Percutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Changes of the Boston Questionnaire for Carpal Tunnel Syndrome
研究概览
简要总结
The aim of this study is to compare the effectiveness of Percutaneous Needle Electrolysis (PNE) versus surgical treatment in the treatment of Carpal Tunnel Syndrome (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
- Single (Participant)
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
- •Over 18 years.
- •CTS diagnosed by Electromyography (EMG)
- •Symptoms of CTS + EMG
排除标准
- •Difficulty expressing your feelings properly
- •Unsurpassed fear of needles
- •History of adverse reactions to needles
- •Epilepsy and / or allergies to metals.
- •Difficulty expressing your feelings properly
- •Existence of diffuse peripheral neuropathy or cervical radiculopathy
- •History of potential concurrent cause of idiopathic CTS (such as diabetes, thyroid, chronic rheumatoid arthritis, renal failure with hemodialysis, pregnancy..)
研究组 & 干预措施
PNE group
Patients received 4 sessions, separated one week between them. The treatment consisted the application of a galvanic current through an acupuncture needle (0,30x30mm). The approach were performed with a transverse axis with a needle in plane, being superficial and deep interface of medium nerve the target tissue. The parameters will be 2 mA (milliamps), 10 seconds, 3 impacts (3: 3: 3).
干预措施: PNE (Other)
Surgery group
Patients received surgery for median nerve release.
干预措施: Surgery for CTS (Procedure)
结局指标
主要结局
Changes of the Boston Questionnaire for Carpal Tunnel Syndrome
时间窗: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms)
次要结局
- Change of Semmes Weinstein Mini monofilament kit(Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months)
- Changes of the Clinical Symptoms Carpal Tunnel Syndrome Scale(Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months)
- Change of pain level(Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months)
- Change of the Hand Dynamometer(Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months)
- Changes of the SF-12 Questionnaire (Short Form 12 Questionnaire)(Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months)
- Changes of the Muscles strength by Kendall´s scale(Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months)
研究者
Jose Antonio Garcia Vidal
Doctor
Universidad de Murcia