Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome: a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carpal Tunnel Syndrome
- Sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Enrollment
- 66
- Primary Endpoint
- Change in Boston Carpal Tunnel Questionnaire
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Julio Domenech
MD-PhD
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Eligibility Criteria
Inclusion Criteria
- •Symptoms of canal tunnel syndrome (CTS) : pain, numbness, paresthesia, diminished grip strength
- •Electromyography confirming CTS
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in Boston Carpal Tunnel Questionnaire
Time Frame: 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
Secondary Outcomes
- 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)