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NCT06018155 Clinical Trial

Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation

Low Back Pain Clinical Trial

— FIMFos  

Official title:
Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06018155
Other study ID # 23Neuro02
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date September 1, 2025

Study information
Verified date August 2023
Source Centre Hospitalier Universitaire de Nice
Contact Denys Fontaine
Phone 0492038449
Email fontaine.d@chu-nice.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the correlation between the fat infiltration of the lumbar multifidus muscle and several parameters including the severity of the lumbar foraminal stenosis. The investigators will analyse lumbar MRI of patients previously included in a database of patients suffering from low back pain. Foraminal stenosis, muscle fat infiltration and other imaging lumbar parameters will be studied by 2D and 3D manuel segmentation, semi-automatic segmentation. Correlations between factors influencing the muscle fat infiltration will be studied by univariate and multivariate statistical analysis.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date September 1, 2025
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted, for who the following parameters are available: lumbar 3D MRI with T2 weighted sequences, informed consent.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Spine surgery
Cohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted

Locations
Country Name City State
France University Hospital of Nice Nice

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of muscle fat infiltration Muscle fat infiltration (%) will be evaluated by 2D segmentation analysis of T2 weighted lumbar spine MRIs 1 year
Primary Percentage of muscle fat infiltration Muscle fat infiltration (%) will be evaluated by 3D segmentation analysis of T2 weighted lumbar spine MRIs 1 year
Secondary Lumbar foraminal stenosis Lumbar foraminal stenosis will be evaluated by 2D segmentation analysis of T2 weighted lumbar spine MRIs and expressed as a nerve/foramen surface ratio, and by the Lee et al. Classification 1 year
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