CompletedNot Applicable

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

France36 participantsStarted 2020-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of muscle fat infiltration

Timeframe: 1 year

Percentage of muscle fat infiltration

Timeframe: 1 year

Trial details

NCT IDNCT06018155

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-01

View on ClinicalTrials.gov More Low Back Pain trials