Intra-discal Steroid Injection for MODIC I Discopathy

Study Overview
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Brief Summary
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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

Detailed Description
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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 blind randomized control trial Setting: 3 tertiary care hospitals in France Patients: 134 patients with disabling chronic low back pain not relieved by usual recommended treatments and MODIC I (inflammatory) discopathy on MRI Intervention: Injection of 25 mg of methylprednisolone in the inter-vertebral disc during a discography (intervention group, 67 patients) or discography alone (control group, 67 patients) Outcome measures: The primary outcome measure is 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. Secondary outcome measures are pain level at 12 months, Disability (Quebec questionnaire), quality of life (SF-12) at 1 and 12 months, anxiety and depression (HAD), analgesics and anti-inflammatories during the last week, return to work, assessment of the disabilities at 1 and 12 months and disc inflammation (on MRI) at 12 months. Tolerance and adverse effects will be recorded. Trial duration: 36 months(24 months for inclusion and 12 months follow-up) Follow-up visits: at 1, 3, 6, and 12 months Statistical analysis: intention to treat

Official Title
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Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial

Conditions
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Back Pain Lower Back Chronic

Intervention / Treatment
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* Drug: Visipaque - Hydrocortancyl
* Drug: Placebo comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visipaque - Hydrocortancyl<br>Administration of two treatments for the experimental arm | Drug: Visipaque - Hydrocortancyl<br>* Visipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route<br>|
| Placebo Comparator: Visipaque<br>Administration of only one treatment in intra discal of visipaque | Drug: Placebo comparator<br>* Visipaque - 320 mg I/ml - 1 ml in intra-discal route<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain level at 12 months |  | 12 months | 
| Disability (Quebec questionnaire) |  | 1 month and 12 months | 
| quality of life (SF-12) at 1 and 12 months |  | 1 month and 12 months | 
| anxiety and depression (HAD) |  | 1 month and 12 months | 
| disc inflammation (on MRI) at 12 month |  | 12 months | 
| analgesics and anti-inflammatories during the last week |  | 1 month and 12 months | 
| return to work |  | 1 month and 12 months | 
| Assessment of the disabilities (scale of 6 classes) |  | 1 month and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, steroid injection, inter-vertebral disc, randomized trial, Lack of efficacy of usual recommended treatments, More than 40 on the pain numeric scale (0-100), Inflammatory discopathy (MODIC I) on MRI