Electrical Stimulation for Clinical and Psychosocial Outcomes in Chronic Pressure Injuries

Healing Beyond the Wound: Clinical and Psychosocial Outcomes of Monophasic Electrical Stimulation in Pressure Injuries - A Randomized Controlled Pilot Study

Pressure injuries are chronic wounds that frequently occur in immobilized patients and are associated with delayed healing, reduced quality of life, and significant psychological burden. Electrical stimulation has been suggested as an adjunctive therapy to promote wound healing by enhancing angiogenesis, improving cell migration, and restoring local bioelectric fields.

This randomized controlled pilot study aims to evaluate the clinical and psychosocial effects of high-voltage monophasic rectangular pulsed current (HVMRPC) in patients with chronic pressure injuries. Twenty adult patients with stage II-IV pressure injuries that did not respond to at least four weeks of standard wound care are randomly assigned to receive either HVMRPC in addition to standard wound care or standard wound care alone.

The intervention consists of electrical stimulation applied to the periwound area five times per week for six weeks. Clinical outcomes include changes in wound size and wound severity measured with the Pressure Ulcer Scale for Healing (PUSH). Psychosocial outcomes include anxiety and depression levels measured with the Hospital Anxiety and Depression Scale (HADS) and health-related quality of life measured with EQ-5D-5L.

The study investigates whether electrical stimulation provides additional benefits beyond standard wound care in improving both wound healing parameters and psychological well-being in patients with chronic pressure injuries.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Spinal Cord Injuries (SCI); Pressure Injuries
• Intervention / Treatment: Device: High-Voltage Monophasic Pulsed Current Electrical Stimulation; Other: Standard Wound Care

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Ankara Gaziler physical therapy and rehabilitation hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 18 years or older

  • Presence of a pressure ulcer
  • Individuals receiving treatment and follow-up in the rehabilitation clinic
  • Ability to understand and comply with study procedures
  • Provision of written informed consent

Exclusion Criteria:

• Presence of severe infection in the wound area

  • Malignant wound or suspected malignancy in the ulcer area
  • Presence of cardiac pacemaker or implanted electrical device
  • Severe cognitive impairment preventing cooperation
  • Participation in another clinical trial during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical Stimulation + Standard Care	Device: High-Voltage Monophasic Pulsed Current Electrical Stimulation; High-voltage monophasic pulsed current electrical stimulation is applied to the periwound area using surface electrodes. The stimulation is delivered with a frequency of 120 Hz and a pulse duration of 150 microseconds. Each session lasts approximately 50 minutes and is administered five times per week for six weeks in addition to standard wound care.; Other: Standard Wound Care; Standard wound care includes routine wound cleaning, dressing changes, pressure off-loading strategies, and wound management according to institutional clinical protocols.
Active Comparator: Standard Wound Care	Other: Standard Wound Care; Standard wound care includes routine wound cleaning, dressing changes, pressure off-loading strategies, and wound management according to institutional clinical protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pressure Ulcer Scale for Healing (PUSH) Score	The PUSH tool assesses pressure injury status across three subscales: wound surface area (0-10), exudate amount (0-3), and tissue type (0-4). Total score ranges from 0 to 17; higher scores indicate greater wound severity. Score on a scale (0-17; higher score = worse outcome)	Baseline and Week 6
Change in Hospital Anxiety and Depression Scale (HADS) total score	The HADS is a 14-item self-report questionnaire with two subscales: anxiety (7 items, 0-21) and depression (7 items, 0-21). Total score ranges from 0 to 42; higher scores indicate greater psychological distress.	Baseline and Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Pain intensity associated with the pressure ulcer measured using the Visual Analog Scale (VAS).	Baseline and Week 6
Change in Wound Diameter	Description: Maximum wound diameter measured in centimeters using a disposable wound ruler at baseline and 6 weeks. Units: Centimeters (cm)	Baseline and Week 6
Depression Level (Hospital Anxiety and Depression Scale - Depression Subscale)	Assessment of depressive symptoms using the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D). The HADS-D consists of 7 items scored on a 4-point Likert scale (0-3); subscale scores range from 0 to 21, with higher scores indicating more severe depressive symptoms	Baseline and Week 6
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score	The EQ-5D-5L VAS measures self-rated overall health on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health). Assessed at baseline and Week 6. Time Frame: Baseline and Week 6 Units: Score on a scale (0-100; higher score = better outcome)	Baseline and Week 6
Wound Edema at Final Assessment	Presence or absence of wound edema assessed by blinded outcome assessor at 6 weeks, reported as percentage of participants with edema present. Units: Percentage of participants (%)	6 weeks
Wound Exudate Presence at Final Assessment	Presence or absence of wound exudate assessed at 6 weeks, reported as percentage of participants with exudate present. Units: Percentage of participants (%)	6 weeks
Wound Edge Integrity at Final Assessment	Presence or absence of wound edge integrity assessed at 6 weeks, reported as percentage of participants demonstrating intact wound edges. Units: Percentage of participants (%)	6 weeks

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Skin Diseases; Skin Ulcer; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Brain Injuries; Skin and Connective Tissue Diseases; Brain Injuries, Traumatic; Spinal Cord Injuries; Pressure Ulcer
• Other Study ID Numbers: HVMRPC-PI-RCT-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared, as this is a small-scale pilot randomized controlled trial with a limited sample size (n=20). Data are available from the corresponding author upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No