Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 11:49 PM
Study NCT ID:
NCT05555394
Status:
RECRUITING
Last Update Posted:
2025-05-08
First Post:
2022-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body Awareness Therapy and Biomarkers in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "the patients don't know what intervention of study. Investigator don't know the allocation of patients outcomes assessor don't know the allocation of patients."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'clinical trial randomized allocated controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serotonin', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Neurotransmitter neurologic'}, {'measure': 'cortisol', 'timeFrame': 'during the procedure', 'description': 'acute hormone relating stress'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Assess of subjective pain of patient. It consists in a number between 0 to 10'}, {'measure': 'Fibromyalgia Impact Questionnaire (FIQ)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Questionnaire about the impact of symptoms of Fibromyalgia in daily life. It measures 21 items with a total score between 0 to 100. The main average is 50.'}, {'measure': 'Beck Depression Inventory- II (BDI-II)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Questionnaire for assess the depression of patient. It consists in 21 items with scale ranking from 0-3 with a total score from 0-63. A score between 10-18 corresponds to mild to moderate depression, further than 30 corresponds to severe depression'}, {'measure': 'State Trait Anxiety Inventory (STAI)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Questionnaire for assess the anxiety of patient. It consists in 20 questions that score range from 20 to 80. The higher scores correlating with greater anxiety. The questionnaire provide information about state (how a person is feeling at the time) and trait (how people feel across typical situations that everyone experiences on a daily basis)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Body awareness therapy', 'physical therapy', 'serotonin', 'cortisol'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '27696917', 'type': 'BACKGROUND', 'citation': 'Atasever M, Namli Kalem M, Sonmez C, Seval MM, Yuce T, Sahin Aker S, Koc A, Genc H. Lower serotonin level and higher rate of fibromyalgia syndrome with advancing pregnancy. J Matern Fetal Neonatal Med. 2017 Sep;30(18):2204-2211. doi: 10.1080/14767058.2016.1243096. Epub 2016 Nov 29.'}, {'pmid': '21725900', 'type': 'BACKGROUND', 'citation': 'Busch AJ, Webber SC, Brachaniec M, Bidonde J, Bello-Haas VD, Danyliw AD, Overend TJ, Richards RS, Sawant A, Schachter CL. Exercise therapy for fibromyalgia. Curr Pain Headache Rep. 2011 Oct;15(5):358-67. doi: 10.1007/s11916-011-0214-2.'}, {'pmid': '29723080', 'type': 'BACKGROUND', 'citation': 'Bravo C, Skjaerven LH, Espart A, Guitard Sein-Echaluce L, Catalan-Matamoros D. Basic Body Awareness Therapy in patients suffering from fibromyalgia: A randomized clinical trial. Physiother Theory Pract. 2019 Oct;35(10):919-929. doi: 10.1080/09593985.2018.1467520. Epub 2018 May 3.'}, {'pmid': '31106558', 'type': 'BACKGROUND', 'citation': 'Bravo C, Skjaerven LH, Guitard Sein-Echaluce L, Catalan-Matamoros D. Effectiveness of movement and body awareness therapies in patients with fibromyalgia: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2019 Oct;55(5):646-657. doi: 10.23736/S1973-9087.19.05291-2. Epub 2019 May 15.'}, {'pmid': '27008285', 'type': 'BACKGROUND', 'citation': 'Coppieters I, Cagnie B, Nijs J, van Oosterwijck J, Danneels L, De Pauw R, Meeus M. Effects of Stress and Relaxation on Central Pain Modulation in Chronic Whiplash and Fibromyalgia Patients Compared to Healthy Controls. Pain Physician. 2016 Mar;19(3):119-30.'}]}, 'descriptionModule': {'briefSummary': 'A randomized trial of Basic Body Awareness Therapy (BBAT) is applied in fibromyalgia patients as compared with a control intervention consisting of stretching. Sessions of BBAT lasted 90 min each and took place twice a week form 12 weeks. The primary end point is a change in the biomarkers and neurotransmitters and the Fibromyalgia Impact Questionnaire and the secondary end points include Visual Analog Scale, State Trait Anxiety inventory, Beck Depression Inventory. All assessments will be repeated at post treatment, 12 and 24 weeks and 1 year follow-up.', 'detailedDescription': 'This work is a clinical trial of randomized and controlled groups. The hypothesis of study is that BBAT applied in patients with fibromyalgia improves, more than stretching exercises, the pain, normalization biomarkers, improve in psychological state and quality life.\n\nThe study population will be selected followed the inclusion criteria of fibromyalgia, and will be selected in Consorci Sociosanitari of Anoia, the patients will be divided in 2 groups, control and treatment group. The groups will be examined at the begin, at 2 weeks, at the end of treatment and 3, 6 and 12 months follow-up.\n\nThe dependence measurements will be biomarkers serotonin, dopamine and cortisol, also Visual Analog Scale, State Trait Anxiety Inventory (STAI A/R), Beck Depression Inventory (BDI-II) and Fibromyalgia Impact Questionnaire (FIQ). 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* whose diagnosed of fibromyalgia almost 6 months before\n* whose could be in different position such as lying, sitting, and stand-up\n\nExclusion Criteria:\n\n* whose are diagnosed of disease that it worse the pain\n* pregnancy\n* whose are diagnosed of other disease such as rheumatology, neurology, cardiac problems o another internal medical condition,malignant disease or acute infections'}, 'identificationModule': {'nctId': 'NCT05555394', 'acronym': 'BATBF', 'briefTitle': 'Body Awareness Therapy and Biomarkers in Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Universitat de Lleida'}, 'officialTitle': 'Effectiveness of a Rehabilitation Programme Based on Lifestyle Changes and Self-care in Patients Diagnosed With Fibromyalgia: Neuroinflammatory and Neuropsychological Biomarkers.', 'orgStudyIdInfo': {'id': '04 University of Lleida'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Basic Body Awareness Therapy', 'description': 'the Basic Body Awareness Therapy is usual therapy of physiotherapy in mental health in nord europe. BBAT is based in twelve movements and massage that improve the movements quality of patient, also improves other movement qualities like biomechanical, physiologic, socio-cultural and existential', 'interventionNames': ['Other: Basic Body Awareness Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stretching group', 'description': 'Stretching exercise will be developed in control group in order to blind the intervention of interest. It will consist in analytic stretching of trunk, upper and lower limb.\n\nIt will last around 45 min twice a week during 12 weeks.', 'interventionNames': ['Other: Stretching Exercise']}], 'interventions': [{'name': 'Basic Body Awareness Therapy', 'type': 'OTHER', 'otherNames': ['BBAT'], 'description': 'The intervention will be twice a week during 12 weeks. It lasts 90 min of movements of daily life, massage and self-reflections.', 'armGroupLabels': ['Basic Body Awareness Therapy']}, {'name': 'Stretching Exercise', 'type': 'OTHER', 'description': 'It consists in stretching movements of whole body', 'armGroupLabels': ['Stretching group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08700', 'city': 'Igualada', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Aurora Garriga, Dr', 'role': 'CONTACT', 'email': 'agarriga@csa.cat', 'phone': '+34 8075800'}, {'name': 'Cristina Bravo, Pt', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Consorci Sanitari de l'Anoia", 'geoPoint': {'lat': 41.58098, 'lon': 1.6172}}, {'zip': '08700', 'city': 'Igualada', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Cristina Bravo Navarro', 'role': 'CONTACT', 'email': 'cristinabn@gmail.com', 'phone': '656312125'}], 'facility': 'Cristina Bravo Navarro', 'geoPoint': {'lat': 41.58098, 'lon': 1.6172}}], 'centralContacts': [{'name': 'Cristina Bravo, PhD', 'role': 'CONTACT', 'email': 'cristina.bravo@udl.cat', 'phone': '+34 656312125'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat de Lleida', 'class': 'OTHER'}, 'collaborators': [{'name': "Consorci Sanitari de l'Anoia", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Researcher', 'investigatorFullName': 'Cristina Bravo', 'investigatorAffiliation': 'Universitat de Lleida'}}}}