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The Effect of Facial Effleurage on Acute Rhinosinusitis

NCT ID: NCT04642989

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-09-01

Brief Summary

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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

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Conditions

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Rhinosinusitis Acute

Keywords

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Osteopathic Manipulative Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants are not informed of the treatment group they are randomized into

Study Groups

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Healthy Control + Sham Treatment

Healthy participants who received the sham treatment

Group Type SHAM_COMPARATOR

Sham Treatment

Intervention Type OTHER

All movements of facial effleurage except applying pressure

Healthy Control + Facial Effleurage

Healthy participants who received the Facial Effleurage treatment

Group Type ACTIVE_COMPARATOR

Facial Effleurage

Intervention Type OTHER

Facial massage to remove any lymphatic blockages

Acute Rhinosinusitis + Antibiotics

Sick participants who received the recommended antibiotics

Group Type ACTIVE_COMPARATOR

Antibiotics

Intervention Type DRUG

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

Acute Rhinosinusitis + Sham Treatment

Sick participants who received the sham treatment

Group Type SHAM_COMPARATOR

Sham Treatment

Intervention Type OTHER

All movements of facial effleurage except applying pressure

Acute Rhinosinusitis + Facial Effleurage

Sick participants who received the Facial Effleurage treatment

Group Type EXPERIMENTAL

Facial Effleurage

Intervention Type OTHER

Facial massage to remove any lymphatic blockages

Acute Rhinosinusitis + Sham Treatment + Antibiotics

Sick participants who received the recommended antibiotics and the sham treatment

Group Type SHAM_COMPARATOR

Sham Treatment

Intervention Type OTHER

All movements of facial effleurage except applying pressure

Antibiotics

Intervention Type DRUG

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

Acute Rhinosinusitis + Facial Effleurage + Antibiotics

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

Group Type EXPERIMENTAL

Facial Effleurage

Intervention Type OTHER

Facial massage to remove any lymphatic blockages

Antibiotics

Intervention Type DRUG

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

Interventions

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Sham Treatment

All movements of facial effleurage except applying pressure

Intervention Type OTHER

Facial Effleurage

Facial massage to remove any lymphatic blockages

Intervention Type OTHER

Antibiotics

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

Intervention Type DRUG

Other Intervention Names

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Osteopathic Manipulative Therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Osteopathic Association

OTHER

Sponsor Role collaborator

Edward Via Virginia College of Osteopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Edward Via College of Osteopathic Medicine

Spartanburg, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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2017/035

Identifier Type: -

Identifier Source: org_study_id