Temperature-Controlled Radiofrequency for Severe Nasal Airway Obstruction: A Non-Inferiority Comparison With Surgical Intervention

Abstract

Introduction

Temperature-controlled radiofrequency (TCRF), septoplasty (ST) with turbinate reduction, and functional rhinoplasty (FR) are treatment options for nasal airway obstruction (NAO) and nasal valve dysfunction (NVD), but no direct comparison of these procedures has been performed.

Methods

This prospective, open-label, non-inferiority (NI) trial, conducted at 29 US sites, used a prespecified NI margin and inverse probability of treatment weighting to simulate randomization and facilitate an unbiased comparison of TCRF to ST and FR in adults with Nasal Obstruction Symptom Evaluation scores ≥ 55 and NVD. NI was determined using a 15% difference in the 3-month responder rate (≥ 24-point NOSE score improvement) for TCRF compared to ST and FR. Additional analyses included return to work/regular activities (RTW) and adverse events (AEs).

Results

A total of 174 patients were treated (116 TCRF and 58 surgery [35 ST, 23 FR]). At 3 months, TCRF was non-inferior to surgery with a 90.5% responder rate compared to 94.3% for ST (mean difference: 0.04 [95% CI, −0.02 to 0.11]; p < 0.001) and 95.7% for FR (mean difference: −0.12 [95% CI, −0.23 to 0]; p < 0.001). TCRF median RTW was 1 day versus 5.5 and 7.5 days for ST and FR, respectively. TCRF had fewer AEs than surgery (6.9% TCRF patients vs. 19.0% for surgical arms combined).

Conclusions

TCRF patient treatment response was non-inferior to ST and FR, with fewer AEs and faster RTW. These findings support TCRF as a minimally invasive alternative to nasal surgery for patients with NAO and NVD.

Trial Registration

ClinicalTrials.gov identifier: NCT06922955