Clinical Pearls & Morning Reports
Bailey et al. conducted a single-center, randomized, controlled trial to determine whether lumbar diskectomy was superior to standardized nonsurgical care in patients with sciatica lasting 4 to 12 months and caused by lumbar disk herniation. Read the NEJM Original Article here.
Q: Has the treatment of chronic sciatica caused by herniation of a lumbar disk been as well studied as sciatica caused by acute disk herniation?
A: The treatment of chronic sciatica caused by herniation of a lumbar disk has not been well studied in comparison with acute disk herniation. Sciatica that is caused by acute herniation of a lumbar disk is expected to improve with conservative care in 90% of patients within 4 months after the onset of symptoms. Several randomized trials involving patients with acute sciatica have shown a short-term benefit of surgery over conservative care, but outcomes with these two approaches are similar by 6 to 12 months. However, these trials do not address sciatica in patients who have more persistent symptoms, since the majority of patients who were recruited had symptoms with a duration of less than 3 months.
Q: What elements comprised “standard care” in the nonsurgical group in the trial by Bailey et al.?
A: Nonsurgical treatment was standardized to include education of patients regarding day-to-day functioning, activity and exercise, use of oral analgesics, and use of active physiotherapy provided at the discretion of physiotherapists not associated with the trial. In addition, patients could receive an epidural glucocorticoid injection administered by a fellowship-trained anesthesiologist. Patients could receive a second or third injection at the discretion of the treating physician on the basis of their response to the previous injection. Patients were seen by a physiatrist or trial physician specializing in spinal care to provide medications and education, as well as assessment of the response to nonsurgical treatment on a 6-week basis for a minimum of 6 months.
A: The primary outcome was the leg-pain intensity score on the visual analogue scale (ranging from 0 to 10, with higher scores indicating a greater intensity of pain) at 6 months after randomization. At 6 months, the score for leg-pain intensity was 2.8±0.4 in the surgical group and 5.2±0.4 in the nonsurgical group (difference, 2.4; 95% confidence interval [CI], 1.4 to 3.4; P<0.001). Secondary outcomes were generally in the same direction as the primary outcome. At 1 year, the leg-pain intensity score was 2.6±0.4 in the surgical group and 4.7±0.4 in the nonsurgical group. The absence of a prespecified plan for adjustment for multiple comparisons does not allow for clinical inferences from secondary outcomes.
A: The authors found that the treatment effect for secondary outcome measures (e.g., back pain and physical functioning) at both 6 months and 12 months were in the same direction as the primary outcome, but a formal analysis was not possible because the original statistical plan made no accommodation for multiple comparisons.