Chiayi Hospital, Ministry of Health and Welfare (MOHW)
Chiayi City, Taiwan, 600
NCT Number: NCT07323888
This study is a prospective, single-center, single-blinded randomized controlled trial designed to compare the clinical effectiveness of traditional radiofrequency ablation of the anterior inferior turbinate alone versus expanded radiofrequency ablation including the middle and posterior portions of the inferior turbinate (posterior nasal region). Patients with chronic rhinitis who remain symptomatic despite at least six months of medical therapy will be randomized in a 2:1 ratio to undergo extended posterior nasal ablation versus traditional anterior treatment. Symptom improvement will be evaluated using rTNSS and other validated questionnaires.
This study is active but is not currently recruiting participants.
18 year–65 year
All sexes
Interventional
Not applicable
Chiayi City, Taiwan, 600
Chronic rhinitis is a common condition characterized by persistent nasal obstruction and rhinorrhea, leading to significant impairment in quality of life. Radiofrequency ablation of the inferior turbinate is an established minimally invasive treatment for patients with symptoms refractory to medical therapy. However, symptom control may be suboptimal in some patients, particularly when posterior nasal neural components contribute to disease persistence.
Posterior nasal radiofrequency ablation, which extends treatment to the middle and posterior portions of the inferior turbinate, has been proposed as an adjunctive technique to enhance symptom relief by targeting posterior nasal regions. Evidence comparing traditional anterior inferior turbinate radiofrequency ablation with expanded posterior nasal radiofrequency ablation remains limited.
In this prospective, single-center, randomized controlled trial, eligible patients with chronic rhinitis refractory to at least six months of medical therapy will be randomized in a 2:1 ratio to receive either expanded radiofrequency ablation including the middle and posterior portions of the inferior turbinate or traditional anterior inferior turbinate radiofrequency ablation alone. The primary outcome is the response rate based on improvement in reflective Total Nasal Symptom Score (rTNSS), defined as a ≥30% reduction from baseline at 3 months after the procedure. Secondary outcomes include changes in validated symptom and quality-of-life questionnaires and the incidence of procedure-related complications.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention:
Radiofrequency Ablation (Olympus Celon Elite ESG-400)
Post-operative care (3 days):
Intervention:
Radiofrequency Ablation (anterior inferior turbinate only)
Time frame: 3 months after the procedure
Response is defined as a ≥30% reduction from baseline in the reflective Total Nasal Symptom Score (rTNSS; range 0-12, higher scores indicate worse symptoms).
Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months after the procedure
Change in reflective Total Nasal Symptom Score (rTNSS; range 0-12, higher scores indicate worse symptoms) from baseline.
Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months after the procedure
Change in Nasal Obstruction Symptom Evaluation (NOSE; range 0-20, higher scores indicate worse symptoms) from baseline.
Time frame: Baseline and 3 months after the procedure
Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ; range 0-6, higher scores indicate worse quality of life) from baseline.
Time frame: From the date of the procedure through 12 months after the procedure
All self-reported and clinically observed complications related to the intervention.
Time frame: Baseline and 3 months after the procedure
Change in Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7; range 7-49, higher scores indicate worse symptoms) from baseline.
Time frame: Baseline and 3 months after the procedure
Change in Patulous Eustachian tube handicap inventory-10 (PHI-10; range 0-40, higher scores indicate worse symptoms) from baseline.
Time frame: Baseline and 3 months after the procedure
Change in Pittsburgh Sleep Quality Index (PSQI; range 0-21, higher scores indicate worse sleep quality) from baseline.
Time frame: Baseline and 3 months after the procedure
Change in Epworth Sleepiness Scale (ESS; range 0-24, higher scores indicate greater daytime sleepiness) from baseline.
Chien Yu Huang
Other
Comparison of Traditional Radiofrequency Ablation of Inferior Turbinates With or Without Posterior Nasal Radiofrequency Ablation: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07050992
Airway Obstruction, Allergic Rhinitis
Chiayi City, Taiwan
View Trial DetailsNCT07568548
Airway Obstruction, Chronic Pharyngitis
View Trial DetailsNCT06438185
Airway Obstruction, Inferior Turbinate Hypertrophy
Tel Aviv, Israel
View Trial DetailsNCT07379775
Airway Obstruction, Nasal Obstruction
Draguignan, Var, France
View Trial Details