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Multicomponent Therapy for Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cognitive behavioral therapy
Sponsored by
University Ghent
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibromyalgia focused on measuring multicomponent therapy

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • woman with fibromyalgia
  • between the age of 20 and 50
  • agreement with therapy protocol

Exclusion Criteria:

  • high indication of depression measured with the Beck Depression Index

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Fibromyalgia Impact Questionnaire
    impact of fibromyalgia on daily life with a questionnaire
    Tampa scale for kinesiophobia
    rating the kinesiophobia with a questionnaire
    Beck Depression Index
    degree of depression with a questionnaire
    Pain Coping Inventory
    inventory of the use of pain coping strategies with a questionnaiire
    Pain at tenderpoints
    measuring tolerable pain at specified tenderpoints with an algometer
    Grip strength
    measuring grip strength of both hands with a dynamometer
    Walking
    6 minute walking test on a treadmill
    cycling
    10 minutes cycling test on a hometrainer

    Secondary Outcome Measures

    Full Information

    First Posted
    October 5, 2017
    Last Updated
    October 23, 2017
    Sponsor
    University Ghent
    Collaborators
    AZ Alma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03319355
    Brief Title
    Multicomponent Therapy for Fibromyalgia
    Official Title
    The Effect of a 12-week Multicomponent Therapy in Fibromyalgia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (Actual)
    Primary Completion Date
    April 2012 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Ghent
    Collaborators
    AZ Alma

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Therapy for fibromyalgia is a well discussed topic in literature, yet not thoroughly evidence-based. Several unicomponent therapies seem to be benificial. Whereas multicomponent and multidisciplinary therapy gains importance and revealing promising results, the investigators aim to combine two well-known therapies in a program for patients with fibromyalgia. From clinical experience, a high drop-out rate has been stated. All data will be explored to analyse explanatory factors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia
    Keywords
    multicomponent therapy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    N/A
    Enrollment
    136 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    cognitive behavioral therapy
    Other Intervention Name(s)
    physical therapy
    Intervention Description
    exercise therapy
    Primary Outcome Measure Information:
    Title
    Fibromyalgia Impact Questionnaire
    Description
    impact of fibromyalgia on daily life with a questionnaire
    Time Frame
    6weeks
    Title
    Tampa scale for kinesiophobia
    Description
    rating the kinesiophobia with a questionnaire
    Time Frame
    6weeks
    Title
    Beck Depression Index
    Description
    degree of depression with a questionnaire
    Time Frame
    6 weeks
    Title
    Pain Coping Inventory
    Description
    inventory of the use of pain coping strategies with a questionnaiire
    Time Frame
    6 weeks
    Title
    Pain at tenderpoints
    Description
    measuring tolerable pain at specified tenderpoints with an algometer
    Time Frame
    6 weeks
    Title
    Grip strength
    Description
    measuring grip strength of both hands with a dynamometer
    Time Frame
    6 weeks
    Title
    Walking
    Description
    6 minute walking test on a treadmill
    Time Frame
    6 weeks
    Title
    cycling
    Description
    10 minutes cycling test on a hometrainer
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: woman with fibromyalgia between the age of 20 and 50 agreement with therapy protocol Exclusion Criteria: high indication of depression measured with the Beck Depression Index

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Multicomponent Therapy for Fibromyalgia

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