Traditional vs. Posterior Nasal Radiofrequency Ablation for Chronic Rhinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasal Obstruction Chronic Rhinitis Nonallergic Rhinitis Rhinorrhea Inferior Turbinate Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Inferior Turbinate RF with Posterior Nasal RF Ablation

Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation

Group Type EXPERIMENTAL

Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation

Intervention Type 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 Ablation

Traditional Radiofrequency Ablation of Inferior Turbinates

Group Type ACTIVE_COMPARATOR

Traditional Radiofrequency Ablation of Inferior Turbinates

Intervention Type 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

Interventions

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Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation

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 Type PROCEDURE

Traditional Radiofrequency Ablation of Inferior Turbinates

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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."

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No