Laser Posterior Nasal Nerve Neurolysis: a Randonmized 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
- 120
- 试验地点
- 2
- 主要终点
- Change in chronic rhinitis score
研究概览
简要总结
This clinical trial aims to learn if laser posterior nasal nerve neurolysis can treat chronic rhinitis in adults. It will also learn about the safety of laser posterior nasal nerve neurolysis. The main questions it aims to answer are:
- Does laser posterior nasal nerve neurolysis improve chronic rhinitis symptoms?
- What side-effects or complications do participants have after laser posterior nasal nerve neurolysis?
Researchers will compare laser posterior nasal nerve neurolysis to a placebo(a sham surgery with the same device and sound to see if laser posterior nasal nerve neurolysis works to treat chronic rhinitis.
Participants will
- Receive laser posterior nasal nerve neurolysis in the office as local anesthesia surgery.
- Visit the clinic in the first week, first month, and 3rd months after the surgery.
- Record their symptom scores before the surgery and during each follow-up visit.
详细描述
Chronic rhinitis is a highly prevalent condition characterized by symptoms such as nasal congestion, rhinorrhea, postnasal drip, nasal itching, and sneezing. First-line treatments typically include nasal irrigation, intranasal corticosteroids, intranasal anticholinergics, oral antihistamines, or topical decongestants. However, many patients fail to achieve satisfactory therapeutic outcomes through pharmacological interventions alone, resulting in significant impairment of quality of life and productivity.
In addition to pharmacotherapy, various surgical approaches have been proposed, including inferior turbinate reduction (partial or submucosal resection), radiofrequency inferior turbinate ablation (RFIT), microdebrider-assisted turbinoplasty, vidian neurectomy, and posterior nasal neurectomy or ablation. Vidian neurectomy is infrequently employed due to potential complications, including hemorrhage, malar and maxillary discomfort, and dry eye symptoms. While the introduction of endoscopic posterior nasal neurectomy has addressed some of these complications (malar and maxillary discomfort), patients may still experience dry eye.
In 2022 and 2023, the American Rhinologic Society (ARS) and the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) issued statements supporting the use of posterior nasal nerve neurolysis (PNNN) for the treatment of chronic rhinitis. These statements indicate that posterior nasal nerve neurolysis techniques, such as radiofrequency ablation and cryotherapy, have been utilized to disrupt the posterior nasal nerve in the sphenopalatine foramen region of the posterior middle meatus.
The application of CO2 laser for posterior nasal nerve cauterization has not yet been evaluated in large-scale randomized controlled clinical trials. In otolaryngological surgery, this laser is widely employed in pharyngolaryngeal procedures, vocal cord surgery, oral mucosal surgery, and intranasal and turbinate surgeries due to its excellent hemostatic properties and precision.
Therefore, the investigators propose this research protocol to conduct a randomized controlled clinical trial to determine whether posterior nasal nerve cauterization using CO2 laser can effectively control chronic rhinitis symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 ≥ 5 with Moderate to severe rhinorrhea symptoms (24-hour reflective Total Nasal Symptom Score [rTNSS] rhinorrhea score of 2-3) 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
研究组 & 干预措施
Laser surgery
Posterior nasal nerve ablation using laser to deliver laser energy to the posterior nasal nerve area.
干预措施: Laser posterior nasal nerve neurolysis (Procedure)
Sham surgery
Sham surgery is performed with the same laser surgical instrument used to enter the nasal cavity for a sham procedure with minimal dosage.
干预措施: Sham surgery (Procedure)
结局指标
主要结局
Change in chronic rhinitis score
时间窗: From the date of randomization and every three months after intervention is performed on 3, 6, 9, and 12 months post intervention.
The investigators will use reflective total nasal symptom score, (rTNSS, 0-12, the higher the worse) and Nasal Obstruction Symptom Evaluation(NOSE, 0-20, the higher the worse) to compare the chronic rhinitis symptoms before and after the intervention.
次要结局
- Complications of the intervention(From the date of randomization and every three months after intervention is performed on 3, 6, 9, and 12 months post intervention.)