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

doi:10.3344/kjp.2022.35.3.336

. 2022 Jul 1;35(3):336-344.

doi: 10.3344/kjp.2022.35.3.336.

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 Lee^{2

3}, Eugene Lee², Jin S Yeom^{4

5}, Ki-Jeong Kim^{6

7}, Hyung-Ik Shin⁸, Heung Sik Kang²

Affiliations

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

PMID: 35768989
PMCID: PMC9251387
DOI: 10.3344/kjp.2022.35.3.336

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 Lee et al. Korean J Pain. 2022.

. 2022 Jul 1;35(3):336-344.

doi: 10.3344/kjp.2022.35.3.336.

Authors

Guen Young Lee¹, Joon Woo Lee^{2

3}, Eugene Lee², Jin S Yeom^{4

5}, Ki-Jeong Kim^{6

7}, Hyung-Ik Shin⁸, Heung Sik Kang²

Affiliations

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

PMID: 35768989
PMCID: PMC9251387
DOI: 10.3344/kjp.2022.35.3.336

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; Epidural; Incidence; Injections; Pain; Spine; Steroids..

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Conflict of interest statement

CONFLICT OF INTEREST

No potential conflict of interest relevant to this article was reported.

Figures

**Fig. 1**
Trial profile: flow diagram of this study. ESI-dexa: epidural steroid injection with dexamethasone, ESI-beta: epidural steroid injection with betamethasone.

**Fig. 2**
Change of pain intensity (VAS) along follow-up period (0-, 2-, 4-, and 8-week) with 95% CI using linear mixed model. The error bars indicate 95% CIs. VAS: visual analog scale, CI: confidence interval, ESI-dexa: epidural steroid injection with dexamethasone, ESI-beta: epidural steroid injection with betamethasone.

**Fig. 3**
Change of disability score (ODI or NDI) along follow-up period (0-, 2-, 4-, and 8-week) with 95% CI using linear mixed model. The error bars indicate 95% CIs. ODI: Oswestry disability index, NDI: neck disability index, CI: confidence interval, ESI-dexa: epidural steroid injection with dexamethasone, ESI-beta: epidural steroid injection with betamethasone.

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References

1. Manchikanti L, Boswell MV, Datta S, Fellows B, Abdi S, Singh V, et al. Comprehensive review of therapeutic interventions in managing chronic spinal pain. Pain Physician. 2009;12:E123–98. doi: 10.36076/ppj.2009/12/E123. - DOI - PubMed
1. Shah RV. Paraplegia following thoracic and lumbar transforaminal epidural steroid injections: how relevant are particulate steroids? Pain Pract. 2014;14:297–300. doi: 10.1111/papr.12110. - DOI - PubMed
1. El Abd O, Amadera J, Pimentel DC, Gomba L. Immediate and acute adverse effects following transforaminal epidural steroid injections with dexamethasone. Pain Physician. 2015;18:277–86. doi: 10.36076/ppj.2015/18/277. - DOI - PubMed
1. Gharibo CG, Fakhry M, Diwan S, Kaye AD. Conus medullaris infarction after a right l4 transforaminal epidural steroid injection using dexamethasone. Pain Physician. 2016;19:E1211–4. doi: 10.36076/ppj/2016.19.E1211. - DOI - PubMed
1. Laemmel E, Segal N, Mirshahi M, Azzazene D, Le Marchand S, Wybier M, et al. Deleterious effects of intra-arterial administration of particulate steroids on microvascular perfusion in a mouse model. Radiology. 2016;279:731–40. doi: 10.1148/radiol.2015142746. - DOI - PubMed

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[1] Manchikanti L, Boswell MV, Datta S, Fellows B, Abdi S, Singh V, et al. Comprehensive review of therapeutic interventions in managing chronic spinal pain. Pain Physician. 2009;12:E123–98. doi: 10.36076/ppj.2009/12/E123. - DOI - PubMed

[2] Manchikanti L, Boswell MV, Datta S, Fellows B, Abdi S, Singh V, et al. Comprehensive review of therapeutic interventions in managing chronic spinal pain. Pain Physician. 2009;12:E123–98. doi: 10.36076/ppj.2009/12/E123. - DOI - PubMed

[3] Shah RV. Paraplegia following thoracic and lumbar transforaminal epidural steroid injections: how relevant are particulate steroids? Pain Pract. 2014;14:297–300. doi: 10.1111/papr.12110. - DOI - PubMed

[4] Shah RV. Paraplegia following thoracic and lumbar transforaminal epidural steroid injections: how relevant are particulate steroids? Pain Pract. 2014;14:297–300. doi: 10.1111/papr.12110. - DOI - PubMed

[5] El Abd O, Amadera J, Pimentel DC, Gomba L. Immediate and acute adverse effects following transforaminal epidural steroid injections with dexamethasone. Pain Physician. 2015;18:277–86. doi: 10.36076/ppj.2015/18/277. - DOI - PubMed

[6] El Abd O, Amadera J, Pimentel DC, Gomba L. Immediate and acute adverse effects following transforaminal epidural steroid injections with dexamethasone. Pain Physician. 2015;18:277–86. doi: 10.36076/ppj.2015/18/277. - DOI - PubMed

[7] Gharibo CG, Fakhry M, Diwan S, Kaye AD. Conus medullaris infarction after a right l4 transforaminal epidural steroid injection using dexamethasone. Pain Physician. 2016;19:E1211–4. doi: 10.36076/ppj/2016.19.E1211. - DOI - PubMed

[8] Gharibo CG, Fakhry M, Diwan S, Kaye AD. Conus medullaris infarction after a right l4 transforaminal epidural steroid injection using dexamethasone. Pain Physician. 2016;19:E1211–4. doi: 10.36076/ppj/2016.19.E1211. - DOI - PubMed

[9] Laemmel E, Segal N, Mirshahi M, Azzazene D, Le Marchand S, Wybier M, et al. Deleterious effects of intra-arterial administration of particulate steroids on microvascular perfusion in a mouse model. Radiology. 2016;279:731–40. doi: 10.1148/radiol.2015142746. - DOI - PubMed

[10] Laemmel E, Segal N, Mirshahi M, Azzazene D, Le Marchand S, Wybier M, et al. Deleterious effects of intra-arterial administration of particulate steroids on microvascular perfusion in a mouse model. Radiology. 2016;279:731–40. doi: 10.1148/radiol.2015142746. - DOI - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

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