The Effect of Facial Effleurage on Acute Rhinosinusitis

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Facial Effleurage on Acute Rhinosinusitis

Conditions
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Rhinosinusitis Acute

Intervention / Treatment
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* Other: Sham Treatment
* Other: Facial Effleurage
* Drug: Antibiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Healthy Control + Sham Treatment<br>Healthy participants who received the sham treatment | Other: Sham Treatment<br>* All movements of facial effleurage except applying pressure<br>|
| Active Comparator: Healthy Control + Facial Effleurage<br>Healthy participants who received the Facial Effleurage treatment | Other: Facial Effleurage<br>* Facial massage to remove any lymphatic blockages<br>* Other names: Osteopathic Manipulative Therapy;|
| Active Comparator: Acute Rhinosinusitis + Antibiotics<br>Sick participants who received the recommended antibiotics | Drug: Antibiotics<br>* Appropriate standard-of-care antibiotics as determined by the physician.<br>|
| Sham Comparator: Acute Rhinosinusitis + Sham Treatment<br>Sick participants who received the sham treatment | Other: Sham Treatment<br>* All movements of facial effleurage except applying pressure<br>|
| Experimental: Acute Rhinosinusitis + Facial Effleurage<br>Sick participants who received the Facial Effleurage treatment | Other: Facial Effleurage<br>* Facial massage to remove any lymphatic blockages<br>* Other names: Osteopathic Manipulative Therapy;|
| Sham Comparator: Acute Rhinosinusitis + Sham Treatment + Antibiotics<br>Sick participants who received the recommended antibiotics and the sham treatment | Other: Sham Treatment<br>* All movements of facial effleurage except applying pressure<br>Drug: Antibiotics<br>* Appropriate standard-of-care antibiotics as determined by the physician.<br>|
| Experimental: Acute Rhinosinusitis + Facial Effleurage + Antibiotics<br>Sick participants who received the recommended antibiotics and the Facial Effleurage treatment | Other: Facial Effleurage<br>* Facial massage to remove any lymphatic blockages<br>* Other names: Osteopathic Manipulative Therapy;Drug: Antibiotics<br>* Appropriate standard-of-care antibiotics as determined by the physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Severity | SinoNasal Outcome Test-20 questionnaire. The scale is from 0-100 where 0 indicates no symptoms and 100 is the worst symptoms possible. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic Manipulative Treatment