Improving Quality of Life of Fibromyalgia Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00715195
• Date of registration: 11/07/2008
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Improving Quality of Life of Fibromyalgia Patients Aquavip
• Scientific title: Evaluation of Improving Quality of Life of Fibromyalgia Patients Treated With a Plurifocal Program : a Controlled Study With 12 Months Monitoring.
• Date of first enrolment: September 2007
• Target sample size: 115
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00715195
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Guy COICHARD, MD Ph
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fibromyalgia

Intervention(s)

Behavioral: Plurifocal educational program

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

P051029

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fondation de France