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NCT Number: NCT02872129

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

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Närhälsan, Region Västra Götaland, Alingsås, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. pain intensity

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

    pain intensity assessed with the Fibromyalgia Impact questionnaire subscale for pain

  2. distribution of pain

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

    Distribution of pain

Secondary outcomes

  1. Fatigue

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

    fatigue assessed with the Multidimensional fatigue inventory (MFI-20)

  2. Fatigue

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

    fatigue assessed with the Fibromyalgia Impact Questionnaire subscale for global fatigue

  3. workability

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

    workability assessed as percentage of full time in work

  4. Walking capacity

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

    Walking capacity assessed with 6 min walk test

  5. Physical function in lower limbs

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

    physical function in lower limbs assessed with chair-test

  6. Hand grip force

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

    Hand grip force assessed with the Grippit

  7. Physical activity

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

    physical activity in leisure time assessed with the Leisure Time Physical Activity Instrument

  8. Depression and anxiety

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

    depression and anxiety assessed with the Hospital Anxiety and Depression Scale

  9. Health related quality of life

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

    Health related quality of life assessed with the Short-Form 36

Other outcomes

  1. sleep

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

    quantity and quality of sleep

  2. alcohol consumption

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

    alcohol consumption assessed with the Balogh questionnaire

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 19, 2016
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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