Comparison of Focused and Radial Extracorporeal Shock Wave for Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change from baseline of Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 24th weeks after treatment
研究概览
简要总结
Extracorporeal shock wave is a novel treatment for peripheral nerve entrapment. This study was designed to compare the efficacy of focused and radial extracorporeal shock wave for carpal tunnel syndrome.
详细描述
Both focused and radial extracorporeal shock wave had been proved to treat carpal tunnel syndrome by several studies. However, there was no study comparing these two methods. Considering different mechanisms and costs, this randomized comparative trial would be conducted to compare the efficacy of focused and radial extracorporeal shock wave for carpal 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
- Single (Outcomes Assessor)
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
- •Clinical and electrophysiological diagnosis of CTS
排除标准
- •Cervical radiculopathy
- •Polyneuropathy
- •Brachial plexopathy
- •Thoracic outlet syndrome
- •Previous wrist surgery or steroid injection for CTS
结局指标
主要结局
Change from baseline of Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 24th weeks after treatment
时间窗: Change of the mean of total SSS and FSS from baseline at 24th weeks after treatment
Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of carpal tunnel syndrome which encompasses two components. eleven questions and eight items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Each question or item ranges from 1 to 5 with a higher score indicating severer symptom or a higher degree of disability. Total score of SSS ranges from 11-55 and FSS from 8-40. The mean of total SSS and FSS divided with each item score were used for further analysis.
次要结局
- Cross-sectional area (CSA) of the median nerve(Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment)
- Nerve conduction amplitude(Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment)
- Nerve conduction velocity(Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment)
- Visual analogue scale (VAS)(Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment)
研究者
Yung-Tsan Wu
Principal Investigator
Tri-Service General Hospital