- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07323888
Traditional vs. Posterior Nasal Radiofrequency Ablation for Chronic Rhinitis
Comparison of Traditional Radiofrequency Ablation of Inferior Turbinates With or Without Posterior Nasal Radiofrequency Ablation: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taiwan
-
Chiayi City, Taiwan, Taiwan, 600
- Chiayi Hospital, Ministry of Health and Welfare (MOHW)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inferior Turbinate RF with Posterior Nasal RF Ablation
Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation
|
Intervention: Radiofrequency Ablation (Olympus Celon Elite ESG-400)
Post-operative care (3 days):
|
|
Active Comparator: Inferior Turbinate RF Ablation
Traditional Radiofrequency Ablation of Inferior Turbinates
|
Intervention: Radiofrequency Ablation (anterior inferior turbinate only)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
3 months after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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
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.
|
Baseline and 3 months after the procedure
|
|
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.
|
From the date of the procedure through 12 months after the procedure
|
|
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.
|
Baseline and 3 months after the procedure
|
|
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.
|
Baseline and 3 months after the procedure
|
|
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.
|
Baseline and 3 months after the procedure
|
|
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.
|
Baseline and 3 months after the procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 25-013
- 25-013 (Other Identifier: Institutional Review Board, Jianan Psychiatric Center, MOHW)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nasal Obstruction
-
Aerin MedicalNot yet recruitingNasal Airway Obstruction
-
Saglik Bilimleri UniversitesiCompletedNasal Obstruction Septal Deviation Compensatory Inferior Turbinate HypertrophyTurkey (Türkiye)
-
BayerRecruitingNasal Obstruction | Nasal CongestionCanada
-
Cumhuriyet University HospitalRecruitingNasal Obstruction | Rhinoplasty | Nasal DeformityTurkey (Türkiye)
-
Spirair, IncActive, not recruitingNasal Airway Obstruction | Nasal Septal DeviationUnited States
-
Aerin MedicalOhio State UniversityCompletedNasal ObstructionUnited States
-
Aerin MedicalActive, not recruiting
-
Aerin MedicalCompletedNasal Airway ObstructionUnited States
-
Aerin MedicalCompletedNasal ObstructionUnited States
-
Medtronic Surgical TechnologiesCompletedNasal Airway ObstructionUnited States, Canada
Clinical Trials on Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation
-
Weill Medical College of Cornell UniversityWithdrawnNasal Obstruction | Septal Deformity | Turbinate HypertrophyUnited States
-
University of Missouri-ColumbiaTerminatedObstructive Sleep Apnea | Upper Airway Resistance Syndrome | Sleep Related Breathing DisorderUnited States
-
Şahide Eda ArtuçActive, not recruitingPlantar Fasciitis, Chronic | Calcaneal Spur | Chronic Heel PainTurkey (Türkiye)
-
University of WashingtonNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)RecruitingChronic Low Back Pain (CLBP)United States
-
Ospedale San FrancescoUnknownTypical Atrial FlutterItaly
-
Ziekenhuis Oost-LimburgBelgium Health Care Knowledge Centre; Klinische Epidemiologie en Medical Technology...RecruitingKnee Osteoarthritis | Chronic Knee Pain | Persistent Postsurgical PainBelgium, Netherlands
-
Esraa Fathy Radwan Abd ElzaherNot yet recruitingDiscogenic Back Pain Patients
-
M.D. Anderson Cancer CenterTerminatedRecurrent Thyroid Gland Carcinoma | Thyroid Gland Nodule | Thyroid Gland Papillary Carcinoma | Benign Thyroid Gland Neoplasm | Thyroid Gland Follicular Tumor of Uncertain Malignant PotentialUnited States
-
Ruiqin xieCompleted
-
Eye & ENT Hospital of Fudan UniversityNot yet recruitingAllergic Rhinitis Due to House Dust Mite