Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure: Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Facial Pain
- Sponsor
- Mayo Clinic
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Change in Facial Pain Visual Analogue Scale (VAS)
- Status
- Terminated
- Last Updated
- 7 months ago
Overview
Brief Summary
The purpose of this study is to investigate if the SinuSonic device decreases facial pain and pressure compared to the placebo device.
Investigators
Amar Miglani
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Participant must be \> 18 years of age inclusive, at the time of signing the informed consent.
- •Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Facial pain or pressure for \> 3 months of symptom duration.
- •Pain/pressure VAS (Visual Analogue Scale) Score of \> 5.
Exclusion Criteria
- •Upper respiratory illness within the last 2 weeks.
- •History of severe epistaxis.
- •Known pregnancy.
- •Allergic sensitivity to silicone or any other component of device.
- •Sinonasal surgery in the last 3 months.
- •Topical decongestant use in the last week.
- •Nasal polyposis, purulence/edema, or other signs of sinusitis on exam.
- •Sinusitis on imaging.
- •Nasal crusting or ulceration on exam.
- •Inability to read or understand English.
Outcomes
Primary Outcomes
Change in Facial Pain Visual Analogue Scale (VAS)
Time Frame: Baseline, 8 weeks
Participants rated sinus or facial pain/pressure using a 0-10 Visual Analogue Scale (VAS) which measured the average sinus pain over the past week. The VAS was displayed as a horizontal sliding scale on an electronic survey, where participants moved a slider along a continuum from 0 = no pain to 10 = worst possible pain. The slider allowed for selection of whole-number values only. Higher scores indicate worse outcomes (greater pain); lower scores indicate better outcomes (less pain).
Change in Brief Pain Inventory Short Form (BPI-SF)
Time Frame: Baseline, 8 weeks
The Brief Pain Inventory - Short Form (BPI-SF) is a 9-item self-report questionnaire that assesses pain severity and its impact on daily functioning. Pain intensity (worst, least, average, current) and pain interference (e.g., activity, mood, sleep) are rated on a 0-10 scale, with 0 = no pain/no interference and 10 = worst pain/completely interferes. Higher scores indicate worse outcomes, whereas lower scores indicate better outcomes.
Secondary Outcomes
- Subjects Reporting Pain With Device Use(8 weeks)
- Subjects Reporting Epistaxis(8 weeks)
- Change in Nasal Obstruction Symptoms(Baseline, 8 weeks)