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Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial
  1. Tim Davis1,
  2. Eric Loudermilk2,
  3. Michael DePalma3,
  4. Corey Hunter4,
  5. David A Lindley5,
  6. Nileshkumar Patel6,
  7. Daniel Choi7,
  8. Marc Soloman8,
  9. Anita Gupta9,
  10. Mehul Desai10,
  11. Elizabeth Cook6 and
  12. Leonardo Kapural11
  1. 1 Orthopedic Pain Specialists, Santa Monica, California, USA
  2. 2 Piedmont Comprehensive Pain Management Group, Greenville, South Carolina, USA
  3. 3 Virginia iSpine Physicians, Richmond, Virginia, USA
  4. 4 Ainsworth Institute of Pain, New York City, New York, USA
  5. 5 Interventional Pain Management of Texas, Mineral Wells, Texas, USA
  6. 6 Advanced Pain Management, Greenfield, Wisconsin, USA
  7. 7 Valley Pain Consultants, Scottsdale, Arizona, USA
  8. 8 Valley Anesthesia Consultants, Phoenix, Arizona, USA
  9. 9 Drexel University, Philadelphia, Pennsylvania, USA
  10. 10 International Spine, Pain & Performance Center, Washington, Washington DC, USA
  11. 11 Center for Clinical Research, Winston Salem, North Carolina, USA
  1. Correspondence to Dr Leonardo Kapural, Center for Clinical Research, Winston Salem, NC 27103, USA; lkapural{at}


Background and objectives As a follow-up to the 6-month report,12 this study investigated the analgesic effect of cooled radiofrequency ablation (CRFA) in patients with knee osteoarthritis (OA) 12 months postintervention and its ability to provide pain relief in patients who experienced unsatisfactory effects of intra-articular steroid injection (IAS).

Methods Seventy-eight per cent (52/67) of patients originally treated with CRFA were evaluated at 12 months, while at 6 months post-IAS, 82% (58/71) of those patients crossed over to CRFA and assessed 6 months later.

Results At 12 months, 65% of the original CRFA group had pain reduction ≥50%, and the mean overall drop was 4.3 points (p<0.0001) on the numeric rating scale. Seventy-five per cent reported ‘improved’ effects. The cross-over group demonstrated improvements in pain and functional capacity (p<0.0001). No unanticipated adverse events occurred.

Conclusions This study demonstrates that analgesia following CRFA for OA knee pain could last for at least 12 months and could rescue patients who continue to experience intolerable discomfort following IAS.

Clinical trial registration The registration number for this study is NCT02343003.

  • chronic pain
  • radiofrequency ablation
  • clinical pain
  • interventional pain management

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  • Contributors All authors equally contributed in completing this manuscript.

  • Funding Financial support was provided to each of the investigator’s institutions by Halyard Health to cover the budgeted costs necessary to conduct this study protocol. Data management, study site monitoring and statistics services were performed by a third party, independently of Halyard Health.

  • Disclaimer This study and its 6-month results were presented as poster and platform abstracts at the American Society of Regional Anesthesia and Pain Medicine (ASRA) 2016 (November) Meeting in San Diego, California, USA, and the American Academy of Pain Medicine (AAPM) 2017 (March) Meeting in Orlando, Florida, USA, and have been published in manuscript form in Regional Anesthesia and Pain Medicine. The 12-month data in this report were presented at the European Society of Regional Anesthesia (ESRA) Congress 2017 in Lugano, Switzerland.

  • Competing interests TD, DePalma, MD, and LK are paid consultants (clinicaladvisory board) for Halyard Health.

  • Patient consent for publication Obtained.

  • Ethics approval This study was approved for engagement by the Western Institutional Review Board (IRB; Puyallup, Washington, USA) and Rush University Medical Center IRB (Chicago, Illinois, USA).

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