Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02872129
Enrollment
126
Registered
2016-08-19
Start date
2016-05-31
Completion date
2016-12-31
Last updated
2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Widespread Pain, Fibromyalgia

Keywords

Fibromyalgia, chronic widespread pain, follow-up, pain, fatigue, symptoms, workability, physical function

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.

Interventions

None listed

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
Göteborg University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

of the present study GAU-U: * All 166 patients who participated in the study GAU in 2004/2005. (The inclusion criteria of GAU was women with FM or CWP, 18-60 years old. Patients with widespread pain; pain in the right and left side of the body, above and below the waist, as well as axial pain, for at least three months were classified as chronic widespread pain (CWP). Patients who fulfilled the criteria for CWP and who also had pain at palpation of at least 11 of 18 pre-defined tender points were classified as fibromyalgia (FM).

Exclusion criteria

for GAU was serious physical or psychological disease)

Design outcomes

Primary

MeasureTime frameDescription
pain intensity2016 (to be compared with previous examination performed in 2004/2005)pain intensity assessed with the Fibromyalgia Impact questionnaire subscale for pain
distribution of pain2016 (to be compared with previous examination performed in 2004/2005)Distribution of pain

Secondary

MeasureTime frameDescription
Fatigue2016 (to be compared with previous examination performed in 2004/2005)fatigue assessed with the Multidimensional fatigue inventory (MFI-20)
workability2016 (to be compared with previous examination performed in 2004/2005)workability assessed as percentage of full time in work
Walking capacity2016 (to be compared with previous examination performed in 2004/2005)Walking capacity assessed with 6 min walk test
Hand grip force2016 (to be compared with previous examination performed in 2004/2005)Hand grip force assessed with the Grippit
Physical activity2016 (to be compared with previous examination performed in 2004/2005)physical activity in leisure time assessed with the Leisure Time Physical Activity Instrument
Health related quality of life2016 (to be compared with previous examination performed in 2004/2005)Health related quality of life assessed with the Short-Form 36
Physical function in lower limbs2016 (to be compared with previous examination performed in 2004/2005)physical function in lower limbs assessed with chair-test
Depression and anxiety2016 (to be compared with previous examination performed in 2004/2005)depression and anxiety assessed with the Hospital Anxiety and Depression Scale

Other

MeasureTime frameDescription
sleep2016 (to be compared with previous examination performed in 2004/2005)quantity and quality of sleep
alcohol consumption2016 (to be compared with previous examination performed in 2004/2005)alcohol consumption assessed with the Balogh questionnaire

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026