Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome
1 other identifier
interventional
66
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedNovember 20, 2015
November 1, 2015
8 months
July 23, 2015
November 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Boston Carpal Tunnel Questionnaire
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
Baseline, 4 weeks, 12 weeks
Secondary Outcomes (4)
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
Change in strength (Dynamometer)
Baseline, 4 weeks, 12 weeks
Study Arms (2)
Manipulative treatment
EXPERIMENTALManipulative Treatment
Simulated manipulative treatment
SHAM COMPARATORSimulated manipulative treatment
Interventions
Manipulative treatment as described by the GBMOIM (Grupo Barcelona de Medicina Ortopédica y Manual) will be perform with extension of the transverse carpal ligament maneuver and fascia release maneuver
Simulated Manipulative Treatment
Eligibility Criteria
You may qualify if:
- Symptoms of canal tunnel syndrome (CTS) : pain, numbness, paresthesia, diminished grip strength
- Electromyography confirming CTS
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julia Schmitt, PM&RResident
Hospital Arnau de Vilanova, Valencia, Spain
- STUDY DIRECTOR
Julio Domenech, MD-PhD
Hospital Arnau de Vilanova, Valencia, Spain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD-PhD
Study Record Dates
First Submitted
July 23, 2015
First Posted
November 20, 2015
Study Start
May 1, 2016
Primary Completion
January 1, 2017
Study Completion
July 1, 2017
Last Updated
November 20, 2015
Record last verified: 2015-11