Evaluating para-disc injections for inflammatory disc disease
Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease: Pilot Study (IPAD)
This study is testing if corticosteroid injections given near the spine can help people with chronic low back pain from a specific type of disc inflammation feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, Occitanie) |
| Trial ID | NCT05615597 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of para-discal corticosteroid injections in patients suffering from lateralized Modic 1 inflammatory disc disease, a condition linked to chronic low back pain. The approach focuses on delivering corticosteroids directly to the area of inflammation identified through MRI, potentially offering a less invasive alternative to traditional intra-disc injections. Participants will be monitored for pain relief and overall improvement in their condition following the treatment. The study targets individuals with specific MRI findings and chronic pain lasting at least three months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with lateralized Modic 1 disc disease and chronic low back pain.
Not a fit: Patients with bilateral Modic 1 changes or those with non-mechanical inflammatory conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief for patients suffering from chronic low back pain due to inflammatory disc disease.
How similar studies have performed: While similar approaches have been explored, this specific method of para-discal infiltration is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient 18 years of age or older * Patient with Modic I lateralized disc disease seen on an MRI less than 6 months old. * Chronic medial or lateralized (same side as MODIC 1) low back pain for at least 3 months with a mean pain intensity ≥ 40/100 mm on a VAS. * Effective contraception for women of childbearing age, at least 6 months after injection (surgical sterilisation, approved hormonal contraceptives, barrier methods, intrauterine intrauterine device) Exclusion Criteria: * Patient with MODIC 1 in both underlying and overlying vertebral spaces. * Patient with an inflammatory signal abnormality of the vertebral body plateau related to non-mechanical pathology (e.g. spondyloarthritis). * Patients with a history of lumbar spine surgery. * Patient with suspected spondylodiscitis or other infection. * Patients on anticoagulant or antiaggregant therapy, or with a coagulation disorder. * Patients with an allergy to iodine or to any of the components of Xylocaine. * Patients with an allergy to prednisolone or to any component of Hydrocortancyl® or Dexamethasone®.. * Patient with severe uncontrolled disease (i.e. cardiac gastrointestinal, neurological, endocrine, autoimmune) that limits patient safety (as determined by the safety (as judged by the investigator). * Prior to the treatment visit : * current and recent morphine use (\< 1 month) * recent systemic or local corticosteroid therapy (\< 1 month). * Patient with sphincter disturbances indicative of cauda equina syndrome. * Psychotic state not controlled by treatment * Pregnancy (βHCG positive), breastfeeding * Vulnerable patient protected by law * Patient under guardianship or curatorship * Patient participating in an interventional study * Patient unable to read and/or write
Where this trial is running
Montpellier, Occitanie
- Departement of Medical Imaging — Montpellier, Occitanie, France (Recruiting)
Study contacts
- Principal investigator: Arthur HAMEL-SENECAL, MD — Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital
- Study coordinator: Arthur HAMEL SENECAL, MD
- Email: arthur.hamelsenecal@chu-montpellier.fr
- Phone: 0467338946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.