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

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

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.

Study Overview

• Status: Completed
• Conditions: Patients With Chronic Rhinitis Who Failed Medical Treatment
• Intervention / Treatment: Procedure: Temperature-controlled RF; Device: Bipolar RF

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Temperature-controlled RF (TCRF); 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; 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.; Other Names: Temperature-controlled RF device is Gyrus ENT.
Active Comparator: Bipolar RF (BRF); 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; 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.; Other Names: Bipolar RF device is Select Sutter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Wish Banhiran, MD, Mahidol University

Publications and helpful links

General Publications

• Banhiran W, Assanasen P, Tantilipikorn P, Nujchanart N, Voraprayoon S, Bunnag C. A randomized study of temperature-controlled versus bipolar radiofrequency for inferior turbinate reduction. Eur Arch Otorhinolaryngol. 2015 Oct;272(10):2877-84. doi: 10.1007/s00405-014-3410-y. Epub 2014 Nov 29.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 21, 2010
• First Submitted That Met QC Criteria: January 21, 2010
• First Posted (Estimate): January 22, 2010

Study Record Updates

• Last Update Posted (Estimate): June 2, 2014
• Last Update Submitted That Met QC Criteria: May 29, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: nasal obstruction; Bipolar radiofrequency; radiofrequency turbinate reduction; Temperature-controlled radiofrequency; chronic rhinitis.
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: wbanhiran