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A Randomized, Controlled, Double-Blind Trial of Fluoroscopic Caudal Epidural Injections in the Treatment of Lumbar Disc Herniation and Radiculitis

Manchikanti, Laxmaiah, MD*,‡; Singh, Vijay, MD; Cash, Kimberly A., RT*; Pampati, Vidyasagar, MSc*; Damron, Kim S., RN*; Boswell, Mark V., MD, PhD

doi: 10.1097/BRS.0b013e31823294f2
Randomized Trial

Study Design. A randomized, controlled, double-blind trial.

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

Summary of Background Data. The available literature on the effectiveness of epidural injections in managing chronic low back pain secondary to disc herniation is highly variable.

Methods. One hundred twenty patients suffering with low back and lower extremity pain with disc herniation and radiculitis were randomized to one of the two groups: group I received caudal epidural injections with an injection of local anesthetic, lidocaine 0.5%, 10 mL; group II patients received caudal epidural injections with 0.5% lidocaine, 9 mL, mixed with 1 mL of steroid.

The Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake were utilized with assessment at 3, 6, and 12 months posttreatment.

Results. The percentage of patients with significant pain relief of 50% or greater and/or improvement in functional status with 50% or more reduction in ODI scores was seen in 70% and 67% in group I and 77% and 75% in group II with average procedures per year of 3.8 ± 1.4 in group I and 3.6 + 1.1 in group II. However, the relief with first and second procedures was significantly higher in the steroid group. The number of injections performed was also higher in local anesthetic group even though overall relief was without any significant difference among the groups. There was no difference among the patients receiving steroids.

Conclusion. Caudal epidural injection with local anesthetic with or without steroids might be effective in patients with disc herniation or radiculitis. The present evidence illustrates potential superiority of steroids compared with local anesthetic at 1-year follow-up.

This randomized, controlled, double-blind trial evaluating the effectiveness of caudal epidural injections in the treatment of lumbar disc herniation and radiculitis showed significant improvement in both groups of patients with or without steroids at 1-year follow-up, with potential superiority of steroids.

*Pain Management Center of Paducah, Paducah, KY

Pain Diagnostics Associates, Niagara, WI

Department of Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KY

Address correspondence and reprint requests to Laxmaiah Manchikanti, MD, 2831 Lone Oak Road, Paducah, KY 42003; E-mail:

Acknowledgment date: June 24, 2010. First revision date: September 9, 2010. Acceptance date: September 13, 2010.

The drugs used in the subject of this manuscript are FDA approved for this indication and are commercially available in the United States.

No funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.

© 2011 Lippincott Williams & Wilkins, Inc.