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Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis
  1. Tim Davis, MD*,
  2. Eric Loudermilk, MD,
  3. Michael DePalma, MD,
  4. Corey Hunter, MD§,
  5. David Lindley, DO,
  6. Nilesh Patel, MD**,
  7. Daniel Choi, MD††,
  8. Marc Soloman, MD‡‡,
  9. Anita Gupta, DO, PharmD§§,
  10. Mehul Desai, MD∥∥,
  11. Asokumar Buvanendran, MD*** and
  12. Leonardo Kapural, MD, PhD†††
  1. *Orthopedic Pain Specialists, Santa Monica, CA
  2. Piedmont Comprehensive Pain Management Group, Greenville, SC
  3. Virginia iSpine Physicians, Richmond, VA
  4. §Ainsworth Institute of Pain, New York, NY
  5. Interventional Pain Management of Texas, Mineral Wells, TX
  6. **Advanced Pain Management, Greenfield, WI
  7. ††Valley Pain Consultants, Scottsdale
  8. ‡‡Valley Anesthesia Consultants, Phoenix, AZ
  9. §§Department of Anesthesiology and Perioperative Medicine, Drexel University, Philadelphia, PA
  10. ∥∥International Spine, Pain & Performance Center, Washington, DC
  11. ***Department of Anesthesiology, Rush University Medical Center, Chicago, IL
  12. †††Center for Clinical Research, Winston Salem, NC
  1. Address correspondence to: Leonardo Kapural, MD, PhD, Carolinas Pain Institute, 145 Kimel park Drive, Res, Winston Salem, NC 27103 (e-mail: lkapuralmd{at}gmail.com).

Abstract

Background and Objectives Osteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain.

Methods This is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention.

Results There were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events.

Conclusions This study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.

Clinical Trial Registration ClinicalTrials.gov (NCT02343003).

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Footnotes

  • Financial support was provided to each of the investigator's institutions by Halyard Health, Inc, 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 independent of Halyard Health, Inc.

    This study and its results have been accepted and/or presented as poster and platform abstracts at the 15th Annual Pain Medicine Meeting of the American Society of Regional Anesthesia and Pain Medicine, November 17–19, 2016, in San Diego, CA, and at the 2017 Annual Meeting of the American Academy of Pain Medicine, March 16–19, 2017, in Orlando, FL.

    T.D., M. DePalma, A.B., M. Desai, and L.K. are members of the clinical advisory board for Halyard Health, Inc. The other authors declare no conflict of interest.

    This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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