Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01533805
Status:
UNKNOWN
Last Update Posted:
2012-02-15
First Post:
2012-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Different Techniques of the Method Pilates in Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-14', 'studyFirstSubmitDate': '2012-02-02', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Up to 8 weeks', 'description': 'low back pain will be assessed with numeric pain scale two times (pre and post-intervention)'}], 'secondaryOutcomes': [{'measure': 'Endurance of the back extensor muscles', 'timeFrame': 'Up to 8 weeks', 'description': 'The endurance of the back extensor muscles will be assessed Biering-Sorensen test'}, {'measure': 'Activity of abdominis transversus', 'timeFrame': 'Up to 8 weeks', 'description': 'Will be assessed with Biofeedback pressure stabilizer'}, {'measure': 'Functional Limitation', 'timeFrame': 'Up to 8 weeks', 'description': 'Will be assessed Rolland Morris Test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lumbago', 'Exercise therapy', 'Spine'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare different methods of application of the Pilates Method with exercises in controlling in low back pain in women aged between 45 and 60 years. Two groups will be formed. One will do Pilates exercises with stabilization segmental. The other group will do classic Pilates exercises. Will be measure pre and pos intervention of the responses already shown above.', 'detailedDescription': 'The purpose of this study is to identify what type of Pilates exercise is more effective in controlling low back pain is exercise that uses the method of the classical manner or trunk mobilizations with exercises that target the neutral position of the lumbar spine and deep muscles and focus on stabilizing the trunk.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic low back pain classified by visual analogue scale being 3-6 points to more than 3 weeks\n* Not be performing any other type of physical therapy\n\nExclusion Criteria:\n\n* Pregnant women\n* Back surgeries\n* Cardiovascular and rheumatic diseases'}, 'identificationModule': {'nctId': 'NCT01533805', 'briefTitle': 'Effects of Different Techniques of the Method Pilates in Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Gama Filho'}, 'officialTitle': 'Effects of Different Techniques of the Method Pilates in Chronic Low Back Pain in Women 46 to 60 Years', 'orgStudyIdInfo': {'id': 'CAAE 0119031200011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilates with stabilization', 'description': 'This group will do pilates exercises with a focus on control of segmental stabilization of the lumbar spine neutral.', 'interventionNames': ['Other: Pilates exercises with stabilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classic Pilates', 'description': 'This group will make Pilates exercises its focus is on mobilization exercises of the lumbar spine.', 'interventionNames': ['Other: Classic Pilates']}], 'interventions': [{'name': 'Pilates exercises with stabilization', 'type': 'OTHER', 'otherNames': ['Pilates with stabilization segmental'], 'description': 'This group will focus on exercises with core stabilizing muscles. The frequency will be 16 sessions lasting 1 hour.', 'armGroupLabels': ['Pilates with stabilization']}, {'name': 'Classic Pilates', 'type': 'OTHER', 'description': 'This group will make Pilates exercises its focus is on mobilization exercises of the lumbar spine. The frequency will be 16 sessions lasting 1 hour.', 'armGroupLabels': ['Classic Pilates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23050-260', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'contacts': [{'name': 'Cintia P Souza, bachelor', 'role': 'CONTACT', 'email': 'centropilates@bol.com.br', 'phone': '2181320046'}], 'facility': 'Gama Filho University', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'centralContacts': [{'name': 'Cintia P Souza, Bachelor', 'role': 'CONTACT', 'email': 'centropilates@bol.com.br', 'phone': '552181320046'}, {'name': 'Elirez B Silva, Doctoral', 'role': 'CONTACT', 'email': 'elirezsilva@ugf.com', 'phone': '552125997170'}], 'overallOfficials': [{'name': 'Cintia P Souza, bachelor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Gama Filho'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Gama Filho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cintia Pereira de Souza', 'investigatorAffiliation': 'Universidade Gama Filho'}}}}