Archived Policies - Medicine


Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds

Number:MED201.027

Effective Date:09-01-2017

End Date:06-14-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Electrical stimulation for the treatment of wounds, including but not limited to low-intensity direct current (LIDC), high-voltage pulsed current (HVPC), alternating current (AC), and transcutaneous electrical nerve stimulation (TENS) is considered experimental, investigational and/or unproven.

Electrical stimulation performed in the home setting for treatment of wounds is considered experimental, investigational and/or unproven.

Electromagnetic therapy for the treatment of wounds is considered experimental, investigational and/or unproven.

NOTE: Diapulse® is one example of an electromagnetic therapy device; see MED201.026 for descriptions and more examples of electrical stimulation devices.

Description:

Electrostimulation (electrical stimulation) refers to the application of electrical current through electrodes placed directly on the skin. Electromagnetic therapy involves the application of electromagnetic fields, rather than direct electrical current. Both are proposed as treatments for wounds, generally 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 diabetic ulcers. Conventional or standard therapy for chronic wounds involves local wound care, as well as systemic measures including débridement of necrotic tissues, wound cleansing, and dressing that promotes a moist wound environment, antibiotics to control infection, and optimizing nutritional supplementation. Avoidance of weight bearing is another important component of wound management.

Since the 1950s, investigators have used electrical stimulation to promote wound healing, based on the theory that electrical stimulation may:

Increase adenosine 5’-triphosphate (ATP) concentration in the skin,

Increase deoxyribonucleic acid (DNA) synthesis,

Attract epithelial cells and fibroblasts to wound sites,

Accelerate the recovery of damaged neural tissue,

Reduce edema,

Increase blood flow, and/or

Inhibit pathogenesis.

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 groups based on the type of current. This includes low-intensity direct current (LIDC, high- voltage pulsed current (HVPC), alternating current (AC), and transcutaneous electrical nerve stimulation (TENS).

Electromagnetic therapy is a related but distinct form of treatment that involves the application of electromagnetic fields, rather than direct electrical current.

Regulatory Status

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 off-label.

Rationale:

This medical policy was originally created in 2005 and was updated regularly with searches of the MEDLINE database. The most recent literature review was performed through July 13, 2017. Following is a summary of the key literature.

A 2005 Blue Cross and Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment concluded that there was insufficient evidence from high-quality, randomized controlled trials (RCTs) that electrical stimulation and/or electromagnetic therapy are effective as standard adjunctive treatments for wound healing. (1) At the time, few RCTs were available, and they tended to have small sample sizes and poor methodologic quality.

Literature updates focused on RCTs, especially larger high-quality trials, and systematic reviews of RCTs. Moreover, the evidence review focused on the most clinically important outcome in evaluating treatments for wound healing-percent of patients who heal completely following a course of treatment. Time to complete healing is another important, objective outcome measure. Secondary outcomes with some clinical relevance are decrease in wound size and wound-associated pain, as well as facilitation of surgical closure. Adverse outcomes with electrical stimulation and electromagnetic therapy are expected to be minimal, but may include discomfort and infection associated with the device.

Electrical Stimulation

Subsequent to the BCBSA TEC Assessment, in addition to individual RCTs, several systematic reviews on electrical stimulation for treating wounds have been published. (2-8) Two of the systematic reviews pooled study findings.

The 2014 systematic review published by Barnes et al. included RCTs evaluating the effectiveness of electrical stimulation for chronic ulcers of any etiology compared with standard treatment and/or sham stimulation. (2) Twenty-one trials were included in the review; 14 used pulsed currents, 5 used alternating currents, and 2 used direct currents. Types of ulcers examined were pressure ulcers in 11 studies, venous ulcers in 3 studies, diabetic ulcers in 2 studies, arterial ulcers in 1 study, and ulcers of mixed etiology in the remaining 4 studies. Only 5 of the 21 trials were rated as “good” quality (i.e., a score of 4 or 5 on the Jadad scale). Studies generally did not report the clinically important outcomes of percent completely healed or time to complete healing. Instead, they tended to report outcomes related to the decrease in the size of wounds. Meta-analyses were performed on several of these secondary outcomes. A pooled analysis of 6 studies with a total of 201 patients found that electrical simulation increased the mean percentage change in ulcer size by 24% to 62% compared with standard care and/or sham stimulation. The difference between groups was statistically significant (p<0.001), and heterogeneity among trials was not significant. Another pooled analysis of 6 RCTs (total N=266 patients) found that electrical stimulation resulted in a significantly greater reduction in mean absolute ulcer size compared with standard care and/or sham stimulation. The mean difference in size between groups was 2.42 cm2 (95% confidence interval [CI], 1.66 to 3.17; p<0.001) and there was significant heterogeneity. The authors conducted sensitivity analyses and the significant benefit of electrical stimulation on ulcer size remained when studies of pulsed current and direct current were analyzed separately. Limitations of the evidence base identified in the systematic review include few high-quality studies, variability in study designs, and lack of data on complete healing.

A 2015 systematic review by Lala et al. addressed electrical stimulation for treating pressure ulcers in individuals with spinal cord injury. (6) A total of 15 studies met the inclusion criteria; 6 were RCTs, 6 were prospective controlled trials, 2 were retrospective controlled trials, and 4 were case series. Several studies, published by the same research group and using the same populations, may have overlapped. The investigators used a 10-point methodological quality score and judged the overall quality of the controlled studies to be low (mean quality score, 5.3). A pooled analysis was conducted of data from 4 RCTs that reported healing rate. Sample sizes were small; 2 of the 4 RCTs included fewer than 20 patients. In the pooled analysis, pressure ulcer healing was significantly higher with electrical stimulation than sham stimulation or usual care (risk ratio [RR], 1.55; 95% CI, 1.12 to 2.15). Several other pooled analyses assessed outcomes related to wound size (of less clinical interest) and were of data from nonrandomized studies.

Representative RCTs on electrical stimulation for treating chronic wounds are described next. This includes the most recently published trials identified in systematic reviews.

In 2010, Houghton et al. 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. (4) The trial included 34 adults with spinal cord injuries and stage II to IV pressure ulcers of at least 3 months in 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 in the standard care only group (n=18) (mean decrease, 70% vs 36%, respectively; p=0.048). By 3 months, all stage II wounds had healed (1 in the HVPC group, 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 no statistically significant difference in the number of wounds completely healed at 3 months, 6 in the HVPC group and 5 in the standard care only group.

In 2012, Franek et al. in Poland evaluated high-voltage electrical stimulation for treating lower-extremity pressure ulcers in an unblinded RCT. (3) 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 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 than in the control group on several outcomes. They included change in wound surface area (88.9% versus 44.4%, p<0.001) and change in the longest length of the wound (74.0% versus 36.1%, respectively, p<0.001). The rate of complete healing was not reported because trialists were unable to follow patients long enough for healing to occur.

Electromagnetic Stimulation

Two Cochrane reviews have evaluated electromagnetic stimulation for treating wounds; 1 addressed treatment of pressure ulcers (last updated in 2012) and the other addressed leg ulcers (last updated in 2015). (9,10) 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.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in July 2017 did not identify any ongoing or completed trials that would likely influence this review.

Summary of Evidence

The evidence for electrostimulation for treating individuals who have any wound type (acute or nonhealing) includes systematic reviews, randomized controlled trials (RCTs), and observational studies. Relevant outcomes are symptoms, change in health status, morbid events, quality of life, and treatment-related morbidity. Systematic reviews of RCTs on electrical stimulation have reported improvements in some outcomes, mainly intermediate outcomes such as decrease in wound size and/or the velocity of wound healing. There are few analyses on the more important clinical outcomes of complete healing and the time to complete healing, and many of the trials are of relatively low quality. The evidence is insufficient to determine the effects of the technology on health outcomes.

The evidence for electromagnetic stimulation for treating individual who have any wound type (acute or nonhealing) includes 2 systematic reviews of RCTs, 1 on pressure ulcers and the other on leg ulcers. Relevant outcomes are symptoms, change in health status, morbid events, quality of life, and treatment-related morbidity. The systematic reviews identified a few RCTs with small sample sizes that do not permit definitive conclusions. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American College of Physicians

In 2015, the American College of Physicians (ACP) published a guideline on treatment of pressure ulcers. (11) The guideline recommended the electrical stimulation be used as adjunctive treatment in patients with pressure ulcers. This was considered by ACP to be a weak recommendation, based on moderate-quality evidence.

Association for the Advancement of Wound Care

In 2010, the Association for the Advancement of Wound Care published a guideline on care of pressure ulcers. (12) Electrical stimulation was included as a potential second-line intervention if first-line treatments did not result in wound healing.

Wound, Ostomy and Continence Nurses Society

In 2016, the Wound, Ostomy and Continence Nurses Society published a guideline on prevention and management of pressure ulcers (injuries). (13) The guideline stated that electrical stimulation can be considered as adjunctive treatment and rated the evidence as level A.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

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.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

64550

HCPCS Codes

A4595, A4630, E0720, E0730, E0761, E0769, G0281, G0282, G0295, G0329

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

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>.

References:

1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Electrical stimulation or electromagnetic therapy as adjunctive treatments for chronic skin wounds. TEC Assessments. 2005; Volume 20, Tab 2.

2. Barnes R, Shahin Y, Gohil R, et al. Electrical stimulation vs. standard care for chronic ulcer healing: a systematic review and meta-analysis of randomised controlled trials. Eur J Clin Invest. Apr 2014; 44(4):429-440. PMID 24456185

3. Franek A, Kostur R, Polak A, et al. Using high-voltage electrical stimulation in the treatment of recalcitrant pressure ulcers: results of a randomized, controlled clinical study. Ostomy Wound Manage. Mar 2012; 58(3):30- 44. PMID 22391955

4. Houghton PE, Campbell KE, Fraser CH, et al. Electrical stimulation therapy increases rate of healing of pressure ulcers in community-dwelling people with spinal cord injury. Arch Phys Med Rehabil. 2010; 91(5):669-678. PMID 20434602

5. Kawasaki L, Mushahwar VK, Ho C, et al. The mechanisms and evidence of efficacy of electrical stimulation for healing of pressure ulcer: a systematic review. Wound Repair Regen. Mar-Apr 2014; 22(2):161-173. PMID 24372691

6. Lala D, Spaulding SJ, Burke SM, et al. Electrical stimulation therapy for the treatment of pressure ulcers in individuals with spinal cord injury: a systematic review and meta-analysis. Int Wound J. Dec 2016; 13(6): 1214-1226. PMID 25869151

7. Liu LQ, Moody J, Traynor M, et al. A systematic review of electrical stimulation for pressure ulcer prevention and treatment in people with spinal cord injuries. J Spinal Cord Med. Nov 2014; 37(6):703-718. PMID 24969965

8. Thakral G, La Fontaine J, Kim P, et al. Treatment options for venous leg ulcers: effectiveness of vascular surgery, bioengineered tissue, and electrical stimulation. Adv Skin Wound Care. Apr 2015; 28(4):164-172. PMID 25775200

9. Aziz Z, Flemming K. Electromagnetic therapy for treating pressure ulcers. Cochrane Database Syst Rev. Dec 12 2012; 12:CD002930. PMID 23235593

10. Aziz Z, Cullum N. Electromagnetic therapy for treating venous leg ulcers. Cochrane Database Syst Rev. Jul 2 2015; (7):CD002933. PMID 26134172

11. Qaseem A, Humphrey LL, Forciea MA, et al. Treatment of pressure ulcers: a clinical practice guideline from the American College of Physicians. Ann Intern Med. Mar 3 2015; 162(5):370-379. PMID 25732279

12. Association for the Advancement of Wound Care guideline of pressure ulcer guidelines. 2010. Available at <http://www.guideline.gov> (accessed - 2017 July 17).

13. Wound, Ostomy and Continence Nurses Society (WOCN). Guideline for prevention and management of pressure ulcers (injuries). 2016. Available at <http://www.guideline.gov> (accessed - 2017 July 17).

14. CMS Manual System. Pub. 100-43 Medicare National Coverage Determinations. 2004. Available at < www.cms.hhs.gov> (accessed - 2015 December 6).

15. Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (January 2016) Medicine 2.01.57.

Policy History:

DateReason
9/1/2017 Document updated with literature review. Coverage unchanged.
5/15/2016 Reviewed. No changes.
1/1/2015 Document updated with literature review. Coverage clarified in the first coverage statement to specify; including but not limited to the types of electrical stimulation mentioned.
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

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