Impedance-Controlled Multipoint Radiofrequency Ablation for Chronic Rhinitis: A Randomized Controlled Trial.

BACKGROUND

The purpose of this randomized controlled trial (RCT) was to demonstrate that posterior nasal nerve ablation treatment with the NEUROMARK System is superior to a sham control procedure in patients with chronic rhinitis.

METHODS

In this prospective, multicenter, single-blinded, superiority RCT, 132 participants were randomized 2:1 to the active treatment arm (88) and sham control arm (44). The primary endpoint was the comparison of the reflective Total Nasal Symptom Score (rTNSS) responder rate between study arms at 90-day follow-up. Secondary efficacy outcomes included postnasal drip, chronic cough, Nasal Obstruction Symptom Evaluation (NOSE), mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ), and Patient Health Questionnaire-9 (PHQ-9) (a depression assessment).

RESULTS

The responder rate was significantly higher for the active treatment arm: 73.3% (95% confidence interval [CI], 64.0%-82.7%) compared to the sham control arm: 35.0% (95% CI, 20.2%-49.8%; p < 0.001). The primary endpoint was met, demonstrating the active treatment arm is superior to the sham control arm. The active treatment arm had significantly greater decreases (improvements) in the rTNSS (-4.0 vs. -1.2, p < 0.0001), postnasal drip (-1.1 vs. -0.3, p < 0.001), cough (-0.9 vs. -0.1, p < 0.001), NOSE score (-32.2 vs. -8.0, p < 0.0001), mini-RQLQ (-1.7 vs. -0.5, p < 0.0001), and PHQ-9 (-3.0 vs. -0.7, p = 0.028), compared to the sham control arm. The NOSE responder rate and mini-RQLQ responder rate were significantly higher for the active treatment arm than the sham control arm (p = 0.001 and p < 0.0001, respectively).

CONCLUSION

Treatment for chronic rhinitis with the NEUROMARK System is superior to sham control.