drugset / Trial / NCT00804531

Intra-discal Steroid Injection for MODIC I Discopathy

NCT00804531 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start
2009-04
Primary completion
2015-05
Completion
2015-11

Outcome

Met primary endpoint

paper At 1 month after the intervention, the percentage of responders (LBP intensity <40) was higher in the GC IDI group PMID 28319997 ↗

paper than the control group (21 of 63 [33.3%]) (absolute risk difference, 22.1 percentage points [95% CI, 5.5 to 38.7 percentage points]; P = 0.009). PMID 28319997 ↗

paper In chronic LBP associated with active discopathy, a single GC IDI reduces LBP at 1 month but not at 12 months. PMID 28319997 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocortancyl Other / unclassified 25 mg Other
Background Iodixanol Diagnostic / imaging agent 1 ml Other

Indications

No indication recorded.