication
No controlled studies were found in the published literature that validated the application of electrical stimulation or electromagnetic therapy for the treatment of wounds. The literature does not prove the improvement of health outcomes with these treatments in comparisons to the health outcomes of conventional therapies.
SOURCES
Adunsky, A., & Ohry, A. (2005). Decubitus direct current treatment (DDCT) of pressure ulcers: Results of a randomized double-blinded placebo controlled study. Archives of Gerontology and Geriatrics, 41 (3), 261 - 269. (Level 2 Evidence - Industry sponsored)
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2010). Electrostimulation and electromagnetic therapy for treating wounds (2.01.57). Retrieved December 16, 2010 from BlueWeb. (7 articles and/ or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, July). Electrical stimulation (ES) and electromagnetic therapy for the treatment of wounds (NCD 270.1, p. 2-207). Ingenix.
Gupta, A., Taly, A., Srivastava, A., Kumar, S., & Thyloth, M. (2009). Efficacy of pulsed electromagnetic field therapy in healing pressure ulcers: A randomized control trial. Neurology India, 57 (5) 622-626. (Level 4 Evidence _ Independent)
Lawson, D., & Petrofsky, J. (2007). A randomized control study on the effect of biphasic electrical stimulation in a warm room on skin blood flow and healing rates in chronic wounds of patients with and without diabetes. Medical Science Monitor, 13 (6), CR 258 - 263. (Level 2 Evidence - Independent)
National Guideline Clearinghouse. Association for the Advancement of Wound Care. (2005). Summary algorithm for venous ulcer care with annotations of available evidence. Retrieved January 7 2011 from http://www.guidelines.gov.
National Guideline Clearinghouse. Institute for Clinical Systems Improvement (ICSI). (2008). Pressure ulcer treatment. Health care protocol. Retrieved January 7, 2011 from http://www.guideline.gov
Ramadan, A., Elsaidy, M., & Zyada, R. (2008). Effect of low-intensity direct current on the healing of chronic wounds: a literature review. Journal of Wound Care, 17 (7), 292 - 296.
Tatsioni, A., Balk, E., O’Donnell, T., & Lau, J. (2007). Usual care in the management of chronic wounds: A review of the recent literature. Journal of the American College of Surgeons, 205 (4), 617 - 624e57. (Level 4 Evidence - Independent)
Technology Evaluation Center. (2005, April). Electrical stimulation ior electromagnetic therapy as adjunctive treatment for chronic skin wounds (Vol. 20, No. 2) Chicago: BlueCross BlueShield Association. ( 69 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/1/2003
MOST RECENT REVIEW DATE: 5/14/2011
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