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临床试验/NCT02986828
NCT02986828已完成不适用

The Long-term Effect of Platelet Rich Plasma and Hydrodissection for Patients With Carpal Tunnel Syndrome

Tri-Service General Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2016年12月1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
26
试验地点
1
主要终点
Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection

研究概览

简要总结

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. Since 2014, three small clinical trials showed the positive effect of PRP in peripheral neuropathy included CTSin a pilot research. However, these studies have not entirely proved the effects of PRP on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP injection in patients with CTS.

详细描述

After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control side. Participants in intervention group received one-dose ultrasound-guided PRP injection and control side received one-dose ultrasound-guided normal saline injection. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the treatment.

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, Investigator)

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

  • Age between 20-80 year-old.
  • Diagnosis was confirmed using an electrophysiological study

排除标准

  • Coagulopathy
  • Pregnancy
  • Inflammation status
  • Cervical radiculopathy
  • Polyneuropathy, brachial plexopathy
  • Thoracic outlet syndrome
  • Previously undergone wrist surgery or steroid injection for CTS

研究组 & 干预措施

platelet rich plasma injection

Experimental

The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies.

干预措施: platelet rich plasma (Drug)

platelet rich plasma injection

Experimental

The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies.

干预措施: Ultrasound (Device)

Normal saline

Active Comparator

Normal saline for ultrasound-guided hydrodissection

干预措施: Normal saline (Drug)

Normal saline

Active Comparator

Normal saline for ultrasound-guided hydrodissection

干预措施: Ultrasound (Device)

结局指标

主要结局

Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection

时间窗: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection

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 of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection(Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection)
  • Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection(Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection)
  • Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and 1 year after injection(Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection)
  • Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection(Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection)

研究者

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

Yung-Tsan Wu

Attending Physician of Department of Physical Medicine and Rehabilitation

Tri-Service General Hospital

研究点 (1)

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