Archived Policies - Medicine
Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds
Electrical stimulation using low-intensity direct current (LIDC), high-voltage pulsed current (HVPC), alternative current (AC), or transcutaneous electrical nerve stimulation (TENS) for the treatment of wounds is considered experimental, investigational and unproven.
Electrical stimulation performed in the home setting for treatment of wounds is considered experimental, investigational and unproven.
Electromagnetic therapy for the treatment of wounds is considered experimental, investigational and unproven.
NOTE: Diapulse® is one example of an electromagnetic therapy device; see MED201.026 for descriptions and more examples of electrical stimulation devices.
Electrical stimulation refers to the application of electrical current through electrodes placed directly on the skin in close proximity to the wound. Electromagnetic therapy involves the application of electromagnetic fields rather than direct electrical current. Both are proposed as treatments for chronic wounds.
The normal wound healing process involves inflammatory, proliferative, and remodeling phases. When the healing process fails to progress properly and the wound persists for longer than 1 month, it may be described as a chronic wound. The types of chronic wounds most frequently addressed in studies of electrical stimulation for wound healing are 1) pressure ulcers, 2) venous ulcers, 3) arterial ulcers, and 4) diabetic ulcers. Conventional or standard therapy for chronic wounds involves local wound care, as well as systemic measures including debridement of necrotic tissues, wound cleansing, and dressing that promotes a moist wound environment, antibiotics to control infection, and optimizing nutritional supplementation. Non-weight bearing is another important component of wound management.
Since the 1950s, investigators have used electrical stimulation as a technique to promote wound healing, based on the theory that electrical stimulation may:
Electrical stimulation refers to the application of electrical current through electrodes placed directly on the skin in close proximity to the wound. The types of electrical stimulation and devices can be categorized into four groups based on the type of current:
Electromagnetic therapy is a related but distinct form of treatment that involves the application of electromagnetic fields rather than direct electrical current.
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.
In February 2005, a TEC Assessment on electrostimulation and electromagnetic therapy for the treatment of chronic wounds was conducted. (1) The following summarizes the conclusions of the TEC Assessment:
Based on the conclusions of the February 2005 TEC Assessment, it has not been established whether electrical stimulation or electromagnetic therapy improves net health outcomes as adjunctive treatment for chronic skin wounds.
Subsequent to the TEC Assessment, several systematic reviews on treatments for wounds have been published that address electrostimulation and/or electromagnetic stimulation. In 2012, Game and colleagues reviewed studies on interventions to enhance healing of diabetic foot ulcers and stated that they did not find sufficient evidence that electrical stimulation was clinically effective for treating foot ulcers. (3) Moreover, two Cochrane reviews have evaluated electromagnetic stimulation for treating wounds; one addressed treatment of pressure ulcers and the other addressed leg ulcers. (4, 5) Each review identified few RCTs (2 and 3 studies, respectively) with small sample sizes. Consequently, the investigators were not able to conduct robust pooled analyses of study findings. Both reviews concluded that there is insufficient evidence that electromagnetic therapy is effective for treating chronic wounds.
Representative RCTs on electrostimulation or electromagnetic stimulation for treating chronic wounds are described below:
In 2005, Adunsky and colleagues published a randomized, double-blind, placebo-controlled trial to determine the benefits of adding direct current electrostimulation to conservative wound care for stage III degree pressure sores of 30 days’ to 24 months’ duration. (6) This multicenter trial of 63 patients found no significant differences in complete wound closure or time to complete wound closure between the treatment groups after 8 consecutive weeks of electrostimulation. Nor were there any significant differences between groups after an additional follow-up of 12 weeks. While the authors reported an increase in absolute wound area reduction and speed of wound healing up until the 45th day of treatment in the electrostimulation group, this was not statistically significant and did not result in a greater rate of complete wound closure.
In 2010, Houghton and colleagues in Canada published a single-blind trial evaluating the effect of adding treatment with high-voltage pulsed current (HVPC) to a community-based standard wound care program. (7) The trial included 34 adults with spinal cord injuries and stage II to IV pressure ulcers of at least 3 months’ duration. The study excluded potential participants who were likely to have limited healing potential e.g., those with anemia or uncontrolled diabetes. Patients in the HVPC group or their caregivers were trained to administer the treatment and instructed to apply it for 8 hours per day e.g., overnight. (An analysis of compliance found that HVPC treatment was actually used for a mean of 3 hours per day.) All randomized patients completed the 3-month follow-up. Two wounds, both in the standard care only group, were unstageable. The primary efficacy outcome, percentage decrease in wound care surface, was significantly greater in the group receiving HVPC (n=16) than the standard care only group (n=18), mean decrease of 70% versus36%, respectively (p=0.048).By 3 months, all of the stage II wounds had healed (1 in the HVPC group and 4 in the standard care only group). The number of the remaining wounds (stage III, IV, or unstageable) that were at least 50% smaller at 3 months was 12 of 15 (80%) in the HVPC group and 5 of 14 (36%) in the standard care only group; this difference was statistically significant (p=0.02). There was not a statistically significant difference in the number of wounds that were completely healed at 3 months, 6 in the HVPC group and 5 in the standard care only group.
In 2012, Franek and colleagues in Poland evaluated high-voltage electrical stimulation for treating lower extremity pressure ulcers in an unblinded RCT. (8) Fifty-seven patients with stage II or III pressure ulcers were randomized to receive electrical stimulation in addition to standard wound care or standard care only. The electrical stimulation intervention involved five 50-minute procedures per week until the wound was healed or until reaching a maximum of 6 weeks. A total of 50 of 57 patients (88%) completed treatment. After 6 weeks, there were statistically significantly greater changes in the treatment group compared to the control group on several outcomes. These included change in wound surface area (88.9% vs. 44.4%, p<0.0001) and change in the longest length of the wound (74.0% vs. 36.1%, p<0.0001). The rate of complete healing was not reported; the authors noted that they were unable to follow patients long enough for healing to occur.
One small RCT on electromagnetic therapy, published in 2009, was identified. (9) The study was conducted in India and included only 12 patients. Patients were in-patients with neurologic disorders and stage 3 or 4 pressure ulcers. Six patients were assigned to active treatment, and the other 6 were assigned to a sham intervention. After 6 months of follow-up, there was no significant difference between groups in the degree of wound healing. The sample size was too small to allow a meaningful comparison of the proportion of patients whose wounds had healed completely.
There is insufficient evidence from well-designed randomized controlled trials (RCTs) that electrostimulation or electromagnetic stimulation improves health outcomes for wound care patients beyond that provided by standard treatment. Some small RCTs on electrostimulation have reported improvements in some intermediate outcomes, such as decrease in wound size and/or the velocity of wound healing. However, these studies have not demonstrated consistent improvements on the more important clinical outcomes of complete healing and the time to complete healing. For electromagnetic therapy, there is a lack of high-quality RCTs. Therefore, these treatments are considered experimental, investigational and unproven for the treatment of wounds.
Practice Guidelines and Position Statements
In 2010, the Association for the Advancement of Wound Care (AAWC) published a guideline on care of pressure ulcers. (10) Electrical stimulation was included as a potential second-line intervention if first-line treatments did not result in wound healing. The guideline did not mention electromagnetic therapy.
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Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.
The following codes may be applicable to this Medical policy and may not be all inclusive.
A4556, A4557, A4595, A4630, E0720, E0730, E0745, E0761, E0769, G0281, G0282, G0295, G0329
ICD-9 Diagnosis Codes
Refer to the ICD-9-CM manual
ICD-9 Procedure Codes
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ICD-10 Diagnosis Codes
ICD-10 Procedure Codes
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.
A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov.
10/15/2013 Document updated with literature review. Coverage unchanged.
6/1/2008 Policy reviewed without literature review; new review date only.
9/1/2007 Revised/updated entire document
12/1/2005 New medical document
|Title:||Effective Date:||End Date:|
|Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds||06-15-2018||04-14-2019|
|Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds||09-01-2017||06-14-2018|
|Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds||05-15-2016||08-31-2017|
|Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds||01-01-2015||05-14-2016|
|Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds||10-15-2013||12-31-2014|
|Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds||06-01-2008||10-14-2013|
|Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds||09-01-2007||05-31-2008|
|Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds||12-01-2005||08-31-2007|