Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain alleviation
研究概览
简要总结
Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline of the median nerve could offer symptoms and clinical improvement
详细描述
Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.
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, 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
- •adult patients
- •complaining of carpal tunnel syndrome of 3 month duration or more
- •diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study
排除标准
- •patient refusal
- •infection at the site of intervention
- •local anesthetic allergy
研究组 & 干预措施
Comparator: Hyalase
injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection
干预措施: Hyalase (Drug)
Saline
Injection 10 cc saline injection as a median nerve hydro-dissection
干预措施: Saline (Drug)
结局指标
主要结局
pain alleviation
时间窗: 6 months
visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain
次要结局
- Changes in ultrasound imaging(6 months)
- Changes in median nerve conduction parameters(6 months)
研究者
Emad Zarief , MD
Associate professor of Anesthesia, ICU, and pain
Assiut University
