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The Effect of Facial Effleurage on Acute Rhinosinusitis

Primary Purpose

Rhinosinusitis Acute

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham Treatment
Facial Effleurage
Antibiotics
Sponsored by
Edward Via Virginia College of Osteopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rhinosinusitis Acute focused on measuring Osteopathic Manipulative Treatment

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Edward Via College of Osteopathic Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Sham Comparator

Experimental

Sham Comparator

Experimental

Arm Label

Healthy Control + Sham Treatment

Healthy Control + Facial Effleurage

Acute Rhinosinusitis + Antibiotics

Acute Rhinosinusitis + Sham Treatment

Acute Rhinosinusitis + Facial Effleurage

Acute Rhinosinusitis + Sham Treatment + Antibiotics

Acute Rhinosinusitis + Facial Effleurage + Antibiotics

Arm Description

Healthy participants who received the sham treatment

Healthy participants who received the Facial Effleurage treatment

Sick participants who received the recommended antibiotics

Sick participants who received the sham treatment

Sick participants who received the Facial Effleurage treatment

Sick participants who received the recommended antibiotics and the sham treatment

Sick participants who received the recommended antibiotics and the Facial Effleurage treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 26, 2020
Last Updated
November 23, 2020
Sponsor
Edward Via Virginia College of Osteopathic Medicine
Collaborators
American Osteopathic Association
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1. Study Identification

Unique Protocol Identification Number
NCT04642989
Brief Title
The Effect of Facial Effleurage on Acute Rhinosinusitis
Official Title
The Effect of Facial Effleurage on Acute Rhinosinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edward Via Virginia College of Osteopathic Medicine
Collaborators
American Osteopathic Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinosinusitis Acute
Keywords
Osteopathic Manipulative Treatment

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are not informed of the treatment group they are randomized into
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Control + Sham Treatment
Arm Type
Sham Comparator
Arm Description
Healthy participants who received the sham treatment
Arm Title
Healthy Control + Facial Effleurage
Arm Type
Active Comparator
Arm Description
Healthy participants who received the Facial Effleurage treatment
Arm Title
Acute Rhinosinusitis + Antibiotics
Arm Type
Active Comparator
Arm Description
Sick participants who received the recommended antibiotics
Arm Title
Acute Rhinosinusitis + Sham Treatment
Arm Type
Sham Comparator
Arm Description
Sick participants who received the sham treatment
Arm Title
Acute Rhinosinusitis + Facial Effleurage
Arm Type
Experimental
Arm Description
Sick participants who received the Facial Effleurage treatment
Arm Title
Acute Rhinosinusitis + Sham Treatment + Antibiotics
Arm Type
Sham Comparator
Arm Description
Sick participants who received the recommended antibiotics and the sham treatment
Arm Title
Acute Rhinosinusitis + Facial Effleurage + Antibiotics
Arm Type
Experimental
Arm Description
Sick participants who received the recommended antibiotics and the Facial Effleurage treatment
Intervention Type
Other
Intervention Name(s)
Sham Treatment
Intervention Description
All movements of facial effleurage except applying pressure
Intervention Type
Other
Intervention Name(s)
Facial Effleurage
Other Intervention Name(s)
Osteopathic Manipulative Therapy
Intervention Description
Facial massage to remove any lymphatic blockages
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Intervention Description
Appropriate "standard-of-care" antibiotics as determined by the physician.
Primary Outcome Measure Information:
Title
Symptom Severity
Description
SinoNasal Outcome Test-20 questionnaire. The scale is from 0-100 where 0 indicates no symptoms and 100 is the worst symptoms possible.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Edward Via College of Osteopathic Medicine
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

The Effect of Facial Effleurage on Acute Rhinosinusitis

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