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OpenTrials
Completed

NCT Number: NCT06018155

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

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.

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Key information

Conditions

Low Back Pain Back Pain Degenerative Condition, Neurologic Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Nice

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spine surgery

Other

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

Primary outcomes

  1. Percentage of muscle fat infiltration

    Time frame: 1 year

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

  2. Percentage of muscle fat infiltration

    Time frame: 1 year

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

Secondary outcomes

  1. Lumbar foraminal stenosis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: FIMFos

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2023
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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