Prospective Case Series Evaluating Short and Long Term Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)
研究概览
简要总结
Empty Nose Syndrome patients suffer from disabling physical symptoms and considerable distress. To date there is no definitive cure for these symptoms. Established treatment modalities include saline irrigation, surgical implantation of materials or simply use of cotton wads/ silicon cones to simulate the resistive action to airflow of the resected turbinates.
This study will research the effectiveness of a new treatment modality in the treatment of Empty Nose Syndrome. This novel treatment method involves the use of botulinum toxin type A (Botox).
详细描述
Background:
Empty Nose Syndrome (ENS) is the term used to describe the condition resulting from over resection of nasal turbinate. Symptoms include depression, dysosmia, bleeding, discharge, crusting, dryness, dysosmia, and pain.
Treatment modalities include adjunctive comfort measures (primarily irrigation), mechanical measures (Silicon cones, cotton wads) and surgical treatment (alloderm implants, plastipore cartilage grafts etc.) We will investigate a new method of treatment for ENS. This will involve injection of botulinum toxin type A into the dilator nasalis muscle thus collapsing the internal nasal valve to provide added resistance to air flow.
Objective:
To evaluate effectiveness of botulinum toxin type A in improving overall quality of life in ENS patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient aged 18-65 years of age presenting with a known diagnosis of ENS who has no known allergies to Botox.
排除标准
- •Patients younger than 18 years or older than 65 years of age.
- •Patients with neuromuscular disorders or neuropathic diseases.
- •Patients with infection and or swelling at the site where Botox is to be injected.
- •Patients with known hypersensitivity to any ingredient in the drug formulation (botulinum toxin, human albumin)
- •Patients who are or plan to become pregnant within the time period in which the study will be conducted.
- •Patients who are nursing
研究组 & 干预措施
Botulinum Toxin Type A
Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)
时间窗: 2 weeks after intervention, 2 months
The SNOT 22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0-110 and lower scores represent better health related quality of life.
次要结局
未报告次要终点