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

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.

• Authors: Benjamin W Friedman, David Esses, Clemencia Solorzano, Hong K Choi, Michael Cole, Michelle Davitt, Polly E Bijur, E J Gallagher
• Journal: Spine (Spine (Phila Pa 1976)) Vol. 33 Issue 18 Pg. E624-9 (Aug 15 2008) ISSN: 1528-1159 [Electronic] United States
• PMID: 18665021 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Chemical References

• Adrenal Cortex Hormones
• Methylprednisolone Acetate
• Methylprednisolone

Topics

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