Conditioning Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Motor unit number estimation
研究概览
简要总结
Cubital tunnel syndrome is the second most common compression neuropathy. In severe cases, functional recovery, even with surgery, is often poor. Therefore, alternative adjunct treatments capable of increasing the speed of nerve regeneration are much needed.
详细描述
The effect of brief conditioning electrical stimulation on nerve regeneration has been showed to be efficacy in animal studies. In this double-blind, randomized, controlled study, the investigators will compare the physiological and functional improvements post surgery compared with the controls who received surgery alone. Because electrical stimulation is reasonably well-tolerated and the treatment only takes an hour, it is a potentially feasible clinical tool for patients with severe nerve injury.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged >18 yr,
- •If signs and symptoms of severe CuTS (ie, McGowan-Goldberg grade 3) were observed,
- •If needle EMG examination showed evidence of chronic motor axonal loss and reduced recruitment in the ulnar-innervated intrinsic hand muscles, and
- •If electrophysiologic evidence of severe motor axonal loss with motor unit number estimation (MUNE) greater than 2 standard deviations below the normative mean.
排除标准
- •1) Patients were excluded if they had concurrent nerve injury, prior surgery for CuTS or coexisting neurologic conditions
研究组 & 干预措施
Control
Control patients will receive cubital tunnel surgery and sham stimulation.
干预措施: Electrical stimulation (Procedure)
Conditioning electrical stimulation
Patients in the stimulation group will receive surgery as well as 1 hour of 20 Hz electrical stimulation 7 days prior to surgery
干预措施: Electrical stimulation (Procedure)
结局指标
主要结局
Motor unit number estimation
时间窗: 3 years
A quantitative physiological measure of the number of motor nerve fibres in the target muscle
次要结局
- Key pinch strength(3 years)
- Disability of the Arm, Shoulder and Hand (DASH) Questionnaire(3 years)