Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 主要终点
- Change in Boston Carpal Tunnel Questionnaire
研究概览
简要总结
Hypothesis: Manipulative treatment can relieve patients of discomfort and dysfunction and then be utilized as a cheap conservative management of CTS. Study design: Two-groups randomized single-blind interventional study.
详细描述
Background: Carpal Tunnel Syndrome (CTS) is the most common compressive neuropathy in the upper limb. It considerably impairs patient's quality of life and generates important social consequences due to the lost of productivity and the cost of treatments. Both surgical and conservative treatment are utilized for CTS management. Manipulative treatment is a conservative, non-drug and cheap management option which can be proposed, but by now, treatment guidelines and reviews do not recommend it due to lack of evidence to assess his efficacy.
Hypothesis
Manipulative treatment can relieve patients of discomfort and dysfunction and then be utilized as a cheap conservative management of CTS.
Study design: Two-groups randomized single-blind interventional study. Methods: Sixty-six patients reporting CTS symptoms that are confirmed by clinical exam and nerve conduction studies will be included. Participants will be randomized in two arms, one receiving manipulative treatment and one receiving simulated manipulative treatment (1/week for 4 weeks). The main outcome measures will be the DASH questionnaire, the Boston Carpal Tunnel Syndrome Questionnaire, patient estimate on Visual Analog Scale for pain and the EuroQol-5D scale. All outcomes measures will be administrated to participants before the first manipulation, after the last session (4 weeks) and 12 weeks after the baseline measure.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of canal tunnel syndrome (CTS) : pain, numbness, paresthesia, diminished grip strength
- •Electromyography confirming CTS
排除标准
- •Previous surgical procedure for CTS in the same wrist
- •Possible secondary CTS : hypothyroidism, diabetes mellitus, pregnancy, rheumatologic diseases, neck or shoulder complaints,
- •Hand and wrist pathological conditions as previous disease, intervention, traumatism, anatomic abnormalities in shape or size.
研究组 & 干预措施
Manipulative treatment
Manipulative Treatment
干预措施: Manipulative treatment (Procedure)
Simulated manipulative treatment
Simulated manipulative treatment
干预措施: Simulated manipulative treatment (Procedure)
结局指标
主要结局
Change in Boston Carpal Tunnel Questionnaire
时间窗: Baseline, 4 weeks, 12 weeks
self-administered questionnaire for the assessment of severity of symptoms and functional status in patients who have carpal tunnel syndrome. It has two distinct scales : a symptom-severity scale (11 \- Page 2 of 3 \[DRAFT\] - items) and a functional-status scale (8 items). It has been validated and demonstrated to show good responsiveness and reliability in evaluating outcome after carpal tunnel release. The Spanish version has been validated
次要结局
- Change in strength (Dynamometer)(Baseline, 4 weeks, 12 weeks)
- Change in DASH Outcome Measure(Baseline, 4 weeks, 12 weeks)
- Change in Visual Analog Scale for pain(Baseline, 4 weeks, 12 weeks)
- Change in EuroQol-5D scale(Baseline, 4 weeks, 12 weeks)
研究者
Julio Domenech
MD-PhD
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana