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| ID | Type | Description | Link |
|---|---|---|---|
| 25-013 | Other Identifier | Institutional Review Board, Jianan Psychiatric Center, MOHW |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inferior Turbinate RF with Posterior Nasal RF Ablation | Experimental | Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation |
|
| Inferior Turbinate RF Ablation | Active Comparator | Traditional Radiofrequency Ablation of Inferior Turbinates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation | Procedure | Intervention: Radiofrequency Ablation (Olympus Celon Elite ESG-400)
Post-operative care (3 days):
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiayi Hospital, Ministry of Health and Welfare (MOHW) | Chiayi City | Taiwan | 600 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34527852 | Background | Stolovitzky JP, Ow RA, Silvers SL, Bikhazi NB, Johnson CD, Takashima M. Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial. OTO Open. 2021 Sep 10;5(3):2473974X211041124. doi: 10.1177/2473974X211041124. eCollection 2021 Jul-Sep. | |
| 34382444 | Background | Ehmer D, McDuffie CM, Scurry WC Jr, McIntyre JB, Mehendale NH, Willis JH, Shealy RB, Watkins JP, Kakarlapudi VV. Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Rhinitis. Am J Rhinol Allergy. 2022 Jan;36(1):149-156. doi: 10.1177/19458924211033400. Epub 2021 Aug 12. |
| Label | URL |
|---|---|
| Position Statement: PNN Ablation for the Treatment of Chronic Rhinitis | View source |
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Individual participant data will not be shared due to patient privacy considerations and institutional data protection policies. Only aggregated results will be presented in publications and reports.
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| Traditional Radiofrequency Ablation of Inferior Turbinates | Procedure | Intervention: Radiofrequency Ablation (anterior inferior turbinate only)
|
|
Change in Nasal Obstruction Symptom Evaluation (NOSE; range 0-20, higher scores indicate worse symptoms) from baseline. |
| 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. | Baseline and 3 months after the procedure |
| Incidence of intervention-related complications | All self-reported and clinically observed complications related to the intervention. | 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. | 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. | 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. | 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. | Baseline and 3 months after the procedure |
| 35818709 | Background | Lee JT, Abbas GM, Charous DD, Cuevas PDMM, Goktas PDMO, Loftus PA, Nachlas NE, Toskala EM, Watkins JP, Brehmer PDMD. Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis. Am J Rhinol Allergy. 2022 Nov;36(6):747-754. doi: 10.1177/19458924221109987. Epub 2022 Jul 11. |
| 35714267 | Background | Takashima M, Stolovitzky JP, Ow RA, Silvers SL, Bikhazi NB, Johnson CD. Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial. Int Forum Allergy Rhinol. 2023 Feb;13(2):107-115. doi: 10.1002/alr.23047. Epub 2022 Jul 5. |
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| D000086722 | Rhinorrhea |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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