Improving Quality of Life of Fibromyalgia Patients (Aquavip)

This study has been completed.
Sponsor:
Collaborator:
Fondation de France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00715195
First received: July 11, 2008
Last updated: December 18, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Fibromyalgia
Behavioral: Plurifocal educational program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of Improving Quality of Life of Fibromyalgia Patients Treated With a Plurifocal Program : a Controlled Study With 12 Months Monitoring.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: September 2007
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cognitive-behavioral therapy : 50 patients planned
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
Other Name: Plurifocal educational program
No Intervention: 2
50 patients planned

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715195

Locations
France
Hopital Saint Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fondation de France
Investigators
Principal Investigator: Guy COICHARD, MD Ph Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00715195     History of Changes
Other Study ID Numbers: P051029
Study First Received: July 11, 2008
Last Updated: December 18, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cognitive behavioral
Long-term study
Education

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014