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OpenTrials
Completed

NCT Number: NCT00545649

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

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.

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Key information

Conditions

Fibromyalgia Behavior Chronic Pain Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alingsas Primary Health Care, Alingsås, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise and Education

Behavioral

Education

Behavioral

Primary outcomes

  1. Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire)

    Time frame: 2004-2007

Secondary outcomes

  1. Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue

    Time frame: 2004-2007

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • The Swedish Research Council

Registry information

Important dates

Study start
2004
Study completion
2007
First posted
Oct 17, 2007
Registry last updated
Oct 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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