HOME
pISSN 2005-9159
eISSN 2093-0569

Clinical Research Article

Korean J Pain 2022; 35(3): 336-344

Published online July 1, 2022 https://doi.org/10.3344/kjp.2022.35.3.336

Copyright © The Korean Pain Society.

Evaluation of the efficacy and safety of epidural steroid injection using a nonparticulate steroid, dexamethasone or betamethasone: a double-blind, randomized, crossover, clinical trial

Guen Young Lee1 , Joon Woo Lee2,3 , Eugene Lee2 , Jin S. Yeom4,5 , Ki-Jeong Kim6,7 , Hyung-Ik Shin8 , Heung Sik Kang2

1Department of Radiology, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong, Korea
2Department of Radiology, Seoul National University Bundang Hospital, Seongnam, Korea
3Department of Radiology, Seoul National University College of Medicine, Seoul, Korea
4Department of Orthopedic Surgery, Seoul National University Bundang Hospital, Seongnam, Korea
5Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, Korea
6Department of Neurosurgery, Seoul National University Bundang Hospital, Seongnam, Korea
7Department of Neurosurgery, Seoul National University College of Medicine, Seoul, Korea
8Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea

Correspondence to:Joon Woo Lee
Department of Radiology, Seoul National University Bundang Hospital, 82 Gumiro, 173beon-gil, Gumi-ro, Bundang-gu, Seongnam 13620, Korea
Tel: +82-31-787-7616
Fax: +82-31-787-4011
E-mail: joonwoo2@gmail.com

Handling Editor: Jeong-Gill Leem

Author contributions: Guen Young Lee: Writing/manuscript preparation; Joon Woo Lee: Study conception; Eugene Lee: Investigation; Jin S. Yeom: Investigation; Ki-Jeong Kim: Writing/manuscript preparation; Hyung-Ik Shin: Resources; Heung Sik Kang: Supervision.

Received: December 14, 2021; Revised: April 1, 2022; Accepted: April 4, 2022

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background: The U.S. Food and Drug Administration has prohibited epidural steroid injection (ESI) with particulate steroids. Thus, this study aimed to compare the efficacy and safety of ESI with two nonparticulate steroids, dexamethasone and betamethasone.
Methods: The eligible patients (n = 600) who received ESI (0 week) with dexamethasone (ESI-dexa) or betamethasone (ESI-beta) had follow-up visits at 2, 4, and 8 weeks with a phone interview at 12 weeks. The primary endpoint was the proportion of effective responders without pain or who were much improved at 2 weeks. The secondary endpoints were the proportion of crossover injections at 2 weeks; changes in the visual analog scale (VAS) and disability index scores at 2, 4, and 8 weeks; the number of additional ESIs in 12 weeks; the number of participants having spinal surgery, as well as the incidence of adverse events over the 12 weeks.
Results: The proportion of effective responders at 2 weeks was not different between ESI-beta (72/216, 33.3%) and ESI-dexa (63/200, 31.5%; P = 0.670). Adverse events were more common with ESI-dexa (40/200, 20.0%) than with ESI-beta (24/216, 11.1%; P = 0.012). VAS scores decreased more with ESI-beta than with ESI-dexa at 2 weeks (difference, 0.35; P = 0.023) and 4 weeks (difference, 0.42; P = 0.011). The disability score improved significantly more with ESI-beta compared with ESI-dexa at 2 weeks (difference, 3.37; P = 0.009), 4 weeks (difference, 4.01; P = 0.002), and 8 weeks (difference, 3.54; P = 0.007).
Conclusions: Betamethasone would be more appropriate for ESI.

Keywords: Betamethasone, Comparative Study, Dexamethasone, Incidence, Injections, Epidural, Pain, Spine, Steroids.