Active — Not RecruitingNot Applicable

Laser Posterior Nasal Nerve Neurolysis

Taiwan120 participantsStarted 2024-11-01

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in chronic rhinitis score

Timeframe: From the date of randomization and every three months after intervention is performed on 3, 6, 9, and 12 months post intervention.

Trial details

NCT IDNCT07050992

SponsorChiayi Christian Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-06