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Improving Quality of Life of Fibromyalgia Patients (Aquavip)

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Fibromyalgia

Treatments

Behavioral: Plurifocal educational program

Study type

Interventional

Funder types

Other

Identifiers

NCT00715195
P051029

Details and patient eligibility

About

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

Full 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).

Enrollment

115 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

115 participants in 2 patient groups

1
Experimental group
Description:
Cognitive-behavioral therapy : 50 patients planned
Treatment:
Behavioral: Plurifocal educational program
2
No Intervention group
Description:
50 patients planned

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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