1. 2012;13;E279-E292Preliminary Results of a Randomized, Double-Blind, Controlled Trial of Fluoroscopic Lumbar Interlaminar Epidural Injections in Managing Chronic Lumbar Discogenic Pain Without Disc Herniation or Radiculitis
   Randomized Trial
   Ramsin M. Benyamin, MD, Vidyasagar Pampati, MSc, Kimberly A. Cash, RT, Carla D. McManus, RN, BSN, and Laxmaiah Manchikanti, MD.

BACKGROUND: Low back pain without disc herniation is the most common problem among chronic pain disorders. Epidural injections are commonly used interventions in managing chronic low back pain 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 disc herniation or radiculitis.

STUDY DESIGN: A randomized, double-blind, controlled trial.

SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States.

OBJECTIVES: To evaluate the ability to provide effective and long-lasting pain relief with lumbar interlaminar epidural injections with local anesthetic with or without steroids in managing chronic low back pain not caused by disc herniation or radiculitis.

METHODS:  Patients were randomly assigned to one of 2 groups with Group I patients receiving local anesthetic only, whereas Group II patients received local anesthetic mixed with non-particulate betamethasone. Seventy patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization.

OUTCOMES ASSESSMENT: Outcome measures included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. The assessments were done 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 were approximately 4.

LIMITATIONS:  The results of this study are limited by the lack of a placebo group and a preliminary report of 35 patients in each group with a total of 70 patients.

CONCLUSION:  Lumbar interlaminar epidural injections of local anesthetic with or without steroids was effective in 63% and 74% of patients with chronic function-limiting low back pain without facet joint pain, disc herniation, and/or radiculitis.
CLINICAL TRIAL: NCT00681447