Ear Acupuncture for Acute Sore Throat. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Reduction in Pain
研究概览
简要总结
The purpose of this study is to compare ear acupuncture plus standard of care versus standard therapy (anti-inflammatory medications) in the reduction of pain, reduction in oral anti inflammatory medication use, hours lost from work in acute sore throat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects (DoD beneficiaries), 18 years or older, with upper respiratory complaints and their primary symptom being acute sore throat.
- •Minimum pain score of 5 points on an 11 point scale (0-10 with 10 being the worst pain)
排除标准
- •History of significant gastrointestinal bleed
- •Previous documented history of stage 2 kidney disease or worse
- •Known Pregnancy
- •History of gastric bypass surgery
- •Known Peritonsillar abscess (PTA)
- •Throat, mouth or esophageal cancer
- •Chronic oral steroids use
- •Absence of one or more ears
- •Active cellulitis of ear
- •Ear anatomy precluding identification of acupuncture landmarks
- •Non-English speaking
- •Use of Hearing Aids that preclude the use of ear acupuncture
- •Allergy to Ibuprofen
结局指标
主要结局
Reduction in Pain
时间窗: 48 hours per subject
Subjects will be randomized to receive either standard treatment alone or standard treatment plus ear acupuncture. Subjects will be asked 15 minutes after their treatment to assess their pain on a likert scale of 0-10. After the subject has left the clinic, phone calls will be made at 6 hours, 24 hours and 48 hours to assess their pain level. Scale: 11-point scale of 0-10 with 10 being the worst pain. Subjects who report back after 48 hours with unimproved sore throat will be instructed to make a same day follow up with the clinic.
Missed Work Hours
时间窗: 48 hours per subject
Ibuprofen Doses Taken
时间窗: 48 hours per subject
Subjects will be randomized to receive either standard treatment alone or standard treatment plus ear acupuncture. After the subject has left the clinic, phone calls will be made at 6 hours, 24 hours and 48 hours to ask the number of doses of ibuprofen taken.
次要结局
未报告次要终点