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

October 16, 2007 updated by: Göteborg University
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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Alingsas, Sweden
        • Alingsas Primary Health Care
      • Göteborg, Sweden
        • Göteborg Primary Health Care
      • Uddevalla, Sweden
        • Uddevalla Primary Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Exercise and education
Behavioral: Exercise and education
Active Comparator: 2
Education only
Behavioral: Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire)
Time Frame: 2004-2007
2004-2007

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue
Time Frame: 2004-2007
2004-2007

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (Estimate)

October 17, 2007

Study Record Updates

Last Update Posted (Estimate)

October 17, 2007

Last Update Submitted That Met QC Criteria

October 16, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O687-03-GAU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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