Intra-discal Steroid Injection for MODIC I Discopathy (PREDID)

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

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

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

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

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

Nguyen C, Boutron I, Baron G, Sanchez K, Palazzo C, Benchimol R, Paris G, James-Belin E, Lefevre-Colau MM, Beaudreuil J, Laredo JD, Bera-Louville A, Cotten A, Drape JL, Feydy A, Ravaud P, Rannou F, Poiraudeau S. Intradiscal Glucocorticoid Injection for Patients With Chronic Low Back Pain Associated With Active Discopathy: A Randomized Trial. Ann Intern Med. 2017 Apr 18;166(8):547-556. doi: 10.7326/M16-1700. Epub 2017 Mar 21.

Daste C, Abdoul H, Foissac F, Lefevre-Colau MM, Poiraudeau S, Rannou F, Nguyen C. Patient acceptable symptom state for patient-reported outcomes in people with non-specific chronic low back pain. Ann Phys Rehabil Med. 2022 Jan;65(1):101451. doi: 10.1016/j.rehab.2020.10.005. Epub 2020 Nov 26.