Multicomponent Therapy for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

The Effect of a 12-week Multicomponent Therapy in Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319355
• Other study ID #: EC/EH/111221
• Status: Completed
• Phase: N/A
• First received: October 5, 2017
• Last updated: October 23, 2017
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: October 2017
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: January 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• cognitive behavioral therapy
exercise therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	Algemeen Ziekenhuis Alma

Outcome

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