Microcurrent Versus Transcutaneous Electrical Nerve Stimulation on Pressure Ulcer

Not Applicable

Completed

• Conditions: Pressure Area
• Interventions: Device: Microcurrent Therapy; Device: Transcutaneous electrical nerve stimulation; Other: physical therapy program; Drug: medial treatment

• Registration Number: NCT06838390
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-16
• Study First Submitted QC: 2025-02-16
• Last Update Submitted: 2025-02-16
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microcurrent therapy	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
Microcurrent therapy	physical therapy program	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
Microcurrent therapy	medial treatment	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
transcutaneous electrical nerve stimulation	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.
transcutaneous electrical nerve stimulation	physical therapy program	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.
transcutaneous electrical nerve stimulation	medial treatment	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.

Primary Outcome Measures

Name	Time	Method
Assessment of ulcers length x width using Pressure Ulcer Scale for Healing	at baseline and after 8 weeks	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.
Assessment of ulcers exudate amount using Pressure Ulcer Scale for Healing	at baseline and after 8 weeks	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.
Assessment of ulcers tissue type using Pressure Ulcer Scale for Healing	at baseline and after 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of blood flow in both the major and the minor vessels of the body.	at baseline and after 8 weeks	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

Trial Locations

Locations (1)

out-patient clinic, faculty of physical therapy, Cairo university; 🇪🇬 Cairo, Egypt