Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-25 @ 5:46 PM
Study NCT ID:
NCT06475092
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2024-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relation Between Muscle Mass, Total Body Fat, Visceral Fat, Waist Hip Ratio and Sleeping Hours in Patient With Nonspecific Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-02', 'studyFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tanita device will be used for measurement of total body fat , muscle mass and visceral fat', 'timeFrame': 'baseline', 'description': 'bioelectric impedance analysis device will be used for assessment of total body fat ,muscle mass and viseral fat'}, {'measure': 'Waist hip ratio will be measured by tape measurement', 'timeFrame': 'base line', 'description': 'The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement (W⁄H).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Back Pain', 'Sleep']}, 'descriptionModule': {'briefSummary': 'Objective: To find out if there are a relation between muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours in patient with nonspecific back pain.\n\nDesign: Cross sectional study. Subjects: 30 male and female patients with age ranged from 25 to 40 years old diagnosed as nonspecific low back pain will participate in this study.\n\nMain measures: the Outcome measures will be including the assessment of muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours.\n\nResults: The results will be analyzed via co relation test.', 'detailedDescription': 'Objective: To find out if there are a relation between muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours in patient with nonspecific back pain.\n\nmethods:\n\n* tatinia bioelectric impedance device used for measurement of muscle mass total body fat and visceral fat\n* waist hip ratio measured by tape measurement The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement (W⁄H).\n\nparticipants 30 male and female patient will participate in this study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '30 male and female patient, Their ages will range from 20-40 years old. All of them suffer from mild to moderate degree of low back pain. and they complain from low back pain for 1 month ago', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* •adulthood with low back pain\n\n * Their ages will range from 20-40 years old.\n * All of them suffer from mild to moderate degree of low back pain.\n * The subjects complain from low back pain for 1 month ago\n\nExclusion criteria:\n\nExclusion criteria were a history of any of the following condition:\n\n* inflammatory diseases or any rheumatic disorders,\n* a history of vertebral fractures\n* surgical spinal fixation.\n* •any neurological disorders like MS'}, 'identificationModule': {'nctId': 'NCT06475092', 'briefTitle': 'Relation Between Muscle Mass, Total Body Fat, Visceral Fat, Waist Hip Ratio and Sleeping Hours in Patient With Nonspecific Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ahram Canadian University'}, 'officialTitle': 'Relation Between Muscle Mass, Total Body Fat, Visceral Fat, Waist Hip Ratio and Sleeping Hours in Patient With Nonspecific Back Pain', 'orgStudyIdInfo': {'id': 'P.T-ORT 06/2024-546'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tanita device', 'type': 'OTHER', 'otherNames': ['tap measurement'], 'description': 'bioelectric impedance analysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12573', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Ahram Canadian university', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahram Canadian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of internal physical therapy', 'investigatorFullName': 'Mohamed Ababa', 'investigatorAffiliation': 'Ahram Canadian University'}}}}