Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain - Full Text View

Sponsored by:	Göteborg University
Information provided by:	Göteborg University
ClinicalTrials.gov Identifier:	NCT00569218

Purpose

A controlled randomised study aiming 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: Physical exercise in temperate pool Behavioral: Education

MedlinePlus related topics: Exercise and Physical Fitness Fibromyalgia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Development of Treatments Aiming ag Improvement of Function in Patients With Chronic Widespread Pain

Further study details as provided by Göteborg University:

Primary Outcome Measures:

The total score of the Fibromyalgia Impact Questionnaire [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Six-minute walk test [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	164
Study Start Date:	May 2004
Study Completion Date:	March 2007

Arms	Assigned Interventions
1: Experimental Intervention in arm 1 comprised pool exercise at 20 sessions combined with education at 6 sessions	Behavioral: Physical exercise in temperate pool 20-week physical exercise in temperate pool combined with 6-week education
2: Active Comparator 6-week educational program	Behavioral: Education 6-week educational self-management program

Detailed Description:

A controlled randomised study. One-hundred-sixty-four patients with fibromyalgia and chronic widespread pain were randomized either to an exercise-education group or to education-only group. The study period was 20 weeks. The primary outcomes comprised the total score of the Fibromyalgia Impact Questionnaire and the six-minute walk test. 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:

Female patients with fibromyalgia or chronic widespread pain.

Exclusion Criteria:

Other severe physical or mental diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569218

Sponsors and Collaborators

Göteborg University

Investigators

Principal Investigator:

Kaisa E Mannerkorpi, Ass prof

Göteborg University, Dept of Rheumatology

More Information

Responsible Party:	Göteborg University, Dep of Rheumatology ( Kaisa Mannerkorpi, Associate professor )
Study ID Numbers:	O687-03
Study First Received:	December 5, 2007
Last Updated:	December 5, 2007
ClinicalTrials.gov Identifier:	NCT00569218
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:

Fibromyalgia
pain
physical exercise
education

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009