The Effect of Facial Effleurage on Acute Rhinosinusitis

NCT04642989 | Completed

• 1 other identifier: 2017/035
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinosinusitis Acute

Keywords

Osteopathic Manipulative Treatment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (7)

Healthy Control + Sham Treatment

SHAM COMPARATOR

Healthy participants who received the sham treatment

Other: Sham Treatment

Healthy Control + Facial Effleurage

ACTIVE COMPARATOR

Healthy participants who received the Facial Effleurage treatment

Other: Facial Effleurage

Acute Rhinosinusitis + Antibiotics

ACTIVE COMPARATOR

Sick participants who received the recommended antibiotics

Drug: Antibiotics

Acute Rhinosinusitis + Sham Treatment

SHAM COMPARATOR

Sick participants who received the sham treatment

Other: Sham Treatment

Acute Rhinosinusitis + Facial Effleurage

EXPERIMENTAL

Sick participants who received the Facial Effleurage treatment

Other: Facial Effleurage

Acute Rhinosinusitis + Sham Treatment + Antibiotics

SHAM COMPARATOR

Sick participants who received the recommended antibiotics and the sham treatment

Other: Sham Treatment; Drug: Antibiotics

Acute Rhinosinusitis + Facial Effleurage + Antibiotics

EXPERIMENTAL

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

Other: Facial Effleurage; Drug: Antibiotics

Interventions

Sham Treatment OTHER

All movements of facial effleurage except applying pressure

Acute Rhinosinusitis + Sham Treatment; Acute Rhinosinusitis + Sham Treatment + Antibiotics; Healthy Control + Sham Treatment

Facial Effleurage OTHER

Facial massage to remove any lymphatic blockages

Also known as: Osteopathic Manipulative Therapy

Acute Rhinosinusitis + Facial Effleurage; Acute Rhinosinusitis + Facial Effleurage + Antibiotics; Healthy Control + Facial Effleurage

Antibiotics DRUG

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

Acute Rhinosinusitis + Antibiotics; Acute Rhinosinusitis + Facial Effleurage + Antibiotics; Acute Rhinosinusitis + Sham Treatment + Antibiotics

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine: lead
• American Osteopathic Association: collaborator

Study Sites (1)

Edward Via College of Osteopathic Medicine

Spartanburg, South Carolina, 29301, United States

Location

MeSH Terms

Interventions

Manipulation, Osteopathic; Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not informed of the treatment group they are randomized into
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: November 24, 2020
• Study Start: September 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)