Intra-discal Steroid Injection for MODIC I Discopathy

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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