Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial
| Autor: | Chad M. McDuffie, David M Yen, Stacey L. Silvers, Joseph K. Han, Jon N Rosenthal |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
business.industry
Temperature Nasal congestion Nose Confidence interval law.invention Nasal valve medicine.anatomical_structure Treatment Outcome Otorhinolaryngology Randomized controlled trial law Anesthesia medicine Clinical endpoint Immunology and Allergy Humans Nasal Airway Obstruction Prospective Studies medicine.symptom Nasal Obstruction business Adverse effect |
| Zdroj: | International forum of allergyrhinology. 11(12) |
| ISSN: | 2042-6984 |
| Popis: | BACKGROUND Nasal valve collapse is one of several causes of nasal obstruction. The safety and efficacy of a temperature-controlled radiofrequency (RF) device for the treatment of the nasal valve for nasal airway obstruction (NAO) has been established in single-arm studies. The objective of this trial was to compare active device treatment against a sham procedure (control). METHODS In a prospective, multicenter, single-blinded, randomized controlled trial (RCT), patients were assigned to bilateral temperature-controlled RF treatment of the nasal valve (n = 77) or a sham procedure (n = 41), in which no RF energy was transferred to the device/treatment area. The device was applied to the mucosa over the lower lateral cartilage on the lateral nasal wall. The primary endpoint was responder rate at 3 months, defined as a ≥20% reduction in Nasal Obstruction Symptom Evaluation (NOSE)-scale score or ≥1 reduction in clinical severity category. RESULTS At baseline, patients had a mean NOSE-scale score of 76.7 (95% confidence interval [CI], 73.8 to 79.5) and 78.8 (95% CI, 74.2 to 83.3) (p = 0.424) in the active treatment and sham-control arms, respectively. At 3 months, the responder rate was significantly higher in the active treatment arm (88.3% [95% CI, 79.2%-93.7%] vs 42.5% [95% CI, 28.5%-57.8%]; p |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|