Microcurrent Versus Transcutaneous Electrical Nerve Stimulation on Pressure Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Assessment of ulcers length x width using Pressure Ulcer Scale for Healing
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: medial treatment (Drug)
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
干预措施: Microcurrent Therapy (Device)
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
干预措施: physical therapy program (Other)
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.
干预措施: Transcutaneous electrical nerve stimulation (Device)
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.
干预措施: physical therapy program (Other)
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.
干预措施: medial treatment (Drug)
结局指标
主要结局
Assessment of ulcers length x width using Pressure Ulcer Scale for Healing
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Evaluation of blood flow in both the major and the minor vessels of the body.(at baseline and after 8 weeks)
研究者
Hajar Jamal Amin Mohammed
principal investigator
Cairo University