The Long-term Effect of Combined Platelet Rich Plasma With Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks
研究概览
简要总结
The platelet rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) are new and potential treatment for patients with kinds of musculoskeletal disorders. Although few clinical studies have showed beneficial effect of PRP and ESWT for regeneration of peripheral neuropathy, the effect of combined PRP and ESWT is absent so far.
详细描述
We perform a prospective randomized, double-blinded study to investigate the combined effect of PRP and ESWT in patients with carpal tunnel syndrome.
Patients were randomized into intervention and control group. Participants in intervention group received sono-guided injection with 3cc PRP and one-session active ESWT and control group received sono-guided injection with 3cc PRP and one-session sham ESWT. The evaluation was performed pretreatment as well as on the 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 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
The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups.
干预措施: Platelet rich plasma (Procedure)
Platelet rich plasma
The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups.
干预措施: shock wave (Device)
Active shock wave
One-session active shock wave 2 weeks later after PRP injection was performed in intervention group.
干预措施: Platelet rich plasma (Procedure)
Active shock wave
One-session active shock wave 2 weeks later after PRP injection was performed in intervention group.
干预措施: shock wave (Device)
Sham shock wave
One-session sham shock wave 2 weeks later after PRP injection was performed in control group.
干预措施: Platelet rich plasma (Procedure)
Sham shock wave
One-session sham shock wave 2 weeks later after PRP injection was performed in control group.
干预措施: shock wave (Device)
结局指标
主要结局
Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks
时间窗: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.
次要结局
- Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment)
- Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment.(Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment)
- Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment)
研究者
Yung-Tsan Wu
Attending physician of physical medicine and rehabilitation
Tri-Service General Hospital