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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00715195

Acronym

Aquavip

Enrollment

115

Registered

2008-07-15

Start date

2007-09-30

Completion date

2012-04-30

Last updated

2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Cognitive behavioral, Long-term study, Education

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

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).

Interventions

BEHAVIORALPlurifocal 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Score of the Fibromyalgia Impact Questionnaire, at one month and twelve months after program end	one month and twelve months after program end

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026