A randomized placebo-controlled trial of single-dose IM corticosteroid for radicular low back pain

Spine (Phila Pa 1976). 2008 Aug 15;33(18):E624-9. doi: 10.1097/BRS.0b013e3181822711.

Abstract

Study design: A randomized, double-blind, placebo-controlled trial of patients with radicular low back pain who present to an emergency department (ED) within 1 week of pain onset.

Objective: We hypothesized that a single intramuscular 160 mg dose of methylprednisolone acetate would improve pain and functional outcomes 1 month after ED discharge if the corticosteroid were administered early in disease symptomotology.

Summary of background data: Parenteral corticosteroids are not recommended for acute, radicular low back pain, though their role in this disease process is ill-defined. To date, this medication class has only been studied in a highly selected group of patients requiring hospitalization. METHODS.: Adults between the ages of 21 and 50 who presented to an ED with low back pain and a positive straight leg raise test were enrolled. The primary outcome was change in pain intensity on an 11 point numerical rating scale 1 month after ED visit. Secondary outcomes 1 month after ED discharge included analgesic use, functional disability, and adverse medication effects.

Results: Six hundred thirty-seven patients were approached for participation, 133 were eligible, and 82 were randomized. Baseline characteristics were comparable between the groups. The primary outcome, a comparison of the mean improvement in pain intensity, favored methylprednisolone by 1.3 (P = 0.10). Some secondary outcomes favored methylprednisolone, such as use of analgesic medication within the previous 24 hours (22% vs. 43%, 95% CI for difference of 20%: 0%-40%) and functional disability (19% vs. 49%, 95% CI for difference of 29%: 9%-49%). Adverse medication effects 1 week after ED discharge were reported by 32% of methylprednisolone and 24% of placebo patients (95% CI for difference of 9%: -12% to 30%).

Conclusion: This study was a negative study, though there was a suggestion of benefit of methylprednisolone acetate in a population of young adults with acute radicular low back pain. Further work with a larger sample of patients is needed.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adrenal Cortex Hormones / administration & dosage*
  • Adult
  • Double-Blind Method
  • Female
  • Humans
  • Injections, Intramuscular
  • Low Back Pain / drug therapy*
  • Low Back Pain / pathology
  • Male
  • Methylprednisolone / administration & dosage
  • Methylprednisolone / analogs & derivatives
  • Methylprednisolone Acetate
  • Middle Aged
  • Radiculopathy / drug therapy*
  • Radiculopathy / pathology

Substances

  • Adrenal Cortex Hormones
  • Methylprednisolone Acetate
  • Methylprednisolone