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OpenTrials
Completed

NCT Number: NCT04642989

The Effect of Facial Effleurage on Acute Rhinosinusitis

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.

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Key information

Conditions

Rhinosinusitis Acute

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Via College of Osteopathic Medicine

Spartanburg, South Carolina, 29301, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham Treatment

Other

All movements of facial effleurage except applying pressure

Facial Effleurage

Other

Facial massage to remove any lymphatic blockages

Other names: Osteopathic Manipulative Therapy

Antibiotics

Drug

Appropriate "standard-of-care" antibiotics as determined by the physician.

Primary outcomes

  1. Symptom Severity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Edward Via Virginia College of Osteopathic Medicine

Other

Collaborators

  • American Osteopathic Association

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 24, 2020
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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