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Improving Quality of Life of Fibromyalgia Patients (Aquavip)

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ClinicalTrials.gov Identifier: NCT00715195
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : December 19, 2013
Sponsor:
Collaborator:
Fondation de France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

July 11, 2008
July 15, 2008
December 19, 2013
September 2007
December 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00715195 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Improving Quality of Life of Fibromyalgia Patients
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
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).
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Fibromyalgia
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
  • Experimental: 1
    Cognitive-behavioral therapy : 50 patients planned
    Intervention: Behavioral: Plurifocal educational program
  • No Intervention: 2
    50 patients planned
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
100
April 2012
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00715195
P051029
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Fondation de France
Principal Investigator: Guy COICHARD, MD Ph Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP