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Active, Not Recruiting

NCT Number: NCT07323888

Traditional vs. Posterior Nasal Radiofrequency Ablation for Chronic Rhinitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chiayi Hospital, Ministry of Health and Welfare (MOHW)

Chiayi City, Taiwan, 600

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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):

  • Tranexamic acid 250mg 1cap BID x3 days
  • Amoxicillin 500mg 1 cap BID x3 days
  • Acetaminophen 500mg 1tab BID x3 days
  • Levocetirizine 5mg 1tab QD x3 days + PRN x4 days

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

Primary outcomes

  1. Response rate based on improvement in reflective Total Nasal Symptom Score (rTNSS)

    Time frame: 3 months after the procedure

    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).

Secondary outcomes

  1. Change in reflective Total Nasal Symptom Score (rTNSS)

    Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months after the procedure

    Change in reflective Total Nasal Symptom Score (rTNSS; range 0-12, higher scores indicate worse symptoms) from baseline.

  2. Change in Nasal Obstruction Symptom Evaluation (NOSE) score

    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; range 0-20, higher scores indicate worse symptoms) from baseline.

  3. Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) score

    Time frame: Baseline and 3 months after the procedure

    Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ; range 0-6, higher scores indicate worse quality of life) from baseline.

  4. Incidence of intervention-related complications

    Time frame: From the date of the procedure through 12 months after the procedure

    All self-reported and clinically observed complications related to the intervention.

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

    Time frame: Baseline and 3 months after the procedure

    Change in Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7; range 7-49, higher scores indicate worse symptoms) from baseline.

  6. Change in Patulous Eustachian tube handicap inventory-10 (PHI-10) score

    Time frame: Baseline and 3 months after the procedure

    Change in Patulous Eustachian tube handicap inventory-10 (PHI-10; range 0-40, higher scores indicate worse symptoms) from baseline.

  7. Change in Pittsburgh Sleep Quality Index (PSQI) score

    Time frame: Baseline and 3 months after the procedure

    Change in Pittsburgh Sleep Quality Index (PSQI; range 0-21, higher scores indicate worse sleep quality) from baseline.

  8. Change in Epworth Sleepiness Scale (ESS) score

    Time frame: Baseline and 3 months after the procedure

    Change in Epworth Sleepiness Scale (ESS; range 0-24, higher scores indicate greater daytime sleepiness) from baseline.

Sponsors and collaborators

Lead sponsor

Chien Yu Huang

Other

Registry information

Official study title

Comparison of Traditional Radiofrequency Ablation of Inferior Turbinates With or Without Posterior Nasal Radiofrequency Ablation: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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