Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT02384603
Status:
COMPLETED
Last Update Posted:
2019-03-21
First Post:
2015-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Physical Therapy in Pain and Posture 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2015-02-18', 'studyFirstSubmitQcDate': '2015-03-04', 'lastUpdatePostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogic scale of pain', 'timeFrame': '11 weeks'}], 'secondaryOutcomes': [{'measure': 'McGill Pain Questionnaire', 'timeFrame': '11 weeks'}, {'measure': 'Dolorimetry of the 18 tender points', 'timeFrame': '11 weeks'}, {'measure': 'Survey of Pain Attitudes - brief version', 'timeFrame': '11 weeks'}, {'measure': 'Body posture evaluation', 'timeFrame': '11 weeks'}, {'measure': 'Modified Clinical Test of Sensory Interaction for Balance (CTSIBm)', 'timeFrame': '11 weeks'}, {'measure': 'Sit-and-Reach Test', 'timeFrame': '11 weeks'}, {'measure': 'Fibromyalgia Impact Questionnaire', 'timeFrame': '11 weeks'}, {'measure': 'Narrative interview about self-care', 'timeFrame': '11 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '21769128', 'type': 'BACKGROUND', 'citation': 'Schmidt-Wilcke T, Clauw DJ. Fibromyalgia: from pathophysiology to therapy. Nat Rev Rheumatol. 2011 Jul 19;7(9):518-27. doi: 10.1038/nrrheum.2011.98.'}, {'pmid': '17631737', 'type': 'BACKGROUND', 'citation': 'Matsutani LA, Marques AP, Ferreira EA, Assumpcao A, Lage LV, Casarotto RA, Pereira CA. Effectiveness of muscle stretching exercises with and without laser therapy at tender points for patients with fibromyalgia. Clin Exp Rheumatol. 2007 May-Jun;25(3):410-5.'}, {'pmid': '21829981', 'type': 'BACKGROUND', 'citation': 'Teodori RM, Negri JR, Cruz MC, Marques AP. Global Postural Re-education: a literature review. Rev Bras Fisioter. 2011 May-Jun;15(3):185-9. English, Portuguese.'}, {'pmid': '23098173', 'type': 'BACKGROUND', 'citation': 'Campbell CM, McCauley L, Bounds SC, Mathur VA, Conn L, Simango M, Edwards RR, Fontaine KR. Changes in pain catastrophizing predict later changes in fibromyalgia clinical and experimental pain report: cross-lagged panel analyses of dispositional and situational catastrophizing. Arthritis Res Ther. 2012 Oct 25;14(5):R231. doi: 10.1186/ar4073.'}, {'pmid': '37280637', 'type': 'DERIVED', 'citation': 'Matsutani LA, Sousa do Espirito Santo A, Ciscato M, Yuan SLK, Marques AP. Global posture reeducation compared with segmental muscle stretching exercises in the treatment of fibromyalgia: a randomized controlled trial. Trials. 2023 Jun 7;24(1):384. doi: 10.1186/s13063-023-07422-w.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effects of two physiotherapeutic treatments of fibromyalgia: global postural reeducation associated with cognitive behavioral therapy and segmental muscle stretching exercises associated with cognitive behavioral therapy.', 'detailedDescription': 'Fibromyalgia is characterized mainly by chronic widespread pain. Segmental muscle stretching therapeutic exercises reduce the shortening of myofascial structures and recover the body flexibility. It is indicated for the treatment of chronic pain caused by osteo-myo-articular dysfunction. The pain behavior may be defined as the adoption of body postures and attitudes that a person communicates his/her pain. In this way, the global postural reeducation - a method of muscles chains stretching exercises - could be an important intervention. In addition, negative thoughts and dysfunctional beliefs are usual in situations of chronic pain, compromising the health recovery process. As part of a pain catastrophizing-related therapeutic approach, physiotherapist may help patients with chronic pain to develop positive, realistic and hope attitudes as based on the cognitive behavioral therapy model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with fibromyalgia according to the 2010 American College of Rheumatology diagnostic criteria and the presence of at least 11 of 18 tender points.\n\nExclusion Criteria:\n\n* Presence of joint deformities\n* Independent walking disability\n* Making another physiotherapeutic treatment at the same time.'}, 'identificationModule': {'nctId': 'NCT02384603', 'briefTitle': 'Effects of Physical Therapy in Pain and Posture of Fibromyalgia Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effects of Two Physiotherapeutic Treatments in Pain and Posture of Fibromyalgia Patients: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '053/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GPR and CBT', 'description': 'Global postural reeducation associated with cognitive behavioral therapy; 01 session per week for 10 weeks', 'interventionNames': ['Other: Global postural reeducation', 'Other: Cognitive behavioral therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SMSE and CBT', 'description': 'Segmental muscle stretching exercises associated with cognitive behavioral therapy; 01 session per week for 10 weeks', 'interventionNames': ['Other: Segmental muscle stretching exercises', 'Other: Cognitive behavioral therapy']}], 'interventions': [{'name': 'Global postural reeducation', 'type': 'OTHER', 'armGroupLabels': ['GPR and CBT']}, {'name': 'Segmental muscle stretching exercises', 'type': 'OTHER', 'armGroupLabels': ['SMSE and CBT']}, {'name': 'Cognitive behavioral therapy', 'type': 'OTHER', 'armGroupLabels': ['GPR and CBT', 'SMSE and CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05360-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine of the University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Luciana A Matsutani, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Amelia P Marques, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Luciana Akemi Matsutani', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}