Correlation Between RMI of Degenerative Disk Disease and Reduction of Pain After Disk-infiltration Treatments
CompletedNCT04142580
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Evolution of Chronic Low Back Pain of Active Discopathy After Intradiscal Corticosteroid Infiltrations According to Modic 1 Distribution and Association With Degenerative Restructuring
- Conditions
- Discopathy
- Lumbago
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Start date
- 2019-11-13
- Primary completion
- 2021-12-28
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04142580