Improving Quality of Life of Fibromyalgia Patients

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Behavioral: Plurifocal educational program

• Registration Number: NCT00715195
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-07-11
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-15
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Status Verified: 2013-11
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Plurifocal educational program	Cognitive-behavioral therapy : 50 patients planned

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital Saint Antoine; 🇫🇷 Paris, France