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Multicomponent Therapy for Fibromyalgia

Sponsor
University Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT03319355
Collaborator
AZ Alma (Other)
136
Enrollment
16
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: cognitive behavioral therapy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
136 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of a 12-week Multicomponent Therapy in Fibromyalgia
Actual Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
Jan 1, 2013

Outcome Measures

Primary Outcome Measures

  1. Fibromyalgia Impact Questionnaire [6weeks]

    impact of fibromyalgia on daily life with a questionnaire

  2. Tampa scale for kinesiophobia [6weeks]

    rating the kinesiophobia with a questionnaire

  3. Beck Depression Index [6 weeks]

    degree of depression with a questionnaire

  4. Pain Coping Inventory [6 weeks]

    inventory of the use of pain coping strategies with a questionnaiire

  5. Pain at tenderpoints [6 weeks]

    measuring tolerable pain at specified tenderpoints with an algometer

  6. Grip strength [6 weeks]

    measuring grip strength of both hands with a dynamometer

  7. Walking [6 weeks]

    6 minute walking test on a treadmill

  8. cycling [6 weeks]

    10 minutes cycling test on a hometrainer

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Ghent
  • AZ Alma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Ghent
ClinicalTrials.gov Identifier:
NCT03319355
Other Study ID Numbers:
  • EC/EH/111221
First Posted:
Oct 24, 2017
Last Update Posted:
Oct 24, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Ghent
multicomponent therapy
Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes

Study Results

No Results Posted as of Oct 24, 2017