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

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.

Long-term Outcomes Following Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Chronic Rhinitis

“… 7 , 8 TCRF neurolysis of the PNN demonstrated superiority over a sham procedure at 3 months postprocedure in a randomized controlled trial. 9 In a separate single-arm study, the procedure showed a significant reduction in rhinitis symptom burden (efficacy) through 12 months, as measured by the reflective total nasal symptom score (rTNSS). 10 Here, we report safety and efficacy results of long-term follow-up of that same single-arm study at 24 months, in addition to patient quality of life (QoL) data and the extent of patient satisfaction with the procedure.…”

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2021

“…This product has similarities to RhinAer (Aerin Medical) and Clarifix (Stryker) in direct ablative targeting of the posterior nasal nerve. 9 , 10 The primary differences relate to the geometry of the electrode array. The device is operated via a slider and an activation switch on the handle.…”

Posterior nasal nerve neurectomy for the treatment of rhinitis: a systematic review and meta-analysis

“…Del Signore et al used variable block size distribution by site with a 1:1 allocation [15]. Stolovitzky et al used a 2:1 site-stratified block randomization [16]. In both RCTs the patients were blinded to their assignment and blindfolded during the treatment.…”

“…All were carried out in the USA and six out of the eight had industry sponsorship. Follow up periods varied between 3 months [13,14,15,16], 9 months [17], 12 months [18,19], and 24 months [20].…”

“…In the seven studies that reported on patient demographics, the average age ranged from 53.3 years [18] to 60 years [14]. Gender split ranged from 35% male [16] to 50% male [19]. Chang et al [17] and Ow et al [20] reported results from the same patient cohort (pilot data and longer term follow up respectively).…”