Clinical trial NCT00804531: Intra-discal Steroid Injection for MODIC I Discopathy
Official title: Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Back Pain Lower Back Chronic
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 1 month
Secondary outcomes:
measure: pain level at 12 months
timeFrame: 12 months
measure: Disability (Quebec questionnaire)
timeFrame: 1 month and 12 months
measure: quality of life (SF-12) at 1 and 12 months
timeFrame: 1 month and 12 months
measure: anxiety and depression (HAD)
timeFrame: 1 month and 12 months
measure: disc inflammation (on MRI) at 12 month
timeFrame: 12 months
measure: analgesics and anti-inflammatories during the last week
timeFrame: 1 month and 12 months
measure: return to work
timeFrame: 1 month and 12 months
measure: Assessment of the disabilities (scale of 6 classes)
timeFrame: 1 month and 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Serge Poiraudeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.