Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial

• Type of Material: Article
• Authors: Masayoshi Takashima, Houston Methodist Hospital; J. Stolovitzky, Emory University; Randall A Ow, Sacramento Ear Nose and Throat Medical and Surgical Group, Roseville CA; Stacey L Silvers, Madison ENT & Facial Plastic Surgery, New York NY; Nadim B Bikhazi, The Ogden Clinic, Ogden UT; Curtis D Johnson, ENT and Allergy Associates of Florida, Plantation FL
• Language: English
• Date: 2022-07-05
• Publisher: WILEY
• Publication Version: Final Published Version
• Copyright Statement: © 2022 The Authors. International Forum of Allergy & Rhinology published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngic Allergy and American Rhinologic Society.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1002/alr.23047
• Title of Journal or Parent Work: INTERNATIONAL FORUM OF ALLERGY & RHINOLOGY
• Volume: 13
• Issue: 2
• Start Page: 107
• End Page: 115
• Keywords: Science & Technology; neurolysis; rhinitis; Life Sciences & Biomedicine; radiofrequency ablation; congestion; Otorhinolaryngology; NERVE; posterior nasal nerve; rhinorrhea

Abstract

Background: Temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis was previously reported as superior to a sham-control procedure at 3 months postprocedure in a randomized controlled trial (RCT). The primary endpoint was a responder rate of ≥30% improvement (decrease) for 24-hour reflective total nasal symptom score (rTNSS) compared with baseline. Herein, 12-month outcomes after active treatment are reported. Methods: In this prospective, multicenter, patient-blinded RCT, patients in the index active treatment arm were unblinded at 3 months and followed through 12 months. At 3 months, eligible patients from the sham-control arm of the study were invited to crossover to active treatment. Eligibility criteria included rTNSS ≥6, with moderate-severe rhinorrhea and mild-severe congestion. The TCRF stylus was applied bilaterally to nonoverlapping areas in the region of the PNN. Results: Patients in the index active treatment arm (n = 77) had a mean baseline rTNSS of 8.3 (95% confidence interval [CI], 7.9-8.7). At 12 months, the responder rate was 80.6% (n = 67) (95% CI, 69.1%-89.2%). At 12 months, the mean change in rTNSS was −4.8 (95% CI, −5.5 to −4.1; p < 0.001), a 57.8% improvement. The available initial rTNSS-based outcomes in the crossover active treatment arm (n = 27) were following the same course as the index treatment arm. No serious adverse events and 8 adverse events related to the device/procedure were reported in the trial to date. Conclusion: TCRF neurolysis of the PNN area is safe and the symptom burden improvement that was superior to a sham procedure at 3 months was sustained through 12 months.