A Randomized Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction

Study Overview
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Brief Summary
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Currently, there are several alternative treatments for patients with chronic rhinitis (CR) who failed medication. Although, most of the researches have been focusing on temperature-controlled RF (TCRF), the cost is a major limitation for applying it worldwide. The investigators objective of this study is to compare the subjective and objective outcomes of Bipolar RF (BRF) with the more popular TCRF for CR treatment. The investigators hypothesized that both have equivalent outcomes but with less operative time and potentially at lower cost.

Official Title
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A Randomized Comparison Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction in Patients With Chronic Rhinitis

Conditions
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Patients With Chronic Rhinitis Who Failed Medical Treatment

Intervention / Treatment
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* Procedure: Temperature-controlled RF
* Device: Bipolar RF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with snoring and chronic nasal obstruction. Respond to topical decongestant but not respond to nasal steroids, oral anti-histamine and oral decongestant Consent to the protocol. Exclusion Criteria: Chronic active sinusitis, severe Deviated nasal septum (DNS), nasal polyps, sinonasal tumor, previous sinonasal surgery or head neck irradiation. Uncontrolled bleeding disorders, hypertension, or cardiovascular diseases Not complete the protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temperature-controlled RF (TCRF)<br>The temperature-controlled RF was done under local anesthesia (0.5% xylocaine with adrenaline 1:200,000 injection at both inferior turbinates.) The RF probe will be inserted at inferior turbinate for 5 points both left and right nasal cavity (2 at anterior end, 2 at middle part and 1 at posterior end). We apply energy of 300 J, 85 C, and 15 W each point. After procedures the patients was observed at 1 hour before discharge without any packings. | Procedure: Temperature-controlled RF<br>* The temperature-controlled RF was done under local anesthesia (0.5% xylocaine with adrenaline 1:200,000 injection at both inferior turbinates.) The RF probe will be inserted at inferior turbinate for 5 points both left and right nasal cavity (2 at anterior end, 2 at middle part and 1 at posterior end). We apply energy of 300 J, 85 C, and 15 W each point. After procedures the patients was observed at 1 hour before discharge without any packings. For nontemperature-controlled RF, the probe will be inserted at the same area with TCRF. We use 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.<br>* Other names: Temperature-controlled RF device is Gyrus ENT.;|
| Active Comparator: Bipolar RF (BRF)<br>The bipolar RF (BRF) probe will be inserted at the same area with TCRF. We use 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF. | Device: Bipolar RF<br>* The bipolar RF probe will be inserted at the same area with TCRF. The energy used will be 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.<br>* Other names: Bipolar RF device is Select Sutter.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog scale scores of nasal obstructive symptom. |  | Up to 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS scores of nasal discharge, sneezing, hyposmia, postnasal drip | Shor-term at 4th week and long-term at 1 year follow-up | Up to 1 year follow-up | 
| Postoperative crust, mucociliary transportation time (MTT), minimal cross sectional area (MCA), total nasal volume (VOL), nasal airway resistance (NAR) at 75 Pa | Crusting was assessed at 1st week and 4th week, MTT at 4th week, and MCA, VOL, and NAR were assessed before and after treatment at 4th week and one year follow-up | Up to 1 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiofrequency turbinate reduction, nasal obstruction, Temperature-controlled radiofrequency, Bipolar radiofrequency, chronic rhinitis.