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| Name | Class |
|---|---|
| American Osteopathic Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control + Sham Treatment | Sham Comparator | Healthy participants who received the sham treatment |
|
| Healthy Control + Facial Effleurage | Active Comparator | Healthy participants who received the Facial Effleurage treatment |
|
| Acute Rhinosinusitis + Antibiotics | Active Comparator | Sick participants who received the recommended antibiotics |
|
| Acute Rhinosinusitis + Sham Treatment | Sham Comparator | Sick participants who received the sham treatment |
|
| Acute Rhinosinusitis + Facial Effleurage | Experimental | Sick participants who received the Facial Effleurage treatment |
|
| Acute Rhinosinusitis + Sham Treatment + Antibiotics | Sham Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Treatment | Other | All movements of facial effleurage except applying pressure |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Via College of Osteopathic Medicine | Spartanburg | South Carolina | 29301 | United States |
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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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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Participants are not informed of the treatment group they are randomized into
Sick participants who received the recommended antibiotics and the sham treatment
|
| Acute Rhinosinusitis + Facial Effleurage + Antibiotics | Experimental | Sick participants who received the recommended antibiotics and the Facial Effleurage treatment |
|
| Facial Effleurage | Other | Facial massage to remove any lymphatic blockages |
|
|
| Antibiotics | Drug | Appropriate "standard-of-care" antibiotics as determined by the physician. |
|
| D012046 | Rehabilitation |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |