CompletedNot Applicable

Correlation Between RMI of Degenerative Disk Disease and Reduction of Pain After Disk-infiltration Treatments

France95 participantsStarted 2019-11-13

Plain-language summary

The primary objective of the study is to demonstrate the difference in the reduction of pain at 1 month after intradiscal infiltration of corticosteroids depending on symmetrical or asymmetrical active discopathies with MRI examination. The difference should be judged significant if it ⩾ 2 points.

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.

Inclusion Criteria: * Age ⩾ 18 years. * Chronic growing lumbago with duration \> 3 mois. * Disabling lumbago with an average ⩾ 4/10 defined by numerical scale. * Common chronic low back pain that has been evolving for more than 3 months. * Disabling lumbalgia defined by an average numerical scale greater than or equal to 4/10 in the month preceding the inclusion. * Failure or intolerance to drug treatments (nonsteroidal anti-inflammatory drugs and systemic corticosteroids). * Absence of biological inflammatory syndrome. * Recent MRI of less than 6 months with active disc disease (Modic 1) defined by degenerative disc disease associated with mirror rearrangements of the subchondral bone of the adjacent vertebral endplates in hyposignal T1 and hypersignal T2. * Signed informed consent obtained. * Affiliation to social security. Exclusion Criteria: * Pregnancy woman. * Immunosuppression. * History of allergy to iodinated contrast agents and / or prednisolone acetate. * Local or general infection. * Fever (temperature\> 38). * History of disc surgery of less than 6 months. * History of infectious spondylodiscitis. * Unbalanced psychiatric disorders. * Severe coagulation disorders or impossible cessation of anticoagulation or anti platelet aggregation. * Impossibility to obtain signed consent form. * Patient under guardianship and/or curatorship.

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

Assessement of change in pain

Timeframe: at 1 month

Trial details

NCT IDNCT04142580

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-28

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