CompletedPhase 4

Intra-discal Steroid Injection for MODIC I Discopathy

France137 participantsStarted 2009-04

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

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 : * 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

What they're measuring

Back pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month

Timeframe: 1 month

Trial details

NCT IDNCT00804531

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-05