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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02872129
Other study ID # GAU1-U
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2016
Est. completion date December 2016

Study information

Verified date May 2019
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


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Study Design


Locations

Country Name City State
Sweden Närhälsan, Region Västra Götaland Alingsås
Sweden Närhälsan, Region Västra Götaland Göteborg
Sweden Närhälsan, Region Västra Götaland Uddevalla

Sponsors (2)

Lead Sponsor Collaborator
Göteborg University Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other sleep quantity and quality of sleep 2016 (to be compared with previous examination performed in 2004/2005)
Other alcohol consumption alcohol consumption assessed with the Balogh questionnaire 2016 (to be compared with previous examination performed in 2004/2005)
Primary pain intensity pain intensity assessed with the Fibromyalgia Impact questionnaire subscale for pain 2016 (to be compared with previous examination performed in 2004/2005)
Primary distribution of pain Distribution of pain 2016 (to be compared with previous examination performed in 2004/2005)
Secondary Fatigue fatigue assessed with the Multidimensional fatigue inventory (MFI-20) 2016 (to be compared with previous examination performed in 2004/2005)
Secondary Fatigue fatigue assessed with the Fibromyalgia Impact Questionnaire subscale for global fatigue 2016 (to be compared with previous examination performed in 2004/2005)
Secondary workability workability assessed as percentage of full time in work 2016 (to be compared with previous examination performed in 2004/2005)
Secondary Walking capacity Walking capacity assessed with 6 min walk test 2016 (to be compared with previous examination performed in 2004/2005)
Secondary Physical function in lower limbs physical function in lower limbs assessed with chair-test 2016 (to be compared with previous examination performed in 2004/2005)
Secondary Hand grip force Hand grip force assessed with the Grippit 2016 (to be compared with previous examination performed in 2004/2005)
Secondary Physical activity physical activity in leisure time assessed with the Leisure Time Physical Activity Instrument 2016 (to be compared with previous examination performed in 2004/2005)
Secondary Depression and anxiety depression and anxiety assessed with the Hospital Anxiety and Depression Scale 2016 (to be compared with previous examination performed in 2004/2005)
Secondary Health related quality of life Health related quality of life assessed with the Short-Form 36 2016 (to be compared with previous examination performed in 2004/2005)
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