Microcurrent Versus Transcutaneous Electrical Nerve Stimulation on Pressure Ulcer

NCT ID: NCT06838390

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-12-01

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.

Conditions

Pressure Area

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

physical therapy program

Intervention Type: OTHER

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

medial treatment

Intervention Type: DRUG

patients was given their drugs from their physicians

Microcurrent Therapy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

physical therapy program

Intervention Type: OTHER

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

medial treatment

Intervention Type: DRUG

patients was given their drugs from their physicians

Transcutaneous electrical nerve stimulation

Intervention Type: 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.

Interventions

physical therapy program

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

Intervention Type: OTHER

medial treatment

patients was given their drugs from their physicians

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hajar Jamal Amin Mohammed

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Hajar-005204

Identifier Type: -

Identifier Source: org_study_id