Comparison of Traditional Radiofrequency Ablation of Inferior Turbinates With or Without Posterior Nasal Radiofrequency Ablation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Response rate based on improvement in reflective Total Nasal Symptom Score (rTNSS)
研究概览
简要总结
This study is a prospective, single-center, single-blinded randomized controlled trial designed to compare the clinical effectiveness of traditional radiofrequency ablation of the anterior inferior turbinate alone versus expanded radiofrequency ablation including the middle and posterior portions of the inferior turbinate (posterior nasal region). Patients with chronic rhinitis who remain symptomatic despite at least six months of medical therapy will be randomized in a 2:1 ratio to undergo extended posterior nasal ablation versus traditional anterior treatment. Symptom improvement will be evaluated using rTNSS and other validated questionnaires.
详细描述
Chronic rhinitis is a common condition characterized by persistent nasal obstruction and rhinorrhea, leading to significant impairment in quality of life. Radiofrequency ablation of the inferior turbinate is an established minimally invasive treatment for patients with symptoms refractory to medical therapy. However, symptom control may be suboptimal in some patients, particularly when posterior nasal neural components contribute to disease persistence.
Posterior nasal radiofrequency ablation, which extends treatment to the middle and posterior portions of the inferior turbinate, has been proposed as an adjunctive technique to enhance symptom relief by targeting posterior nasal regions. Evidence comparing traditional anterior inferior turbinate radiofrequency ablation with expanded posterior nasal radiofrequency ablation remains limited.
In this prospective, single-center, randomized controlled trial, eligible patients with chronic rhinitis refractory to at least six months of medical therapy will be randomized in a 2:1 ratio to receive either expanded radiofrequency ablation including the middle and posterior portions of the inferior turbinate or traditional anterior inferior turbinate radiofrequency ablation alone. The primary outcome is the response rate based on improvement in reflective Total Nasal Symptom Score (rTNSS), defined as a ≥30% reduction from baseline at 3 months after the procedure. Secondary outcomes include changes in validated symptom and quality-of-life questionnaires and the incidence of procedure-related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years old
- •Chronic rhinitis symptoms for at least 6 months that have not responded effectively to medication (should include at least Intranasal corticosteroid (ICS) combined with intermittent use of oral antihistamine and, as needed, combination nasal spray) or where medication has not provided sustained improvement
- •Total rTNSS ≥ 4 with Moderate to severe rhinorrhea symptoms (24-hour reflective Total Nasal Symptom Score [rTNSS] rhinorrhea score of 1-3) and mild to severe nasal congestion symptoms (rTNSS nasal congestion score of 1-3)
- •All enrolled patients routinely undergo endonasal endoscopic examination, or have had a sinus CT within the past month confirming no significant rhinosinusitis."
排除标准
- •Obstructive anatomical abnormalities limiting access to posterior nasal passages
- •Nasal anatomical changes due to previous sinus or nasal surgery or injury
- •Ongoing nasal or sinus infection
- •History of severe dry eye, chronic epistaxis, rhinitis medicamentosa, or head and neck radiotherapy
- •Self-reported history of bleeding tendency
- •Current use of anticoagulants with inability to discontinue
- •Previous chronic rhinitis surgery
- •History of poor wound healing after head, neck, or throat surgery
- •Pregnancy/lactation
- •Neuromuscular disease preventing supine positioning
研究组 & 干预措施
Inferior Turbinate RF Ablation
Traditional Radiofrequency Ablation of Inferior Turbinates
干预措施: Traditional Radiofrequency Ablation of Inferior Turbinates (Procedure)
Inferior Turbinate RF with Posterior Nasal RF Ablation
Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation
干预措施: Traditional Radiofrequency Ablation of Inferior Turbinates With Posterior Nasal Radiofrequency Ablation (Procedure)
结局指标
主要结局
Response rate based on improvement in reflective Total Nasal Symptom Score (rTNSS)
时间窗: 3 months after the procedure
Response is defined as a ≥30% reduction from baseline in the reflective Total Nasal Symptom Score (rTNSS; range 0-12, higher scores indicate worse symptoms).
次要结局
- Change in reflective Total Nasal Symptom Score (rTNSS)(Baseline, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months after the procedure)
- Change in Nasal Obstruction Symptom Evaluation (NOSE) score(Baseline, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months after the procedure)
- Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) score(Baseline and 3 months after the procedure)
- Incidence of intervention-related complications(From the date of the procedure through 12 months after the procedure)
- Change in Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) score(Baseline and 3 months after the procedure)
- Change in Patulous Eustachian tube handicap inventory-10 (PHI-10) score(Baseline and 3 months after the procedure)
- Change in Pittsburgh Sleep Quality Index (PSQI) score(Baseline and 3 months after the procedure)
- Change in Epworth Sleepiness Scale (ESS) score(Baseline and 3 months after the procedure)
研究者
Chien Yu Huang
Attending Physician, Department of Otolaryngology
Chia-Yi Hospital, Ministry of Health and Welfare