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.

Study Overview

• Status: Completed
• Conditions: Rhinosinusitis Acute
• Intervention / Treatment: Other: Sham Treatment; Other: Facial Effleurage; Drug: Antibiotics

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Spartanburg, South Carolina, United States, 29301
      • Edward Via College of Osteopathic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Edward Via Virginia College of Osteopathic Medicine
• Collaborators: American Osteopathic Association

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Osteopathic Manipulative Treatment
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2017/035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Any identifying information obtained during the course of this study will be kept confidential. The results of this study, including but not limited to laboratory, clinical, or statistical data may be published. However, no names or other personally identifying information will be published. All subjects participating in this study will be assigned a unique identifier to de-identify their information. The patient number and identifying information will only be on one form during enrollment. All other documents will utilize the patient number. There will be a key that matches each identifier to the study participant. This key will be kept separately from the collected study data and only the study coordinator will have access to it. These records will be kept private in-so-far as permitted by law. All identifiable information will be stored on password-protected computers or in locked file cabinets.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No