Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of radiofrequency ablation (RFA) of the posterior nasal nerve (PNN) in chronic rhinitis (CR) patients by comparing patient reflective total nasal symptom score (rTNSS) and nasal obstruction symptom evaluation (NOSE) , peak nasal inspiratory flow (PNIF) , and levels of Type 2 cytokines pre- and post-procedure.

Official Title
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Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis

Conditions
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Chronic Rhinitis

Intervention / Treatment
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* Device: Radiofrequency ablation (RFA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic rhinitis symptoms for at least 6 months (rhinorrhea, congestion, post-nasal drip) poor response to medical management that was attempted for at least 4 weeks a rTNSS score ≥6, as well as ≥2 for rhinorrhea, and ≥1 for congestion. Exclusion Criteria: active sinusitis rhinitis medicamentosa recurrent and ongoing epistaxis immunodeficiency as defined by an illness or a history of sinus surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency ablation (RFA)<br> | Device: Radiofrequency ablation (RFA)<br>* The NEUROMARK device is an in-office, disposable bipolar RFA device with a treatment tip consisting of micro electrodes which delivers RF energy while monitoring appropriate tissue contact to maximize delivery to posterior nasal nerve and its variable branching. After topical anesthesia consisting of oxymetazoline and 1% lido followed by 4% lidocaine, the device will be placed in the posterior inferior turbinate under endoscopic visualization. The device will be activated per manufacturer's instructions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nasal congestion as assessed by the peak nasal inspiratory flow (PNIF) | this directly measures nasal airflow during maximal inspiration in liters per minute | Baseline, 12 weeks post intervention | 
| Change in levels of type 2 cytokines |  | Baseline,12 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nasal congestion as assessed by the reflective total nasal symptom score (rTNSS) | This is a 4 item questionnaire and each is scored from 0(none) to 3(severe), with a maximum score of 12,a higher number indicating more congestion | Baseline,12 weeks post intervention | 
| Change in nasal obstruction as assessed by the nasal obstruction symptom evaluation survey (NOSE) | This is a 5 item self reported questionnaire and each is scored from 0(not a problem)-4(severe problem), with a maximum score of 20, a higher number indicating more obstruction | Baseline,12 weeks post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiofrequency ablation