Clinical trial NCT04642989: The Effect of Facial Effleurage on Acute Rhinosinusitis
Official title: The Effect of Facial Effleurage on Acute Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinosinusitis Acute
Keywords: Osteopathic Manipulative Treatment
Lead sponsor: Edward Via Virginia College of Osteopathic Medicine
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2020-11-24
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Symptom Severity
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: Edward Via College of Osteopathic Medicine
state: South Carolina
Study officials:
References: