The Long-term Effect of Platelet Rich Plasma and Perineural Injection 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
- 52
- 试验地点
- 2
- 主要终点
- Change from baseline in severity of symptoms and functional status on 2nd, 4th, 8th, 12th, 16th and 24th weeks after 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. 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, two small clinical trials showed the positive effect of PRP in peripheral neuropathy. One study shown the PRP has therapeutic effect for peripheral neuropathy in patients with leprosy. In addition, PRP having protective effect against neurological deficit of facial nerve during superficial parotidectomy. 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. In addition, the PRP was not used for treating CTS so far. 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 of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided PRP injection and control group received one-dose ultrasound-guided 5% dextrose injection. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), 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, 4th, 8th, 12th, 16th and 24th 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 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
- •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
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 (Other)
5% dextrose
5% dextrose for hydrodissection
干预措施: 5% dextrose (Other)
结局指标
主要结局
Change from baseline in severity of symptoms and functional status on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
时间窗: Pre-treatment, 2nd, 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 in finger pinch on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.(Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.)
- Change from baseline in conduction velocity, amplitude of median nerve on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.(Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.)
- Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.(Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.)
研究者
Yung-Tsan Wu
Attending Physician of Department of Physical Medicine and Rehabilitation
Tri-Service General Hospital