Clinical trial NCT06838390: Microcurrent Versus Transcutaneous Electrical Nerve Stimulation on Pressure Ulcer
Official title: Microcurrent Versus Transcutaneous Electrical Nerve Stimulation on Pressure Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Area
Keywords: Micro current versus TENs on pressure ulcer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assessment of ulcers length x width using Pressure Ulcer Scale for Healing
timeFrame: at baseline and after 8 weeks
measure: Assessment of ulcers exudate amount using Pressure Ulcer Scale for Healing
timeFrame: at baseline and after 8 weeks
measure: Assessment of ulcers tissue type using Pressure Ulcer Scale for Healing
timeFrame: at baseline and after 8 weeks
Secondary outcomes:
measure: Evaluation of blood flow in both the major and the minor vessels of the body.
timeFrame: at baseline and after 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: out-patient clinic, faculty of physical therapy, Cairo university
Study officials:
References: