Improving Quality of Life of Fibromyalgia Patients

Fibromyalgia Clinical Trial

— Aquavip  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715195
• Other study ID #: P051029
• Status: Completed
• Phase: N/A
• First received: July 11, 2008
• Last updated: December 18, 2013
• Start date: September 2007
• Est. completion date: April 2012

Study information

• Verified date: November 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
France	Hopital Saint Antoine	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of the Fibromyalgia Impact Questionnaire, at one month and twelve months after program end		one month and twelve months after program end	No
Secondary	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	No