12-years Follow-up on 166 Female Patients With Fibromyalgia or Chronic Widespread Pain

NCT ID: NCT02872129

Last Updated: 2019-05-29

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

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-12-31

Brief Summary

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A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP) in western Sweden.

The 166 women participated in a Randomised Controlled Trial called GAU in 2004-2005, aiming to investigate the effect of pool exercise and patient education.

The primary aim of the present study is to examine the change of symptoms after 11-12 years in 166 women with FM or CWP and also investigate predictors of change of symptoms and work ability.

The 166 women will be asked to participate in the present follow-up study. The follow-up examination comprises a standardised interview of symptoms and demographic variables, a battery of self-administered questionnaires and tests of physical function.

Detailed Description

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A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP).

The 166 women participated in a Randomised Controlled Trial called GAU 2004-2005 in three cities in western Sweden; Göteborg, Alingsås and Uddevalla. The RCT aimed to investigate the effect of pool exercise and patient education.

The primary aim of the present study is to examine the change of symptoms after 11-12 years in 166 women with FM or CWP and also investigate predictors of change of symptoms and work ability.

The 166 women will be contacted by mail and telephone, and asked to participate in the present follow-up study.

The follow-up examination comprises a standardised interview of symptoms and demographic variables, a battery of self-administered questionnaires and tests of physical function.

Conditions

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Fibromyalgia Chronic Widespread Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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166 women with FM/CWP

166 women with Fibromyalgia (FM) or Chronic Widespread Pain (CWP) that participated in an Randomised Controlled Trial called GAU in western Sweden 2004-2005.

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

* Patients who has developed serious physical or psychological disease since participating in the GAU 2004/2005
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Bergenheim, PhD

Role: STUDY_DIRECTOR

University of Gothenburg, Sahlgrenska Academy, Institution of Neuroscience and Physiology - Section of Health and Rehabilitation, Physiotherapy, Göteborg, Sweden

Locations

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Närhälsan, Region Västra Götaland

Alingsås, , Sweden

Site Status

Närhälsan, Region Västra Götaland

Gothenburg, , Sweden

Site Status

Närhälsan, Region Västra Götaland

Uddevalla, , Sweden

Site Status

Countries

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Sweden

References

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Bergenheim A, Juhlin S, Nordeman L, Joelsson M, Mannerkorpi K. Stress levels predict substantial improvement in pain intensity after 10 to 12 years in women with fibromyalgia and chronic widespread pain: a cohort study. BMC Rheumatol. 2019 Jun 24;3:5. doi: 10.1186/s41927-019-0072-9. eCollection 2019.

Reference Type DERIVED
PMID: 31286111 (View on PubMed)

Other Identifiers

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GAU1-U

Identifier Type: -

Identifier Source: org_study_id

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