Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
120 participants
INTERVENTIONAL
2024-11-01
2026-12-31
Brief Summary
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1. Does laser posterior nasal nerve neurolysis improve chronic rhinitis symptoms?
2. What side-effects or complications do participants have after laser posterior nasal nerve neurolysis?
Researchers will compare laser posterior nasal nerve neurolysis to a placebo(a sham surgery with the same device and sound to see if laser posterior nasal nerve neurolysis works to treat chronic rhinitis.
Participants will
1. Receive laser posterior nasal nerve neurolysis in the office as local anesthesia surgery.
2. Visit the clinic in the first week, first month, and 3rd months after the surgery.
3. Record their symptom scores before the surgery and during each follow-up visit.
Detailed Description
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In addition to pharmacotherapy, various surgical approaches have been proposed, including inferior turbinate reduction (partial or submucosal resection), radiofrequency inferior turbinate ablation (RFIT), microdebrider-assisted turbinoplasty, vidian neurectomy, and posterior nasal neurectomy or ablation. Vidian neurectomy is infrequently employed due to potential complications, including hemorrhage, malar and maxillary discomfort, and dry eye symptoms. While the introduction of endoscopic posterior nasal neurectomy has addressed some of these complications (malar and maxillary discomfort), patients may still experience dry eye.
In 2022 and 2023, the American Rhinologic Society (ARS) and the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) issued statements supporting the use of posterior nasal nerve neurolysis (PNNN) for the treatment of chronic rhinitis. These statements indicate that posterior nasal nerve neurolysis techniques, such as radiofrequency ablation and cryotherapy, have been utilized to disrupt the posterior nasal nerve in the sphenopalatine foramen region of the posterior middle meatus.
The application of CO2 laser for posterior nasal nerve cauterization has not yet been evaluated in large-scale randomized controlled clinical trials. In otolaryngological surgery, this laser is widely employed in pharyngolaryngeal procedures, vocal cord surgery, oral mucosal surgery, and intranasal and turbinate surgeries due to its excellent hemostatic properties and precision.
Therefore, the investigators propose this research protocol to conduct a randomized controlled clinical trial to determine whether posterior nasal nerve cauterization using CO2 laser can effectively control chronic rhinitis symptoms.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Laser surgery
Posterior nasal nerve ablation using laser to deliver laser energy to the posterior nasal nerve area.
Laser posterior nasal nerve neurolysis
Posterior nasal nerve ablation using laser is performed through an angled nasal probe at 20 degrees and a 90-degree endoscope to deliver laser energy to the posterior nasal nerve area. The thermal energy is conducted to the middle meatus and the posterior superior part of the inferior turbinate, targeting the area supplied by the posterior nasal nerve. The ablation continues until there is widespread mucosal blanching and the formation of at least one continuous brown eschar
Sham surgery
Sham surgery is performed with the same laser surgical instrument used to enter the nasal cavity for a sham procedure with minimal dosage.
Sham surgery
The same laser surgical instrument is used to enter the nasal cavity for a sham procedure with minimal dosage. The energy setting uses the lowest limit of 0.5W with intermittent emission (0.01 second emission with 1 second rest), and the emission mode is Super Pulse to reduce heat dispersion. It is applied to the mucosal surface without blood supply at the lower edge of the middle turbinate for 2 minutes on each side, totaling only 1.2 seconds of cumulative laser emission. Compared to the experimental group using 2W energy with continuous irradiation for 2 minutes, the total energy release difference in the sham surgery group is only 1/400 of the experimental group (2W120sec/0.5W1.2sec). This is to produce the sound, light, and tactile effects of the laser, but without sufficient energy transfer to cause high-temperature mucosal changes and tissue alterations, serving as a high-quality sham surgery control group.
Interventions
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Laser posterior nasal nerve neurolysis
Posterior nasal nerve ablation using laser is performed through an angled nasal probe at 20 degrees and a 90-degree endoscope to deliver laser energy to the posterior nasal nerve area. The thermal energy is conducted to the middle meatus and the posterior superior part of the inferior turbinate, targeting the area supplied by the posterior nasal nerve. The ablation continues until there is widespread mucosal blanching and the formation of at least one continuous brown eschar
Sham surgery
The same laser surgical instrument is used to enter the nasal cavity for a sham procedure with minimal dosage. The energy setting uses the lowest limit of 0.5W with intermittent emission (0.01 second emission with 1 second rest), and the emission mode is Super Pulse to reduce heat dispersion. It is applied to the mucosal surface without blood supply at the lower edge of the middle turbinate for 2 minutes on each side, totaling only 1.2 seconds of cumulative laser emission. Compared to the experimental group using 2W energy with continuous irradiation for 2 minutes, the total energy release difference in the sham surgery group is only 1/400 of the experimental group (2W120sec/0.5W1.2sec). This is to produce the sound, light, and tactile effects of the laser, but without sufficient energy transfer to cause high-temperature mucosal changes and tissue alterations, serving as a high-quality sham surgery control group.
Eligibility Criteria
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Inclusion Criteria
* Chronic rhinitis symptoms for at least 6 months that have not responded effectively to medication (should include at least Intranasal corticosteroid (ICS) combined with intermittent use of oral antihistamine and, as needed, combination nasal spray) or where medication has not provided sustained improvement
* Total rTNSS ≥ 5 with Moderate to severe rhinorrhea symptoms (24-hour reflective Total Nasal Symptom Score \[rTNSS\] rhinorrhea score of 2-3) and mild to severe nasal congestion symptoms (rTNSS nasal congestion score of 1-3)
* All enrolled patients routinely undergo endonasal endoscopic examination, or have had a sinus CT within the past month confirming no significant rhinosinusitis."
Exclusion Criteria
* Nasal anatomical changes due to previous sinus or nasal surgery or injury
* Ongoing nasal or sinus infection
* History of severe dry eye, chronic epistaxis, rhinitis medicamentosa, or head and neck radiotherapy
* Self-reported history of bleeding tendency
* Current use of anticoagulants with inability to discontinue
* Previous chronic rhinitis surgery
* History of poor wound healing after head, neck, or throat surgery
18 Years
65 Years
ALL
No
Sponsors
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Chiayi Christian Hospital
OTHER
Responsible Party
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Locations
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Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, Taiwan, Taiwan
Countries
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References
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Lee JT, Abbas GM, Charous DD, Cuevas PDMM, Goktas PDMO, Loftus PA, Nachlas NE, Toskala EM, Watkins JP, Brehmer PDMD. Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis. Am J Rhinol Allergy. 2022 Nov;36(6):747-754. doi: 10.1177/19458924221109987. Epub 2022 Jul 11.
Takashima M, Stolovitzky JP, Ow RA, Silvers SL, Bikhazi NB, Johnson CD. Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial. Int Forum Allergy Rhinol. 2023 Feb;13(2):107-115. doi: 10.1002/alr.23047. Epub 2022 Jul 5.
Related Links
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Position Statement: PNN Ablation for the Treatment of Chronic Rhinitis
Other Identifiers
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IRB2024071
Identifier Type: -
Identifier Source: org_study_id