NCT03810326Unknown不适用
Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
Yuinvent Innovations Ltd.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in pain score
研究概览
简要总结
Interventional study to evaluate efficacy and safety of an active splint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients, above 40 years of age.
- •Able to understand and sign informed consent
- •Pain associated with mild to moderate carpal tunnel syndrome in a single wrist
- •Numbness and tingling in the median nerve distribution
- •Nocturnal Numbness
- •Weakness and/or atrophy of the thenar musculature
- •Demonstrate positive Phalen's Test of the affected extremity
- •Demonstrate positive Tinel's Test of the affected extremity
- •Sensory impairment defined as a loss of 2-point discrimination
- •Have recent (within 3 months) electro-diagnostic evidence of Carpal Tunnel Syndrome
排除标准
- •Currently receiving treatment for carpal tunnel syndrome
- •History of surgical carpal tunnel release
- •Pregnancy
- •Diabetes not controlled by medication
- •Radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy
- •Thoracic outlet syndrome
- •Compromised skin integrity
- •Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand
研究组 & 干预措施
Intervention
Experimental
干预措施: CTR device (tradename named Xtend) (Device)
结局指标
主要结局
Reduction in pain score
时间窗: 10 weeks
Reduction in NRS reported pain score
次要结局
未报告次要终点
研究者
研究点 (1)
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