A randomized, double-blind, active-controlled trial of fluoroscopic lumbar interlaminar epidural injections in chronic axial or discogenic low back pain: Results of 2-year follow-up

Abstract

Background: Chronic low back with or without lower extremity pain is extremely common, expensive, and disabling. Although it is responsible for a very small proportion of patients, disc herniation is the primary focus of modalities of treatments. In fact, chronic low back pain without disc herniation is common. Multiple modalities of treatments are utilized in managing axial or discogenic pain without disc herniation including surgery, intradiscal therapies, and epidural injections. There is, however, continued debate on the effectiveness, indications, and medical necessity of all modalities of treatments in managing axial or discogenic pain in the lumbar spine. Objectives: To assess the effectiveness of lumbar interlaminar epidural injections in managing chronic axial or discogenic low back pain with epidural injections of local anesthetic with or without steroids. Study Design: A randomized, double-blind, active-controlled trial. Setting: A private practice, specialty referral, interventional pain management practice in the United States. Methods: In this study, a total of 120 patients were randomly allocated to one of 2 groups of 60 patients receiving either local anesthetic alone or local anesthetic with steroids. The primary outcome measure was at least a 50% improvement in the numeric rating scale (NRS) and Oswestry Disability Index (ODI). Outcomes were assessed at 3, 6, 12, 18, and 24 months post treatment. Results: Significant pain relief and functional status improvement, defined as a reduction in scores from baseline of at least 50% or more, were observed in 72% of patients receiving local anesthetic alone and 67% of patients receiving local anesthetic with steroids. Opioid intake was reduced from the baseline in each group for 2 years. 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 without steroids are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis.