1. 2012;15;273-286Effect of Fluoroscopically Guided Caudal Epidural Steroid or Local Anesthetic Injections in the Treatment of Lumbar Disc Herniation and Radiculitis: A Randomized, Controlled, Double Blind Trial with a Two-Year Follow-Up
   Randomized Trial
   Kim S. Damron, RN, Vidyasagar Pampati, MSc, Kimberly A. Cash, RT, Vijay Singh, MD, Laxmaiah Manchikanti, MD, and Mark V. Boswell, MD, PhD.

BACKGROUND: Lumbar disc herniation and radiculitis are common elements of low back and lower extremity pain. Among minimally invasive treatments, epidural injections are one of the most commonly performed interventions. However, the literature is mixed about their effectiveness in managing low back and lower extremity pain. In general, individual studies and systematic reviews of epidural steroid injections have been hampered by their study design, baseline differences between treatment groups, inadequate sample sizes, highly controlled settings, lack of validated outcome measures, and the inability to confirm the injectate location because fluoroscopy was not used.

STUDY DESIGN: A randomized, controlled, double blind, active control trial.

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

OBJECTIVES: To assess the effectiveness of fluoroscopically directed caudal epidural injections with local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis.

METHODS: One hundred twenty patients were randomized to two groups: Group I received 10 mL caudal epidural injections of local anesthetic, lidocaine 0.5%; Group II patients received caudal epidural injections of 0.5% lidocaine, 9 mL, mixed with 1 mL of steroid.

OUTCOME ASSESSMENT: Multiple outcome measures were utilized. The primary outcome measures were Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake.

Significant pain relief improvement was defined as 50% or more improvement in NRS and ODI scores.

RESULTS: In the successful category, 77% of Group I had significant pain relief of >/= 50% and functional status improvement of >/=  50% reduction in ODI scores; in Group II it was 76%, whereas overall it was 60% and 65% in Groups I and II. Over the two years, Group I had an average number of procedures of 5.5 ± 2.8; Group II was 5.3 ± 2.4. Even though there was no significant difference in overall relief between the two groups, the average relief for each procedure was superior for steroids.

LIMITATIONS: Presumed limitations of this evaluation include lack of a placebo group.

CONCLUSION: Caudal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the potential superiority of steroids compared with local anesthetic at two year follow up based on average relief per procedure.

TRIAL REGISTRATION: NCT00370799