Improving Quality of Life of Fibromyalgia Patients

Study Overview
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Brief Summary
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Comparison of two treatments of fibromyalgia; the QOL score should improve rather and, twelve months after the end of the program, remain higher in Plurifocal educational group than in control group

Detailed Description
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Comparing two forms of non-drug treatment of fibromyalgia: Information (an information group session on the fibromyalgia management modalities) versus Plurifocal educational program  (intensive group program of 8 weeks, including, in addition to the briefing, measures and exercises for the implementation of the principles of managing fibromyalgia, and cognitive-behavioral therapy).

Official Title
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Evaluation of Improving Quality of Life of Fibromyalgia Patients Treated With a Plurifocal Program : a Controlled Study With 12 Months Monitoring.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Plurifocal educational program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fibromyalgia Patients according to the criteria of the American College of Rheumatology defined by: diffuse pain evolving for over three months pain on palpation of at least 11 of the 18 sites listed age between 18 and 65 FIQ Score higher than 35/100 at inclusion Ability to respond to questionnaires monitoring possibility for at least a year Affiliation to the French Health System (social security) Exclusion Criteria: Association with chronic pain from other sources which can interfere with fibromyalgia assessment Inability to follow the full educational program previous participation in an educational program of same nature psychological disorder (personality disorder or behaviour, schizophrenia), preventing participation in the program group

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cognitive-behavioral therapy : 50 patients planned | Behavioral: Plurifocal educational program<br>* intensive group program of 8 weeks, including, in addition to the briefing, measures and exercises for the implementation of the principles of managing fibromyalgia, and cognitive-behavioral therapy<br>|
| No Intervention: 2<br>50 patients planned | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the Fibromyalgia Impact Questionnaire, at one month and twelve months after program end |  | one month and twelve months after program end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Numeric scale,Number of tender points, Sleep quality numeric scale,Pain Impact Questionnaire ANAES,STAI-Y anxiety questionnaire,Beck Depression Index II,Coping Strategy Questionnaire,Multidimensional self-assessment(SF36, PSOCQ) |  | one , six and twelve months after program end | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavioral, Long-term study, Education