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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fibromyalgia, Chronic Widespread Pain

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 166 women with FM/CWP<br>166 women with Fibromyalgia (FM) or Chronic Widespread Pain (CWP) that participated in an Randomised Controlled Trial called GAU in western Sweden 2004-2005. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | fatigue assessed with the Multidimensional fatigue inventory (MFI-20) | 2016 (to be compared with previous examination performed in 2004/2005) | 
| Fatigue | fatigue assessed with the Fibromyalgia Impact Questionnaire subscale for global fatigue | 2016 (to be compared with previous examination performed in 2004/2005) | 
| workability | workability assessed as percentage of full time in work | 2016 (to be compared with previous examination performed in 2004/2005) | 
| Walking capacity | Walking capacity assessed with 6 min walk test | 2016 (to be compared with previous examination performed in 2004/2005) | 
| Physical function in lower limbs | physical function in lower limbs assessed with chair-test | 2016 (to be compared with previous examination performed in 2004/2005) | 
| Hand grip force | Hand grip force assessed with the Grippit | 2016 (to be compared with previous examination performed in 2004/2005) | 
| Physical activity | physical activity in leisure time assessed with the Leisure Time Physical Activity Instrument | 2016 (to be compared with previous examination performed in 2004/2005) | 
| Depression and anxiety | depression and anxiety assessed with the Hospital Anxiety and Depression Scale | 2016 (to be compared with previous examination performed in 2004/2005) | 
| Health related quality of life | Health related quality of life assessed with the Short-Form 36 | 2016 (to be compared with previous examination performed in 2004/2005) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, chronic widespread pain, follow-up, pain, fatigue, symptoms, workability, physical function