Microcurrent Versus Transcutaneous Electrical Nerve Stimulation on Pressure Ulcer

The purpose of the study was to evaluate which is more effective, microcurrent or transcutaneous electrical nerve stimulation, in treating pressure ulcers in elderly patients.

Study Overview

• Status: Completed
• Conditions: Pressure Area
• Intervention / Treatment: Device: Microcurrent Therapy; Other: physical therapy program; Drug: medial treatment; Device: Transcutaneous electrical nerve stimulation

Detailed Description

• Pressure sores are common problems in today's health care. A pressure sore leads to physiological as well as psychological suffering for the individual affected. The cost for the society, associated with prevention and treatment of pressure sores, is considerable
• Furthermore, the need for this study was developed from the lack of quantitative knowledge and information in the published studies about the effect of microcurrent and transcutaneous electrical nerve stimulation in treating pressure ulcers in elderly patients.
• This study will be carried out to provide guidelines about the effectiveness of microcurrent and transcutaneous electrical nerve stimulation in treating pressure ulcer and to assist in planning an ideal treatment regimen to increase healing of pressure ulcers in elderly patients.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • out-patient clinic, faculty of physical therapy, Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subject selection was done according to the following criteria:

• Age range between 40 and 60 years.
• Male and female patients will participate in the study.
• All patients enrolled in the study had their informed consent.
• Pressure ulcer grades were grade II and III.
• A relative or legal tutor provided consent when participants were incapable of making decisions.
• The trial complied with the ethical principles of the Helsinki Declaration for medical research in humans.
• Pressure ulcers were located in the sacral area

Exclusion Criteria:

• Age less than 40 years or more than 60 years
• A cardiac pacemaker or another implanted electric device.
• Cognitive problems or hearing loss.
• Pre-existing joint disorder before pressure ulcer.
• Patients who have co-morbidities such as diabetes mellitus, rheumatoid arthritis, hypertension, and cardiac and renal patients,
• Osteosynthesis implants near the ulcer, pressure ulcers in the occipital region, cancer, and osteomyelitis.
• Abnormal blood markers at baseline indicating limited healing potential (anemia, iron deficit, protein deficit, dehydration, non-controlled diabetes, or hypothyroidism).
• Allergy to the usual treatment for ulcer healing, systemic infection, and ulcer treatment with growth factor or vacuum-assisted closure in the 30 days before the Trial

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: Microcurrent therapy; This group included 22 patients with pressure ulcer who received microcurrent therapy 8 weeks (3times /daily) in addition to their physical therapy program (circulatory exercise,stretching exercise, and ROM ex.) and medical treatment	Device: Microcurrent Therapy; The study uses a four-channel microcurrent therapy device to treat pressure ulcers. The treatment involves applying four electrodes to the area around the ulcer, ensuring microcurrent passage throughout the wound bed. The treatment is done three times a day, lasting 35-40 minutes. The microcurrents are delivered in a monophasic, pulsed, square-form wave pulse with a voltage of 21 mV, an intensity of 42 µA, and a current density of 4.2 µA/cm.; Other: physical therapy program; The physiotherapy program included circulatory circulatory exercises, stretching exercises, and ROM exercises.; Drug: medial treatment; patients was given their drugs from their physicians
Active Comparator: transcutaneous electrical nerve stimulation; This group included 22 patients with pressure ulcers who received transcutaneous electrical nerve stimulation 8 weeks (3 times daily) in addition to their physical therapy program (circulatory exercise, stretching exercise, and range of motion exercise) and medical treatment.	Other: physical therapy program; The physiotherapy program included circulatory circulatory exercises, stretching exercises, and ROM exercises.; Drug: medial treatment; patients was given their drugs from their physicians; Device: Transcutaneous electrical nerve stimulation; The study aimed to treat ulcers with TENS using a two-channel device, delivered three times a day, for 8 weeks. The device induced peripheral vasodilation and activate local blood flow, potentially promoting wound healing. The treatment was delivered using a pulse train duration of 300 ms, with an internal frequency of 100 Hz and a burst frequency of 2 Hz.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of ulcers length x width using Pressure Ulcer Scale for Healing	The Pressure Ulcer Scale for Healing is a tool used to measure ulcer healing. It assesses the length x width of the ulcer (measuring the greatest length-head to toe-and the greatest width-side to side-using a centimeter ruler). It scores from 0-surface area of 0 cm²-to 10-surface area >24 cm²); The total score of pressure ulcer healing is calculated by adding three sub-scores, ranging from 0 (completely healed) to 17 (worst wound state), and comparing it at each time point indicates improvement or deterioration.	at baseline and after 8 weeks
Assessment of ulcers exudate amount using Pressure Ulcer Scale for Healing	The Pressure Ulcer Scale for Healing is a tool used to measure ulcer healing.It assesses exudate amount (classified as none: score 0; light: score 1; moderate: score 2; or heavy: score 3); The total score of pressure ulcer healing is calculated by adding three sub-scores, ranging from 0 (completely healed) to 17 (worst wound state), and comparing it at each time point indicates improvement or deterioration.	at baseline and after 8 weeks
Assessment of ulcers tissue type using Pressure Ulcer Scale for Healing	The Pressure Ulcer Scale for Healing is a tool used to measure ulcer healing. It assesses tissue type (score 1: superficial wound with epithelial tissue; score 2: the wound is clean and contains granulation tissue; score 3: there is any amount of slough present; score 4:necrotic tissue is present). If the wound is closed, the score is 0. The total score of pressure ulcer healing is calculated by adding three sub-scores, ranging from 0 (completely healed) to 17 (worst wound state), and comparing it at each time point indicates improvement or deterioration.	at baseline and after 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of blood flow in both the major and the minor vessels of the body.	Medical Doppler ultrasound is used in clinical adjustments to evaluate blood flow in major and minor vessels. It shows normal and abnormal sign waveforms using spectral Doppler technique, which is individual to each vessel. Understanding normal and abnormal diagnostics is crucial for operators and clinicians	at baseline and after 8 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: February 16, 2025
• First Submitted That Met QC Criteria: February 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Micro current versus TENs on pressure ulcer
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: Hajar-005204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes