Intra-discal Steroid Injection for MODIC I Discopathy
CompletedPhase 4NCT00804531
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
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)
To assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on magnetic resonance imaging. Hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients with inflammatory discopathy
Study details
- Official title
- Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial
- Conditions
- Interventions
- Drug: Visipaque - Hydrocortancyl
- Drug: Placebo comparator
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Start date
- 2009-04
- Primary completion
- 2015-05
- Sex
- All
- Age range
- from 18 Years to 70 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 : * More than 18 and less than 70 years old * Low back pain * Daily pain for at least 3 months * Pain level during the last 48 hours \> 40 on the numeric pain scale (0-100) * Lack of efficacy of usual recommended treatments and of other spine steroid injections (epidural or facet joints injections) * Modic I discopathy on MRI * Intra-discal injection at least 6 months before inclusion * Written informed consent * Social security * Medical examination Non inclusion criteria : * Pregnancy * Hypersensitivity to methylprednisolone or contrast * Local or general infection * Previous disc surgery less than 6 months * Steroid treatment * Previous infectious spondylodiscitis * Ankylosing spondylitis * Sciatica with neurologic defects * Uncontrolled psychiatric conditions * Inability to read or understand French language * Anti-vitamin K treatments * Severe coagulation diseases * Fever \> 38 or sedimentation rate \> 20 * Discopathy with MODIC 1 signal on several different lumbar stages
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00804531