The Effect of Facial Effleurage on Acute Rhinosinusitis

Not Applicable

Completed

• Conditions: Rhinosinusitis Acute
• Interventions: Other: Sham Treatment; Other: Facial Effleurage; Drug: Antibiotics

• Registration Number: NCT04642989
• Lead Sponsor: Edward Via Virginia College of Osteopathic Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2020-05-26
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-23
• Last Update Submitted: 2020-11-23
• Study First Posted: 2020-11-24
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Control + Sham Treatment	Sham Treatment	Healthy participants who received the sham treatment
Healthy Control + Facial Effleurage	Facial Effleurage	Healthy participants who received the Facial Effleurage treatment
Acute Rhinosinusitis + Sham Treatment + Antibiotics	Antibiotics	Sick participants who received the recommended antibiotics and the sham treatment
Acute Rhinosinusitis + Sham Treatment + Antibiotics	Sham Treatment	Sick participants who received the recommended antibiotics and the sham treatment
Acute Rhinosinusitis + Antibiotics	Antibiotics	Sick participants who received the recommended antibiotics
Acute Rhinosinusitis + Facial Effleurage	Facial Effleurage	Sick participants who received the Facial Effleurage treatment
Acute Rhinosinusitis + Facial Effleurage + Antibiotics	Facial Effleurage	Sick participants who received the recommended antibiotics and the Facial Effleurage treatment
Acute Rhinosinusitis + Sham Treatment	Sham Treatment	Sick participants who received the sham treatment
Acute Rhinosinusitis + Facial Effleurage + Antibiotics	Antibiotics	Sick participants who received the recommended antibiotics and the Facial Effleurage treatment

Primary Outcome Measures

Name	Time	Method
Symptom Severity	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.

Trial Locations

Locations (1)

Edward Via College of Osteopathic Medicine; 🇺🇸 Spartanburg, South Carolina, United States