Multicomponent Therapy for Fibromyalgia

October 23, 2017 updated by: University Ghent

The Effect of a 12-week Multicomponent Therapy in Fibromyalgia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

AZ Alma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 5, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (Actual)

October 24, 2017

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/EH/111221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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