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Traditional vs. Posterior Nasal Radiofrequency Ablation for Chronic Rhinitis

C

Chien Yu Huang

Status

Not yet enrolling

Conditions

Nasal Obstruction
Rhinorrhea
Inferior Turbinate Hypertrophy
Nonallergic Rhinitis
Chronic Rhinitis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07323888
25-013
IRB 25-013

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Inferior Turbinate RF with Posterior Nasal RF Ablation
Experimental group
Description:
Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation
Treatment:
Procedure: Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation
Inferior Turbinate RF Ablation
Active Comparator group
Description:
Traditional Radiofrequency Ablation of Inferior Turbinates
Treatment:
Procedure: Traditional Radiofrequency Ablation of Inferior Turbinates

Trial contacts and locations

1

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Central trial contact

Chien-Yu Huang, MD; Han-Lo Teng

Data sourced from clinicaltrials.gov

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