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

Not Applicable

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT00545649
• Lead Sponsor: Göteborg University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2004-05
• Study Completion: 2007-03
• Status Verified: 2007-09
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Last Update Submitted: 2007-10-16
• Study First Posted: 2007-10-17
• Last Update Posted: 2007-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire)	2004-2007

Secondary Outcome Measures

Name	Time	Method
Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue	2004-2007

Trial Locations

Locations (3)

Alingsas Primary Health Care; 🇸🇪 Alingsas, Sweden

Göteborg Primary Health Care; 🇸🇪 Göteborg, Sweden

Uddevalla Primary Health Care; 🇸🇪 Uddevalla, Sweden