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Completed

NCT Number: NCT00715195

Improving Quality of Life of Fibromyalgia Patients

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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Saint Antoine

Paris, 75012, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plurifocal educational program

Behavioral

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

Primary outcomes

  1. 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 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)

    Time frame: one , six and twelve months after program end

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation de France

Registry information

Official study title

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

Acronym: Aquavip

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Jul 15, 2008
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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