Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow: A Randomized Double-blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS)
研究概览
简要总结
Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy after carpal tunnel syndrome (CTS). Although many conservative managements of UNE were found, their effectiveness were often unsatisfied without existed guideline. Recently, the perineural injection of 5% dextrose wate (D5W) is a novel management for CTS but its effect for UNE is not obviously as CTS. Hence, it is very important to find another novel injectate for UNE.
详细描述
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. Our previous research shown single injection with PRP was superior to D5W for CTS. However there is no study investigating the effect of PRP for UNE now. Hence, the purpose of this study was to assess the effect of perineural PRP injection for UNE.
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, 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 as ulnar neuropathy at elbow at least one month
排除标准
- •Coagulopathy
- •Any active infection status
- •Polyneuropathy of upper extremity
- •Brachial plexopathy
- •Thrombocytopenia Previously undergone wrist surgery or steroid injection for ulnar neuropathy
研究组 & 干预措施
platelet-rich plasma
The perineural injection with PRP is a potential treatment for peripheral entrapment neuropathy
干预措施: platelet-rich plasma (Drug)
5% dextrose
The perineural injection of 5% dextrose is a novel management for peripheral entrapment neuropathy
干预措施: 5% dextrose (Drug)
结局指标
主要结局
Visual analog scale (VAS)
时间窗: Change from baseline at 6 month after injection
Digital pain severity or paresthesia/dysthesia was evaluated using VAS. Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
次要结局
- Disabilities of the Arm, Shoulder and Hand (DASH)(Change from baseline at 6 month after injection)
- Electrophysiological study(Change from baseline at 6 month after injection)
- Cross-sectional area of ulnar nerve(Change from baseline at 6 month after injection)
研究者
Yung-Tsan Wu
Attending Physician and associated professor of Department of Physical Medicine and Rehabilitation
Tri-Service General Hospital