Improving Quality of Life of Fibromyalgia Patients
Aquavip
Evaluation of Improving Quality of Life of Fibromyalgia Patients Treated With a Plurifocal Program : a Controlled Study With 12 Months Monitoring.
1 other identifier
interventional
115
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 11, 2008
CompletedFirst Posted
Study publicly available on registry
July 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedDecember 19, 2013
November 1, 2013
4.3 years
July 11, 2008
December 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score of the Fibromyalgia Impact Questionnaire, at one month and twelve months after program end
one month and twelve months after program end
Secondary Outcomes (1)
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
Study Arms (2)
1
EXPERIMENTALCognitive-behavioral therapy : 50 patients planned
2
NO INTERVENTION50 patients planned
Interventions
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 Criteria
You may qualify if:
- 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
- Ability to respond to questionnaires
- monitoring possibility for at least a year
- Affiliation to the French Health System (social security)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Fondation de Francecollaborator
Study Sites (1)
Hopital Saint Antoine
Paris, 75012, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guy COICHARD, MD Ph
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2008
First Posted
July 15, 2008
Study Start
September 1, 2007
Primary Completion
December 1, 2011
Study Completion
April 1, 2012
Last Updated
December 19, 2013
Record last verified: 2013-11