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Randomized Controlled Trial
. 2008 Aug 15;33(18):E624-9.
doi: 10.1097/BRS.0b013e3181822711.

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

Benjamin W Friedman  1 , David Esses, Clemencia Solorzano, Hong K Choi, Michael Cole, Michelle Davitt, Polly E Bijur, E J Gallagher
Affiliations
Randomized Controlled Trial

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

Benjamin W Friedman et al. Spine (Phila Pa 1976). .

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.

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Conflict of interest statement

Disclosure: The authors report no conflicts of interest.

Figures

Figure 1
Figure 1
CONSORT flow diagram
See this image and copyright information in PMC

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