Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT01488760
Status:
COMPLETED
Last Update Posted:
2011-12-08
First Post:
2011-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abdominal Wall Evaluation in Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-06', 'studyFirstSubmitDate': '2011-12-06', 'studyFirstSubmitQcDate': '2011-12-06', 'lastUpdatePostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Abnormally Decreased Muscle Contraction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate feed-forward contraction of the transversus abdominis and thickness of the transversus abdominis, obliquus internus, and obliquus externus during calm and standardized respiration in low back pain patients and pain-free subjects.', 'detailedDescription': 'Low back pain patients have alterations in abdominal wall function, especially in the feed-forward activation of transversus muscle during limbs movements. However, there are no reports on the abdominal function in low back pain patients during physiological respiratory movement.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For the low back pain group: women with history of non-specific chronic low back pain for more than three months\n* For the pain-free group: pain-free women\n\nExclusion Criteria:\n\n* For both groups were: pregnancy, neurological condition, obesity (body mass index: BMI \\>30), or previous spine or abdominal surgery.\n* For the low back pain group: rheumatology diseases other than low back pain.\n* For the pain-free group: any rheumatology disease.'}, 'identificationModule': {'nctId': 'NCT01488760', 'briefTitle': 'Abdominal Wall Evaluation in Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Deep Abdominal Wall Muscle Dysfunction During Calm Respiration in Chronic Low Back Pain Patients', 'orgStudyIdInfo': {'id': 'FRACINI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nineteen women with low back pain'}, {'label': 'Twenty pain-free women'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Clarice Tanaka, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Full Professor - Department of Physical Therapy, Communication Science & Disorders, Occupational Therapy, Faculty of Medicine - USP'}, {'name': 'Patricia R Patarro', 'role': 'STUDY_CHAIR', 'affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil'}, {'name': 'Renato A Sernik', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Radiology, School of Medicine: University of São Paulo, Brazil'}, {'name': 'Débora M Meira', 'role': 'STUDY_CHAIR', 'affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil'}, {'name': 'América C Fracini', 'role': 'STUDY_CHAIR', 'affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil'}, {'name': 'Cássio M Siqueira', 'role': 'STUDY_CHAIR', 'affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}