Rhinosinusitis AcuteNCT04642989
The Effect of Facial Effleurage on Acute Rhinosinusitis
A study testing Facial Effleurage and Antibiotics in people with Rhinosinusitis Acute, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinosinusitis Acute
- What is being tested?
- Facial Effleurage and Antibiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Via College of Osteopathic Medicine
Spartanburg, South Carolina, 29301
About this study
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
- Being tested
- Sham Treatment, Facial Effleurage, Antibiotics
- Keywords
- Osteopathic Manipulative Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham TreatmentOther
All movements of facial effleurage except applying pressure
Facial EffleurageOther
Also called Osteopathic Manipulative Therapy
Facial massage to remove any lymphatic blockages
AntibioticsDrug
Appropriate "standard-of-care" antibiotics as determined by the physician.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control + Sham Treatment | Sham comparator | Healthy participants who received the sham treatment Receives: Other: Sham Treatment |
| Healthy Control + Facial Effleurage | Active comparator | Healthy participants who received the Facial Effleurage treatment Receives: Other: Facial Effleurage |
| Acute Rhinosinusitis + Antibiotics | Active comparator | Sick participants who received the recommended antibiotics Receives: Drug: Antibiotics |
| Acute Rhinosinusitis + Sham Treatment | Sham comparator | Sick participants who received the sham treatment Receives: Other: Sham Treatment |
| Acute Rhinosinusitis + Facial Effleurage | Experimental | Sick participants who received the Facial Effleurage treatment Receives: Other: Facial Effleurage |
| Acute Rhinosinusitis + Sham Treatment + Antibiotics | Sham comparator | Sick participants who received the recommended antibiotics and the sham treatment Receives: Other: Sham Treatment; Drug: Antibiotics |
| Acute Rhinosinusitis + Facial Effleurage + Antibiotics | Experimental | Sick participants who received the recommended antibiotics and the Facial Effleurage treatment Receives: Other: Facial Effleurage; Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Sep 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinosinusitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Via Virginia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642989
- Sponsor's protocol ID
- 2017/035
- Status last verified
- Nov 2020
- First submitted
- 26 May 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Facial Effleurage on Acute Rhinosinusitis
- ClinicalTrials.gov ID
- NCT04642989
- Acronym / sponsor ID
- 2017/035
- Conditions
- Rhinosinusitis Acute
- Keywords
- Osteopathic Manipulative Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Edward Via Virginia College of Osteopathic MedicineUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Healthy Control + Sham Treatment | Sham comparator | Other: Sham TreatmentHealthy participants who received the sham treatment |
| Healthy Control + Facial Effleurage | Active comparator | Other: Facial EffleurageHealthy participants who received the Facial Effleurage treatment |
| Acute Rhinosinusitis + Antibiotics | Active comparator | Drug: AntibioticsSick participants who received the recommended antibiotics |
| Acute Rhinosinusitis + Sham Treatment | Sham comparator | Other: Sham TreatmentSick participants who received the sham treatment |
| Acute Rhinosinusitis + Facial Effleurage | Experimental | Other: Facial EffleurageSick participants who received the Facial Effleurage treatment |
| Acute Rhinosinusitis + Sham Treatment + Antibiotics | Sham comparator | Other: Sham Treatment, Drug: AntibioticsSick participants who received the recommended antibiotics and the sham treatment |
| Acute Rhinosinusitis + Facial Effleurage + Antibiotics | Experimental | Other: Facial Effleurage, Drug: AntibioticsSick participants who received the recommended antibiotics and the Facial Effleurage treatment |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham TreatmentAll movements of facial effleurage except applying pressure | Other | Acute Rhinosinusitis + Sham Treatment, Acute Rhinosinusitis + Sham Treatment + Antibiotics, Healthy Control + Sham Treatment |
| Facial EffleurageAlso: Osteopathic Manipulative TherapyFacial massage to remove any lymphatic blockages | Other | Acute Rhinosinusitis + Facial Effleurage, Acute Rhinosinusitis + Facial Effleurage + Antibiotics, Healthy Control + Facial Effleurage |
| AntibioticsAppropriate "standard-of-care" antibiotics as determined by the physician. | Drug | Acute Rhinosinusitis + Antibiotics, Acute Rhinosinusitis + Facial Effleurage + Antibiotics, Acute Rhinosinusitis + Sham Treatment + Antibiotics |
Primary outcome
Symptom Severity
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial Effleurage and Antibiotics in people with Rhinosinusitis Acute, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Severity (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.