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

Completed

• Conditions: Fibromyalgia; Chronic Widespread Pain

• Registration Number: NCT02872129
• Lead Sponsor: Göteborg University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-19
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-27
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
distribution of pain	2016 (to be compared with previous examination performed in 2004/2005)	Distribution of pain
pain intensity	2016 (to be compared with previous examination performed in 2004/2005)	pain intensity assessed with the Fibromyalgia Impact questionnaire subscale for pain

Secondary Outcome Measures

Name	Time	Method
workability	2016 (to be compared with previous examination performed in 2004/2005)	workability assessed as percentage of full time in work
Hand grip force	2016 (to be compared with previous examination performed in 2004/2005)	Hand grip force assessed with the Grippit
Fatigue	2016 (to be compared with previous examination performed in 2004/2005)	fatigue assessed with the Fibromyalgia Impact Questionnaire subscale for global fatigue
Walking capacity	2016 (to be compared with previous examination performed in 2004/2005)	Walking capacity assessed with 6 min walk test
Physical function in lower limbs	2016 (to be compared with previous examination performed in 2004/2005)	physical function in lower limbs assessed with chair-test
Physical activity	2016 (to be compared with previous examination performed in 2004/2005)	physical activity in leisure time assessed with the Leisure Time Physical Activity Instrument
Depression and anxiety	2016 (to be compared with previous examination performed in 2004/2005)	depression and anxiety assessed with the Hospital Anxiety and Depression Scale
Health related quality of life	2016 (to be compared with previous examination performed in 2004/2005)	Health related quality of life assessed with the Short-Form 36

Trial Locations

Locations (1)

Närhälsan, Region Västra Götaland; 🇸🇪 Uddevalla, Sweden