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临床试验/NCT02907671
NCT02907671Unknown不适用

Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome Comparing Two Different Injection Sites

Rehabilitace MUDr. Hasan Mezian s.r.o.3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
3
主要终点
Visual analogue scale

研究概览

简要总结

Effectiveness of ultrasound guided corticoanesthetic injection in carpal tunnel syndrome treatment comparing two different injection sites. Single-blind randomized trial.

详细描述

Carpal tunnel syndrome (CTS) is the most common nerve entrapment neuropathy. Six placebo-controlled trials with 393 participants proved corticosteroid injection to be effective in symptom relief. However, all injections were palpation-guided. Therefore, the exact injection site was uncertain. Although three studies comparing palpation and ultrasound (US) guided CTS injection showed US superiority, the optimal injection site for the injectate delivery remains unclear. Some authors believe in thinning of the flexor tenosynovium as the mechanism of the median nerve decompression, and therefore recommend injection between the tendons, away from the nerve. Other authors stress the importance of hydrodissection and direct contact of the injectate with the nerve and suggest injection targeting the median nerve. According to our best knowledge, no study comparing different injection sites for a corticosteroid delivery in CTS has been published in English written literature. The objective of this study was to determine the optimal target site for the corticosteroid delivery in CTS injection.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary idiopathic CTS
  • symptoms of classic or probable CTS (numbness or tingling in at least 2 of the 4 radial fingers)
  • unsuccessful 1-month treatment with wrist splinting
  • nerve conduction test results that showed median neuropathy at the wrist

排除标准

  • previous steroid injection
  • diabetes mellitus,
  • thyroid disorder
  • inflammatory disease
  • polyneuropathy
  • current pregnancy
  • previous carpal tunnel surgery
  • severe illness
  • inability to respond to questionnaires

研究组 & 干预措施

Group A

Active Comparator

carpal tunnel corticoanesthetic injection between the flexor tendons

干预措施: carpal tunnel corticoanesthetic injection (Procedure)

Group B

Active Comparator

carpal tunnel corticoanesthetic injection next to the median nerve with hydrodissection

干预措施: carpal tunnel corticoanesthetic injection (Procedure)

结局指标

主要结局

Visual analogue scale

时间窗: up to 1 year

pain severity scale

次要结局

  • Michigan Hand Outcomes Measure(up to 1 year)
  • Boston carpal tunnel questionnaire(up to 1 year)
  • Procedural CAS(up to 1 year)

研究者

发起方
Rehabilitace MUDr. Hasan Mezian s.r.o.
申办方类型
Other
责任方
Sponsor

研究点 (3)

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