CADTH Health Technology Review

Electrostimulation Devices for Wounds

Rapid Review

Authors: Qiukui Hao, Jennifer Horton, Angie Hamson

Acknowledgements

Many thanks to patient contributor, Stewart Midwinter, for his time and energy sharing his lived experiences and perspectives. His contribution was invaluable.

Key Messages

• We found that electrostimulation as an adjunct to usual wound care might be better than usual care alone for wound management without increasing the risk of adverse events.

• Electrostimulation therapy may have greater effectiveness for patients with chronic wounds versus acute wounds or those with venous leg ulcers (VLUs) who do not have surgery compared with those who do have surgery.

• Electrostimulation using pulsed current may have greater effectiveness on wound management than using direct current for patients with pressure ulcers.

• Limited evidence from subgroup analyses suggests that the effectiveness of electrostimulation may be similar to negative pressure wound therapy (NPWT) in wound surface area (WSA) and time to complete wound healing.

• One economic evaluation study used a within-trial time horizon (up to 24 weeks) and, based on the UK National Health Service perspective, suggests that electrostimulation is less costly and more effective than placebo at 24 weeks. We did not find any studies reporting on the cost-effectiveness between electrostimulation and NPWT that met the inclusion criteria for this report.

• One guideline suggests using electrostimulation as an adjunct intervention for managing postoperative pain in patients who have undergone elective caesarean section; another guideline strongly recommends against physical therapies (including electrostimulation) for diabetic foot ulcer management.

• A patient with lived experience of using an electrostimulation device for the treatment of a wound was involved in this report. He identified outcomes that are important to patients, primarily avoiding hospitalization and surgery, which were not outcomes reported in the identified literature. Considerations included the accessibility of the devices, training, and integration into homecare services.

Context and Policy Issues

Basic Principles of Wound Management

For optimal wound healing, it is important to follow basic principles such as wound bed preparation, wound dressing, and wound closure.¹ Effective wound management usually involves a multidisciplinary team, consisting of primary care providers, specialists, physical therapists, and nursing staff whenever possible.² Typically, wound management requires debridement and topical therapy to remove devitalized tissue, clear infection, and provide an appropriate moist environment. To enhance wound healing, clinicians may suggest other adjunctive therapies, such as hyperbaric oxygen therapy, ultrasound stimulation, electrostimulation, and electromagnetic energy stimulation.^1,3

What Are Electrostimulation Devices?

Electrostimulation devices provide low-level currents via surface electrodes on the skin.⁴ There are multiple electrostimulation devices available with varying costs. For a particular device, the expenses could vary from a monthly fee of $125 to a 1-time purchase cost of $750.⁵ It is now feasible to develop a cost-effective electrostimulation device that costs less than US$70.⁶ The electrostimulation devices are generally safe, stable, and compact.⁴

How Might Electrostimulation Treatment Work?

There are several theories on how electrostimulation can aid wound healing, but a systematic review focusing on these theories to understand the mechanisms of electrostimulation on wound management has yet to be conducted so none of these theories have been fully established.⁷ According to prior research, electrostimulation has been found to affect all 4 phases of the healing process, including inflammatory, proliferative, epithelialization, and remodelling phases.⁷ The underlying effect of electrostimulation may involve the resolution of inflammation, increase of tissue blood flow, reduction in edema, increase of cell migration, angiogenesis, and collagen deposition in scars.^4,8,9 Moreover, electrostimulation therapy has been found to be beneficial for individuals with spinal cord injuries who experience chronic wounds due to immobility and continuous pressure. The possible advantages of this treatment include that it promotes muscle hypertrophy and enhances muscle contraction.¹⁰

Why Is it Important to Do This Review?

Wounds have a major impact on one's quality of life, and their management has a significant economic impact on health care.^11,12 In Canada’s health care facilities, the prevalence of pressure ulcers is estimated to be more than 25%, which is higher than the reported rates in the US (most studies have been conducted in the US) and the Netherlands (which has a higher prevalence rate than the international average).¹³

Increasing evidence suggests that electrostimulation is beneficial for wound management, and this therapy is becoming an important component of physical therapies for wound management.³ Health Quality Ontario and several guidelines suggest using electrostimulation as an adjunct therapy to standard wound care (SWC) for patients with pressure injuries.^14,15 Despite the potential clinical effectiveness, electrostimulation has not gained much usage in clinical practice in Canada.¹⁵ In addition, medical insurance policies do not currently recognize electrostimulation as an essential treatment for managing wounds and do not cover its usage.¹⁶

Objectives

The purpose of this report is to provide a summary of the latest evidence on electrostimulation devices for wound management, including clinical effectiveness and safety, cost-effectiveness, and relevant clinical practice guidelines.

Research Questions

1. What is the clinical effectiveness of electrostimulation devices as an adjunct to usual care for the management of wounds?

2. What is the clinical effectiveness of electrostimulation devices versus negative pressure wound therapy for the management of wounds?

3. What is the cost-effectiveness of electrostimulation devices as an adjunct to usual care for the management of wounds?

4. What is the cost-effectiveness of electrostimulation devices versus negative pressure wound therapy for the management of wounds?

5. What are the evidence-based guidelines regarding the use of electrostimulation devices for the management of wounds?

Methods

Literature Search Methods

An information specialist conducted a literature search on key resources, including MEDLINE, the Cochrane Database of Systematic Reviews, the International HTA Database, the websites of Canadian and major international health technology agencies, as well as a focused internet search. The search approach was customized to retrieve a limited set of results, balancing comprehensiveness with relevancy. The search strategy comprised both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. Search concepts were developed based on the elements of the research questions and selection criteria. The main search concepts were electrostimulation and wounds. No filters were applied to limit the retrieval by study type. A supplemental search was conducted with CADTH-developed search filters applied to limit retrieval to guidelines. Retrieval was limited to the human population. The search was completed on May 30, 2023, and limited to English-language documents published since January 1, 2018.

Selection Criteria and Methods

One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed, and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1.

Table 1: Selection Criteria

Exclusion Criteria

We excluded articles if they did not meet the selection criteria outlined in Table 1, they were duplicate publications, or if they were published before 2018 for the economic evaluation and evidence-based guidelines. For health technology assessment and systematic reviews that addressing the questions 1 and 2, articles published before 2022 were excluded due to substantial amount of literature identified during our search. We also excluded publications that are not published in the English language.

Critical Appraisal of Individual Studies

The included publications were critically appraised by 1 reviewer using the following tools as a guide: A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2)¹⁷ for systematic reviews, the Drummond checklist¹⁸ for economic evaluations, and the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument¹⁹ for guidelines. Summary scores were not calculated for the included studies; rather, the strengths and limitations of each included publication were described narratively.

Patient Engagement

CADTH has adopted the CADTH Framework for Patient Engagement in Health Technology Assessment,²⁰ which includes standards for patient involvement in individual health technology assessments and is used to support and guide CADTH activities involving patients. For this report, CADTH engaged a patient contributor with lived experience of an electrostimulation device for wound care.

Invitation to Participate and Consent

CADTH reached out through social media and by direct email to a patient advocacy group. The preliminary engagement request included an overview of this project, the purpose of engagement, and the nature of engagement activities. An interested individual was identified, and the CADTH Patient Engagement Officer obtained the person’s informed consent to share with CADTH staff their lived experience with a wound and their treatment with an electrostimulation device.

Engagement Activities

An individual contributor shared their personal experience by video call during the drafting of the report. Patient perspectives gained through engagement processes are used to understand relevance of outcomes of interest and to provide contexts or insights to inform the summary, limitation, and conclusion sections.

Patient involvement was reported using the Guidance for Reporting Involvement of Patients and the Public (version 2) (GRIPP2) short form reporting checklist,²¹ which is outlined in Appendix 6. Regarding outcomes, the patient contributor noted the importance of minimizing chances of being hospitalized or undergoing surgery.

Summary of Evidence

Quantity of Research Available

A total of 432 citations were identified in the literature search. Following screening of titles and abstracts, 393 citations were excluded and 39 potentially relevant reports from the electronic search were retrieved for full-text review. Ten potentially relevant publications were retrieved from the grey literature search for full-text review. Of these potentially relevant articles, 39 publications were excluded for various reasons and 10 publications met the inclusion criteria and were included in this report. These comprised 7 systematic reviews,1 economic evaluation, and 2 evidence-based guidelines. Appendix 1 presents the PRISMA²² flow chart of the study selection. Additional references of potential interest are provided in Appendix 7.

Summary of Study Characteristics

This report included 7 systematic reviews,^23-29 1 economic evaluation,³⁰ and 2 evidence-based guidelines.^31,32 We did not identify any health technology assessments that met the inclusion criteria. Further, we did not come across any studies that reported surgery or hospitalization outcomes, which were identified as important during our patient engagement activities. Characteristics of included publications are provided in Appendix 2.

Included Studies for Question 1: Electrostimulation Versus Usual Care

We included 7 systematic reviews that examined the clinical effectiveness of electrostimulation devices as an additional treatment for wound management compared with usual care without electrostimulation. The included systematic reviews were conducted in Portugal,^23,25 Poland,²⁴ China,^26,27 the UK,²⁸ and Spain.²⁹ Five systematic reviews^23,26-29 included primary studies from various countries, such as Canada, Slovenia, Germany, Brazil, Italy, Poland, the UK, the US, Nigeria, Israel, Egypt, Spain, Iran, Colombia, Sweden, and Belgium. Three of the systematic reviews only considered eligible randomized controlled trials (RCTs),^24,26,29 whereas the remaining reviews also incorporated observational studies^23,25,28 or quasi-experimental studies²⁷ in addition to RCTs. These systematic reviews included patients with venous leg ulcers (VLUs),²³ pressure ulcers,^24,26 diabetic ulcers,^25,27,28 and both chronic and acute wounds.²⁹

Electrostimulation varied in anatomical location, frequency, duration, and parameters in the included systematic reviews. One systematic review included 10 RCTs used high-voltage monophasic pulsed current (HVMPC), 2 RCTs used low-voltage monophasic pulsed current (LVMPC), 3 RCTs used low-voltage biphasic pulsed current (LVBPC), and 1 RCT low-intensity direct current. A systematic review was conducted on studies involving HVMPC.²⁵ One systematic review included only studies with the current intensity of 1 mA or greater. Other systematic reviews included diverse electrostimulation methods^23,26,28 or unclear details.²⁷ The comparators were SWC with or without sham stimulation. Outcomes included healing rate, incidence of worsening of healing, wound surface area (WSA) measures, ulcer size, number of completely healed ulcers, time to healing, pain score, quality of life, adverse effects, and other outcomes, such as wound tissue granulation and capillary blood flow.

Included Studies for Question 2: Electrostimulation Versus Negative Pressure Wound Therapy

A systematic review²⁹ included 1 RCT with 3 treatment groups for patients with burn wounds: electrostimulation plus SWC, negative pressure wound therapy (NPWT) plus SWC, and SWC. This systematic review conducted a subgroup analysis, using the data from the RCT, that compared electrostimulation with NPWT. Outcomes included WSA measures and time to healing; no adverse effects were reported for this comparison.

Included Cost-Effectiveness Study Regarding Electrostimulation Versus Placebo for Wound Management

We included 1 cost-utility analysis based on data from 1 RCT³⁰ , which was included in 2 systematic reviews in this report.^23,29 We have only provided details about the participants and the results pertaining to the economic assessment. The evaluation used a within-trial time horizon (8 weeks, 16 weeks, and 24 weeks) from the perspective of the UK National Health Service. The study enrolled 90 people with nonhealing leg ulcers. Patients in the intervention group were treated with an electrostimulation device for 12 days in addition to usual care, while patients in the control group were treated with usual care and a placebo device that looked the same as the electrostimulation device but did not deliver a microcurrent. The intervention group had a mean age of 71 years (SD = 15.0 years) and 60% were male, while the control group had a mean age of 68 years (SD = 15.1) and 50% were male. Data on effectiveness were gathered through the RCT, with the patients' utility values determined from participants’ responses to the EQ-5D-5L questionnaire. Quality-adjusted life-years (QALYs) were calculated at 8, 16, and 24 weeks following randomization. NHS tariffs from 2015 or 2016 were used to estimate national unit costs and were applied to health care resource usage to determine the cost per patient within each group. The authors compared the cost-effectiveness of 2 groups by calculating the incremental cost per QALY gained and the incremental cost for each additional healed patient.

Included Cost-Effectiveness Study Regarding Electrostimulation Versus Placebo for Wound Management

We did not find any studies that reported on the cost-effectiveness of electrostimulation compared with NPWT that met the inclusion criteria for this report.

Included Clinical Practice Guidelines Regarding Electrostimulation for Wound Management

We included 2 evidence-based clinical practice guidelines from International Working Group on the Diabetic Foot (IWGDF)³¹ and procedure-specific postoperative pain management (PROSPECT) working group.³² These guidelines are updated versions of 2 existing ones.

The IWGDF guideline development group comprised independent international experts in wound healing for diabetes-related foot ulcers that conducted an updated systematic review to identify relevant RCTs.³¹ The ratings of the quality of evidence and strength of recommendations were reported based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence to recommendation framework. A team of clinical experts, the IWGDF editorial board, and individuals with lived experience reviewed and assessed the guideline recommendations and rationales.

The PROSPECT guideline³² included recommendations for pain management in patients who undergo elective caesarean section under neuraxial anesthesia. The panel of experts (authors of the guideline were from Belgium, Sweden, and the US) followed their own methodology to obtain formal consensus and develop recommendations after conducting a systematic review. However, they did not specify how to interpret the strength of recommendations (Grades A to D). The PROSPECT working group used a modified Delphi approach to review recommendations and reach a consensus. The final document was approved by the working group and received support from the Obstetric Anesthetists’ Association’s executive committee.

Summary of Critical Appraisal

Systematic Reviews

In all 7 systematic reviews,^23-29 the objective was clearly described, multiple databases were searched, and keywords or full search strategies and study selection flow charts were provided, the review authors declared no conflicts of interest, lists of included articles were presented, and the study characteristics were described. Two systematic reviews^24,29 did not provided lists of excluded articles or the reasons for exclusion, and only 1 systematic review²⁵ assessed the sources of funding in individual studies. Despite searching in multiple databases, 4 systematic reviews^23,26,27,29 did not report performing a grey literature search and 4 systematic reviews^23-25,29 did not report searching the Embase database specifically. These limitations may result in missing some studies (unpublished or studies conducted in Europe) or misidentification of potential publication bias.

At least 2 reviewers independently performed or verified the article selection and data extraction in 5 systematic reviews.^23,26-29 Two reviewers independently conducted data extraction in 1 systematic review,²⁴ but it was unclear how the article selection was performed. In the remaining systematic review,²⁵ it was unclear how article selection and data extraction were conducted. The possibility of inappropriate inclusion or exclusion or errors in data extraction cannot be ruled out. Although all 7 systematic reviews assessed the risk of bias of the included individual studies and reported study quality, only 1 systematic review²⁵ assessed the potential impact of study risk of bias on the interpretation of results. One systematic review²⁷ judged that only 2 of 8 primary studies had a low risk of bias. Some subgroup analyses in this systematic review only included 2 primary studies; therefore, the results of these analyses may be driven by individual studies with high risk of bias.

Two systematic reviews^9,13 assessed the quality of evidence using the GRADE framework. However, 1 of these reviews²⁹ did not adhere completely to the GRADE principles because it rated up the certainty of evidence on pain and adverse events outcomes even when the risk difference was less than 0.20. Thus, the accuracy of the overall quality evidence on pain and adverse events was uncertain in this review.

Four systematic reviews^25-27,29 conducted meta-analyses to compare effectiveness in several outcomes. Considering the significant clinical heterogeneities, such as diverse electrostimulation methods and wound types, it is uncertain whether pooling these data is suitable. The authors conducted subgroup analyses to examine some heterogeneities, including chronic or acute wounds and pulsed or direct currents of electrostimulation. However, none of the 4 systematic reviews assessed the credibility of their subgroup analyses.^25-27,29 Two of the systematic reviews^26,27 failed to mention the procedures used to manage trials with multiple arms (3 or more). When conducting a meta-analysis with a study that involves multiple or correlated comparisons, the Cochrane group suggests overcoming the unit-of-analysis error by combining groups to form a single pairwise comparison³³ instead of dividing the shared group, which is a suboptimal approach. The authors of the 2 systematic reviews^25,29 stated that they followed the Cochrane Group Guidelines to avoid double counting by splitting the shared control group. However, some forest plots presented in the 2 systematic reviews did not reflect this split.^25,29 It is possible that the meta-analysis had unit-of-analysis error and double-counting issues, which could have influenced the outcome in favour of the intervention.

Economic Evaluation

The included economic evaluation study³⁰ outlined its design and analysis perspective clearly, with thorough data collection and stated outcome measures. The authors of the study examined and interpreted the results and presented their conclusions with appropriate caveats. However, the primary objective of the study did not involve estimating the cost-effectiveness of electrostimulation, and the study lacks clarity in its research question and economic significance.³⁰ Moreover, the study lacks details on currency price adjustments for inflation or conversion, and the intervention’s effectiveness measures were based on a single RCT rather than a synthesis or meta-analysis of estimates from multiple sources.³⁰ The treatment effects from the single RCT align with the included meta-analysis in the healing outcomes, but the RCT indicates a higher treatment effect of WSA compared with the meta-analysis, with a 50% reduction³⁰ versus a 30% reduction.^25,26 It is worth noting that the time horizon for costs and benefits — which is up to 24 weeks — may be considered relatively short if taking into account the mean duration of nonhealing VLUs, which can last for more than 2 years. Additionally, more than 20% of patients still exhibited heavy exudate at the end of the study (after 24 weeks).³⁰ This study was also conducted from the UK NHS perspective and may not necessarily apply to the health care system in Canada.

Evidence-Based Guidelines

In this report, we included 2 evidence-based guidelines,^31,32 which had clear descriptions of objectives, scope, population, and target users. Their recommendation statements were stated and reviewed by members in related working groups, but they did not provide clear guidance on their applicability.

The IWGDF guidelines used the GRADE evidence to recommendation framework to formulate their recommendations and included individuals with lived experience and the IWGDF editorial board reviewed and assessed the guideline recommendations and rationales.³¹ However, the guideline panel did not provide a thorough explanation regarding why they made strong recommendations despite having low-quality evidence for electrostimulation and the evidence of electrostimulation was not clearly described.^31,34 The authors of the IWGDF guidelines declared no conflicts of interest.

The PROSPECT guideline used their own methodology³⁵ to develop recommendations but did not clarify the interpretation of recommendation strength, and the links between the evidence and the recommendations were unclear. The recommendation statement regarding electrostimulation was ambiguous. The PROSPECT working group reviewed and approved the final guideline, which also received support from the Obstetric Anesthetists’ Association. Although some authors of the guideline disclosed potential conflicts of interest and had received grants or consultation fees from industries, it remains unclear how these were addressed.

Additional details regarding the strengths and limitations of the included publications are provided in Appendix 3.

Summary of Findings

All 7 included systematic reviews^23-29 compared the effectiveness of electrostimulation plus usual care with only usual care. One of the systematic reviews included data from 1 RCT comparing electrostimulation plus usual care with NPWT plus usual care.²⁹ The review conducted a subgroup analysis for the comparison. Of the 7 systematic reviews included, 4 conducted a pooled meta-analysis^25-27,29 while the remaining 3 systematic reviews^23,24,28 provided narrative summaries of the individual studies' findings. We included 1 economic evaluation study³⁰ about the cost-effectiveness of electrostimulation compared with placebo. There are 2 guidelines based on evidence that offer recommendations for electrostimulation in patients with diabetes-related foot ulcers³¹ and for postoperative pain management in patients undergoing an elective caesarean section with neuraxial anesthesia.³² We did not find any studies that reported outcomes that were considered important during our patient engagement activities, which included avoiding surgery and hospitalization.

Appendix 4 presents the main study findings. Due to some overlap in the studies included in the included systematic reviews, the pooled estimates or narrative summaries may be based on some of the same individual study data (Appendix 5).

Clinical Effectiveness of Electrostimulation Plus Usual Care Versus Usual Care

Wound Surface Area

Five systematic reviews^24-27,29 have reported on the comparison of electrostimulation versus a control group (usual care with or without sham stimulation) in reducing WSA. The reports on WSA in these systematic reviews used various measures and statistical indicators, and there were inconsistencies in the results of the statistical tests among different populations:

• Relative WSA reduction from baseline (3 systematic reviews: MD^25,26 or SMD,²⁷ the differences were statistically significant): 1 systematic review²⁷ conducted a subgroup analysis and found no statistically significant subgroup effect between pulsed current and direct current or between leg ulcers and foot ulcers. One systematic review²⁵ evaluated the overall evidence quality on this outcome as very low.

• Raw WSA (2 systematic reviews^26,29: cm², the differences were statistically significant for patients with pressure ulcer,²⁶ but not statistically significant for patients with all types of wounds with moderate certainty evidence²⁹): Subgroup analysis in the 2 systematic reviews found statistically significant subgroup effects between pulsed current and direct current (larger effect was observed in the pulsed current subgroup in treating pressure ulcers),²⁶ but no statistically significant subgroup effects between chronic and acute wounds.²⁹

• Qualitative summaries (1 systematic review²⁴): WSA decreased more from baseline in the intervention group than that in the control group based on 9 RCTs.

Rate of Complete Healing

Three systematic reviews^25,26,29 have reported on the comparison of electrostimulation versus a control (usual care with or without sham stimulation) in improving the rate of complete healing for diabetic ulcer and pressure ulcer. There were inconsistencies in the results of the statistical tests among different populations or subgroups:

• Diabetic ulcers (1 systematic review²⁵): There was no statistically significant difference between electrostimulation and control (usual care with or without sham stimulation).

• Pressure ulcer (2 systematic reviews^25,26): There was a statistically significant difference between electrostimulation and control (usual care with or without sham stimulation) (GRADE: moderate certainty from 1 systematic review²⁵); subgroup analysis in 1 systematic review²⁶ found statistically significant subgroup effects between pulsed current and direct current (larger effect was observed in the pulsed current subgroup; the effect in the direct current subgroup was not statistically significant).

• All types of wounds (1 systematic review²⁹): There was no statistically significant difference between electrostimulation and control (GRADE: very low certainty).

Rate of Nonhealing or Worsened Wounds

Two systematic reviews^25,27 have reported that electrostimulation was statistically significantly more effective than a control group (usual care with or without sham stimulation) in reducing the rate of nonhealing or worsened (wound size increase) wounds for treating diabetic ulcers. One systematic review²⁷ did not find statistically significant subgroup effects for electrostimulation between diabetic leg and foot ulcers.

Time to Complete Wound Healing

Two systematic reviews^28,29 reported the time to complete wound healing. One systematic review²⁹ has reported that electrostimulation was statistically significantly more effective than the control group (usual care with or without sham stimulation) in reducing the time to healing or the rate of worse healing wounds for treating different types of wounds. The systematic review found statistically significant subgroup effects between acute wounds and chronic wounds, with a larger effect observed in the chronic wounds subgroup; the effects in the acute wounds subgroup were not statistically significant.²⁹ The other systematic review reported the difference between electrostimulation and control was not statistically significant.

Pain

Three systematic reviews^23,25,29 have reported on the comparison of electrostimulation versus control in pain. According to 1 systematic review,²⁹ the participants in the electrostimulation group experienced a statistically significant decrease in pain scores compared with those in the control group (GRADE: low certainty). However, 2 other systematic reviews^23,25 offered qualitative summaries and noted inconsistent results in pain outcomes.

Exudate Levels

A systematic review provided qualitative summaries of the exudate level outcome, which showed inconsistent results. Electrostimulation reduced exudate levels in 1 study, but 2 other studies found no difference compared with the control group.

Adverse Events

According to 1 systematic review,²⁹ the risk of adverse events among participants in the electrostimulation group was similar to that of the control group (GRADE: moderate certainty). In other systematic reviews reported on adverse events,^23-26 it was found that most studies did not report these events. However, the few adverse events related to electrostimulation were minor and rare, and included uncomfortable sensations, infection, skin rash, itchiness, pain, or wound deterioration.

Other Outcomes

Several systematic reviews also report other outcomes such as percentage of wounds healed, composite healing outcomes, edema and function, quality of life, recurrence or development of new ulcers, and amputation. We have highlighted the following points in this report:

• Percentage of wounds healed²⁸: There was no statistically significant difference between electrostimulation and control at week 2 and week 4 (1 RCT); statistically significant differences were found between the 2 groups at week 8 (1 RCT) and week 12 (2 RCTs).

• Composite healing outcomes: Electrostimulation appeared to be more effective than control treatment (usual care with or without sham stimulation) for patients who had not undergone surgical treatment for VLU. However, the benefit of electrostimulation compared to the control was not statistically significant for patients with VLUs who had undergone the surgery.²³

• Quality of life: According to 1 study in 1 systematic review,²⁵ there were no statistically significant differences between electrostimulation and control.

Clinical Effectiveness of Electrostimulation Plus Usual Care Versus NPWT Plus Usual Care

A systematic review provided a subgroup analysis that compared the effectiveness of electrostimulation and NPWT in treating acute wounds. However, they did not observe any statistically significant differences in the following 2 outcomes:

• raw WSA (1 subgroup analysis from 1 systematic review²⁹)

• time to complete wound healing (1 subgroup analysis from 1 systematic review²⁹).

Cost-Effectiveness of Electrostimulation Versus Placebo

Evidence regarding the cost-effectiveness of electrostimulation versus placebo for patients with nonhealing VLUs was available from 1 economic evaluation.³⁰

Measures of Cost-Effectiveness

Patients With Nonhealing VLUs

The results of the economic evaluation suggested that the incremental cost per QALY gained of the intervention (versus sham stimulation) was £4,480 at 8 weeks, £2,655 at 16 weeks, and –£2,388 at 24 weeks, and the incremental cost per each additional ulcer for the intervention (versus placebo) was £1,867 at 8 weeks, £1,850 at 16 weeks, and –£4,775 at 24 weeks. Electrostimulation was less costly and more effective at 24 weeks (dominant). The results were supported by sensitivity analyses conducted using bootstrapping sample methods. The estimated probability of the electrostimulation being cost-effective with a threshold of £20,000 per QALY was 88% at 8 weeks, 91% at 16 weeks, and 92% at 24 weeks.

Cost-Effectiveness of Electrostimulation Versus NPWT

We did not find any studies that reported on the cost-effectiveness of electrostimulation compared with NPWT that met the inclusion criteria for this report; therefore, no summary can be provided.

Guidelines Regarding the Use of Electrostimulation

Based on the low quality of evidence according to the GRADE evidence to recommendation framework, the IWGDF guideline strongly recommends against physical therapy interventions (which includes electrostimulation) for diabetic foot ulcer management and wound healing. Within the GRADE framework, a strong recommendation suggests that the majority of patients with diabetic foot ulcers should not undergo electrostimulation for wound healing. However, the guideline did not provide descriptions of evidence and the specific reasoning for the recommendation on electrostimulation. The guideline authors stated that limited (low-quality) evidence suggests physical therapies (including electrostimulation) may have a small positive impact on wound healing, with no substantial difference from usual care for patients with diabetic foot ulcers. Few negative effects were reported, and it is uncertain if physical therapies are more beneficial overall. In addition, these physical therapies are costly and resource-intensive and may not be suitable for all patients. Thus, the guideline did not recommend any physical therapies for managing diabetic foot ulcers.

The PROSPECT guideline provided the recommendation for managing postoperative pain in patients undergoing elective caesarean section with neuraxial anesthesia. The guideline suggests considering the use of electrostimulation as an analgesic adjunct for postoperative pain management (Grade A recommendation). The guideline did not cover the possible application of electrostimulation for wound healing. The quality of evidence supporting the recommendation was unclear. The guideline also lacked instructions on how to interpret the strength of recommendations, which is difficult for people who are trying to implement the recommendation. The clinical practice guidelines did not provide information on suggested electrostimulation parameters, frequency, and duration in the related recommendation, which might be another potential barrier for implementation.

Limitations

We found some methodological limitations in the body of evidence presented. In this report, we identified 7 systematic reviews to answer the research question on clinical effectiveness of electrostimulation plus usual care versus only usual care. Four^23,25,27,28 of these reviews included observational studies or quasi-experimental studies with only a small number of RCTs with a low risk of bias (for example, 2 of 8 included RCTS were low risk of bias in 1 systematic review²⁷). Therefore, the body of evidence may have selection bias, recall bias, or performance bias. None of the 4 systematic reviews with meta-analysis^25-27,29 used the Cochrane-recommended approach to address the unit-of-analysis error that could potentially skew the pooled estimate in favour of electrostimulation.

The body of evidence also has substantial heterogeneity and inconsistency in some reported outcomes. Although 4 systematic reviews with meta-analysis^25-27,29 carried out subgroup analysis to explore possible heterogeneity, they neglected to conduct a thorough assessment of the credibility of this analysis. Therefore, the observed subgroup effect may not be entirely reliable, and the interpretations of evidence regarding these subgroup analyses were limited.

In this report, we also found some evidence gaps. We could not identify a systematic review that specifically compared electrostimulation and NPWT. The only available evidence on this comparison comes from a subgroup analysis in 1 systematic review with small sample size (n = 15 for the NPWT arm).²⁹ We also did not find any evidence on the cost-effectiveness of electrostimulation and NPWT. The only economic evaluation study conducted was in the UK from the perspective of the NHS, which compared electrostimulation to sham stimulation. We had to adjust our criteria for including studies for our research questions 1 and 2 due to the large volume of literature we found during our search, which may have caused some relevant studies to be missed. However, we provide the additional references of potential interest in Appendix 7. In addition, we did not find any evidence on patient satisfaction, hospitalization and surgery outcomes that were considered important during patient engagement activities (Appendix 6), but our patient contributor was satisfied with electrostimulation therapy and recommended it for wound healing, stating he did not experience noticeable side effects related to electrostimulation therapy.

Additionally, we did not find evidence-based guidelines or economic evaluations from Canada. In the 2 included guidelines, no panel member was from a Canadian institution. Thus, the generalizability of the findings to a Canadian setting was unclear.

Conclusions and Implications for Decision- or Policy-Making

In this report, we identified 7 systematic reviews^23-29 that addressed the clinical effectiveness of electrostimulation as an adjunct to usual care for wound management. One economic evaluation study³⁰ compared the cost-effectiveness of electrostimulation with placebo for treating patients with nonhealing VLUs. Two evidence-based practice guidelines regarding the use of electrostimulation as an adjunct treatment were included,^31,32 1 for diabetic foot ulcers and another for postoperative pain management in patients who had undergone elective caesarean section with neuraxial anesthesia.

We identified 7 systematic reviews^23-29 to address the clinical effectiveness of electrostimulation as an adjunct to usual care for various types of wound management, including chronic and acute wounds. Specifically, most eligible studies focused on pressure ulcers, diabetic ulcers, and VLUs. Based on both RCTs and observational studies, the evidence suggests that combining electrostimulation with usual wound care could be more effective than usual care alone in at least 1 measure of wound healing (WSA, rate of complete healing, rate of nonhealing or worsened wounds, time to complete wound healing) or pain outcomes. The evidence suggests that patients with chronic wounds or those who did not undergo surgery for VLUs experienced larger positive effects from electrostimulation compared with those with acute wounds or who received surgery for VLU. Similarly, electrostimulation using pulsed current had a greater effectiveness than direct current on would healing outcomes (WSA and rate of complete healing) for patients with pressure ulcers. No serious adverse effects related to electrostimulation were reported in all included systematic reviews.

We identified subgroup analyses in 1 systematic review,²⁹ which suggested that the effectiveness of electrostimulation and NPWT may be similar in WSA reduction from baseline and time to complete wound healing. One economic evaluation study suggested that electrostimulation was less costly and more effective than placebo at 24 weeks (dominant). With a threshold of £20,000 per QALY, the estimated probabilities of electrostimulation being cost-effective were more than 88% at any follow-up time point.

The IWGDF guideline strongly recommends against physical therapies, including electrostimulation, for diabetic foot ulcer management based on low quality of evidence on effectiveness and the potential cost. However, the IWGDF guideline did not provide any recommendations specific to electrostimulation. Additionally, the evidence supporting these guidelines (which included only 6 citations related to electrostimulation) may not be as comprehensive as this report (7 systematic reviews) and the guidelines do not include any cost-effectiveness analysis comparing electrostimulation to a sham stimulation device. The PROSPECT guideline offered a grade A recommendation for using electrostimulation as an adjunct in managing postoperative pain in patients who have undergone elective caesarean section with neuraxial anesthesia.

The prognosis of an acute or minor wound is relatively good because most patients recover with usual care. One systematic review²⁴ noted that electrostimulation should be used in patients with stage 2 to 4 pressure ulcers. Identifying individuals who would receive a significant benefit is crucial when considering electrostimulation referrals. Patients’ values and preferences, accessibility, and cost of using electrostimulation can also play a significant role in the decision-making process. During our patient engagement activities, another barrier was identified, which was the lack of proper training for using the electrostimulation device.

Considering the current limitations of the body of evidence, primary studies with robust designs and adequate sample sizes that address the relative effects of electrostimulation versus NPWT are needed. To obtain precise relative risk estimates, a thorough systematic review with robust methodology is required, particularly using a better approach to overcome the potential unit-of-analysis error when dealing with data from a single trial with multiple interested arms. Due to the potential bias and inconsistency across included primary studies in eligible systematic reviews, limitations of the body of evidence, and small sample size in the NPWT arm (n = 15), these findings need to be interpreted with caution.

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Appendix 1: Selection of Included Studies

Figure 1: Selection of Included Studies

Appendix 2: Characteristics of Included Publications

Note that this appendix has not been copy-edited.

Table 2: Characteristics of Included Systematic Reviews

DC = direct current; DW = degenerate wave current; HVPC = high-voltage pulsed current; HVMPC = high-voltage monophasic pulsed current; LVMPC = low-voltage monophasic pulsed current; LVBPC = low-voltage monophasic pulsed current; NA = not applicable; NPWT = negative pressure wound therapy; NR = not reported; PC = pulsed current; SWC = standard wound care; WSA = wound surface area.

Appendix 3: Critical Appraisal of Included Publications

Note that this appendix has not been copy-edited.

Table 5: Strengths and Limitations of Systematic Reviews Using AMSTAR 2¹⁷

AMSTAR 2 = A Measurement Tool to Assess Systematic Reviews 2; CCAT = Crowe Critical Appraisal Tool; GRADE = Grading of Recommendations, Assessment, Development and Evaluation; RCT = randomized controlled trial; RoB = risk of bias

Table 6: Strengths and Limitations of Economic Evaluation Using the Drummond Checklist¹⁸

NHS = National Health Service.

Table 7: Strengths and Limitations of Guidelines Using AGREE II¹⁹

AGREE II = Appraisal of Guidelines for Research and Evaluation II.

^aPfizer, Baxter, Pacira, Sintetica, Grunenthal, Vifor Pharma, MSD, Nordic Pharma, Janssen Pharmaceuticals, Heron Therapeutics, Mundipharma, Grunenthal, Janssen-Cilag GmbH, Fresenius Kabi and AcelRx.

Appendix 4: Main Study Findings

Note that this appendix has not been copy-edited.

Table 8: Summary of Findings by Outcome — Wound Surface Area

CI = confidence interval; CGs = control groups; EGs = electrical stimulation groups; RR = risk ratio; NPWT = negative pressure wound therapy; NR = not reported; RCTs = Randomized controlled trials; MD = mean difference; SMD = standardized mean difference; WSA = wound surface area.

Table 9: Summary of Findings by Outcome — Rate of Complete Healing

CI = confidence interval; GRADE = Grading of Recommendations, Assessment, Development and Evaluation; NR = not reported; RCT = Randomized controlled trial; RR = risk ratio.

Table 10: Summary of Findings by Outcome — Rate of Nonhealing or Worsened Wounds

CI = confidence interval; GRADE = Grading of Recommendations, Assessment, Development and Evaluation; NR = not reported; RCT = randomized controlled trial; RR = risk ratio.

Table 11: Summary of Findings by Outcome — Time to Complete Wound Healing

CI = confidence interval; GRADE = Grading of Recommendations, Assessment, Development and Evaluation; RCT = randomized controlled trial; MD = mean difference; NPWT = negative pressure wound therapy.

^aThe study provided data for both control comparator and NPWT comparator.

Table 12: Summary of Findings by Outcome — Pain

Table 13: Summary of Findings by Outcome — Exudate Levels

EST = electric stimulation therapy; GRADE = Grading of Recommendations, Assessment, Development and Evaluation; NR = not reported; VLU = venous leg ulcer.

Table 14: Summary of Findings by Outcome — Adverse Events

CI = confidence interval; EST = Electric stimulation therapy; GRADE = Grading of Recommendations, Assessment, Development and Evaluation; NR = not reported; RCT = randomized controlled trial; RR = risk ratio; RD = risk difference.

Table 15: Summary of Findings by Outcome — Other Healing Outcomes

CG = control group; CI = confidence interval; ES = electric stimulation; EST = electric stimulation therapy; HVMPC = high-voltage monophasic pulsed current; IG = intervention group; NA = not applicable; NR = not reported; PI = Pressure Injuries; RCT = randomized controlled trial; VLU = venous leg ulcer.

Table 16: Summary of Findings by Outcome — Other Outcomes

CI = confidence interval; NA = not applicable; NR = not reported; RR = risk ratio; RD = risk difference; DC = direct current; DW = degenerate wave current; HVPC = high-voltage pulsed current; HVMPC = high-voltage monophasic pulsed current; LVMPC = low-voltage monophasic pulsed current; LVBPC = low-voltage monophasic pulsed current; NA = not applicable; NPWT = negative pressure wound therapy; NR = not reported; PC = pulsed current; SWC = standard wound care; WSA = wound surface area.

Table 17: Summary of Findings of Included Economic Evaluation

EAE = electroceutical device; NHS = National Health Service; QALY = quality-adjusted life-year.

Table 18: Summary of Recommendations in Included Guidelines

GRADE = Grading of Recommendations, Assessment, Development and Evaluation; IWGDF = International Working Group on the Diabetic Foot; PROSPECT = procedure-specific postoperative pain management

Appendix 5: Overlap Between Included Systematic Reviews

Note that this appendix has not been copy-edited.

Table 19: Overlap in Relevant Primary Studies Between Included Systematic Reviews

— = not included.

Appendix 6: Patient Involvement

Note that this appendix has not been copy-edited.

Table 20: Summary of Patient Involvement Using the Guidance for Reporting Involvement of Patients and the Public (Version 2) Short Form Reporting Checklist²¹

NA = not applicable.

Appendix 7: References of Potential Interest

Systematic Reviews (Outside of Date Range)

Rajendran SB, Challen K, Wright KL, Hardy JG. Electrical Stimulation to Enhance Wound Healing. J Funct Biomater. 2021;12(2):19. PubMed

Milne J, Swift A, Smith J, Martin R. Electrical stimulation for pain reduction in hard-to-heal wound healing. J Wound Care. 2021;30(7):568-580. PubMed

Ofstead CL, Buro BL, Hopkins KM, Eiland JE. The impact of continuous electrical microcurrent on acute and hard-to-heal wounds: a systematic review. J Wound Care. 2020;29(Sup7):S6-S15.

Goodall RJ, Langridge B, Lane T, Davies AH, Shalhoub J. A Narrative Review of the Use of Neuromuscular Electrical Stimulation in Individuals With Diabetic Foot Ulceration. Int J Low Extrem Wounds. 2020;19(3):242-250. PubMed

Chen Z, Chen ZY, Liu WH, Li GS. Electric Stimulation as an Effective Adjunctive Therapy for Diabetic Foot Ulcer: A Meta-analysis of Randomized Controlled Trials. Adv Skin Wound Care. 2020;33(11):608-612. PubMed

Arora M, Harvey LA, Glinsky JV, et al. Electrical stimulation for treating pressure ulcers. Cochrane Database Syst Rev. 2020;1:CD012196. PubMed

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. 2018;27(4):274-284. PubMed

Randomized Controlled Trials

Zulbaran-Rojas A, Park C, El-Refaei N, Lepow B, Najafi B. Home-Based Electrical Stimulation to Accelerate Wound Healing-A Double-Blinded Randomized Control Trial. J Diabetes Sci Technol. 2023;17(1):15-24. PubMed

Bull RH, Clements D, Collarte AJ, Harding KG. The impact of a new intervention for venous leg ulcers: A within-patient controlled trial. Int Wound J. 2023 Feb 13. PubMed

Zhao Y, Zhang B, Wang Y, Liu J. Effectiveness of Neuromuscular Electrical Stimulation for Enhanced Recovery After Total Hip Replacement Surgery: A Randomized Controlled Trial. Geriatr Orthop Surg Rehabil. 2022;13:21514593221129528. PubMed

Yoshikawa Y, Hiramatsu T, Sugimoto M, Uemura M, Mori Y, Ichibori R. Efficacy of Low-frequency Monophasic Pulsed Microcurrent Stimulation Therapy in Undermining Pressure Injury: A Double-blind Crossover-controlled Study. Prog Rehabil Med. 2022;7:20220045. PubMed

Elfahl AM, Abd El Baky AM, Yousef MT, Elgohary HM. High Versus Low Frequency Transcutaneous Electric Nerve Stimulation On Chronic Venous Lower Limb Ulceration Randomized Controlled Trial. Int J Low Extrem Wounds. 2022:15347346221093860. PubMed

Avendano-Coy J, Martin-Espinosa NM, Ladrinan-Maestro A, Gomez-Soriano J, Suarez-Miranda MI, Lopez-Munoz P. Effectiveness of Microcurrent Therapy for Treating Pressure Ulcers in Older People: A Double-Blind, Controlled, Randomized Clinical Trial. Int J Environ Res Public Health. 2022;19(16):15. PubMed

Miguel MMV, Mathias-Santamaria IF, Rossato A, et al. Microcurrent electrotherapy improves palatal wound healing: Randomized clinical trial. J Periodontol. 2021;92(2):244-253. PubMed

Aquil S, Sharma H, Alharbi B, Pacoli K, Luke PP, Sener A. The impact of a muscle pump activator on incisional wound healing compared to standard stockings and compression devices in kidney and kidney-pancreas transplant recipients: A randomized controlled trial. Can Urol Assoc J. 2019;13(11):E341-E349. PubMed

Guidelines and Recommendations (Unclear Methods or No Specific Recommendation Regarding Electrostimulation)

Foundations of Best Practice for Skin and Wound Management. Wounds Canada. 2018. https://www.woundscanada.ca/health-care-professional/publications/dfc-2. Accessed 2023 Jun 2.

Additional References (Outside of Date Range)

Electrical Stimulation for Pressure Injuries. Toronto (ON): Health Quality Ontario. 2017. https://www.hqontario.ca/evidence-to-improve-care/health-technology-assessment/reviews-and-recommendations/electrical-stimulation-for-pressure-injuries. Assessed 2023 Jun 3.