Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis
Assessment of the Effectiveness and Safety of Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy in Patients with Idiopathic Rhinitis: a Multicentre, Randomised, Parallel-controlled Study
Xu Yu
150 participants
Mar 1, 2025
INTERVENTIONAL
Conditions
Summary
The present study was a randomised, parallel controlled, open-label, multicentre clinical study. The trial was divided into two groups, the posterior nasal nerve combined with anterior ethmoid neurotomy group (group A) and the conventional drug treatment group (group B). Patients with idiopathic rhinitis (IR) who met the inclusion criteria were included in a 7-day introductory period of nasal spray hormone (Budesonide nasal spray) treatment. Subjects with IR who met the randomization criteria after the introductory period were randomized 1:1 to either group A or group B for a 1-year treatment follow-up study. In group A, subjects will undergo the posterior nasal nerve combined with anterior ethmoid neurotomy. In group B, subjects will be treated with medication according to guideline recommendations when nasal-related symptoms occur. Oral antihistamines (Loratadine) or nasal antihistamines (Azelastine Hydrochloride) are preferred, and nasal hormones (Budesonide nasal spray), or a combination of two or three drugs, may be used in severe cases. Participants will be evaluated for safety and efficacy throughout the entire three-year period.
Eligibility
Inclusion Criteria6
- Patients signed the free and informed consent form and understood the explanation of the study.
- patients with IR between 18 and 65 years and their body mass index (BMI) should be ≥19 kg/m2 and ≤24 kg/m2.
- Patients diagnosed with idiopathic rhinitis （IR）that were defined as nonsmoking patients with at least 2 nasal complaints of nasal obstruction, rhinorrhea, itching, and/or sneezing for more than 1 hour a day and for more than 1 year.
- Patients with negative skin prick test (SPT) responses or sIgE
- Nasal cytological exam with eosinophilia less than 20%.
- Patients had a Total Nasal Symptom Score (TNSS) of ≥6 and a subscore of nasal discharge ≥2 and a subscore of nasal congestion ≥1.
Exclusion Criteria8
- Patients with colored secretions, inflammation，nasal polyps, chronic sinusitis, nasal tumours.
- Patients with other chronic rhinitis such as occupational rhinitis, drug rhinitis, gustatory rhinitis, hormonal rhinitis, atrophic rhinitis, etc.
- Patients with anatomic nasal abnormalities responsible for nasal symptoms.
- Patients with nasal/sinus surgery 3 months before the study.
- Patients with severe mental illness.
- Patients with uncontrolled asthma, systemic disorders or malignancies.
- Patients with history of chronic smoking, substance abuse, drug use, and/or excessive alcohol consumption.
- Patients in pregnancy or lactation.
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Interventions
First, a vertical incision was made in the posterior portion of the middle nasal turbinate. Dissection was performed along the bone to elevate the mucosal flap to expose the thick orbital process of the vertical plate of the palatine bone and the sphenopalatine foramen. The 3-4 mm of mucosal and submucosal neurovascular bundles surrounding the sphenopalatine foramen were subjected to full radiofrequency ablation, directly to the bone. The mucoperiosteal flap is reposited back. The bilateral nasal cavity was packed with Merocel nasal pack and hemostasis was achieved. The anterior ethmoidal nerves of the lateral nasal branch and septal branch of the nasal cavity were cut off with a plasma treatment needle. Below 30°, the mucous membrane of the posterior lateral wall of the nasal colliculus was cut down to the bone surface using the needle of the nasal endoscope plasma therapy instrument. The contralateral side was then treated in the same way, with an arc cut line and a length of 2cm.
Subjects will be treated with medication according to guideline recommendations when nasal-related symptoms occur. Oral antihistamines or nasal antihistamines are preferred, and nasal hormones (budesonide nasal spray), or a combination of two or three drugs, may be used in severe cases.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06870292