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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00545649
First Posted: October 17, 2007
Last Update Posted: October 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Swedish Research Council
Information provided by:
Göteborg University
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00545649     History of Changes
Obsolete Identifiers: NCT00569218
Other Study ID Numbers: O687-03-GAU
First Submitted: October 16, 2007
First Posted: October 17, 2007
Last Update Posted: October 17, 2007
Last Verified: September 2007

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

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms