The Effect of Facial Effleurage on Acute Rhinosinusitis

Rhinosinusitis Acute Clinical Trial

Official title:

The Effect of Facial Effleurage on Acute Rhinosinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642989
• Other study ID #: 2017/035
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2020
• Source: Edward Via Virginia College of Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinosinusitis Acute
• Sinusitis

Intervention

Other:
• Sham Treatment
All movements of facial effleurage except applying pressure
• Facial Effleurage
Facial massage to remove any lymphatic blockages

Drug:
• Antibiotics
Appropriate "standard-of-care" antibiotics as determined by the physician.

Locations

Country	Name	City	State
United States	Edward Via College of Osteopathic Medicine	Spartanburg	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Edward Via Virginia College of Osteopathic Medicine	American Osteopathic Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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