Promoting Healing of Nerves Through Electrical Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Change in Grip Strength at 1 year.
研究概览
简要总结
This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for nerve compression. A single dose of the therapeutic stimulation is delivered as part of the surgical intervention to address compression of the ulnar nerve at the elbow.
详细描述
Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This study is investigating the use of a single dose of therapeutic electrical stimulation to promote nerve healing. The therapy is delivered as part of the surgical intervention to address compression of the ulnar nerve at the elbow, commonly referred to as Cubital Tunnel Syndrome.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Electrodiagnostic evidence of ulnar neuropathy at the elbow.
- •Are candidates for surgical intervention.
- •Evidence of motor involvement such as intrinsic muscle atrophy or weakness.
- •Are age 18-80 years.
- •Signed and dated informed consent form.
排除标准
- •Severe comorbid condition, such as arrythmia or congestive heart failure, preventing surgery
- •Previous history or current transection of ulnar nerve, or concomitant upper extremity nerve injury
- •Global peripheral neuropathy affecting the hands
- •Age less than 18 or greater than 80 years
- •Un-affected hand maximum grip strength <12kg
结局指标
主要结局
Change in Grip Strength at 1 year.
时间窗: 1 year
Change in grip strength at 1 year from baseline (pre-operative) assessment.
次要结局
- Medical Research Council (MRC) motor grading.(Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function(Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Michigan Hand Questionnaire (MHQ)(Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- 2-point discrimination(Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Lateral Pinch Strength(Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Patient Reported Outcome Measurement System (PROMIS) Pain Interference(Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Electromyography (EMG)(Pre-surgery, 3 months, and 7 months)
- Grip Strength(Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Semmes-Weinstein Monofilament Testing(Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Maximal finger spread measurement.(Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Nerve Conduction Velocity (NCV)(Pre-surgery, 3 months, and 7 months)