The Effectiveness of Focused Extracorporeal Shock Wave Therapy in the Treatment of Carpal Tunnel Syndrome: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- VAS
研究概览
简要总结
The carpal tunnel syndrome (CTS) is the most common entrapment neuropathy in the general population.The focus extracorporeal shock wave (fEWST) is a non invasive treatment for various diseases. FESWT is new and potential treatment for peripheral nerve entrapment/ peripheral neuropathy . But there is still little known about the effects and long term effects of fESWT in the treatment of CTS.
详细描述
The aim of this study is to determine the effectiveness of fESWT in patients with carpal tunnel syndrome compared to participants receiving only night splint. Therefore 40 patients with mild to moderate CTS (verified by nerve conduction velocity) will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
Evaluation will be performed at baseline (VAS, hand grip, electrodiagnostic parameters, questionnaires), 3 weeks (VAS, hand grip, questionnaires), 12 and 24 weeks (VAS, hand grip, electrodiagnostic parameters, questionnaires) after 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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to moderate CTS verified by nerve conduction velocity
排除标准
- •metabolic diseases
- •blood clotting problems
- •systemic diseases
- •polyneuropathy
- •chemotherapy during the study
- •corticosteroid therapy
- •use of anticoagulation
- •history of trauma/surgery or nerve lesion of the teated extremity
- •CTS surgery on the affected hand
- •ICD/ pacemaker implantation
- •other therapy for the affected hand during the study
- •acute inflammation or infections
- •severe mental illnesses/psychiatric diseases
- •severe neurological diseases
结局指标
主要结局
VAS
时间窗: baseline, 3th,12th and 24th weeks after treatment
Visual Analog Scale: Change from baseline of pain 3th,12th and 24th weeks after treatment.
次要结局
- hand grip strength(baseline, 3th,12th and 24th weeks after treatment)
- sensory conduction velocity of the median nerve(baseline, 12th and 24th weeks after treatment)
- SF-36(baseline, 3th,12th and 24th weeks after treatment)
- distal motor latency of the median nerve(baseline,12th and 24th weeks after treatment)
- Boston Scale(baseline, 3th,12th and 24th weeks after treatment)
研究者
Richard Crevenna
Ao.Univ.-Prof. Dr., MMSc. MBA, Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine
Medical University of Vienna