You are here

  • Home
  • Online First
  • Non-inferiority study assessing the utility of postcervical and lumbar radiofrequency ablation steroid use

Article Text

Article menu
Download PDFPDF
Chronic and interventional pain
Non-inferiority study assessing the utility of postcervical and lumbar radiofrequency ablation steroid use
  1. Mark R Williams1,
  2. Annie Philip1,
  3. Soun Sheen2,
  4. Saumya Aujla1,
  5. Changyong Feng3,
  6. Shan Gao3,
  7. Sarah Kralovic1,
  8. Joseph Poli1,
  9. Tammy Ortiz1,
  10. Tatsiana Stefanos1,
  11. Janet Pennella-Vaughan1 and
  12. Jennifer S Gewandter1
  1. 1Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, New York, USA
  2. 2Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  3. 3Department of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, USA
  1. Correspondence to Dr Mark R Williams, Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY 14642, USA; mark1_williams{at}urmc.rochester.edu

Abstract

Introduction Many physicians administer steroids after radiofrequency ablation (RFA) to mitigate postprocedural inflammation and decrease postprocedural pain. However, robust evidence supporting the benefits of steroids after RFA is lacking and steroids have risks.

Methods This study was a single-center, prospective, observational study designed to assess whether RFA alone is inferior to RFA with steroids for postprocedure pain. Eligible patients were at least 18 years of age and scheduled to undergo cervical or lumbar RFA. The primary outcome measure was the average pain score on the numeric rating scale (NRS) 7 days after the RFA. The secondary outcome measures included anxiety, depression and physical function, measured via the Patient-Reported Outcomes Measurement Information System short forms. All outcome measures were completed prior to the procedure and at 7 and 60 days postprocedure.

Results Out of the 365 participants who completed baseline assessments, 175 received steroids and 190 did not receive steroids. The pain intensity at 7 days postprocedure was similar between the steroid and non-steroid groups (mean difference (steroid−non-steroid): −0.23). The 95% CI of the estimate (−0.76 to 0.30) was within the prespecified non-inferiority margin of 1.5 NRS points. Similar results were obtained for pain at 60 days (mean difference: 0.09; 95% CI −0.48 to 0.65). No significant differences between groups were observed for anxiety, depression or physical function at either 7 or 60 days.

Conclusion This study suggests that the addition of steroids to the RFA procedure does not provide added benefits and is therefore not worth the additional risks that they pose.

  • Pain Management
  • analgesia
  • Back Pain
  • Injections, Spinal
  • Neck Pain

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/rapm-2024-105501

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    Data availability statement

    Data are available upon reasonable request.

    View Full Text

    Footnotes

    • MRW and AP are joint first authors.

    • Contributors MW and AGP contributed to the design of the study, conducted the study, contributed to data collection, statistical analyses and contributed to first draft and revisions of the manuscript. MW is the guarantor. SS and SA contributed to data collection and first draft and provided input on subsequent drafts of the manuscript. CF contributed to design of analyses, oversaw statistical analyses and provided input on first draft and subsequent drafts of the manuscript. SG contributed to design of analyses, performed statistical analyses and provided input on first draft and subsequent drafts of the manuscript. SK and JP contributed to data collection and provided input on subsequent drafts of the manuscript. TO and TS contributed to data collection and revisions of manuscript. JP-V contributed to the design of protocol and revisions of manuscript. JG contributed to the design of the study and statistical analyses and contributed to first draft and revisions of the manuscript.

    • Funding This work was supported by funds from the Department of Anesthesiology and Perioperative Medicine and a grant from the National Institutes of Health (K24NS126861).

    • Competing interests JG has received compensation from Neurometrix for serving on a scientific advisory board (past relationship) and grant funding for an investigator-initiated trial in an unrelated indication. Neurometrix had no influence over the design, analysis, interpretation or writing of this manuscript. In the past 36 months, JG has also received consulting income from Algo Therapeutix, Eikonizo Therapeutics, Eli Lilly, GW Pharma, Hoba Therapeutics and Saluda Medical. She owns vesting shares in Eisana Corp. She has also received personal compensation for serving as Associate Editor for the Clinical Journal of Pain.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.