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Completed

NCT Number: NCT06838390

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.

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Key information

Conditions

Pressure Area

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

physical therapy program

Other

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

medial treatment

Drug

patients was given their drugs from their physicians

Primary outcomes

  1. Assessment of ulcers length x width using Pressure Ulcer Scale for Healing

    Time frame: 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.

  2. Assessment of ulcers exudate amount using Pressure Ulcer Scale for Healing

    Time frame: 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.

  3. Assessment of ulcers tissue type using Pressure Ulcer Scale for Healing

    Time frame: 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 outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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