Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05749705
Status:
COMPLETED
Last Update Posted:
2023-03-15
First Post:
2023-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fat to Lean Mass Ratio and Its Effect on Low Back Pain and Permanent Functional Disability.
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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-12', 'studyFirstSubmitDate': '2023-02-18', 'studyFirstSubmitQcDate': '2023-02-18', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat to Lean mass ratio', 'timeFrame': 'Immediately after the admission', 'description': 'Body composition analyzer will be used to measure the percentage of fat'}], 'secondaryOutcomes': [{'measure': 'Low Back Pain and disability', 'timeFrame': 'Immediately after the admission', 'description': 'Oswestry disability index arabic version will be used.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain, Mechanical']}, 'descriptionModule': {'briefSummary': 'The study was conducted for people who suffer from excess fat mass and their age is over 18 years will be calculated with G\\*power will be used body composition analyzer to calculate the percentage of fat.', 'detailedDescription': 'Cross-sectional study was applied. Data was collected through a questionnaire (oswestry disability index arabic version). Fat percentage was taken by Body composition analyzer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'People who suffer from excess fat mass and their age is over 18 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Excess fat mass\n* Age must be over 18 years.\n\nExclusion Criteria:\n\n* People under the age of 18.\n* Low back pain not associated with increased fat mass.'}, 'identificationModule': {'nctId': 'NCT05749705', 'briefTitle': 'Fat to Lean Mass Ratio and Its Effect on Low Back Pain and Permanent Functional Disability.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University of Jazan'}, 'officialTitle': 'Fat to Lean Mass Ratio and Its Effect on Low Back Pain and Permanent Functional Disability.', 'orgStudyIdInfo': {'id': '94177'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fat to Lean Mass Ratio', 'type': 'OTHER', 'description': 'The study will be conducted for people who suffer from excess fat mass and their age is over 18 years.\n\nyears will be calculated with G power'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45142', 'city': 'Jizan', 'state': 'Gizan', 'country': 'Saudi Arabia', 'facility': 'Jazan University', 'geoPoint': {'lat': 16.88917, 'lon': 42.55111}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jazan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mohamed Moustafa Mohamed Ahmed', 'investigatorAffiliation': 'University of Jazan'}}}}