Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, Taiwan, 600
NCT Number: NCT07050992
This clinical trial aims to learn if laser posterior nasal nerve neurolysis can treat chronic rhinitis in adults. It will also learn about the safety of laser posterior nasal nerve neurolysis. The main questions it aims to answer are:
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.
This study is active but is not currently recruiting participants.
18 year–65 year
All sexes
Interventional
Not applicable
Chiayi City, Taiwan, 600
Chronic rhinitis is a highly prevalent condition characterized by symptoms such as nasal congestion, rhinorrhea, postnasal drip, nasal itching, and sneezing. First-line treatments typically include nasal irrigation, intranasal corticosteroids, intranasal anticholinergics, oral antihistamines, or topical decongestants. However, many patients fail to achieve satisfactory therapeutic outcomes through pharmacological interventions alone, resulting in significant impairment of quality of life and productivity.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: From the date of randomization and every three months after intervention is performed on 3, 6, 9, and 12 months post intervention.
The investigators will use reflective total nasal symptom score, (rTNSS, 0-12, the higher the worse) and Nasal Obstruction Symptom Evaluation(NOSE, 0-20, the higher the worse) to compare the chronic rhinitis symptoms before and after the intervention.
Time frame: From the date of randomization and every three months after intervention is performed on 3, 6, 9, and 12 months post intervention.
The investigators will document all the self-reported and observed complications after the intervention.
Time frame: From the date of randomization and every three months after intervention is performed on 3, 6, 9, and 12 months post intervention.
The investigators will compare the Pittsburgh Sleep Quality Index, (PSQI, 0-21, the higher the worse the sleep) and Epworth sleepiness Scale, (ESS, 0-24, with over 11 indicate sleepy, the higher the worse) of the enrolled patients before and after the intervention.
Chiayi Christian Hospital
Other
Laser Posterior Nasal Nerve Neurolysis: a Randonmized Controlled Trial
Acronym: LPN3
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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