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NCT05771493 Clinical Trial

The Spinopelvic Parameters, Body Mass Index and Waist Circumference in Patientd Chronic Non-specific Low Back Pain

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05771493
Other study ID # Vitaz Sint-Niklaas
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 23, 2022

Study information
Verified date March 2023
Source AZ Nikolaas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 272
Est. completion date December 23, 2022
Est. primary completion date December 23, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - presenting with non-specific low back pain - having undergone full spine X-ray during the diagnostic proces Exclusion Criteria: - patients with missing data - double entry of patients

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Measurement of baseline characteristics
Calculation of the correlation between BMI, WC and PI

Locations
Country Name City State
Belgium Vitaz Sint-Niklaas

Sponsors (1)
Lead Sponsor Collaborator
AZ Nikolaas

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Spinopelvic parameters and correlation with BMI and WC Cross sectional study January 1st 2020 - December 23, 2022
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