Compare Between Temperature-controlled and Nontemperature-controlled Radiofrequency Nose (CompareRF)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Both chronic rhinitis and obstructive sleep disordered breathing (OSDB) are very common and have a relatively strong association to each other. Treatment of rhinitis will have at least some benefits on OSDB patients. Currently, there are several alternative treatments for these patients including radiofrequency (RF) inferior turbinate reduction. 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 effectiveness and safety of non-temperature-controlled RF (NTCRF) with the more popular TCRF. The investigators hypotheses that both have equal effectiveness and safety. However, the investigators believe that NTCRF have a lot less cost and faster to apply for OSDB patients in Thailand and other developing countries.
| Condition | Intervention |
|---|---|
|
Snoring Chronic Rhinitis |
Procedure: Temperature-controlled RF Device: ์NTCRF |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Comparison Study Between Temperature-controlled Radiofrequency and Nontemperature-controlled Inferior Turbinate Reduction in Patients With Snoring and Chronic Nasal Obstruction |
- Visual Analog scale scores of nasal obstruction severity. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- pain and safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TCRF
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.
|
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 Name: Temperature-controlled RF device is Gyrus ENT.
|
|
Active Comparator: NTCRF
non-temperature-controlled RF 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: ์NTCRF
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 Name: NONTemperature-controlled RF device is Select Sutter.
|
Detailed Description:
We will include around 100 patients, 50 for TCRF and 50 for NTCRF) and follow up for 1 year. We will compare both VAS, mucociliary test, ARM, RMM on all patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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 DNS, nasal polyps, sinonasal tumor, previous sinonasal surgery or head neck irradiation.
- Uncontrolled bleeding disorders, hypertension, or cardiovascular diseases
- Not complete the protocol
Contacts and Locations| Thailand | |
| Siriraj Hospital | Recruiting |
| Bangkok, Thailand, 10700 | |
| Contact: Wish Banhiran, MD 6624198040 wishbanh@hotmail.com | |
| Principal Investigator: wish banhiran, MD | |
| Principal Investigator: | Wish Banhiran, MD | Mahidol University |
More Information
No publications provided
| Responsible Party: | Mahidol University |
| ClinicalTrials.gov Identifier: | NCT01054521 History of Changes |
| Other Study ID Numbers: | wbanhiran |
| Study First Received: | January 21, 2010 |
| Last Updated: | November 1, 2011 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Mahidol University:
|
radiofrequency turbinate reduction nasal obstruction temperature-controlled radiofrequency nontemperature-controlled radiofrequency snoring in patients with chronic rhinitis. |
Additional relevant MeSH terms:
|
Rhinitis Nasal Obstruction Snoring Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
Airway Obstruction Respiratory Insufficiency Respiration Disorders Respiratory Sounds Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013