The Effect of Extracorporeal Shock Wave Therapy in Patients With Cubital Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment
研究概览
简要总结
The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the effect of extracorporeal shock wave therapy on cubital tunnel syndrome.
详细描述
Investigators perform a prospective randomized, single-blinded study to investigate the effect of ESWT in patients with cubital tunnel syndrome.
Patients were randomized into intervention and control group. Participants in intervention group received three-sessions of ESWT and single one session of ESWT was given in control group. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20-80 year-old.
- •Typical symptoms and signs of cubital tunnel, such as positive Tinel's sign numbness/tingling in at least 5th digits, and in whom the diagnosis was confirmed using an electrophysiological study.
排除标准
- •Coagulopathy
- •Inflammation status
- •Patients who had conditions mimicking cubital tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for cubital tunnel syndrome.
结局指标
主要结局
Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment
时间窗: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Visual analog scale (VAS)
次要结局
- Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment)
- Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment)
研究者
Yung-Tsan Wu
Attending physician of physical medicine and rehabilitation
Tri-Service General Hospital