The Effect of Sono-guided Injection With Platelet Rich Plasma for Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
研究概览
简要总结
The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for regeneration of peripheral neuropathy in animal study, the associated study in human is rare.
详细描述
The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for regeneration of peripheral neuropathy in animal study, the associated study in human is rare. We performe a prospective study to investigate the effect of PRP in patients with carpal tunnel syndrome.
Patients with carpal tunnel syndrome (CTS) were randomized into intervention and control group. Participants in intervention group received sono-guided injection with 3cc PRP and control group received night splint. The evaluation was performed pretreatment as well as on the 1st, 4th, 8th, 12th, 16th and 24 week 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
- Single (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
- 否
入选标准
- •Age between 20-80 year-old.
- •Typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test, numbness/tingling in at least two of the first, second, or third digits, and in whom the diagnosis was confirmed using an electrophysiological study.
排除标准
- •Coagulopathy
- •Inflammation status
- •Patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for CTS.
研究组 & 干预措施
platelet rich plasma
Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve in intervention group.
干预措施: platelet rich plasma (Biological)
splinting
The wrist night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study in control group.
干预措施: splint (Device)
结局指标
主要结局
Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
时间窗: 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Visual analog scale (VAS)
次要结局
- Change from baseline of severity of symptoms and functional status 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.)
- Change from baseline of cross-sectional area in median nerve on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.)
- Change from baseline of electrophysiological study on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.)
- Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.)
研究者
Yung-Tsan Wu
Attending physician
Tri-Service General Hospital