NCT05771493

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

March 6, 2023

Last Update Submit

March 6, 2023

Conditions

Low Back Pain

Keywords

Weight,Body mass indexPelvic indexWaist circumference

Outcome Measures

Primary Outcomes (1)

  • Spinopelvic parameters and correlation with BMI and WC

    Cross sectional study

    January 1st 2020 - December 23, 2022

Interventions

Measurement of baseline characteristicsOTHER

Calculation of the correlation between BMI, WC and PI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • presenting with non-specific low back pain
  • having undergone full spine X-ray during the diagnostic proces

You may not qualify if:

  • patients with missing data
  • double entry of patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vitaz

Sint-Niklaas, 91#00, Belgium

Location

MeSH Terms

Conditions

Low Back PainBody Weight

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of neursurgery

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 16, 2023

Study Start

January 1, 2020

Primary Completion

December 23, 2022

Study Completion

December 23, 2022

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

This is an analysis of patient record forms. Sharing the information would be against the privacy protection

Locations

BE(1)