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.

For individuals who have any wound type (acute or nonhealing) who receive electrostimulation, the evidence includes systematic reviews, a meta-analysis, and randomized controlled trials (RCTs). 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 a 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. 

For individuals who have any wound type (acute or nonhealing) who receive electromagnetic therapy, the evidence includes 2 systematic reviews of RCTs (one on pressure ulcers and the other on leg ulcers) and an RCT of electromagnetic treatment following Cesarean section. 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 drawing definitive conclusions. The evidence is insufficient to determine the effects of the technology on health outcomes.

Background 
Standard Treatment
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.

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

• Increase adenosine 5¢-triphosphate concentration in the skin
• Increase DNA synthesis
• Attract epithelial cells and fibroblasts to wound sites
• Accelerate the recovery of damaged neural tissue
• Reduce edema
• Increase blood flow
• Inhibit pathogenesis.

Electrostimulation refers to the application of electrical current through electrodes placed directly on the skin near the wound. The types of electrostimulation and devices can be categorized into groups based on the type of current. This includes low-intensity direct current, high-voltage pulsed current, alternating current, and transcutaneous electrical nerve stimulation.

Electromagnetic Therapy
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 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.

Policy:
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 investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY.

Electrical stimulation performed by the patient in the home setting for the treatment of wounds is investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY.

Electromagnetic therapy for the treatment of wounds is investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY.

Policy Guidelines
Please see the Codes table for details.

Benefit Application
BlueCard^®/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.

Rationale
Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., people of color [African American, Asian, Black, Latino and Native American]; LGBTQIA [lesbian, gay, bisexual, transgender, queer, intersex, asexual]; women; and people with disabilities [physical and invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Electrostimulation
Clinical Context and Therapy Purpose
The purpose of electrostimulation is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with any wound type (acute or nonhealing).

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with any wound type (acute or nonhealing).

Interventions
The therapy being considered is electrostimulation.

Comparators
Comparators of interest include standard wound care.

Outcomes
The general outcomes of interest are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity.

Follow-up over months is of interest for electrostimulation to monitor relevant outcomes.

Study Selection Criteria
Methodologically credible studies for indications within this review were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Several RCTs and systematic reviews on electrostimulation for treating wounds have been published.^{1,2,3,4,5,6,7,8}

Systematic Reviews
In a meta-analysis specific to patients with diabetes-related ulcers, Zheng et al. (2022) identified 10 trials (N = 352) comparing electrostimulation to standard of care or placebo.⁸ Electrostimulation improved ulcer area reduction and healing rates; however, 4 studies were considered at high risk of bias, and there was high heterogeneity limiting applicability of these findings. Individual trial sample sizes were quite small, and additional properly designed RCTs are necessary to establish electrostimulation efficacy in patients with diabetes-related ulcers.

Arora et al. (2020) performed a Cochrane review comparing electrical stimulation plus standard care to sham/no electrical stimulation plus standard care for the management of pressure ulcers.⁹ The review included 20 RCTs with a total of 913 patients (mean age range: 26 to 83 years) with pressure ulcers ranging from a mean of 4 days to more than 12 months. Fifty percent of the included studies were at risk of performance and detection bias; 25% were at risk of attrition and selective reporting bias. The Grading of Recommendations, Assessment, Development, and Education (GRADE) assessment of the certainty of evidence for outcomes was moderate to very low. Overall, the authors concluded that electrical stimulation probably increased the proportion of pressure ulcers healed and the rate of healing (moderate certainty evidence), but the effect on time to complete healing was uncertain compared to standard care (very low certainty evidence). Whether electrical stimulation reduces pressure ulcer surface area was also uncertain. The authors stated that current evidence is insufficient to support the widespread use of electrical stimulation for pressure ulcer management in clinical practice.

A systematic review by Girgis and Duarte (2018) assessed the efficacy of high-voltage monophasic pulsed current (HVMPC) to treat stage II to IV pressure ulcers, determine the HVMPC intervention parameters and best protocol, and identify other benefits and the safety of HVMPC.¹⁰ Of the 11 eligible studies, 9 were RCTs and 2 were case series, which included a total of 483 patients. Five studies were included in the quantitative analysis (treatment arm n = 137; control arm n = 139). All studies found HVMPC had positive effects on wound surface area reduction and the incidence of complete healing, with a net effect on wound surface area reduction of 5.4% per week. Of studies that reported adverse reactions to HVMPC, none were seen in 5 studies, with no patient discomfort reported, and minor adverse reactions were seen in 1 study; 3 studies concluded that HVMPC is safe.

A meta-analysis by Khouri et al. (2017) included 29 randomized trials (N = 1,510 patients; N = 1,753 ulcers) of individuals treated with electrostimulation, sham stimulation, or standardized wound care.¹¹ The primary finding was a highly heterogeneous overall standardized mean difference of 0.72. Modalities varied: in 18 studies, active electrostimulation was placed near the wound, and in 17 studies, electrostimulation was placed over the wound; additionally, types of waveform varied between studies (types included direct-, high-, or low-voltage current, and alternating current). Electrostimulation had the greatest efficacy when the active electrode was placed over the wound, and high-voltage pulsed current (HVPC) was used (standardized mean difference, 0.8; 95% confidence interval [CI], 0.38 to 1.21; I2 = 79%). Other factors that may have affected the efficacy of electrostimulation were ulcer type, size, and duration (small, quick-healing pressure ulcers were favorable), although the association was not statistically significant (p = .28). In subgroup analyses, reviewers found a greater sensitivity for wound size area than for other outcomes. Potential sources of heterogeneity were electrode polarity, ulcer etiology, and type of outcome. Reviewers noted that 52% of the studies had a high risk of bias but concluded that the overall safety and efficacy of electrostimulation seem confirmed, given the current evidence.

A systematic review by Lala et al. (2016) addressed electrostimulation for treating pressure ulcers in individuals with spinal cord injury.⁵ Fifteen studies met 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, might have overlapped. Reviewers used a 10-point methodologic 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 electrostimulation than sham stimulation or usual care (relative risk, 1.55; 95% CI, 1.12 to 2.15). Several other pooled analyses assessed outcomes related to wound size (of less clinical interest) and data from nonrandomized studies.

A systematic review by Barnes et al. (2014) included RCTs evaluating the comparative effectiveness of electrostimulation for chronic ulcers of any etiology and standard treatment and/or sham stimulation.¹ Twenty-one trials were selected; 14 used pulsed currents, 5 used alternating currents, and 2 used direct currents. Pressure ulcers were evaluated 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, these studies reported outcomes related to the decrease in wound size. Meta-analyses were performed on several of these secondary outcomes. A pooled analysis of 6 studies (n = 201) found that electrostimulation 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 < .001), and heterogeneity among trials was not significant. Another pooled analysis of 6 RCTs (n = 266) found that electrostimulation 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% CI, 1.66 to 3.17 cm2; p < .001) and there was significant heterogeneity. Reviewers conducted sensitivity analyses, and the significant benefit of electrostimulation 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 included few high-quality studies, variability in study designs, and lack of data on complete healing.

Tables 1 and 2 describe the characteristics and results of the 4 systematic reviews described above that had the least overlap and the most recent data.

Table 1. Characteristics of Key Systematic Reviews with Meta-Analyses on Electrical Stimulation to Treat Chronic Ulcers

NA: not available; RCT: randomized controlled trial.

Table 2. Results of Key Systematic Reviews with Meta-Analyses on Electrical Stimulation to Treat Chronic Ulcers

CI: confidence interval; I2: indicates heterogeneity of studies; HR: hazard ratio; RR: risk ratio; SD: standard deviation; SEM: standard error of the mean; SMD: standard mean difference.

Section Summary: Electrostimulation
The evidence on the use of electrostimulation to treat wounds includes multiple systematic reviews of RCTs and other study designs. Many studies reported short-term outcomes such as wound healing rate or decrease in wound size; several meta-analyses of the trials found improvements for these outcomes. However, few studies included within meta-analyses evaluated complete healing or time to complete healing, 2 more clinically important outcomes. In 1 meta-analysis, the time to complete wound healing did not reach statistical significance in favor of electrostimulation for the treatment of pressure ulcers. Systematic reviews were limited by the inclusion of studies with poor methodological quality and high heterogeneity.

Electromagnetic Therapy
Clinical Context and Therapy Purpose
The purpose of electromagnetic therapy is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with any wound type (acute or nonhealing).

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with any wound type (acute or nonhealing).

Interventions
The therapy being considered is electromagnetic therapy.

Comparators
Comparators of interest include standard wound care.

Outcomes
The general outcomes of interest are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity.

Follow-up over months is of interest for electromagnetic therapy to monitor relevant outcomes.

Review of Evidence
Systematic Reviews
Two Cochrane reviews have evaluated electromagnetic therapy for treating wounds: 1 addressed the treatment of pressure ulcers (last updated in 2012) and the other addressed leg ulcers (last updated in 2015).^12,13 Each review identified a few RCTs (2 and 3 studies, respectively) with small sample sizes. Consequently, these reviewers were unable to conduct robust pooled analyses of study findings. Both concluded that there is insufficient evidence that electromagnetic therapy is effective for treating chronic wounds.

Randomized Controlled Trials
Khooshideh et al. (2017) reported on a RCT of 72 women treated with pulsed electromagnetic field (PEMF) therapy or sham PEMF following Cesarean section.¹⁴ The primary outcome was a reduction of pain during recovery, which was assessed using a visual analog scale (VAS) at regular intervals for 7 days following surgery. At each assessment, women treated with PEMF (n = 36) reported significantly lower levels of pain than did their counterparts treated with sham (n = 36). For example, 2 hours after surgery, PEMF patients had a mean VAS score of 53 compared with that of sham patients (VAS score, 63; p = .01). Comparisons were similar between groups through the seventh day of follow-up, when the PEMF group reported a mean VAS score of 0.8 and the sham group reported a mean VAS score of 3 (p = .01). The percentage of patients who reported severe pain (defined as VAS score, ≥ 75) 24 hours or less after surgery was lower in the PEMF group (36%) than in the sham group (72%; p = .002). Secondary outcomes were wound healing and use of the pain medication available to each patient at discharge (diclofenac suppository 100 mg as needed); unlike other outcomes, wound healing was assessed 10 days after surgery, rather than 7. None of the patients in the PEMF group showed signs of wound exudate or edema, compared with 13% and 11% of sham patients who had exudate or edema, respectively (p = .04). Patients in the PEMF group consistently used fewer suppositories to treat postoperative pain (mean, 1.7) than those treated with sham (mean, 3.7; p < .001). Patients in both groups took an average of 3 to 4 days before they were able to resume normal activities, with no significant difference between groups (p = .58).

Section Summary: Electromagnetic Therapy
The evidence on the use of electromagnetic therapy includes 2 systematic reviews of RCTs (1 on pressure ulcers and the other on leg ulcers) and a RCT of electromagnetic treatment following Cesarean section. The reviews were limited by the inclusion of small studies and a lack of robust pooled analyses. The RCT was focused primarily on postoperative pain, with wound healing being a secondary outcome that was assessed according to a previous protocol. The evidence on the use of electromagnetic therapy to treat wounds is inadequate to support drawing a conclusion about efficacy.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in Supplemental Information if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American College of Physicians
In 2015, the American College of Physicians published guidelines on the treatment of pressure ulcers.¹⁵ The guidelines recommended that electrostimulation be used as adjunctive treatment in patients with pressure ulcers. This was considered by the College to be a weak recommendation, based on moderate-quality evidence. This guideline is listed as "inactive" on the ACP website.¹⁶

Association for the Advancement of Wound Care
In 2014, the Association for the Advancement of Wound Care (AAWC) published guidelines on the care of venous ulcers and pressure ulcers.¹⁷ Guidelines for venous ulcer care included electrostimulation and electromagnetic stimulation as treatment modalities. Guidelines for pressure ulcer care include electrostimulation as adjunctive interventions when pressure ulcers do not respond to the first-line of treatment.

Previously, the AAWC (2010) published guidelines on the care of pressure ulcers.¹⁸ Electrostimulation 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 guidelines on the prevention and management of pressure ulcers.¹⁹ The guidelines stated that electrostimulation can be considered as adjunctive treatment and rated the evidence as level A.

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in November 2022 did not identify any ongoing or unpublished trials that would likely influence this review.

References:    

1. 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): 429-40. PMID 24456185
2. 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
3. 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. May 2010; 91(5): 669-78. PMID 20434602
4. 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. 2014; 22(2): 161-73. PMID 24372691
5. 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
6. 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): 703-18. PMID 24969965
7. 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): 164-72. PMID 25775200
8. Zheng Y, Du X, Yin L, et al. Effect of electrical stimulation on patients with diabetes-related ulcers: a systematic review and meta-analysis. BMC Endocr Disord. Apr 27 2022; 22(1): 112. PMID 35477391
9. Arora M, Harvey LA, Glinsky JV, et al. Electrical stimulation for treating pressure ulcers. Cochrane Database Syst Rev. Jan 22 2020; 1(1): CD012196. PMID 31962369
10. Girgis B, Duarte JA. High Voltage Monophasic Pulsed Current (HVMPC) for stage II-IV pressure ulcer healing. A systematic review and meta-analysis. J Tissue Viability. Nov 2018; 27(4): 274-284. PMID 30177421
11. Khouri C, Kotzki S, Roustit M, et al. Hierarchical evaluation of electrical stimulation protocols for chronic wound healing: An effect size meta-analysis. Wound Repair Regen. Sep 2017; 25(5): 883-891. PMID 29052946
12. Aziz Z, Flemming K. Electromagnetic therapy for treating pressure ulcers. Cochrane Database Syst Rev. Dec 12 2012; 12: CD002930. PMID 23235593
13. Aziz Z, Cullum N. Electromagnetic therapy for treating venous leg ulcers. Cochrane Database Syst Rev. Jul 02 2015; 2015(7): CD002933. PMID 26134172
14. Khooshideh M, Latifi Rostami SS, Sheikh M, et al. Pulsed Electromagnetic Fields for Postsurgical Pain Management in Women Undergoing Cesarean Section: A Randomized, Double-Blind, Placebo-controlled Trial. Clin J Pain. Feb 2017; 33(2): 142-147. PMID 28060214
15. 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 03 2015; 162(5): 370-9. PMID 25732279
16. American College of Physicians (ACP). Inactive ACP guidelines. https://www.acponline.org/clinical-information/guidelines/inactive-acp-guidelines. Accessed November 29, 2022.
17. Bolton LL, Girolami S, Corbett L, et al. The Association for the Advancement of Wound Care (AAWC) venous and pressure ulcer guidelines. Ostomy Wound Manage. Nov 2014; 60(11): 24-66. PMID 25380098
18. Association for the Advancement of Wound Care (AAWC). Association for the Advancement of Wound Care guideline of pressure ulcer guidelines. Malvern, PA: AAWC; 2010.
19. Wound, Ostomy and Continence Nurses Society-Wound Guidelines Task Force. WOCN 2016 Guideline for Prevention and Management of Pressure Injuries (Ulcers): An Executive Summary. J Wound Ostomy Continence Nurs. 2017; 44(3): 241-246. PMID 28472816
20. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds (270.1). 2004; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?ncdid=131&ver=3

Coding Section

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. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2024 Forward     

07/11/2024 Annual review, no change to policy intent

01012024  NEW POLICY