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

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.

Radiofrequency Neurolysis of the Posterior Nasal Nerve: A Systematic Review and Meta‐Analysis

“…Allergic, non-allergic, and mixed subtypes of rhinitis were all included, but seasonal allergies were excluded in three studies. [7][8][9] Patients with altered anatomy of the posterior nose as a result of prior sinus or nasal surgery/injury or who had prior procedure/surgery for chronic rhinitis were excluded in three of the studies. [7][8][9] All five studies were pragmatic in their design, which meant that concomitant medications for chronic rhinitis were not discontinued or controlled for.…”

“…8 Postnasal drip and cough scores were measured in four out of the five studies, where these symptoms also improved significantly from baseline to each follow up time point (Table II). 7,[9][10][11] Quality of Life (QoL) Measures Two studies evaluated patient QoL outcomes, and both showed an overall improvement in QoL with treatment. 7,11 Lee 2022 used the mini-RQLQ, which is a validated questionnaire that consists of 14 questions in five domains (activity limitations, practical problems, nose symptoms, eye symptoms, and other symptoms), with a maximum score of 14 points.…”

“…Four studies reported nasal pain as measured by the VAS immediately post-procedure, and during follow up at 1 month and/or 3 months (Table II). [7][8][9][10] Nasal pain was recorded on either a 10-cmVAS 8,9 or 100-point VAS 7,10 with 0 being no pain and 10 cm or 100 points indicating the worst pain possible. The post-procedure VAS reported in the studies were all lower than 20 points if on 100-point scale or lower than 2.5 cm if on the 10-cm scale.…”

“…Since the approval of the Rhinaer system by the Food and Drug Administrations (FDA) in 2020, there have been several studies published that have investigated its efficacy in reducing chronic rhinitis symptoms. [7][8][9][10][11] This systematic review seeks to evaluate the existing literature to determine if radiofrequency neurolysis of the PNN as a single procedure is effective in reducing symptoms among adult chronic rhinitis patients.…”

Cadaveric analysis of autonomic nerve fiber density in posterior nasal, posterolateral nasal, and anterior ethmoid nerves

“…Studies on surgical interventions for rhinitis have shown success with posterior nasal nerve (PNN) cryoablation, 3 radiofrequency, 4 or endoscopic posterior nasal neurectomy (EPNN) 2,3 . These interventions remove postganglionic parasympathetic nasal innervation, which helps avoid endoscopic vidian neurectomy (EVN)‐related complications like xerophthalmia and facial/palatal hypesthesia 3,5 …”