Improving Quality of Life of Fibromyalgia Patients

NCT ID: NCT00715195

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-04-30

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).

Conditions

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Fibromyalgia

Keywords

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Cognitive behavioral Long-term study Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

Cognitive-behavioral therapy : 50 patients planned

Group Type EXPERIMENTAL

Plurifocal educational program

Intervention Type BEHAVIORAL

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

2

50 patients planned

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation de France

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guy COICHARD, MD Ph

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital Saint Antoine

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P051029

Identifier Type: -

Identifier Source: org_study_id