Session Information
Date: Thursday, November 14, 2019
Session Title: Research Spotlight: Spine and Pain Medicine
Session Time: 2:30pm-3:15pm
Location: Research Hub - Live Theater
Disclosures: Michael J. DePalma, MD: Mesoblast; Vivex; Samumed; Discgenics; Halyard: Research Grant or Support
Objective: This prospective, randomized, multi-center study was conducted to compare pain relief, functional improvement, and the safety of Coolief* Cooled radiofrequency ablation (CRFA) to Hyaluronic Acid (HA) to treat osteoarthritis (OA) knee pain.
Design: Randomized, Controlled, Multicenter Study.
Setting: Outpatient procedure
Participants: 177 subjects randomly assigned to the CRFA or HA groups.
Interventions: We performed CRFA on 4 genicular nerves compared to a single intraarticular injection of HA.
Main Outcome Measures: One-hundred seventy-seven patients underwent diagnostic block injections and those who had a minimum of 50% pain relief were randomized to receive either CRFA or a single HA injection. One hundred and seventy-five patients were treated (n=88 CRFA and 89 HA) and subsequently evaluated for pain (numerical rating system=NRS), function (WOMAC), Global Perceived Effect (GPE), and safety at 1, 3, and 6 months.
Results: The two treatment groups had statistically similar demographics and pain at baseline. One hundred and fifty-eight patients completed 6-months post treatment (n=76 CRFA and 82 HA). In the CRFA group, 71.1% of patients (95%CI 60.9-81.2) had ≥50% reduction in NRS pain score compared to 37.8% (95%CI 27.3-48.3) in the HA group (P<.0001, primary endpoint). The mean NRS was 2.7±2.3 for the CRFA group and 4.5±2.7 for the HA group (P<.0001). The mean WOMAC score improvement from baseline was 48.2% in the CRFA group and 22.6% in the HA group (P<.0001). At 6 months, 72.4% (55/76) of subjects in the CRFA group reported improvement in Global Perceived Effect compared to 40.2% (33/82) in the HA group (P<.0001). No serious adverse events related to either procedure were noted, and overall adverse event profiles were similar.
Conclusions: In this study, CRFA treated patients demonstrated a significant improvement in pain relief and overall function compared to patients treated with HA. Further follow-up from this study will evaluate the long-term durability of cooled RFA in this patient population.
Level of Evidence: Level I
To cite this abstract in AMA style:
DePalma MJ, Chen AF, Khalouf F, Zora KM, Kohan L, Guirguis M, Beall D, Pingree M, Badiola I, Lyman J. A Prospective, Multi-center, Randomized, Clinical Trial Comparing the Effectiveness and Safety of Cooled Radiofrequency Ablation versus Hyaluronic Acid in the Management of Osteoarthritis Knee Pain [abstract]. PM R. 2019; 11(S2)(suppl 2). https://pmrjabstracts.org/abstract/a-prospective-multi-center-randomized-clinical-trial-comparing-the-effectiveness-and-safety-of-cooled-radiofrequency-ablation-versus-hyaluronic-acid-in-the-management-of-osteoarthritis-knee-pain/. Accessed May 12, 2025.« Back to AAPM&R Annual Assembly 2019
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/a-prospective-multi-center-randomized-clinical-trial-comparing-the-effectiveness-and-safety-of-cooled-radiofrequency-ablation-versus-hyaluronic-acid-in-the-management-of-osteoarthritis-knee-pain/