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

Masayoshi Takashima, Jose Pablo Stolovitzky, Randall A. Ow, Stacey L. Silvers, Nadim B. Bikhazi, Curtis D. Johnson

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)107-115
Number of pages9
JournalInternational Forum of Allergy and Rhinology
Volume13
Issue number2
DOIs
StatePublished - Feb 2023

Keywords

  • congestion
  • neurolysis
  • posterior nasal nerve
  • radiofrequency ablation
  • rhinitis
  • rhinorrhea
  • Rhinorrhea
  • Temperature
  • Rhinitis
  • Humans
  • Nose
  • Treatment Outcome

ASJC Scopus subject areas

  • Immunology and Allergy
  • Otorhinolaryngology

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