Back Pain Lower Back Chronic
Conditions
Keywords
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
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 imaging. Hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients with inflammatory discopathy
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 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
Interventions
DRUGVisipaque - Hydrocortancyl
Visipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route
DRUGPlacebo comparator
Visipaque - 320 mg I/ml - 1 ml in intra-discal route
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| pain level at 12 months | 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 |
| disc inflammation (on MRI) at 12 month | 12 months |
Countries
France
Outcome results
None listed