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

NCT ID: NCT00545649

Last Updated: 2007-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-03-31

Brief Summary

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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

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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.

Conditions

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Fibromyalgia

Keywords

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Fibromyalgia chronic pain physical exercise activity education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Exercise and education

Group Type EXPERIMENTAL

Exercise and education

Intervention Type BEHAVIORAL

2

Education only

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

Interventions

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Exercise and education

Intervention Type BEHAVIORAL

Education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Principal Investigators

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Kaisa Mannerkorpi, Ass prof

Role: PRINCIPAL_INVESTIGATOR

Göteborg University, Institute of Medicine, Department of Rheumatology and Inflammation Research

Kaisa Mannerkorpi, Ass prof

Role: PRINCIPAL_INVESTIGATOR

Göteborg University, Institute of Medicine, Department of Rheumtology and Inflammation Research

Locations

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Alingsas Primary Health Care

Alingsås, , Sweden

Site Status

Göteborg Primary Health Care

Gothenburg, , Sweden

Site Status

Uddevalla Primary Health Care

Uddevalla, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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O687-03-GAU

Identifier Type: -

Identifier Source: org_study_id

NCT00569218

Identifier Type: -

Identifier Source: nct_alias