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NCT00545649 Clinical Trial

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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00545649
Other study ID # O687-03-GAU
Secondary ID
Status Completed
Phase N/A
First received October 16, 2007
Last updated October 16, 2007
Start date May 2004
Est. completion date March 2007

Study information
Verified date September 2007
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.

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.

Other known NCT identifiers
  • NCT00569218

Recruitment information / eligibility
Status Completed
Enrollment 164
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Exercise and education

• Education

Locations
Country Name City State
Sweden Alingsas Primary Health Care Alingsas
Sweden Göteborg Primary Health Care Göteborg
Sweden Uddevalla Primary Health Care Uddevalla

Sponsors (2)
Lead Sponsor Collaborator
Göteborg University The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire) 2004-2007
Secondary Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue 2004-2007
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