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

Mahidol University

Status: Completed

Conditions: Patients With Chronic Rhinitis Who Failed Medical Treatment

Treatments: Device: Bipolar RF; Procedure: Temperature-controlled RF

Study type: Interventional

Funder types: Other

Identifiers

NCT01054521

wbanhiran

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Temperature-controlled RF (TCRF)

Experimental group

Description:

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.

Treatment:

Procedure: Temperature-controlled RF

Bipolar RF (BRF)

Active Comparator group

Description:

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.

Treatment:

Device: Bipolar RF