NCT02891512已完成不适用
Effectiveness of Very Low Frequency Magnetic Fields Versus the Supplement "Xinepa" in the Treatment of the Carpal Tunnel Syndrome: Randomized Double-blind Controlled Clinical Trial.
University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
研究概览
简要总结
The purpose of the study is to determine the effectiveness of the treatment with very low frequency magnetic fields (ELF) on the reduction of pain and the relief of the associated signs such as sensitivity disorders that affect the first three fingers and half of the fourth finger of the hand in patients with carpal tunnel syndrome versus the supplement (= Xinepa).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of carpal tunnel syndrome
排除标准
- •Pregnancy;
- •Pacemaker or other metallic implants;
- •Systemic infectious disorders;
- •Neoplastic disorders;
- •Epilepsy;
- •Severe heart disease.
- •Known hypersensitivity to the components of Xinepa
结局指标
主要结局
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
时间窗: baseline, 4 weeks, 12 weeks
It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements.
次要结局
- Change of Boston Carpal Tunnel Questionnaire from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of the measurement of the grip strength trough the Jamar dynamometer from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of Semmes-Weinstein Monofilaments of light touch and pressure sensation test from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of the measurement of the pinch strength trough the Pinch Gauges dynamometer from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of electroneurography from baseline to 12 months(baseline, 4 weeks, 12 weeks)
研究者
Teresa Paolucci
Medical Director
University of Roma La Sapienza
研究点 (2)
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