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JAMA. 2015 May 19;313(19):1915-23. doi: 10.1001/jama.2015.4468.

Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial.

Author information

1
Kaiser Permanente Northern California Spine Care Program, San Jose2Division of Research, Kaiser Permanente Northern California, Oakland.
2
Kaiser Permanente Northern California Spine Care Program, Redwood City.
3
Kaiser Permanente Northern California Spine Care Program, Roseville.
4
Division of Research, Kaiser Permanente Northern California, Oakland5Sutter Health Research, Development, and Dissemination, Walnut Creek, California.
5
Division of Research, Kaiser Permanente Northern California, Oakland.
6
Kaiser Permanente Northern California Spine Care Program, San Jose.
7
Orthopedic Spine Surgery Division, Department of Orthopedics, Stanford University, Palo Alto, California.
8
Division of Research, Kaiser Permanente Northern California, Oakland7Department of Medicine, University of California, San Francisco8Department of Epidemiology and Biostatistics, University of California, San Francisco.

Abstract

IMPORTANCE:

Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial.

OBJECTIVE:

To determine if oral prednisone is more effective than placebo in improving function and pain among patients with acute sciatica.

DESIGN, SETTING, AND PARTICIPANTS:

Randomized, double-blind, placebo-controlled clinical trial conducted from 2008 to 2013 in a large integrated health care delivery system in Northern California. Adults (n=269) with radicular pain for 3 months or less, an Oswestry Disability Index (ODI) score of 30 or higher (range, 0-100; higher scores indicate greater dysfunction), and a herniated disk confirmed by magnetic resonance imaging were eligible.

INTERVENTIONS:

Participants were randomly assigned in a 2:1 ratio to receive a tapering 15-day course of oral prednisone (5 days each of 60 mg, 40 mg, and 20 mg; total cumulative dose = 600 mg; n = 181) or matching placebo (n = 88).

MAIN OUTCOMES AND MEASURES:

The primary outcome was ODI change at 3 weeks; secondary outcomes were ODI change at 1 year, change in lower extremity pain (measured on a 0-10 scale; higher scores indicate more pain), spine surgery, and Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores (0-100 scale; higher scores better).

RESULTS:

Observed baseline and 3-week mean ODI scores were 51.2 and 32.2 for the prednisone group and 51.1 and 37.5 for the placebo group, respectively. The prednisone-treated group showed an adjusted mean 6.4-point (95% CI, 1.9-10.9; P = .006) greater improvement in ODI scores at 3 weeks than the placebo group and a mean 7.4-point (95% CI, 2.2-12.5; P = .005) greater improvement at 52 weeks. Compared with the placebo group, the prednisone group showed an adjusted mean 0.3-point (95% CI, -0.4 to 1.0; P = .34) greater reduction in pain at 3 weeks and a mean 0.6-point (95% CI, -0.2 to 1.3; P = .15) greater reduction at 52 weeks. The prednisone group showed an adjusted mean 3.3-point (95% CI, 1.3-5.2; P = .001) greater improvement in the SF-36 PCS score at 3 weeks, no difference in the SF-36 PCS score at 52 weeks (mean, 2.5; 95% CI, -0.3 to 5.4; P = .08), no change in the SF-36 MCS score at 3 weeks (mean, 2.2; 95% CI, -0.4 to 4.8; P = .10), and an adjusted 3.6-point (95% CI, 0.6-6.7; P = .02) greater improvement in the SF-36 MCS score at 52 weeks. There were no differences in surgery rates at 52-week follow-up. Having 1 or more adverse events at 3-week follow-up was more common in the prednisone group than in the placebo group (49.2% vs 23.9%; P < .001).

CONCLUSIONS AND RELEVANCE:

Among patients with acute radiculopathy due to a herniated lumbar disk, a short course of oral steroids, compared with placebo, resulted in modestly improved function and no improvement in pain.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT00668434.

PMID:
25988461
PMCID:
PMC5875432
DOI:
10.1001/jama.2015.4468
[Indexed for MEDLINE]
Free PMC Article

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