Clinical trial NCT02872129: 12-years Follow-up on 166 Female Patients With Fibromyalgia or Chronic Widespread Pain
Official title: 12-years Follow-up on 166 Female Patients With Fibromyalgia or Chronic Widespread Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Chronic Widespread Pain
Keywords: Fibromyalgia
chronic widespread pain
follow-up
pain
fatigue
symptoms
workability
physical function
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2016-08-19
Enrollment: 126
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 166 women who 2004/2005 participated in the study GAU.

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.

Eligibility criteria: 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)

Exclusion Criteria of the present study GAU-U:

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

Primary outcomes:
measure: pain intensity
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
measure: distribution of pain
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
Secondary outcomes:
measure: Fatigue
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
measure: Fatigue
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
measure: workability
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
measure: Walking capacity
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
measure: Physical function in lower limbs
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
measure: Hand grip force
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
measure: Physical activity
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
measure: Depression and anxiety
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
measure: Health related quality of life
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
Other outcomes:
measure: sleep
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
measure: alcohol consumption
timeFrame: 2016 (to be compared with previous examination performed in 2004/2005)
Locations:
city: Alingsås
country: Sweden
facility: Närhälsan, Region Västra Götaland
city: Göteborg
country: Sweden
facility: Närhälsan, Region Västra Götaland
city: Uddevalla
country: Sweden
facility: Närhälsan, Region Västra Götaland
Study officials:
affiliation: University of Gothenburg, Sahlgrenska Academy, Institution of Neuroscience and Physiology - Section of Health and Rehabilitation, Physiotherapy, Göteborg, Sweden
name: Anna Bergenheim, PhD
role: STUDY_DIRECTOR
References:
citation: 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.