Traditional vs. Posterior Nasal Radiofrequency Ablation for Chronic Rhinitis

NCT07323888 | Not Yet Recruiting

• 2 other identifiers: IRB 25-01325-013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inferior Turbinate Hypertrophy; Nasal Obstruction; Chronic Rhinitis; Nonallergic Rhinitis; Rhinorrhea

Keywords

Radiofrequency Ablation; Inferior Turbinate Hypertrophy; Chronic Rhinitis; Nasal Obstruction; Rhinorrhea; Posterior Nasal Nerve; Randomized Controlled Trial; Single-Center Study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Change in reflective Total Nasal Symptom Score (rTNSS)

  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

  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

  Baseline and 3 months after the procedure

• Incidence of intervention-related complications

  From the date of the procedure through 12 months after the procedure

• Change in Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) score

  Baseline and 3 months after the procedure

Study Arms (2)

Inferior Turbinate RF with Posterior Nasal RF Ablation

EXPERIMENTAL

Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation

Procedure: Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation

Inferior Turbinate RF Ablation

ACTIVE COMPARATOR

Traditional Radiofrequency Ablation of Inferior Turbinates

Procedure: Traditional Radiofrequency Ablation of Inferior Turbinates

Interventions

Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation PROCEDURE

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

Inferior Turbinate RF with Posterior Nasal RF Ablation

Traditional Radiofrequency Ablation of Inferior Turbinates PROCEDURE

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

Inferior Turbinate RF Ablation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years old
• Chronic rhinitis symptoms for at least 6 months that have not responded effectively to medication (should include at least Intranasal corticosteroid (ICS) combined with intermittent use of oral antihistamine and, as needed, combination nasal spray) or where medication has not provided sustained improvement
• Total rTNSS ≥ 4 with Moderate to severe rhinorrhea symptoms (24-hour reflective Total Nasal Symptom Score \[rTNSS\] rhinorrhea score of 1-3) and mild to severe nasal congestion symptoms (rTNSS nasal congestion score of 1-3)
• All enrolled patients routinely undergo endonasal endoscopic examination, or have had a sinus CT within the past month confirming no significant rhinosinusitis."

You may not qualify if:

• Obstructive anatomical abnormalities limiting access to posterior nasal passages
• Nasal anatomical changes due to previous sinus or nasal surgery or injury
• Ongoing nasal or sinus infection
• History of severe dry eye, chronic epistaxis, rhinitis medicamentosa, or head and neck radiotherapy
• Self-reported history of bleeding tendency
• Current use of anticoagulants with inability to discontinue
• Previous chronic rhinitis surgery
• History of poor wound healing after head, neck, or throat surgery
• Pregnancy/lactation
• Neuromuscular disease preventing supine positioning

Sponsors & Collaborators

• Chien Yu Huang: lead

Study Sites (1)

Chiayi Hospital, Ministry of Health and Welfare (MOHW)

Chiayi City, Taiwan, 600, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 34527852 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.

  PMID: 34382444 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.

  PMID: 35818709 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.

  PMID: 35714267 BACKGROUND

Related Links

• Position Statement: PNN Ablation for the Treatment of Chronic Rhinitis

MeSH Terms

Conditions

Nasal Obstruction; Rhinorrhea

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chien-Yu Huang, MD

CONTACT

+886-5-231-9090; skyf16@gmail.com

Han-Lo Teng

CONTACT

+886-5-231-9090; tenghanlo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician, Department of Otolaryngology

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)