Status:
COMPLETED
Intra-discal Steroid Injection for MODIC I Discopathy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Back Pain Lower Back Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 i...
Detailed Description
Objective: to assess the efficacy on pain level of a steroid injection in the inter-vertebral disc for patients with chronic back pain and MODIC I discopathy on MRI Methods: a multicenter double blin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00804531
Start Date
April 1 2009
End Date
November 1 2015
Last Update
September 12 2025
Active Locations (1)
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1
Hôpital Cochin
Paris, France, 75014