Low Back PainFIMFosNCT06018155
Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation
An observational study of Low Back Pain and Degenerative Condition, Neurologic, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Degenerative Condition, Neurologic
- What is being tested?
- Spine surgery
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Back Pain, Degenerative Condition, Neurologic
- Being tested
- Spine surgery
- Medical subject headings
- Low Back Pain, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine surgeryOther
Cohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted
| Study group | Role | What they receive |
|---|---|---|
| Single cohort | Cohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted Receives: Other: Spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of muscle fat infiltration
Muscle fat infiltration (%) will be evaluated by 2D segmentation analysis of T2 weighted lumbar spine MRIs
Measured: 1 year
Percentage of muscle fat infiltration
Muscle fat infiltration (%) will be evaluated by 3D segmentation analysis of T2 weighted lumbar spine MRIs
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Jan 2020
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018155
- Sponsor's protocol ID
- 23Neuro02
- Acronym
- FIMFos
- Status last verified
- Mar 2025
- First submitted
- 24 Aug 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation
- ClinicalTrials.gov ID
- NCT06018155
- Acronym / sponsor ID
- FIMFos / 23Neuro02
- Conditions
- Low Back Pain, Degenerative Condition, Neurologic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort | – | Other: Spine surgeryCohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spine surgeryCohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted | Other | Single cohort |
Primary outcome
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
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
1 secondary outcome
Lumbar foraminal stenosis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Degenerative Condition, Neurologic, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of muscle fat infiltration (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.