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Improving Quality of Life of Fibromyalgia Patients (Aquavip)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fondation de France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00715195
First received: July 11, 2008
Last updated: December 26, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention
Fibromyalgia
 Behavioral: Plurifocal educational program
Behavioral: Information

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of Improving Quality of Life of Fibromyalgia Patients Treated With a Plurifocal Program : a Controlled Study With 12 Months Monitoring.

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: September 2007
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Plurifocal educational program
No Intervention: 2
50 patients planned
 Behavioral: Information
an information group session on the fibromyalgia management modalities
Other Name: Information

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715195

Locations
France
Hopital Saint Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fondation de France
Investigators
Principal Investigator: Guy COICHARD, MD Ph Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00715195     History of Changes
Other Study ID Numbers: P051029
Study First Received: July 11, 2008
Last Updated: December 26, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cognitive behavioral
Long-term study
Education

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013