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

Not Applicable

Completed

• Conditions: Patients With Chronic Rhinitis Who Failed Medical Treatment
• Interventions: Procedure: Temperature-controlled RF; Device: Bipolar RF

• Registration Number: NCT01054521
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-21
• Study First Posted: 2010-01-22
• Study Start: 2010-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-29
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Temperature-controlled RF (TCRF)	Temperature-controlled RF	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.
Bipolar RF (BRF)	Bipolar RF	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog scale scores of nasal obstructive symptom.	Up to 1 year follow-up

Secondary Outcome Measures

Name	Time	Method
VAS scores of nasal discharge, sneezing, hyposmia, postnasal drip	Up to 1 year follow-up	Shor-term at 4th week and long-term at 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	Up to 1 year follow-up	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

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand