Improving Quality of Life of Fibromyalgia Patients

Assistance Publique - Hôpitaux de Paris115 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

115

Conditions

Fibromyalgia

Interventions

Plurifocal educational programBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopital Saint Antoine

Paris, France

Outcomes

Primary Outcomes

Score of the Fibromyalgia Impact Questionnaire, at one month and twelve months after program end

Time frame: one month and twelve months after program end

Secondary Outcomes

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)

Time frame: one , six and twelve months after program end

Data from ClinicalTrials.gov

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