Ultrasound-assisted Percutaneous Release of Carpal Tunnel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain (visual analogic scale)
研究概览
简要总结
The objective of the study is to evaluate in patients suffering from carpal tunnel syndrome resistant to medical treatment, clinical course after percutaneous treatment under ultrasound guidance. 40 patients will be included in the study. The following parameters will be evaluated: patient satisfaction, pain, functional disability, quality of life and time to return to work. The medico-economic aspect will be analyzed.
详细描述
Ultrasound analysis of Carpal tunnel is used for many years, especially for diagnostic purposes. Investigators have shown, first by a study of 104 cadavers that it was possible to reduce the opening by making the gesture under ultrasound guidance and to perform the procedure under local anesthesia. Then investigators performed an open study of 25 patients confirming the absence of iatrogenic lesions with this new technique.
The percutaneous treatment of carpal tunnel syndrome under ultrasound guidance is a gesture of interventional radiology. One can envisage making this type of treatment in interventional radiology room which overcomes the operating room and thus reduce costs.
The objective of the study is to continue the study of percutaneous treatment of carpal tunnel syndrome under ultrasound guidance by an open study conducted in interventional radiology room.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient older than 18 years who signed the informed consent.
- •Patient with an Carpal Tunnel Syndrome
排除标准
- •patient has already undergone surgery of Carpal Tunnel Syndrome
- •Patient with contra-indications to anesthesia (heart failure, kidney, liver).
- •Pregnant women
- •alcoholics in weaning period
- •Patient whose consent is altered or unable to get a safety procedure
- •Patient with contra-indication to lidocaine
- •Patient with contra-indication for the realization of ultrasound endoscopy (carpal tunnel syndrome secondary or anastomosis between the median and ulnar nerves: anastomosis Berritini)
研究组 & 干预措施
percutaneous treatment
percutaneous treatment of carpal tunnel syndrome under ultrasound guidance in interventional radiology room.
干预措施: percutaneous treatment (Procedure)
percutaneous treatment
percutaneous treatment of carpal tunnel syndrome under ultrasound guidance in interventional radiology room.
干预措施: Ultrasound (Device)
结局指标
主要结局
Pain (visual analogic scale)
时间窗: change between baseline and day 90 after surgery
visual analogic scale
paresthesia
时间窗: change between baseline and day 90 after surgery
muscle strength (dynamometer JAMARD)
时间窗: change between baseline and day 90 after surgery
dynamometer JAMARD
次要结局
未报告次要终点