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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
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
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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.
Time frame: 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
Time frame: 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
Time frame: 12 weeks post intervention
Interleukin-10 (IL-10)
cytokine
Time frame: Baseline
Interleukin-22 (IL-22)
cytokine
Time frame: Baseline
Interleukin-10 (IL-10)
cytokine
Time frame: 12 weeks post intervention
Interleukin-22 (IL-22)
cytokine
Time frame: 12 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks post intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.