NCT03888274已完成不适用
ClearUP Longitudinal Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale for Pain
研究概览
简要总结
Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain Relief for four weeks.
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 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-71 years of age (inclusive)
- •Present with symptoms of sinus pain or facial pain in the forehead, periorbital, facial, or nasal region
- •Current pain score ≥ 5 (Numeric Rating Scale 0-10)
- •Frequency of sinus/facial pain at least twice weekly for 1 month
- •Able to read and understand English
- •Agree to participate in the study
- •Able and willing to provide Informed Consent
排除标准
- •Do not meet Inclusion Criteria
- •Currently taking or recently taken any oral steroid medications in the last 90 days
- •Sinus surgery in previous 90 days
- •History of Chronic Migraine (≥ 15 headache days per month)
- •Pain location in the vertex, occiput, or temporal region of the skull or in mandibular region
- •Purulent rhinorrhea
结局指标
主要结局
Numeric Rating Scale for Pain
时间窗: 4 weeks
Change in Numeric Rating Scale for Pain from Baseline to Four Weeks. Scale range 0, no pain, to 10 severe pain.
次要结局
- Congestion Quantifier 7(4 Weeks)
- Numeric Rating Scale for Pain(6 hours)
研究者
研究点 (2)
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