Acute lumbar radiculopathy is characterized by radiating buttock and leg pain in a lumbar nerve root distribution caused by herniation of the nucleus pulposus. It has a lifetime prevalance greater than 10% and can result in significant pain and disability. Epidural steroid injections and lumbar diskectomy are commonly performed, however oral steroids may provide the same anti-inflammatory benefits are less invasive, less expensive, and can be readily prescribed by primary care physicians. Over the past 35 years, 6 comparative trials have studied the use of nonepidural steroids in patients with sciatica and did not find steroid therapy to be effective, however these studies have been small with low statistical power.
Are oral steroids more effective than placebo in improving function and pain in patients with acute sciatica?
Patients 18 – 70 years old with leg pain extending below the knee in a nerve root distribution, with a herniated disc confirmed on MRI, and an Oswestry Disability Index (ODI) score > 30
Prednisone 60mg for 5 days, then 40mg for 5 days, then 20mg for 5 days
Primary: Self-reported ODI change at 3 weeks
Secondary: ODI change at 1 year, Change in lower extremity pain on a scale from 0 – 10, Spine surgery, Short Form 36 Health Survey Physical Component Summary and Mental Component Summary
Randomized, double-blind, placebo-controlled clinical trial
Onset of radicular pain > 3 months prior
Previous lumbar surgery
Oral or epidural steroid treatment in past 3 months
Substantial or progressive motor loss
Ongoing litigation or worker’s compensation claim
A short course of prednisone compared to placebo resulted in a minimal improvement in function but no improvement in pain.
- At 3 weeks, participants receiving prednisone showed 5.6 point reduction in ODI scores compared to those in the placebo group (p = 0.01)
- At 3 weeks, 88 participants in the prednisone group (49.2%) reported at least 1 adverse event, most of which were minor and expected from short-term use of prednisone – insomnia, nervousness, increased appetite; compared to 23.9% in the placebo group (p < 0.001)
- No severe adverse events related to use of study medication
- There was no statistically significant difference between groups in lower extremity pain scores at 3 weeks or 52 weeks
- Over 1 year, there was no significant difference between groups in the likelihood of undergoing spine surgery (p = 0.68)
- Effective randomization
- High adherence to intervention
- High follow-up rates (99.3% at 3 weeks)
- Use of standardized patient reported outcomes
- NSAIDs were not allowed for 3 weeks after randomization. This is not standard care of acute low back pain
- Study does not clarify use of other treatment modalities (advise, education, self care, medications) followed by physical therapy, ultrasound, electrical stimulation, epidural steroids, and microdiskectomy
- Patient population limited to Kaiser Permanente in Northern California
- Partially successful blinding due to common adverse effects of oral steroids
- Limited generalizability of results since all patients had a positive MRI and baseline ODI > 30
- High likelihood of unblinding – the authors note that 74.7% of patients in the prednisone group thought they were on prednisone. This may be due to the significant bitter taste of prednisone tablets.
“Among patients with acute radiculopathy due to a herniated lumbar disc, a short course of oral steroids, compared with placebo, resulted in modest improvement in function and no significant improvement in pain.”
In patients with moderate disability from lumbar radicular symptoms with confirmed lumber disk prolapse on MRI, a short course of prednsione (15 days) resulted in a small improvement of function with unclear clinical benefit and no reduction in pain at 3 weeks making this treatment of limited utility.
Potential Impact To Current Practice
These results are unlikely to change clinical practice as the change in disability was small and of unclear clinical benefit.
A short course of prednisone is unlikely to provide any significant benefit to patients with sciatic pain.