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临床试验/NCT04346030
NCT04346030Unknown不适用

Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年4月17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
入组人数
60
试验地点
1
主要终点
change from baseline in the scores on Boston Carpal tunnel Questionnaire (BQ)

研究概览

简要总结

The objective of this study is to investigate the effect of ultrasound guided steroid injection versus ultrasound guided steroid hydrodissection to treat patients with CTS.

详细描述

This study was a prospective, randomized clinical trial. Patients with CTS were randomly treated with sonographically guided corticosteroid injection (group A); sonographically guided hydrodissection and corticosteroid injection (group B).

Boston Carpal tunnel questionnaire, nerve conduction studies and VAS pain score were performed on initial visit and after 6 weeks and 12 weeks .

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
Single (Participant)

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

  • Clinical diagnosis of CTS The diagnosis of CTS was confirmed by electrophysiological tests.

排除标准

  • presence of thenar atrophy any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome prior steroid injection into the affected carpal tunnel within 6 months or ever received carpal tunnel surgery history of distal radius fracture pregnancy or lactation regular use of systemic NSAIDs ,corticosteroids or diuretics known allergy to corticosteroids and local anesthetics. impaired cognitive function

研究组 & 干预措施

steroid and hydrodissection

Experimental

ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS

干预措施: Triamcinolone Acetonide (Drug)

steroid and hydrodissection

Experimental

ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS

干预措施: lidocaine hydrochloride (Drug)

steroid and hydrodissection

Experimental

ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS

干预措施: normal saline (Drug)

steroid only

Active Comparator

ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine)

干预措施: Triamcinolone Acetonide (Drug)

steroid only

Active Comparator

ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine)

干预措施: lidocaine hydrochloride (Drug)

结局指标

主要结局

change from baseline in the scores on Boston Carpal tunnel Questionnaire (BQ)

时间窗: 0, 6, 12 weeks.

The BQ was interviewed-administered to assess the severity of symptoms and functional status

次要结局

  • change from baseline in self reported pain intensity(0, 6, 12 weeks)
  • Change from Baseline in sensory nerve conduction velocity(0, 6, 12 weeks)
  • change from baseline in median nerve distal motor latency(0, 6, 12 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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