Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-02-25 @ 7:20 PM
Study NCT ID:
NCT02830295
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2016-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Basic Body Awareness Therapy (BBAT) in Patients Suffering From Fibromyalgia
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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-08', 'studyFirstSubmitDate': '2016-06-11', 'studyFirstSubmitQcDate': '2016-07-08', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'up to 24 weeks', 'description': 'This scale evaluates the pain refered by patient with a scale from 0 to 10 being 10 the maximum pain'}], 'secondaryOutcomes': [{'measure': 'Hospital Anxiety Depression', 'timeFrame': 'up to 24 weeks', 'description': 'this scale evaluates the level of depression and anxiety with a questionary that score goes from 0 to 21, being 21 the maximum level of disease'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'up to 24 weeks', 'description': 'this scale evaluates the level of depression with a questionary that scores from 0 to 63, being 63 the maximum level of depression'}, {'measure': 'State Trait Anxiety Inventory', 'timeFrame': 'up to 24 weeks', 'description': 'this questionary evaluates the level of anxiety that scores from 0 to 60, being 60 the maximum level of anxiety'}, {'measure': 'Short Form 36', 'timeFrame': 'up to 24 weeks', 'description': 'this questionary evaluates the quality of life in different components. The score goes from 0 to 100 being 100 the best score for quality of life'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['body awareness therapy', 'physical therapy', 'movement therapy'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '16012065', 'type': 'RESULT', 'citation': 'Gard G. Body awareness therapy for patients with fibromyalgia and chronic pain. Disabil Rehabil. 2005 Jun 17;27(12):725-8. doi: 10.1080/09638280400009071.'}, {'pmid': '25603742', 'type': 'RESULT', 'citation': 'Courtois I, Cools F, Calsius J. Effectiveness of body awareness interventions in fibromyalgia and chronic fatigue syndrome: a systematic review and meta-analysis. J Bodyw Mov Ther. 2015 Jan;19(1):35-56. doi: 10.1016/j.jbmt.2014.04.003. Epub 2014 Apr 18.'}, {'pmid': '21810264', 'type': 'RESULT', 'citation': 'Jones KD, King LA, Mist SD, Bennett RM, Horak FB. Postural control deficits in people with fibromyalgia: a pilot study. Arthritis Res Ther. 2011 Aug 2;13(4):R127. doi: 10.1186/ar3432.'}]}, 'descriptionModule': {'briefSummary': 'A randomized trial of Basic Body Awareness Therapy (BBAT) is applied in fibromyalgia patients as compared with a control intervention consisting of treatment as an usual. Sessions of BBAT lasted 90 minutes each and took place twice a week for 5 weeks. The primary end point is a change in the Visual Analog Scale score and Body Awareness Rating Scale and the secondary end points include Hospital Anxiety Depression, State Trait Anxiety Inventory, Beck Depression Inventory and Short Form 36. All assessments will be repeated at post treatment, 12 weeks and 24 weeks', 'detailedDescription': 'This work is a clinical trial of randomised and controlled groups. The hypothesis of study is that Basic Body Awareness Therapy applied in patients with fibromyalgia improves, more than usual treatment, the pain, normalization of postural pattern and movement, improve in psychologic state and improve of quality life.\n\nThe study population will be selected followed the inclusion criteria of fibromyalgia, and will be selected in area of primary health center, the patients will be divided in 2 groups, control group and treatment group. The groups will be examined at the begin, at 1 month of the begin of treatment, in 3 months, 6 months and one year to evaluated the outcomes in long time.\n\nThe dependence measurements will be Visual Analog Scale, Basic Body Awareness Rating Scale (BARS), SF-36, STAI A/R, BDI-II. The independence measurements will be demographic items: sex, age, country, level of studies, social status,..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed of fibromyalgia according the American college of Rheumatology with 6 months at least\n* the patients have to stay in different position as lying, sitting and standing\n\nExclusion Criteria:\n\n* pregnancy\n* suffering from another diseases that increase the pain or another specific diagnosis as rheumatic, heart disease and infectious disease'}, 'identificationModule': {'nctId': 'NCT02830295', 'acronym': 'BBAT', 'briefTitle': 'Effectiveness of Basic Body Awareness Therapy (BBAT) in Patients Suffering From Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Universitat de Lleida'}, 'officialTitle': 'Physiotherapy in Mental Health: A Clinical Trial of Basic Body Awareness Therapy in Patients Suffering From Fibromyalgia', 'orgStudyIdInfo': {'id': 'University of Lleida'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Basic Body Awareness Therapy', 'description': 'The Basic Body Awareness Therapy is usual therapy of physiotherapy in health mental in nord of europe. BBAT is based in twelve movements and massage that improve the movement quality of patient, also BBAT improves others movement qualities like biomechanical, physiologic, socio-cultural and existential.', 'interventionNames': ['Other: Basic Body Awareness Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'the patients which below receive the treatment as usual, according the clinic guidelines of Health government'}], 'interventions': [{'name': 'Basic Body Awareness Therapy', 'type': 'OTHER', 'otherNames': ['BBAT (acronym)'], 'description': "Basic body awareness therapy is a health oriented and person-centred approach with focus on the patient's resources. This is a method in physiotherapy, where we search to promote movement quality in daily life through self-exploration and self-experience.BBAT conceives the person from the biomechanical, physiological, bio-psycho-social and existential aspects, using the movement quality as a witness of the link in between all these perspectives.It can be done individually or in groups, through different daily life movements: lying, sitting, standing, walking, pair movements, use of voice and massages. BBAT has validated and reliable assesment tools, as BARS and BAS-I", 'armGroupLabels': ['Basic Body Awareness Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08700', 'city': 'Igualada', 'state': 'Barcelona', 'country': 'Spain', 'facility': "Consorci Sanitari de l'Anoia", 'geoPoint': {'lat': 41.58098, 'lon': 1.6172}}], 'overallOfficials': [{'name': 'Bravo Cristina, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitat de Lleida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cristina Bravo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Cristina Bravo', 'investigatorAffiliation': 'Universitat de Lleida'}}}}