Epidural steroid injections for spinal stenosis back pain simply don't work

Objective. To determine the effectiveness of epidural injections of glucocorticoids plus anesthetic compared with injections of anesthetic alone in patients with lumbar spinal stenosis. Design. The LESS (Lumbar Epidural Steroid Injection for Spinal Stenosis) trial-a double-blind, multisite, randomized controlled trial. Setting and participants. The study was conducted at 16 sites in the United States and enrolled 400 patients between April 2011 and June 2013. Patients at least 50 years of age with spinal stenosis as evidenced by magnetic resonance imaging (MRI) or computed tomography (CT) were invited to participate. Additional eligibility criteria included an average pain rating of more than 4 on a scale of 0 to 10 (0 being the lowest score) for back, buttock, or leg pain. Patients were excluded if they did not have stenosis of the central canal, had spondylolisthesis requiring surgery, or had received epidural glucocorticoid injections within the previous 6 months. Patients were randomly assigned to receive a standard epidural injection of glucocorticoids plus lidocaine or lidocaine alone. At the 3-week follow-up they could choose to receive a repeat injection. At the 6-week assessment they were allowed to cross over to the other treatment group. Patients were blinded throughout the study. The treating physicians were also blinded through the use of 2 opaque prefilled syringes provided by the study staff-one marked "inject" and one marked "discard." Main outcome measures. The 2 outcomes, measured at 6 weeks, were the Roland-Morris Disability Questionnaire (RMDQ) score (range, 0 to 24, with higher scores indicating greater physical disability) and the patient's rating of average buttock, hip, or leg pain in the previous week (scale of 0 to 10 with 0 indicating no pain and 10 indicating "pain as bad as you can imagine"). Eight secondary patient-oriented outcomes were also measured: (1) at least minimal clinically meaningful improvement (≥ 30%), (2) substantial clinically meaningful improvement (≥ 50%), (3) average back pain in the previous week, and scores on the (4) Brief Pain Inventory (BPI) interference scale, (5) 8-question Patient Health Questionnaire (PHQ-8), (6) Generalized Anxiety Disorder 7 scale (GAD-7), (7) EQ-5D (a health status measure) and (8) Swiss Spinal Stenosis Questionnaire (SSSQ). Main results. The 2 groups were similar with respect to baseline characteristics, except that the duration of pain was shorter in the lidocaine-alone group. At 6 weeks, both groups had improved RMDQ scores (glucocorticoid -4.2 points vs. no glucocorticoid -3.1 points, respectively). However, the difference in RMDQ score between the 2 groups was not statistically significant (-1.0 points [95% CI, -2.1 to 0.1]; P = 0.07). In addition, there was no difference in treatment effect at 6 weeks as measured by patient's reported leg pain (-0.2 points [95% CI, -0.8 to 0.4]; P = 0.48). Furthermore, there were no significant differences in the secondary outcomes of clinically meaningful improvement, BPI, SSSQ symptoms and physical function, EQ-5D, and GAD-7 scales at 6 weeks. Among the secondary outcomes, only symptoms of depression and patient satisfaction showed a statistically significant improvement in the glucocorticoid plus lidocaine group. Of note, though not statistically significant, there were more adverse events in the glucocorticoid plus lidocaine group compared to the lidocaine alone group (21.5% vs. 15.5%, respectively). Finally, the glucocorticoid plus lidocaine group also had a significantly higher proportion of patients with cortisol serum suppression compared to the lidocaine alone group. Conclusion. The authors concluded that there was no difference in pain-related functional disability (as measured by the RMDQ score) and pain intensity between patients receiving fluoroscopically guided epidural injections with glucocorticoids plus lidocaine compared with lidocaine alone for lumbar spinal stenosis. The injection of glucocorticoid should be avoided due to its potentially systemic effects, including suppression of the hypothalamic-pituitary axis and reduction in bone mineral density, which may increase the risk of fracture.