Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-02 @ 1:08 AM
Study NCT ID:
NCT00789204
Status:
COMPLETED
Last Update Posted:
2009-09-22
First Post:
2008-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postural Re-education in Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-21', 'studyFirstSubmitDate': '2008-11-10', 'studyFirstSubmitQcDate': '2008-11-10', 'lastUpdatePostDateStruct': {'date': '2009-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Roland & Morris Disability Questionnaire', 'timeFrame': 'Baseline, 3 months, 6 months'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index', 'timeFrame': 'Baseline, 3 months, 6 months'}, {'measure': 'Pain Drawing and Visual Analogue Scale (V.A.S.)', 'timeFrame': 'Baseline, 3 mounths, 6 months'}, {'measure': 'Fingertip-to-floor test', 'timeFrame': 'Baseline, 3 mounths, 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['exercise', 'low back pain', 'posture', 'rehabilitation'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '17898878', 'type': 'BACKGROUND', 'citation': 'Vanti C, Generali A, Ferrari S, Nava T, Tosarelli D, Pillastrini P. [ General postural rehabilitation in musculoskeletal diseases: scientific evidence and clinical indications]. Reumatismo. 2007 Jul-Sep;59(3):192-201. Italian.'}, {'pmid': '15905654', 'type': 'BACKGROUND', 'citation': 'Fernandez-de-Las-Penas C, Alonso-Blanco C, Morales-Cabezas M, Miangolarra-Page JC. Two exercise interventions for the management of patients with ankylosing spondylitis: a randomized controlled trial. Am J Phys Med Rehabil. 2005 Jun;84(6):407-19. doi: 10.1097/01.phm.0000163862.89217.fe.'}, {'pmid': '16034851', 'type': 'BACKGROUND', 'citation': 'Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.'}, {'pmid': '21162726', 'type': 'DERIVED', 'citation': "Bonetti F, Curti S, Mattioli S, Mugnai R, Vanti C, Violante FS, Pillastrini P. Effectiveness of a 'Global Postural Reeducation' program for persistent low back pain: a non-randomized controlled trial. BMC Musculoskelet Disord. 2010 Dec 16;11:285. doi: 10.1186/1471-2474-11-285."}]}, 'descriptionModule': {'briefSummary': 'The Global Postural Re-Education is a global approach for the treatment of musculoskeletal disease. Using specific progressive posture for stretching particular shortened chain muscle the method wants to equilibrate the never-ending war between static and dynamic muscles by guiding the patient in a particular breathing pattern to maintain a correct posture and feeling it.', 'detailedDescription': 'In some countries there is a physical therapy method called "Global Posture Reeducation" (GPR), which was developed by Philippe Emmanuel Souchard based on 20 years of clinical experience.The method consist to balance the miofascial tension probably responsible for an articular overloading. The method stretches the shortened antigravity muscles that are inside a different static muscles chains. GPR is a global approach that search the biomechanics cause in the near areas, and involves actively the patient in the postural and gestural changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lumbalgia Diagnosis\n* Age 18-80\n\nExclusion Criteria:\n\n* Migrated hernia\n* Calcified disc hernia\n* Spondylolisthesis\n* Other physiotherapeutic interventions within 6 months of the baseline assessment.\n* Surgical operation within six months of baseline\n* Cancer syndrome, Neurological and rheumatic diseases'}, 'identificationModule': {'nctId': 'NCT00789204', 'briefTitle': 'Postural Re-education in Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'Effectiveness of a "Global Posture Reeducation" Program for Patients With Low Back Pain', 'orgStudyIdInfo': {'id': 'FB001022008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GPR', 'description': 'Global Postural Re-Education', 'interventionNames': ['Other: Global Postural Re-education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SEP', 'description': 'Standard Exercise Programm', 'interventionNames': ['Other: Standard Exercise Training']}], 'interventions': [{'name': 'Global Postural Re-education', 'type': 'OTHER', 'otherNames': ['GPR'], 'description': 'The treatment in Global Postural Re-education is a global approach that seeks to identify the biomechanical cause of the problem also in other parts of the body and involves actively the patient in the postural change. Using principles like causality, globality and individuality, the treatment consists of the use for one hour of progressive active stretching posture for specific muscular chain that are shortened. Every posture is maintained for 20 minutes with controlled breathing and the use of manual traction', 'armGroupLabels': ['GPR']}, {'name': 'Standard Exercise Training', 'type': 'OTHER', 'otherNames': ['SEP'], 'description': 'The exercise programme included passive lumbar flexion, pelvic tilt, strengthening of flexor muscles, strengthening of extensor muscles, spine mobilization and stretching exercises.', 'armGroupLabels': ['SEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Ecm Eur Centro Medico', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Francesca Bonetti, Laurea', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Paolo Pillastrini', 'oldOrganization': 'University of Bologna'}}}}