Laser Posterior Nasal Nerve Neurolysis (LPN3)

Chiayi Christian Hospital

Status: Enrolling

Conditions: Nasal Obstruction; Rhinorrhea; Nasal Stuffiness; Nasal Allergies; Sneezing; Allergic Rhinitis; Nasal Congestion; Chronic Rhinitis

Treatments: Procedure: Sham surgery; Procedure: Laser posterior nasal nerve neurolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT07050992

IRB2024071

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 65 years old
• 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

• Obstructive anatomical abnormalities limiting access to posterior nasal passages
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Laser surgery

Active Comparator group

Description:

Posterior nasal nerve ablation using laser to deliver laser energy to the posterior nasal nerve area.

Treatment:

Procedure: Laser posterior nasal nerve neurolysis

Sham surgery

Sham Comparator group

Description:

Sham surgery is performed with the same laser surgical instrument used to enter the nasal cavity for a sham procedure with minimal dosage.

Treatment:

Procedure: Sham surgery