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

Abstract

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.

Keywords: congestion; neurolysis; posterior nasal nerve; radiofrequency ablation; rhinitis; rhinorrhea.

© 2022 The Authors. International Forum of Allergy & Rhinology published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngic Allergy and American Rhinologic Society.

Figures

FIGURE 1

Patient disposition, including crossover of the index sham‐control arm to active treatment at 3 months, if eligible. Patients who underwent additional nasal procedures were excluded from the trial. Abbreviations: LTFU = lost to follow‐up; MV = missed visit; WD = withdrawal from the trial.

FIGURE 2

Responder rate of the index active treatment arm through 12 months, defined as ≥30% improvement in 24‐hour reflective total nasal symptom score (rTNSS) from baseline. The responder rate of the index active treatment arm, which was previously reported as superior to the index sham‐control arm at 3 months, was sustained through 12 months. Bars represent 95% confidence intervals.

FIGURE 3

Adjusted mean reflective total nasal symptom score (rTNSS) of the index active treatment arm at baseline and follow‐up. The improvement in rTNSS of the index active treatment arm, which was previously reported as significantly greater than that in the index sham‐control arm at 3 months, was sustained through 12 months; p < 0.001, when comparing each follow‐up timepoint vs baseline. Bars represent 95% confidence interval.

FIGURE 4

The percentage of patients in the index active treatment arm reporting each reflective total nasal symptom score (rTNSS) subscore at baseline and follow‐up. The distributions of rTNSS subscores were significantly improved over baseline at all timepoints; p < 0.001, when comparing each follow‐up timepoint vs baseline for all subscores. Nasal itching was severe in 2.6% and 1.4% of patients at 3 and 6 months, respectively; no sneezing was reported by 5.2% at baseline, and severe sneezing was reported by 1.4% and 1.5% at 6 and 12 months, respectively. Baseline and 3 months, n = 77; 6 months, n = 72; 12 months, n = 67.

FIGURE 5

The percentage of patients in the index active treatment arm reporting each postnasal drip and cough score at baseline and follow‐up. The distributions of both scores were significantly improved over baseline at all timepoints; p < 0.001, when comparing each follow‐up timepoint vs baseline for both scores. No postnasal drip at baseline was reported by 2.6% of patients; severe cough at 3 months was reported by 5.2%, and severe cough at 6 months was 4.2%. Baseline and 3 months, n = 77; 6 months, n = 72; 12 months, n = 67.

FIGURE 6

Unadjusted mean reflective 24‐hour reflective total nasal symptom score (rTNSS) of the index active treatment arm and the crossover active treatment arm at their respective baseline and through 6 months. The mean rTNSS of the crossover active treatment arm has continued to follow the same course as that of the index active treatment. Bars represent 95% confidence intervals.