Temperature‐controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12‐month outcomes after treatment in a randomized controlled trial

BACKGROUND: Temperature‐controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis was previously reported as superior to a sham‐control procedure at 3 months postprocedure in a randomized controlled trial (RCT). The primary endpoint was a responder rate of ≥30% improvement (decrease) for 24‐hour reflective total nasal symptom score (rTNSS) compared with baseline. Herein, 12‐month outcomes after active treatment are reported. METHODS: In this prospective, multicenter, patient‐blinded RCT, patients in the index active treatment arm were unblinded at 3 months and followed through 12 months. At 3 months, eligible patients from the sham‐control arm of the study were invited to crossover to active treatment. Eligibility criteria included rTNSS ≥6, with moderate‐severe rhinorrhea and mild‐severe congestion. The TCRF stylus was applied bilaterally to nonoverlapping areas in the region of the PNN. RESULTS: Patients in the index active treatment arm (n = 77) had a mean baseline rTNSS of 8.3 (95% confidence interval [CI], 7.9‐8.7). At 12 months, the responder rate was 80.6% (n = 67) (95% CI, 69.1%‐89.2%). At 12 months, the mean change in rTNSS was −4.8 (95% CI, −5.5 to −4.1; p < 0.001), a 57.8% improvement. The available initial rTNSS‐based outcomes in the crossover active treatment arm (n = 27) were following the same course as the index treatment arm. No serious adverse events and 8 adverse events related to the device/procedure were reported in the trial to date. CONCLUSION: TCRF neurolysis of the PNN area is safe and the symptom burden improvement that was superior to a sham procedure at 3 months was sustained through 12 months.