Preliminary Results of a Randomized, DoubleBlind, Controlled Trial of Fluoroscopic Lumbar Interlaminar Epidural Injections in Managing Chronic Lumbar Discogenic Pain Without Disc Herniation or Radiculitis

Background: Low back pain without disc herniation is the most common problem among chronicpain disorders. Epidural injections are commonly used interventions in managing chronic low backpain without disc herniation. However, little evidence exists regarding the effectiveness, indications,and medical necessity of lumbar epidural injections in managing axial low back pain without discherniation or radiculitis.Study Design: A randomized, double-blind, controlled trial.Setting: An interventional pain management practice, a specialty referral center, a private practicesetting in the United States.Objectives: To evaluate the ability to provide effective and long-lasting pain relief with lumbarinterlaminar epidural injections with local anesthetic with or without steroids in managing chroniclow back pain not caused by disc herniation or radiculitis.Methods: Patients were randomly assigned to one of 2 groups with Group I patients receivinglocal anesthetic only, whereas Group II patients received local anesthetic mixed with non-particulatebetamethasone. Seventy patients were included in this analysis. Randomization was performed bycomputer-generated random allocation sequence by simple randomization.Outcomes Assessment: Outcome measures included the Numeric Rating Scale (NRS), theOswestry Disability Index 2.0 (ODI), employment status, and opioid intake. The assessments weredone at baseline, 3 months, 6 months, and 12 months post-treatment.Significant pain relief and/or improvement in disability were defined as at least 50% improvement.Results: Significant pain relief (≥ 50%) was demonstrated in 74% of patients in Group I and 63%in Group II. Functional status improvement (reduction of ≥ 50%) in the ODI scores was seen in 71%of patients in Group I and 60% of patients in Group II. The overall average procedures per year wereapproximately 4.Limitations: The results of this study are limited by the lack of a placebo group and that it is apreliminary report of 35 patients in each group with a total of 70 patients.Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroidswas effective in 63% and 74% of patients with chronic function-limiting low back pain withoutfacet joint pain, disc herniation, and/or radiculitis.Key words: Chronic low back pain, lumbar interlaminar epidural injections, discogenic pain, discherniation, radiculitis, local anesthetic, steroids, controlled comparative local anesthetic blocks