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临床试验/NCT03675295
NCT03675295已完成不适用

Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年4月2日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

干预措施: Hyalase (Drug)

Saline

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emad Zarief , MD

Associate professor of Anesthesia, ICU, and pain

Assiut University

研究点 (1)

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