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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
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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