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OpenTrials
Completed

NCT Number: NCT03319355

Multicomponent Therapy for 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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

exercise therapy

Other names: physical therapy

Primary outcomes

  1. Fibromyalgia Impact Questionnaire

    Time frame: 6weeks

    impact of fibromyalgia on daily life with a questionnaire

  2. Tampa scale for kinesiophobia

    Time frame: 6weeks

    rating the kinesiophobia with a questionnaire

  3. Beck Depression Index

    Time frame: 6 weeks

    degree of depression with a questionnaire

  4. Pain Coping Inventory

    Time frame: 6 weeks

    inventory of the use of pain coping strategies with a questionnaiire

  5. Pain at tenderpoints

    Time frame: 6 weeks

    measuring tolerable pain at specified tenderpoints with an algometer

  6. Grip strength

    Time frame: 6 weeks

    measuring grip strength of both hands with a dynamometer

  7. Walking

    Time frame: 6 weeks

    6 minute walking test on a treadmill

  8. cycling

    Time frame: 6 weeks

    10 minutes cycling test on a hometrainer

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • AZ Alma

Registry information

Official study title

The Effect of a 12-week Multicomponent Therapy in Fibromyalgia

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 24, 2017
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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