Microcurrent Versus Transcutaneous Electrical Nerve Stimulation on Pressure Ulcer

NCT06838390 | Completed

• 1 other identifier: Hajar-005204
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pressure Area

Keywords

Micro current versus TENs on pressure ulcer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Evaluation of blood flow in both the major and the minor vessels of the body.

  at baseline and after 8 weeks

Study Arms (2)

Microcurrent therapy

EXPERIMENTAL

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; Other: physical therapy program; Drug: medial treatment

transcutaneous electrical nerve stimulation

ACTIVE COMPARATOR

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.

Device: Transcutaneous electrical nerve stimulation; Other: physical therapy program; Drug: medial treatment

Interventions

Microcurrent Therapy DEVICE

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.

Microcurrent therapy

Transcutaneous electrical nerve stimulation DEVICE

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.

transcutaneous electrical nerve stimulation

physical therapy program OTHER

The physiotherapy program included circulatory circulatory exercises, stretching exercises, and ROM exercises.

Microcurrent therapy; transcutaneous electrical nerve stimulation

medial treatment DRUG

patients was given their drugs from their physicians

Microcurrent therapy; transcutaneous electrical nerve stimulation

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Cairo, Egypt

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: February 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)