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

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ClinicalTrials.gov Identifier: NCT02872129
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
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.


Condition or disease
Fibromyalgia Chronic Widespread Pain

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.

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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 12-years Follow-up on 166 Female Patients With Fibromyalgia or Chronic Widespread Pain
Study Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
166 women who 2004/2005 participated in the study GAU.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872129


Locations
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Sweden
Närhälsan, Region Västra Götaland
Alingsås, Sweden
Närhälsan, Region Västra Götaland
Göteborg, Sweden
Närhälsan, Region Västra Götaland
Uddevalla, Sweden
Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Investigators
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Study Director: Anna Bergenheim, PhD University of Gothenburg, Sahlgrenska Academy, Institution of Neuroscience and Physiology - Section of Health and Rehabilitation, Physiotherapy, Göteborg, Sweden
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02872129    
Other Study ID Numbers: GAU1-U
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Göteborg University:
Fibromyalgia
chronic widespread pain
follow-up
pain
fatigue
symptoms
workability
physical function
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations