The Effect of Extracorporeal Shock Wave Therapy in Patients With Mild to Moderate Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 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 dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome.
详细描述
The investigator perform a prospective randomized, single-blinded study to investigate the dose effect of ESWT in patients with carpal tunnel syndrome.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 85 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 CTS, such as positive Tinel's sign or Phalen's test, numbness/tingling in at least two of the first, second, or third digits, and in whom the diagnosis was confirmed using an electrophysiological study.
排除标准
- •Coagulopathy
- •Inflammation status
- •Patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for CTS.
研究组 & 干预措施
three-sessions of ESWT
Active three-sessions of ESWT ( once a week for 3 weeks) was given.
干预措施: ESWT (Device)
one-session of ESWT
One-session of ESWTactive ESWT was given.
干预措施: ESWT (Device)
Night splint
The night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study. Another 3 sessions of sham ESWT was given.
干预措施: ESWT (Device)
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 cross-sectional area in median nerve 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)
- 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)
研究者
Yung-Tsan Wu
Attending Physician of Physical medicine and rehabilitation
Tri-Service General Hospital