A Randomized Comparison Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction in Patients With Chronic Rhinitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Visual Analog scale scores of nasal obstructive symptom.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Temperature-controlled RF (Procedure)
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.
Intervention: Bipolar RF (Device)
Outcomes
Primary Outcomes
Visual Analog scale scores of nasal obstructive symptom.
Time Frame: Up to 1 year follow-up
Secondary Outcomes
- VAS scores of nasal discharge, sneezing, hyposmia, postnasal drip(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(Up to 1 year follow-up)