The Effect of Facial Effleurage on Acute Rhinosinusitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Symptom Severity
研究概览
简要总结
Rhinosinusitis accounts for 12% of the total antibiotic prescriptions filled in the United States annually; however, the majority of rhinosinusitis cases have been proposed to have a viral etiology, or are capable of spontaneously resolving. This overuse of antibiotics is contributing to the development of antibiotic-resistant human pathogenic bacteria, and increasing patient mortality to previously easily cured diseases. This is also causing an unnecessary financial burden especially for uninsured, rural families. Facial Effleurage (FE) is an osteopathic manipulative therapy that allows physicians an alternative therapy to prescribing antibiotics; however, the only scientific literature on the technique is weak in design and execution. This will be a randomized, placebo-controlled clinical trial to test the ability of FE to reduce symptom severity over time, reduce the cellular infiltrate into the nasal cavity, and to more quickly resolve the symptoms of rhinosinusitis compared to antibiotic treatment. This methodical approach to the efficacy of FE has the potential to impact the treatment recommendations of physicians immediately, and to convince more physicians to prescribe less antibiotics and rely more heavily on FE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participants are not informed of the treatment group they are randomized into
入排标准
- 年龄范围
- 18 Years 至 69 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presents with no acute disease OR
- •Presents with anterior/posterior mucopurulent drainage and nasal obstruction/facial pain/pressure/fullness
- •Independently and without coercion read, understood, and signed the informed consent form
- •Is between 18-69 years old.
排除标准
- •History of: cancer, HIV, HIV exposure, osteoporosis, acute hepatitis, cystic fibrosis, type-1 diabetes, taking insulin for diabetes, deep vein thrombosis, pulmonary embolism
- •History of recent trauma to the liver or spleen or surgery within the past 6 months
- •Currently pregnant or nursing
- •Have a comorbidity that requires antibiotics or antiviral therapy
- •Have a fever greater than 102.5F
- •Used topical antimicrobials in the past 30 days
- •Taken oral antimicrobials in the past 15 days
- •Participated in a clinical trial in the past 6 months
- •Have current face or neck bone fractures
- •Have abscesses, incisions, or nasal polyps visible on physical examination
- •Need to be hospitalized for any reason
研究组 & 干预措施
Healthy Control + Sham Treatment
Healthy participants who received the sham treatment
干预措施: Sham Treatment (Other)
Healthy Control + Facial Effleurage
Healthy participants who received the Facial Effleurage treatment
干预措施: Facial Effleurage (Other)
Acute Rhinosinusitis + Antibiotics
Sick participants who received the recommended antibiotics
干预措施: Antibiotics (Drug)
Acute Rhinosinusitis + Sham Treatment
Sick participants who received the sham treatment
干预措施: Sham Treatment (Other)
Acute Rhinosinusitis + Facial Effleurage
Sick participants who received the Facial Effleurage treatment
干预措施: Facial Effleurage (Other)
Acute Rhinosinusitis + Sham Treatment + Antibiotics
Sick participants who received the recommended antibiotics and the sham treatment
干预措施: Sham Treatment (Other)
Acute Rhinosinusitis + Sham Treatment + Antibiotics
Sick participants who received the recommended antibiotics and the sham treatment
干预措施: Antibiotics (Drug)
Acute Rhinosinusitis + Facial Effleurage + Antibiotics
Sick participants who received the recommended antibiotics and the Facial Effleurage treatment
干预措施: Facial Effleurage (Other)
Acute Rhinosinusitis + Facial Effleurage + Antibiotics
Sick participants who received the recommended antibiotics and the Facial Effleurage treatment
干预措施: Antibiotics (Drug)
结局指标
主要结局
Symptom Severity
时间窗: 7 days
SinoNasal Outcome Test-20 questionnaire. The scale is from 0-100 where 0 indicates no symptoms and 100 is the worst symptoms possible.
次要结局
未报告次要终点
