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

Patients With Chronic Rhinitis Who Failed Medical Treatment Clinical Trial

— CompareRFIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054521
• Other study ID #: wbanhiran
• Status: Completed
• Phase: N/A
• First received: January 21, 2010
• Last updated: May 29, 2014
• Start date: September 2010
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patients With Chronic Rhinitis Who Failed Medical Treatment
• Rhinitis

Intervention

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.

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.

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog scale scores of nasal obstructive symptom.		Up to 1 year follow-up	No
Secondary	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	Yes
Secondary	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	Yes