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

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06018155
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain; Degenerative Condition, Neurologic	Other: Spine surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Single cohort Cohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted	Other: Spine surgery; Cohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted

Outcome Measures

Primary Outcome Measures

1. Percentage of muscle fat infiltration [1 year]

   Muscle fat infiltration (%) will be evaluated by 2D segmentation analysis of T2 weighted lumbar spine MRIs

2. Percentage of muscle fat infiltration [1 year]

   Muscle fat infiltration (%) will be evaluated by 3D segmentation analysis of T2 weighted lumbar spine MRIs

Secondary Outcome Measures

1. Lumbar foraminal stenosis [1 year]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Nice	Nice		France	06000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT06018155
• Other Study ID Numbers: 23Neuro02
• First Posted: Aug 30, 2023
• Last Update Posted: Sep 1, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neurodegenerative Diseases; Low Back Pain

Study Results

No Results Posted as of Sep 1, 2023