The Long-term Effect of Platelet-rich Plasma in Patients With Carpal Tunnel Syndrome: a Prospective Randomized Double-blind Controlled Trial
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 one year after the treatment.
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. 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, four small clinical trials showed the positive effect of PRP in peripheral neuropathy. Among these studies, two small trials showed beneficial effect of PRP for patients with mild CTS. However, the definite clinical effect of PRP for peripheral neuropathy from currently published studies is unclarified because these studies enrolled a few patients and lacked long-term follow-up (no more than 6 months follow-up).
详细描述
After obtaining written informed consent, patients of clinically diagnosed with bilateral CTS were randomized into intervention and control side. Intervention group received one-dose ultrasound-guided PRP injection and control group 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 是
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
- •Polyneuropathy, brachial plexopathy
- •Thoracic outlet syndrome
- •Previously undergone wrist surgery or steroid injection for CTS
研究组 & 干预措施
Normal saline
Normal saline for hydrodissection
干预措施: Normal saline (Drug)
platelet rich plasma injection
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 (Procedure)
结局指标
主要结局
Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and one year after the treatment.
时间窗: Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.
Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of carpal tunnel syndrome which encompasses symptom severity and functional status. Each question ranges from 1 to 5 with a higher score indicating severer symptom or a higher degree of disability. Total score ranges from 19 to 95 and the mean of total scores divided with each item score were used for further analysis.
次要结局
- Change from baseline in conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and one year after the treatment.(Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.)
- Change from baseline in finger pinch on 2nd week, 1st, 3rd, 6th month and one year after the treatment.(Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.)
- Change from baseline in severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and one year after the treatment.(Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.)
- Change from baseline in cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and one year after the treatment.(Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.)
研究者
Yung-Tsan Wu
Attending Physician of Department of Physical Medicine and Rehabilitation
Tri-Service General Hospital