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临床试验/NCT04642989
NCT04642989已完成不适用

The Effect of Facial Effleurage on Acute Rhinosinusitis

Edward Via Virginia College of Osteopathic Medicine1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2018年9月1日最近更新:
适应症
干预措施
相关药物

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

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

Sham Comparator

Healthy participants who received the sham treatment

干预措施: Sham Treatment (Other)

Healthy Control + Facial Effleurage

Active Comparator

Healthy participants who received the Facial Effleurage treatment

干预措施: Facial Effleurage (Other)

Acute Rhinosinusitis + Antibiotics

Active Comparator

Sick participants who received the recommended antibiotics

干预措施: Antibiotics (Drug)

Acute Rhinosinusitis + Sham Treatment

Sham Comparator

Sick participants who received the sham treatment

干预措施: Sham Treatment (Other)

Acute Rhinosinusitis + Facial Effleurage

Experimental

Sick participants who received the Facial Effleurage treatment

干预措施: Facial Effleurage (Other)

Acute Rhinosinusitis + Sham Treatment + Antibiotics

Sham Comparator

Sick participants who received the recommended antibiotics and the sham treatment

干预措施: Sham Treatment (Other)

Acute Rhinosinusitis + Sham Treatment + Antibiotics

Sham Comparator

Sick participants who received the recommended antibiotics and the sham treatment

干预措施: Antibiotics (Drug)

Acute Rhinosinusitis + Facial Effleurage + Antibiotics

Experimental

Sick participants who received the recommended antibiotics and the Facial Effleurage treatment

干预措施: Facial Effleurage (Other)

Acute Rhinosinusitis + Facial Effleurage + Antibiotics

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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