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

Abstract

BackgroundNasal 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).MethodsIn 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.ResultsAt 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.ConclusionThis RCT shows temperature‐controlled RF treatment of the nasal valve is safe and effective in reducing symptoms of NAO in short‐term follow‐up.