Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial

• Type of Material: Article
• Authors: J. Stolovitzky, Emory University; Randall A Ow, Sacramento Ear Nose and Throat Medical and Surgical Group; Stacey L Silvers, Madison ENT & Facial Plastic Surgery; Nadim B Bikhazi, The Ogden Clinic; Curtis D Johnson, ENT and Allergy Associates of Florida; Mayayoshi Takashima, Houston Methodist Hospital
• Language: English
• Date: 2021-01-01
• Publisher: John Wiley & Sons, Inc.
• Publication Version: Final Published Version
• Copyright Statement: © The Authors 2021
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1177/2473974X211041124
• Title of Journal or Parent Work: OTO Open
• Volume: 5
• Issue: 3
• Start Page: 2473974X211041124
• End Page: 2473974X211041124
• Grant/Funding Information: This trial was sponsored by Aerin Medical. The sponsor also provided funding for data analysis and manuscript preparation assistance by independent consultants and reviewed the content of the manuscript; however, the final content was solely the responsibility of the authors.
• Keywords: radiofrequency ablation; rhinorrhea; posterior nasal nerve; neurolysis; congestion; rhinitis
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

Objective: To determine the safety and efficacy of temperature-controlled radiofrequency (RF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis. Study Design: A multicenter, prospective, single-blinded, randomized controlled trial, in which the control arm underwent a sham procedure. Setting: Sixteen otolaryngology centers. Methods: Patients with 24-hour reflective Total Nasal Symptom Score (rTNSS) ≥6, including moderate to severe rhinorrhea and mild to severe congestion, were randomized 2:1 to active treatment of the posterior nasal nerve area with a temperature-controlled RF device or a sham procedure, with no RF energy delivery. The stylus was applied bilaterally to nonoverlapping areas of the posterior middle meatus and posterior inferior turbinate in each nostril in the region of the PNN. The primary endpoint was responder rate at 3 months, where a response was defined as ≥30% improvement (decrease) in rTNSS from baseline. Results: Patients had a mean baseline rTNSS of 8.3 (95% CI, 7.9-8.7) and 8.2 (95% CI, 7.6-8.8) (P =.797) in the active treatment (n = 77) and sham control (n = 39) arms, respectively. At 3 months, responder rate was significantly higher in the active treatment arm: 67.5% (95% CI, 55.9%-77.8%) vs 41.0% (95% CI, 25.6%-57.9%) (P =.009). The active treatment arm had a significantly greater decrease in rTNSS (mean, −3.6 [95% CI, −4.2 to −3.0] vs −2.2 [95% CI, −3.2 to −1.3]) (P =.013). Three adverse events related to the device/procedure were reported, and all resolved. Conclusion: This randomized controlled trial showed temperature-controlled neurolysis of the PNN area is free from significant adverse events and superior to a sham procedure in decreasing the symptom burden of chronic rhinitis.