Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05095402
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2021-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomechanics of Lumbar Region in 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2021-10-14', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability caused by low back pain assessed by Oswestry Low Back Pain Disability Questionnaire', 'timeFrame': '6 months', 'description': 'Low back pain disability is assessed with Oswestry Low Back Pain Disability Questionnaire.\n\nOswestry Disability Index (ODI) score as a percentage is obtained from the questionnaire result.'}, {'measure': 'Lumbar lordosis angle', 'timeFrame': '6 months', 'description': '* Measured with the COBB angle method as LLA degree.\n* It is determined by looking at the angle between the vertebrae forming the lumbar lordosis curvature (L1-L5).\n* All radiological measurements are performed on the RAdiant DICOM viewer program.'}, {'measure': 'Muscles thickness measurements', 'timeFrame': '6 months', 'description': '* Measured on the horizontal plane corresponding to the L3-L4 level in the sagittal plane.\n* Bilaterally, the thickest parts of the muscles are measured anterior-posterior and transverse and recorded in millimetres (mm).\n* All radiological measurements are performed on the RAdiant DICOM viewer program.\n* Muscles measured are listed below:\n* m. psoas major\n* m. multifidus\n* m. erector spinae muscles\n* m. quadratus lumborum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low Back Pain', 'Lumbar Lordosis Angle', 'Magnetic Resonance Imaging', 'Muscle Thickness'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to examine the relationship between non-specific low back pain (NSLBP) and lumbar lordosis angle (LLA) and lumbar muscle thickness (LMT) by evaluating magnetic resonance images (MRI) in individuals with LBP.', 'detailedDescription': "The study included a total of 96 individuals, 43 males, and 53 females, who applied to the Department of Radiology of the Karabuk University Training and Research Hospital between March-June 2019 with complaints of LBP. Individuals' sociodemographic information and medical history were recorded using the LBP assessment form. The Oswestry LBP Disability Questionnaire was used for LBP. Thickness measurements of muscle (m.) psoas major, m. multifidus, m. quadratus lumborum and m. erector spinae were taken on MRI corresponding to the L3-L4 vertebra level. Cobb Angle method was used for LLA determination. Measurements were made in three repetitions using the Radiant DICOM viewer program, and their averages were recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study included a total of 96 individuals, 43 males, and 53 females, who applied to the Department of Radiology of the Karabuk University Training and Research Hospital between March-June 2019 with complaints of LBP.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The age range of 18-65\n* Having non-specific LBP\n* Volunteering to participate in the study\n\nExclusion Criteria:\n\n* Having any psychiatric and mental problems\n* The presence of any disc, bone, and muscular pathology in the lumbar region\n* Having any previous operation on the lumbar region'}, 'identificationModule': {'nctId': 'NCT05095402', 'briefTitle': 'Biomechanics of Lumbar Region in Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'Evaluation of the Relationship Between Lumbar Lordosis Angle and Lumbar Muscle Thickness With Non-Specific Low Back Pain', 'orgStudyIdInfo': {'id': 'KU-ANA-ACD-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '78050', 'city': 'Karabük', 'country': 'Turkey (Türkiye)', 'facility': 'Karabuk University', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}], 'overallOfficials': [{'name': 'Ali dagli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karabuk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ali Cihan Dagli', 'investigatorAffiliation': 'Karabuk University'}}}}