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  • Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study

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Original research
Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study
  1. Steven P Cohen1,
  2. Leonardo Kapural2,
  3. Lynn Kohan3,
  4. Sean Li4,
  5. Robert W Hurley5,
  6. Richard Vallejo6,
  7. Yashar Eshraghi7,
  8. Pradeep Dinakar8,
  9. Shravani Durbhakula1,
  10. Douglas P Beall9,
  11. Mehul J Desai10,
  12. David Reece11,
  13. Sandy Christiansen12,
  14. Min Ho Chang13,
  15. Adam J Carinci14 and
  16. Michael DePalma15
  1. 1 Pain Medicine Division, Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
  2. 2 Carolinas Pain Institute, Winston-Salem, North Carolina, USA
  3. 3 Divsion of Pain Medicine, Department of Anesthesia, University of Virginia, Charlottesville, Virginia, USA
  4. 4 Premier Pain Centers, Shrewsbury, New Jersey, USA
  5. 5 Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA
  6. 6 NSPC Millennium Pain Center, Bloomington, Illinois, USA
  7. 7 Ochsner Clinic Foundation, New Orleans, Louisiana, USA
  8. 8 Brigham and Women's Hospital, Boston, Massachusetts, USA
  9. 9 Clinical Investigations, LLC, Edmond, Oklahoma, USA
  10. 10 International Spine, Pain & Performance Center, Washington, DC, USA
  11. 11 Physical Medicine & Rehabilitation, Walter Reed National Military Medical Center, Bethesda, Maryland, USA
  12. 12 Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, Oregon, USA
  13. 13 Womack Army Medical Center, Fort Bragg, North Carolina, USA
  14. 14 Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, New York, USA
  15. 15 Virginia iSpine Physicians Interventional Spine Care, Richmond, Virginia, USA
  1. Correspondence to Dr Steven P Cohen, Pain Medicine Division, Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA; scohen40{at}jhmi.edu

Abstract

Introduction Low back pain is the leading cause of disability worldwide, with sacroiliac joint pain comprising up to 30% of cases of axial lower back pain. Conservative therapies provide only modest relief. Although placebo-controlled trials show efficacy for sacral lateral branch cooled radiofrequency ablation, there are no comparative effectiveness studies.

Methods In this randomized, multicenter comparative effectiveness study, 210 patients with clinically suspected sacroiliac joint pain who obtained short-term benefit from diagnostic sacroiliac joint injections and prognostic lateral branch blocks were randomly assigned to receive cooled radiofrequency ablation of the L5 dorsal ramus and S1–S3 lateral branches or standard medical management consisting of pharmacotherapy, injections and integrative therapies. The primary outcome measure was mean reduction in low back pain score on a 0–10 Numeric Rating Scale at 3 months. Secondary outcomes included measures of quality of life and function.

Results 3 months post-treatment, the mean Numeric Rating Scale pain score for the cooled radiofrequency ablation group was 3.8±2.4 (mean reduction 2.5±2.5) compared with 5.9±1.7 (mean reduction 0.4±1.7) in the standard medical management group (p<0.0001). 52.3% of subjects in the cooled radiofrequency ablation group experienced >2 points or 30% pain relief and were deemed responders versus 4.3% of standard medical management patients (p<0.0001). Comparable improvements favoring cooled radiofrequency ablation were noted in Oswestry Disability Index score (mean 29.7±15.2 vs 41.5+13.6; p<0.0001) and quality of life (mean EuroQoL-5 score 0.68±0.22 vs 0.47±0.29; p<0.0001).

Conclusions In patients with sacroiliac joint pain, cooled radiofrequency ablation provided statistically superior improvements across the spectrum of patient outcomes compared with standard medical management.

Trial registration number NCT03601949.

  • Anesthesia, Local
  • Back Pain
  • Pain Management
  • CHRONIC PAIN

Data availability statement

No data are available.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, an indication of whether changes were made, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/rapm-2023-104568

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    Data availability statement

    No data are available.

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    Footnotes

    • Twitter @kohanlynn, @ShravaniD_MD

    • Correction notice This article has been corrected since it published Online First. The 'Role of funding organization' paragraph has been corrected.

    • Contributors All authors were involved in the acquisition of data. SPC, LKa, LKo and SL were responsible for the design of the study, drafting the work, revisions and final approval. SPC is the guarantor for the data, ensuring that questions related to the accuracy of the manuscript are appropriately investigated and resolved.

    • Funding Financial support was provided to each of the study investigators’ institutions by Avanos Medical, the manufacturer of the device under study, to cover the budgeted costs necessary to conduct the study protocol. Sponsor was responsible for identifying and managing independent statisticians, study monitors and data management. Editorial assistance was provided by the sponsor.

    • Disclaimer The views expressed in this manuscript are those of the authors and do not reflect the official policy of the Departments of Army and Navy, Department of Defense, or the US government. The identification of specific products or scientific instrumentation is considered an integral part of the scientific endeavor and does not constitute endorsement or implied endorsement on the part of the authors, the Department of Defense, or any component agency.

    • Competing interests All authors received institutional research funding. SPC, LKa, LKo, SL, DPB and MJD are consultants for Avanos (which makes radiofrequency equipment). Currently, SPC is the editorial board member of RAPM.

    • 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.