NCT02872129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

June 30, 2016

Last Update Submit

May 27, 2019

Conditions

FibromyalgiaChronic Widespread Pain

Keywords

Fibromyalgiachronic widespread painfollow-uppainfatiguesymptomsworkabilityphysical function

Outcome Measures

Primary Outcomes (2)

  • pain intensity

    pain intensity assessed with the Fibromyalgia Impact questionnaire subscale for pain

    2016 (to be compared with previous examination performed in 2004/2005)

  • distribution of pain

    Distribution of pain

    2016 (to be compared with previous examination performed in 2004/2005)

Secondary Outcomes (9)

  • Fatigue

    2016 (to be compared with previous examination performed in 2004/2005)

  • Fatigue

    2016 (to be compared with previous examination performed in 2004/2005)

  • workability

    2016 (to be compared with previous examination performed in 2004/2005)

  • Walking capacity

    2016 (to be compared with previous examination performed in 2004/2005)

  • Physical function in lower limbs

    2016 (to be compared with previous examination performed in 2004/2005)

  • +4 more secondary outcomes

Other Outcomes (2)

  • sleep

    2016 (to be compared with previous examination performed in 2004/2005)

  • alcohol consumption

    2016 (to be compared with previous examination performed in 2004/2005)

Study Arms (1)

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.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

166 women who 2004/2005 participated in the study GAU.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Närhälsan, Region Västra Götaland

Alingsås, Sweden

Location

Närhälsan, Region Västra Götaland

Gothenburg, Sweden

Location

Närhälsan, Region Västra Götaland

Uddevalla, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 31286111DERIVED

MeSH Terms

Conditions

FibromyalgiaChronic PainPainFatigue

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Bergenheim, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

August 19, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 29, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(3)