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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Intervention: Radiofrequency Ablation (Olympus Celon Elite ESG-400) * Local anesthesia with 2% lidocaine * RF ablation at 15W * Multiple punctures along anterior, middle, and posterior inferior turbinate (15-20 per side) * Includes posterior nasal region (superior, medial, inferior aspects) * No nasal packing required Post-operative care (3 days): 1. Tranexamic acid 250mg 1cap BID x3 days 2. Amoxicillin 500mg 1 cap BID x3 days 3. Acetaminophen 500mg 1tab BID x3 days 4. Levocetirizine 5mg 1tab QD x3 days + PRN x4 days
Intervention: Radiofrequency Ablation (anterior inferior turbinate only) * Same anesthesia and device * RF applied only to anterior inferior turbinate (≈2 punctures per side) * No treatment to middle/posterior inferior turbinate Post-operative care: Same as experimental arm
Chiayi Hospital, Ministry of Health and Welfare (MOHW)
Chiayi City, Taiwan, Taiwan
Response rate based on improvement in reflective Total Nasal Symptom Score (rTNSS)
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: 3 months after the procedure
Change in reflective Total Nasal Symptom Score (rTNSS)
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) score
Change in Nasal Obstruction Symptom Evaluation (NOSE; range 0-20, 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 Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) score
Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ; range 0-6, higher scores indicate worse quality of life) from baseline.
Time frame: Baseline and 3 months after the procedure
Incidence of intervention-related complications
All self-reported and clinically observed complications related to the intervention.
Time frame: From the date of the procedure through 12 months after the procedure
Change in Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) score
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) score
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) score
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) score
Change in Epworth Sleepiness Scale (ESS; range 0-24, higher scores indicate greater daytime sleepiness) from baseline.
Time frame: Baseline and 3 months after the procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.