The Effect of Extracorporeal Shock Wave Therapy on Spasticity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline of spasticity on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
研究概览
简要总结
The effect of traditional treatment for spasticity is barely satisfactory. The shock wave has been used to treat the spasticity with expressively response and the effect could persist for 1-3 months in different studies. However most sutdies lack the sham or control group. The purpose of this study was to assess the effect of shock wave for spasticity in wrist and hand.
详细描述
The patients with spasticity for at least 6 months were randomized for 3 groups. Group I: patients receive one session of shock wave per week for 3 weeks; Group II: patients receive only one session of shock wave; Group III: patients receive the sham shock wave per week for 3 weeks. The outcome measurements include Modified Asthow scale, passive range of motion, Disability Assessment Scale and Fugl-Meyer Assessment Scale (hand function and wrist control).
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 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 Spasticity measured as Modified Asthow Scale more than 1+ point and persist at least 6 months Clear consciousness No receive Phenol injection or Botulinum toxin in past 6 months
排除标准
- •Cancer Joint contracture Coagulopathy Pregnancy Pacemaker Inflammation status
结局指标
主要结局
Change from baseline of spasticity on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
时间窗: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Using the modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.
次要结局
- Change from baseline of disability on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.(Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.)
- Change from baseline of range of motion on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.(Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.)
- Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.(Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.)
研究者
Yung-Tsan Wu
Attending Physician
Tri-Service General Hospital