Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial

Background Nasal valve collapse is one of several causes of nasal obstruction. The safety and efficacy of a temperature-controlled radiofrequency (RF) device for the treatment of the nasal valve for nasal airway obstruction (NAO) has been established in single-arm studies. The objective of this trial was to compare active device treatment against a sham procedure (control). Methods In a prospective, multicenter, single-blinded, randomized controlled trial (RCT), patients were assigned to bilateral temperature-controlled RF treatment of the nasal valve (n = 77) or a sham procedure (n = 41), in which no RF energy was transferred to the device/treatment area. The device was applied to the mucosa over the lower lateral cartilage on the lateral nasal wall. The primary endpoint was responder rate at 3 months, defined as a >= 20% reduction in Nasal Obstruction Symptom Evaluation (NOSE)-scale score or >= 1 reduction in clinical severity category. Results At baseline, patients had a mean NOSE-scale score of 76.7 (95% confidence interval [CI], 73.8 to 79.5) and 78.8 (95% CI, 74.2 to 83.3) (p = 0.424) in the active treatment and sham-control arms, respectively. At 3 months, the responder rate was significantly higher in the active treatment arm (88.3% [95% CI, 79.2%-93.7%] vs 42.5% [95% CI, 28.5%-57.8%]; p < 0.001). The active treatment arm had a significantly greater decrease in NOSE-scale score (mean, -42.3 [95% CI, -47.6 to -37.1] vs -16.8 [95% CI, -26.3 to -7.2]; p < 0.001). Three adverse events at least possibly related to the device and/or procedure were reported, and all resolved. Conclusion This RCT shows temperature-controlled RF treatment of the nasal valve is safe and effective in reducing symptoms of NAO in short-term follow-up.