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

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.

Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Carragee reports travel support from the US Army, grants from the Orthopaedic Research and Education Foundation and AOSpine, and options from Simpirica and Intrinsic Orthopedics. No other disclosures were reported.

Figures

Figure 1. Flow of Participants in Randomized, Double-Blind Trial of Oral Prednisone vs Placebo Through 3-Week (Primary) and 52-Week (Secondary) Follow-up

MRI indicates magnetic resonance imaging; ODI, Oswestry Disability Index. a One of the 2 participants lost to 3-week follow-up visits was lost to follow-up for the entire study after the baseline visit. The other participant was contacted and included in the final 52-week follow-up.

Figure 2. Scores on the Oswestry Disability Index and Pain Numerical Rating Scale

Observed mean values for the (A) Oswestry Disability Index (ODI) and (B) pain numerical rating scale (NRS) for average pain below the waist in the prior 3 days in the prednisone-treated and placebo-treated groups. The ODI is measured on a 0- to 100-point scale, with higher numbers indicating more functional disability. The pain NRS is measured on a 0- to 10-point scale, with higher numbers indicating more pain. Treatment occurred during the first 15 days after randomization. Errors bars indicate 95% CIs.