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

Not Applicable

Completed

• Conditions: Chronic Rhinitis
• Interventions: Device: Radiofrequency ablation (RFA)

• Registration Number: NCT05648565
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-13
• Study Start: 2023-01-10
• Primary Completion: 2024-02-20
• Study Completion: 2024-02-20
• Results First Submitted: 2025-02-18
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Results First Posted: 2025-04-03
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiofrequency ablation (RFA)	Radiofrequency ablation (RFA)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)	12 weeks post intervention	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
Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)	12 weeks post intervention	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States