Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-30 @ 2:12 PM
Study NCT ID:
NCT00715195
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2008-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Quality of Life of Fibromyalgia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2008-07-11', 'studyFirstSubmitQcDate': '2008-07-11', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of the Fibromyalgia Impact Questionnaire, at one month and twelve months after program end', 'timeFrame': 'one month and twelve months after program end'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': 'one , six and twelve months after program end'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cognitive behavioral', 'Long-term study', 'Education'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fibromyalgia Patients according to the criteria of the American College of Rheumatology defined by:\n\n * diffuse pain evolving for over three months\n * pain on palpation of at least 11 of the 18 sites listed\n* age between 18 and 65\n* FIQ Score higher than 35/100 at inclusion\n* Ability to respond to questionnaires\n* monitoring possibility for at least a year\n* Affiliation to the French Health System (social security)\n\nExclusion Criteria:\n\n* Association with chronic pain from other sources which can interfere with fibromyalgia assessment\n* Inability to follow the full educational program\n* previous participation in an educational program of same nature\n* psychological disorder (personality disorder or behaviour, schizophrenia), preventing participation in the program group'}, 'identificationModule': {'nctId': 'NCT00715195', 'acronym': 'Aquavip', 'briefTitle': 'Improving Quality of Life of Fibromyalgia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of Improving Quality of Life of Fibromyalgia Patients Treated With a Plurifocal Program : a Controlled Study With 12 Months Monitoring.', 'orgStudyIdInfo': {'id': 'P051029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Cognitive-behavioral therapy : 50 patients planned', 'interventionNames': ['Behavioral: Plurifocal educational program']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': '50 patients planned'}], 'interventions': [{'name': 'Plurifocal educational program', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Guy COICHARD, MD Ph', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation de France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}