Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks
研究概览
简要总结
The purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS).
详细描述
A variety of treatment options exist at present for carpal tunnel syndrome (CTS) with no universal agreement. Recent reports suggested that untreated CTS might improve or remain stationary. In this respect, treatment directing towards symptom suppression alone may have a role in the initial management of CTS. Gabapentin (1-[aminomethyl]-cyclohexaneacetic acid; Neurontin, Pfizer) is an effective drug for treatment of neuropathic pain and has been reported to be effective in case series for the treatment of CTS with relatively benign side effects profile. The purpose of this study was to evaluate the safety and efficacy of gabapentin in the treatment of CTS.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sensory symptoms over median nerve distribution for more than three months.
- •Confirmatory electrophysiologic results defined as prolonged median nerve distal motor latencies (DML) > 4 ms or median-ulnar palmer sensory latency differences > 0.5 ms.
排除标准
- •Patients with evidence of severe CTS: fibrillation potentials or reinnervation on needle examination of the abductor pollicis brevis muscle or clinical examination showing wastage of the thenar muscles. (These patients were referred for surgical decompression on presentation.)
- •Clinical or electrophysiological evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as proximal median neuropathy, cervical radiculopathy, or significant polyneuropathy.
- •Known epilepsy.
- •Patients who have received previous steroid injection or oral steroid therapy for CTS.
研究组 & 干预措施
1
Gabapentin
干预措施: Gabapentin (Drug)
2
Placebo
干预措施: placebo (Other)
结局指标
主要结局
Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks
时间窗: 8 weeks
次要结局
- Grip strength as functional assessment at 2 and 8 weeks(2 weeks, 8 weeks)
- GSS at 2 weeks(2 weeks)
- Tolerability(throughout subject's participation in trial)