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Temperature‐controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial

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 tri...

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Autores principales: Silvers, Stacey L., Rosenthal, Jon N., McDuffie, Chad M., Yen, David M., Han, Joseph K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9292281/
https://www.ncbi.nlm.nih.gov/pubmed/34240571
http://dx.doi.org/10.1002/alr.22861
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author Silvers, Stacey L.
Rosenthal, Jon N.
McDuffie, Chad M.
Yen, David M.
Han, Joseph K.
author_facet Silvers, Stacey L.
Rosenthal, Jon N.
McDuffie, Chad M.
Yen, David M.
Han, Joseph K.
author_sort Silvers, Stacey L.
collection PubMed
description 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 < 0.001). The active treatment arm had a significantly greater decrease in NOSE‐scale score (mean, −42.3 [95% CI, −47.6 to −37.1] vs −16.8 [95% CI, −26.3 to −7.2]; p < 0.001). Three adverse events at least possibly related to the device and/or procedure were reported, and all resolved. CONCLUSION: This RCT shows temperature‐controlled RF treatment of the nasal valve is safe and effective in reducing symptoms of NAO in short‐term follow‐up.
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spelling pubmed-92922812022-07-20 Temperature‐controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial Silvers, Stacey L. Rosenthal, Jon N. McDuffie, Chad M. Yen, David M. Han, Joseph K. Int Forum Allergy Rhinol Original Articles 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 < 0.001). The active treatment arm had a significantly greater decrease in NOSE‐scale score (mean, −42.3 [95% CI, −47.6 to −37.1] vs −16.8 [95% CI, −26.3 to −7.2]; p < 0.001). Three adverse events at least possibly related to the device and/or procedure were reported, and all resolved. CONCLUSION: This RCT shows temperature‐controlled RF treatment of the nasal valve is safe and effective in reducing symptoms of NAO in short‐term follow‐up. John Wiley and Sons Inc. 2021-07-09 2021-12 /pmc/articles/PMC9292281/ /pubmed/34240571 http://dx.doi.org/10.1002/alr.22861 Text en © 2021 The Authors. International Forum of Allergy & Rhinology published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngic Allergy and American Rhinologic Society https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Articles
Silvers, Stacey L.
Rosenthal, Jon N.
McDuffie, Chad M.
Yen, David M.
Han, Joseph K.
Temperature‐controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial
title Temperature‐controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial
title_full Temperature‐controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial
title_fullStr Temperature‐controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial
title_full_unstemmed Temperature‐controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial
title_short Temperature‐controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial
title_sort temperature‐controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: a randomized controlled trial
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9292281/
https://www.ncbi.nlm.nih.gov/pubmed/34240571
http://dx.doi.org/10.1002/alr.22861
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