The Effects of Extracorporeal Shockwave Therapy (ESWT) for Upper Extremity Pain Related to Spasticity in Patients With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Numerical rating scale (NRS)
研究概览
简要总结
This study aimed to investigate the efficacy and safety of extracorporeal shockwave therapy (ESWT) for upper extremity pain related to spasticity in patients with spinal cord injury.
详细描述
6 times of ESWT (3,000 pulses per time, low energy under 0.3 mJ/m^2, tolerable range) on forearm area to reduce pain related to spasticity in patients with cervical myelopathy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord damage confirmed in the spinal cord image
- •1 month after spinal cord injury
- •Spasticity of upper extremities
- •Pain in areas below spinal cord injury more than 4 points on the numerical scale (NRS)
- •Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE)
- •Age: 20 and older
- •Person who has agreed in writing to decide his or her participation and comply with the precautions
排除标准
- •Pain due to trauma
- •Injection treatments two weeks before participating in the study
- •Severe coagulopathy (excluding antiplatelet use)
- •Impaired cognition
研究组 & 干预措施
Experimental group
3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range
干预措施: Extracorporeal shockwave therapy (Device)
Control group
Sham therapy
干预措施: Sham therapy (Device)
结局指标
主要结局
Numerical rating scale (NRS)
时间窗: Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
Pain intensity (0-10, ordinal scale)
次要结局
- Modified Ashworth scale (MAS)(Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks))
- Range of motion (ROM)(Up to 4 weeks (baseline, 1 week, 2 weeks, 2 weeks + 1 day, 4 weeks))
- Grasp power(Up to 4 weeks (baseline, 2 weeks, 4 weeks))
研究者
MinYoung Kim, MD, PhD
Principal Professor of Rehabilitation Medicine
Bundang CHA Hospital