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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinitis
• Intervention / Treatment: Device: Radiofrequency ablation (RFA)

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiofrequency ablation (RFA)

Device: Radiofrequency ablation (RFA); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)	PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute.	Baseline
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)	PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute	4 weeks post intervention
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)	PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute	12 weeks post intervention
Interleukin-10 (IL-10)	cytokine	Baseline
Interleukin-22 (IL-22)	cytokine	Baseline
Interleukin-10 (IL-10)	cytokine	12 weeks post intervention
Interleukin-22 (IL-22)	cytokine	12 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion	Baseline
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). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion	4 weeks post intervention
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). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion	12 weeks post intervention
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). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction.	Baseline
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). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction.	4 weeks post intervention
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). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction.	12 weeks post intervention

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: American Academy of Otolaryngic Allergy
• Investigators: Principal Investigator: David Z Allen, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: radiofrequency ablation
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis
• Other Study ID Numbers: HSC-MS-22-0899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No