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临床试验/NCT02217293
NCT02217293已完成不适用

Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome

Tri-Service General Hospital2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Change from baseline of pain on1st, 4th, 8th and 12th weeks after treatment.

研究概览

简要总结

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy. Although many conservative forms of management including the use of wrist splint, steroid injections and therapeutic ultrasound are applicable, their effectiveness is typically insignificant or short-lived.

Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain for certain kinds of chronic pain conditions without damaging nerve. However, the application of PRF in CTS is scarce.

The purpose of this study was to assess the analgesic effect and prognosis of ultrasound-guided PRF in the median nerve in patients with CTS.

详细描述

Background and Purpose:

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy. Although many conservative forms of management including the use of wrist splint, steroid injections and therapeutic ultrasound are applicable, their effectiveness is typically insignificant or short-lived.

Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain for certain kinds of chronic pain conditions without damaging nerve. However, the application of PRF in CTS is scarce. The purpose of this study was to assess the analgesic effect and prognosis of ultrasound-guided PRF in the median nerve in patients with CTS.

Study design Duration: 2012/1/1 to 2012/12/31. Subjects: Outpatient subjects who had typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test and numbness/tingling in at least two of the first, second, and third digits and were all confirmed by electrophysiological study, were considered and enrolled. The patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previous wrist surgery or steroid injection for CTS, were all excluded. Patient number: 40. Methods: The enrolled patients were randomized into two groups as the intervention group, who received one dose of PRF and the control group, who did not received RPF treatment by using drawing sealed envelope. To provide fundamental medical care of CTS, a wrist night splint was prescribed for each subject in both groups. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study. All procedures were conducted by single physician. All the measurements were performed by single physician who was blinded for the randomization, and the evaluation time was performed before intervention as well as the 1st, 4th, 8th and 12th weeks after treatment. All patients were instructed to keep away from getting any other treatments for their pain or discomfort resulting from CTS including analgesic agents, injection or acupuncture etc. during the period of follow-up. They were asked to notify us if they had taken these therapies.

Outcome measurements:

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

  • Outpatient subjects who had typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test and numbness/tingling in at least two of the first, second, and third digits and were all confirmed by electrophysiological study, were considered and enrolled.

排除标准

  • The patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previous wrist surgery or steroid injection for CTS

结局指标

主要结局

Change from baseline of pain on1st, 4th, 8th and 12th weeks after treatment.

时间窗: Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.

Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.

次要结局

  • Change from baseline in severity of symptoms and functional status on 1st, 4th, 8th and 12th weeks after treatment.(Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.)
  • Change from baseline in finger pinch on 1st, 4th, 8th and 12th weeks after treatment.(Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.)
  • Change from baseline in cross-sectional area of the median nerve on 1st, 4th, 8th and 12th weeks after treatment.(Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.)
  • Change from baseline in conduction velocity, ampliture of median nerve on 1st, 4th, 8th and 12th weeks after treatment.(Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.)

研究者

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

Yung-Tsan Wu

Attending Physician

Tri-Service General Hospital

研究点 (2)

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