Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-30 @ 11:06 PM
Study NCT ID:
NCT05771493
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2023-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Spinopelvic Parameters, Body Mass Index and Waist Circumference in Patientd Chronic Non-specific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D001835', 'term': 'Body Weight'}], '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': 272}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spinopelvic parameters and correlation with BMI and WC', 'timeFrame': 'January 1st 2020 - December 23, 2022', 'description': 'Cross sectional study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weight,', 'Body mass index', 'Pelvic index', 'Waist circumference'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This pilot study aims at styding the correlations between body mass index, waist circumference and the potential for positional adaptation of the pelvis to support overweight or obesity', 'detailedDescription': 'Record cards of patients presenting with non specific low back pain between January 1st 2020 and December 23rd 2022 were analysed.\n\nAll included patients had undergone a full spine X-ray allowing to calculate the pelvic index (PI). Weight status was described in 4 categories, in-line with the WHO definitions; Underweight (boddy mass index (BMI)) \\< 18.5 kg/m²; normal weight BMI 18.5 - 24.9 kg/m² , overweight BMI 25 - 29.9 kg/m², and obesity BMI ≥ 30 kg/m². To identify people with increased BMI-values and central (abdominal) fat distribution, we used the waist circumference (WC). The cut-off points of waist measurement that are used are 102 cm and 88 cm for men and women respectively. A high sacral slope (SS) means a greater the lumbar curvature, which results in a dynamic back. Due to the correlation between SS and PI, people with high PI values generally have higher values of SS. Therefore types 1 and 2 have a low-grade PI and types 3 and 4 have a high-grade PI Analysis of 272 patient records, shows that the mean PI is significantly different in the group with a low WC compared with the group with a high WC. BMI and WC show a significant correlation with PI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '272 patients; 51.8% male, 3.7% underweight; 28.7 % normal weight; 34.2% overweight and 33.5% obees. 50.4% has high WC. Mean PI 57.78', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presenting with non-specific low back pain\n* having undergone full spine X-ray during the diagnostic proces\n\nExclusion Criteria:\n\n* patients with missing data\n* double entry of patients'}, 'identificationModule': {'nctId': 'NCT05771493', 'briefTitle': 'The Spinopelvic Parameters, Body Mass Index and Waist Circumference in Patientd Chronic Non-specific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'AZ Nikolaas'}, 'officialTitle': 'The Spinopelvic Parameters, Body Mass Index and Waist Circumference in Patients With Chronic Non-specific Low Back Pain: an Observational Cross-sectional Correlation Study', 'orgStudyIdInfo': {'id': 'Vitaz Sint-Niklaas'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Measurement of baseline characteristics', 'type': 'OTHER', 'description': 'Calculation of the correlation between BMI, WC and PI'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91#00', 'city': 'Sint-Niklaas', 'country': 'Belgium', 'facility': 'Vitaz', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is an analysis of patient record forms. Sharing the information would be against the privacy protection'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ Nikolaas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of neursurgery', 'investigatorFullName': 'Erik Van de Kelft, M.D., PhD', 'investigatorAffiliation': 'AZ Nikolaas'}}}}