Improving Quality of Life of Fibromyalgia Patients (Aquavip)

December 18, 2013 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Hôpital Saint Antoine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Cognitive-behavioral therapy : 50 patients planned
Behavioral: 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
No Intervention: 2
50 patients planned

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one month and twelve months after program end

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: one , six and twelve months after program end
one , six and twelve months after program end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fondation de France

Investigators

  • Principal Investigator: Guy COICHARD, MD Ph, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 11, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P051029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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