Patients With Chronic Rhinitis Who Failed Medical Treatment
Conditions
Keywords
radiofrequency turbinate reduction, nasal obstruction, Temperature-controlled radiofrequency, Bipolar radiofrequency, chronic rhinitis.
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.
Interventions
PROCEDURETemperature-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.
DEVICEBipolar 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.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog scale scores of nasal obstructive symptom. | Up to 1 year follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Thailand
Outcome results
None listed