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:
AZ Nikolaas
Organization:
Study Overview
Official Title:
The Spinopelvic Parameters, Body Mass Index and Waist Circumference in Patients With Chronic Non-specific Low Back Pain: an Observational Cross-sectional Correlation Study
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Record cards of patients presenting with non specific low back pain between January 1st 2020 and December 23rd 2022 were analysed.
All 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
All 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: