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临床试验/NCT06251674
NCT06251674已完成不适用

Comparison of Ultrasound-guided Transverse Carpal Ligament Needle Release Via Different Approaches for Patients With Mild-to-moderate Carpal Tunnel Syndrome

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月1日最近更新:
适应症

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
visual analogue scale(VAS) scores

研究概览

简要总结

Carpal tunnel syndrome (CTS) is one of the most common peripheral nerve entrapment neuropathies, and it is characterized by pain, numbness, tingling, and weakness in the regions innervated by the median nerve (MN). CTS is believed to result from compression of the MN as it passes through the narrowed carpal tunnel with regard to gradual ischemia and fibrosis.Ultrasound-guided needle release of transverse carpal ligament(TCL) is an effective method to decompress the carpal.There are two main approaches to perform the release, short-axis or long-axis. However, there is no consensus about the optimal strategy.Thus, this study aimed to compare the efficacy of these two approaches for patients with mild-to-moderate CTS.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-80 years old
  • typical clinical signs of CTS present for at least three months, including pain, numbness, and tingling of the hands
  • positive Phalen or Tinel sign
  • electrophysiological parameters supportive of mild to moderate CTS
  • high-resolution ultrasonography demonstrated MN compression at the carpal.

排除标准

  • bifid MN or bilateral CTS
  • pregnancy
  • disorders such as rheumatic immune diseases, chronic renal failure, diabetes mellitus, hypothyroidism and other systemic diseases
  • any accompanying disorder that could mimic CTS, such as thoracic outlet syndrome, cervical radiculopathy, polyneuropathy, proximal median nerve entrapment
  • history of carpal tunnel surgery or injection into the affected carpal tunnel
  • CTS caused by trauma, surgery, intracarpal lesions, or MN lesions malignant tumors or severe cardiorespiratory diseases

结局指标

主要结局

visual analogue scale(VAS) scores

时间窗: Baseline as well as 1 month, 3 month and 6 months after injection.

The VAS scores is the most common tool to assess the level of pain. Possible scores range from 0(no pain) to 10(worst possible pain).

次要结局

  • cross-sectional area(CSA) of the median nerve(Baseline as well as 1 month, 3 month and 6 months after injection.)
  • Boston carpal tunnel syndrome questionnaire(BCTQ)(Baseline as well as 1 month, 3 month and 6 months after injection.)

研究者

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

Zhu Jiaan

Professor

Peking University People's Hospital

研究点 (1)

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