Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Interleukin-10 (IL-10)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •active sinusitis
- •rhinitis medicamentosa
- •recurrent and ongoing epistaxis
- •immunodeficiency as defined by an illness or a history of sinus surgery.
研究组 & 干预措施
Radiofrequency ablation (RFA)
干预措施: Radiofrequency ablation (RFA) (Device)
结局指标
主要结局
Interleukin-10 (IL-10)
时间窗: 12 weeks post intervention
cytokine
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)
时间窗: 12 weeks post intervention
PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute
Interleukin-22 (IL-22)
时间窗: 12 weeks post intervention
cytokine
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)
时间窗: Baseline
PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute.
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)
时间窗: 4 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)
时间窗: Baseline
cytokine
Interleukin-22 (IL-22)
时间窗: Baseline
cytokine
次要结局
- Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)(12 weeks post intervention)
- Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)(12 weeks post intervention)
- Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)(Baseline)
- Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)(4 weeks post intervention)
- Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)(Baseline)
- Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)(4 weeks post intervention)
研究者
David Z. Allen
Resident
The University of Texas Health Science Center, Houston