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.

Abstract

Background: Active discopathy is associated with a specific phenotype of chronic low back pain (LBP). Local inflammation has a role in active discopathy-associated symptoms.

Objective: To assess the efficacy of a single glucocorticoid intradiscal injection (GC IDI) in patients with chronic LBP with active discopathy.

Design: Prospective, parallel-group, double-blind, randomized, controlled study. (ClinicalTrials.gov: NCT00804531).

Setting: 3 tertiary care centers in France.

Patients: 135 patients with chronic LBP with active discopathy on magnetic resonance imaging (MRI).

Intervention: A single GC IDI (25 mg prednisolone acetate) during discography (n = 67) or discography alone (n = 68).

Measurements: The primary outcome was the percentage of patients with LBP intensity less than 40 on an 11-point numerical rating scale (0 [no pain] to 100 [maximum pain] in 10-point increments) in the previous 48 hours at 1 month after the intervention. The main secondary outcomes were LBP intensity and persistent active discopathy on MRI at 12 months and spine-specific limitations in activities, health-related quality of life, anxiety and depression, employment status, and use of analgesics and nonsteroidal anti-inflammatory drugs at 1 and 12 months.

Results: All randomly assigned patients were included in the primary efficacy analysis. At 1 month after the intervention, the percentage of responders (LBP intensity <40) was higher in the GC IDI group (36 of 65 [55.4%]) than the control group (21 of 63 [33.3%]) (absolute risk difference, 22.1 percentage points [95% CI, 5.5 to 38.7 percentage points]; P = 0.009). The groups did not differ in LBP intensity at 12 months and in most secondary outcomes at 1 and 12 months.

Limitation: Tertiary care setting.

Conclusion: In chronic LBP associated with active discopathy, a single GC IDI reduces LBP at 1 month but not at 12 months.

Primary funding source: French Ministry of Health.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Chronic Pain / complications*
  • Chronic Pain / drug therapy*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Glucocorticoids / administration & dosage*
  • Glucocorticoids / adverse effects
  • Humans
  • Injections
  • Intervertebral Disc
  • Intervertebral Disc Degeneration / complications*
  • Intervertebral Disc Displacement / complications*
  • Low Back Pain / complications*
  • Low Back Pain / drug therapy*
  • Male
  • Middle Aged
  • Prednisolone / administration & dosage
  • Prednisolone / adverse effects
  • Prednisolone / analogs & derivatives*
  • Prospective Studies
  • Treatment Outcome

Substances

  • Glucocorticoids
  • prednisolone acetate
  • Prednisolone

Supplementary concepts

  • Intervertebral disc disease

Associated data

  • ClinicalTrials.gov/NCT00804531