Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manipulative treatment
Simulated manipulative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Manipulative treatment
Simulated manipulative treatment
Arm Description
Manipulative Treatment
Simulated manipulative treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in DASH Outcome Measure
30-item, self-report questionnaire designed to measure physical function and symptoms in people with a musculoskeletal disorder of the upper limb. It showed a large degree of responsiveness after CTS treatment and the Spanish version has been validated
Change in Visual Analog Scale for pain
VAS has eleven points from 0 to 10, being 0 no pain at all, and 10 the worst pain could ever be imagined
Change in EuroQol-5D scale
Quality-of-life's measure instrument which consists of a combination of a 5 items questionnaire and a Visual analogue scale. Both validity and responsiveness have been demonstrated in patients with chronic pain, and it has been evaluated in patients with CTS symptoms. The Spanish version has been validated
Change in strength (Dynamometer)
Measuring pulp pinch strength with digits I and II
Full Information
NCT ID
NCT02611193
First Posted
July 23, 2015
Last Updated
November 18, 2015
Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
1. Study Identification
Unique Protocol Identification Number
NCT02611193
Brief Title
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
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manipulative treatment
Arm Type
Experimental
Arm Description
Manipulative Treatment
Arm Title
Simulated manipulative treatment
Arm Type
Sham Comparator
Arm Description
Simulated manipulative treatment
Intervention Type
Procedure
Intervention Name(s)
Manipulative treatment
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Simulated manipulative treatment
Intervention Description
Simulated Manipulative Treatment
Primary Outcome Measure Information:
Title
Change in Boston Carpal Tunnel Questionnaire
Description
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
Time Frame
Baseline, 4 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in DASH Outcome Measure
Description
30-item, self-report questionnaire designed to measure physical function and symptoms in people with a musculoskeletal disorder of the upper limb. It showed a large degree of responsiveness after CTS treatment and the Spanish version has been validated
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Change in Visual Analog Scale for pain
Description
VAS has eleven points from 0 to 10, being 0 no pain at all, and 10 the worst pain could ever be imagined
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Change in EuroQol-5D scale
Description
Quality-of-life's measure instrument which consists of a combination of a 5 items questionnaire and a Visual analogue scale. Both validity and responsiveness have been demonstrated in patients with chronic pain, and it has been evaluated in patients with CTS symptoms. The Spanish version has been validated
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Change in strength (Dynamometer)
Description
Measuring pulp pinch strength with digits I and II
Time Frame
Baseline, 4 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Schmitt
Email
juliaschmitt81@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Schmitt, PM&RResident
Organizational Affiliation
Hospital Arnau de Vilanova, Valencia, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julio Domenech, MD-PhD
Organizational Affiliation
Hospital Arnau de Vilanova, Valencia, Spain
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome
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