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Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain

This study has been completed.
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT00545649
First received: October 16, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

The study aims to evaluate the effects of adding supervised exercise in supplement to an educational self-management program, and to determine which subgroups would gain effects of the treatment.


Condition Intervention
Fibromyalgia
 Behavioral: Exercise and education
Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire) [ Time Frame: 2004-2007 ]

Secondary Outcome Measures:
  • Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue [ Time Frame: 2004-2007 ]

Enrollment: 164
Study Start Date: May 2004
Study Completion Date: March 2007
Arms Assigned Interventions
Experimental: 1
Exercise and education
 Behavioral: Exercise and education
Active Comparator: 2
Education only
 Behavioral: Education

Detailed Description:

164 patients with fibromyalgia and chronic widespread pain were randomized to an exercise-education group or to education-only group. The study period was 20 week. The primary outcome measures comprised the six-minute walk test and the Fibromyalgia Impact Questionnaire. Several other self-administered instruments were included.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with Fibromyalgia or Chronic widespread pain, aged from 18 to 60 years.

Exclusion Criteria:

  • Other somatic or psychiatric disorders, inability to understand Swedish, allergy to chlorine, ongoing treatments or plans to start other treatments during the study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545649

Locations
Sweden
Alingsas Primary Health Care
Alingsas, Sweden
Göteborg Primary Health Care
Göteborg, Sweden
Uddevalla Primary Health Care
Uddevalla, Sweden
Sponsors and Collaborators
Göteborg University
The Swedish Research Council
Investigators
Principal Investigator: Kaisa Mannerkorpi, Ass prof Göteborg University, Institute of Medicine, Department of Rheumatology and Inflammation Research
Principal Investigator: Kaisa Mannerkorpi, Ass prof Göteborg University, Institute of Medicine, Department of Rheumtology and Inflammation Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00545649     History of Changes
Obsolete Identifiers: NCT00569218
Other Study ID Numbers: O687-03-GAU
Study First Received: October 16, 2007
Last Updated: October 16, 2007
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:
Fibromyalgia
chronic pain
physical
 exercise
activity
education

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013