Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial.
Int Forum Allergy Rhinol
; 13(2): 107-115, 2023 Feb.
Article
em En
| MEDLINE
| ID: mdl-35714267
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.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Rinite
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article