Clinical trial NCT02611193: Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome
Official title: Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Boston Carpal Tunnel Questionnaire
timeFrame: Baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Change in DASH Outcome Measure
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Change in Visual Analog Scale for pain
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Change in EuroQol-5D scale
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Change in strength (Dynamometer)
timeFrame: Baseline, 4 weeks, 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Arnau de Vilanova, Valencia, Spain
name: Julia Schmitt, PM&RResident
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Arnau de Vilanova, Valencia, Spain
name: Julio Domenech, MD-PhD
role: STUDY_DIRECTOR
References: