The Volume Effect of Hydrodissection for Injection Therapies in Patients With Carpal Tunnel Syndrome - Evaluation Model by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Change of Visual analog scale (VAS)
研究概览
简要总结
The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis
详细描述
The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis
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
- Triple (Participant, Care Provider, 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
- •Age 20-80
- •Electrophysiological diagnosis of carpal tunnel syndrome
- •At least one of the following two:
- •Tenderness or numbness over median nerve innervated dermatome over 2 months
- •Phalen test or Tinel sign or flick sign positive
排除标准
- •History of wrist surgery
- •Wrist trauma in recent two years
- •Received wrist injection in recent three months
- •History of brachial plexopathy, cervical radiculopathy or thoracic outlet syndrome
- •History of DM, thyroid disorder or autoimmune disease
- •Unable to cooperate with interview, examination or injection
研究组 & 干预措施
Dextrose 1mL
Dextrose injection, Dextrose 1mL, active comparator
干预措施: Dextrose 1mL injection (Procedure)
Dextrose 2mL
Dextrose injection, Dextrose 2mL
干预措施: Dextrose 2mL injection (Procedure)
Dextrose 4mL
'Dextrose injection, Dextrose 4mL
干预措施: Dextrose 4mL injection (Procedure)
结局指标
主要结局
Change of Visual analog scale (VAS)
时间窗: 1 week, 4 weeks, 12 weeks, 24 weeks
Change of Visual analog scale (VAS), from Baseline
次要结局
- Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ)(1 week, 4 weeks, 12 weeks, 24 weeks)
- MSK US finding(1 week, 4 weeks, 12 weeks, 24 weeks)
- QuickDASH(1 week, 4 weeks, 12 weeks, 24 weeks)