A Randomized, Double-Blind, Active-Control Trial of the Effectiveness of Lumbar Interlaminar Epidural Injections in Disc Herniation

Background: Among the multiple nonsurgical modalities, epidural injections are one ofthe most commonly utilized treatment modalities in managing chronic low back and lowerextremity pain due to disc herniation and radiculitis. There is a paucity of randomized trialsfrom contemporary interventional pain management settings utilizing fluoroscopy withlong-term follow-up.Study Design: Randomized, double-blind, active-controlled trial with 2-year follow-up.Setting: An interventional pain management practice in the United States.Objective: The objective was to assess the effectiveness of lumbar interlaminar epiduralinjections of local anesthetic with or without steroids for managing chronic low back painof disc herniation or radiculitis.Methods: Two groups of patients were studied, with 60 patients in each group receivingeither local anesthetic only or local anesthetic mixed with betamethasone.Outcome Measures: The primary outcome measure was defined as pain relief andfunctional status improvement of 50%. The outcomes were assessed by numeric ratingscale (NRS) of pain and functional status with Oswestry Disability Index (ODI). Secondaryoutcome measures included employment status and opioid intake.Results: Results showed significant improvement in 60% of patients in Group I and 70%of patients in Group II at the end of 2 years. In addition, in the successful groups, thosewith at least 3 weeks of relief (with the first 2 procedures), the improvement was 72% inGroup I and 71% in Group II. Results were somewhat superior for pain relief at 6 monthsand functional status at 12 months in the steroid group. Thus, the results indicate thata patient’s failure to respond to local anesthetic alone, may be treated with addition ofsteroids.Limitations: The results of the study are limited by the lack of a placebo group.Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or withoutsteroids is an effective modality, in patients with chronic function limiting low back andlower extremity pain secondary to disc herniation after failure of conservative modalities.Key words: Lumbar disc herniation, lumbar radiculitis, lumbar interlaminar epiduralinjections, local anesthetic, steroids, randomized controlled trial, active-controlled trial