NCT02609113已完成不适用
A Double Blinded, Prospective, Randomized Trial of Static Magnetic Therapy for Carpal Tunnel Syndrome (CTS)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks
研究概览
简要总结
The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for 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
- Double (Participant, Investigator)
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
- •Diagnosis of mild to moderate Carpal Tunnel Syndrome by history, clinical exam and Electromyography (EMG) study.
- •≥ 18 years
排除标准
- •Current use of magnets as therapy for Carpal Tunnel Syndrome
- •Known allergy to silicone
- •Unwillingness to wear wristband for 6 weeks
- •Patients who have devices that may be affected by exposure to magnets such as vagal nerve stimulator, pacemaker or insulin pump.
研究组 & 干预措施
Strong Magnetic Wristband
Active Comparator
Magnetic wristband of 1,795 Gauss strength
干预措施: Strong Magnetic Wristband (Device)
Weaker Magnetic Wristband
Placebo Comparator
Magnetic wristband of 5 Gauss strength.
干预措施: Weaker Magnetic Wristband (Device)
结局指标
主要结局
Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks
时间窗: Baseline and 6 weeks
Patient reported outcome measure of symptom severity and functional status. Is made of the Symptom severity scale (11 items) score 1 to 5 where lower numbers denotes better outcomes; and the Functional status scale (8 items) score 1 to 5 where lower numbers denotes better outcomes. Total score 1- 95 where lower numbers denotes better outcomes.
次要结局
- Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks(Baseline and 6 weeks)
- Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks(Baseline and 6 weeks)
- Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks(Baseline and 6 weeks)
研究者
研究点 (2)
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