Facial Pain
Conditions
Keywords
Facial Pressure
Brief summary
The purpose of this study is to investigate if the SinuSonic device decreases facial pain and pressure compared to the placebo device.
Interventions
DEVICESinuSonic
Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.
DEVICESham Device
Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Facial Pain Visual Analogue Scale (VAS) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Subjects Reporting Pain With Device Use | 8 weeks | Number of subjects reporting pain with device use |
| Subjects Reporting Epistaxis | 8 weeks | Number of subjects reporting epistaxis |
| Change in Nasal Obstruction Symptoms | Baseline, 8 weeks | The Nasal Obstruction Symptom Evaluation (NOSE) Score is a 5-item, self-reported survey that assesses the impact of nasal obstruction on quality of life over the past month; each item is rated from 0 (not a problem) to 4 (severe problem). These five items form a single subscale (i.e., nasal obstruction symptom severity). The responses to all 5 items are summed to yield a raw total score ranging from 0 to 20. Raw scores are scaled to a total score out of 100, by multiplying by 5. Nasal Obstruction Severity Classification categories: Mild (5-25), Moderate (30-50), Severe (55-75), Extreme (80-100). A score of 0 means that there are no problems with nasal obstruction and a score of 100 means that they are experiencing the worst possible problems with nasal obstruction. NOSE scores will be obtained at 'Baseline' and 'Week 8,' to measure obstruction changes with device use (sham vs real). |
Countries
United States
Participant flow
Pre-assignment details
The study consisted of both pre-screening and screening measures, where screening measures took place after consent. Two participants were assigned study numbers at the time of consent and screen failed based on screening criteria. Another two participants who were assigned study numbers refused further participation following the consent visit, who met screening criteria, prior to being randomized. One participant met screening criteria, but the study was stopped prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| SinuSonic Group Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks
SinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming. | 9 |
| Sham Group Subjects will use the sham device for 2 minutes twice daily for 8 weeks
Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device | 13 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 5 |
Baseline characteristics
| Characteristic | SinuSonic Group | Sham Group | Total |
|---|---|---|---|
| Age, Continuous | 52 Years STANDARD_DEVIATION 13.8 | 54 Years STANDARD_DEVIATION 11.8 | 53 Years STANDARD_DEVIATION 12.7 |
| Baseline Visual Analogue Scale (VAS) | 5.8 Units on a scale STANDARD_DEVIATION 1.5 | 5.7 Units on a scale STANDARD_DEVIATION 1.9 | 5.7 Units on a scale STANDARD_DEVIATION 1.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 12 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 13 Participants | 22 Participants |
| Region of Enrollment United States | 9 participants | 13 participants | 22 participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 13 |
| other Total, other adverse events | 1 / 9 | 0 / 13 |
| serious Total, serious adverse events | 0 / 9 | 0 / 13 |
Outcome results
Primary
Change in Brief Pain Inventory Short Form (BPI-SF)
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.
Time frame: Baseline, 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic Group | Change in Brief Pain Inventory Short Form (BPI-SF) | 2.4 score on a scale | Standard Deviation 1.6 |
| Sham Group | Change in Brief Pain Inventory Short Form (BPI-SF) | 3.9 score on a scale | Standard Deviation 2.6 |
Primary
Change in Facial Pain Visual Analogue Scale (VAS)
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).
Time frame: Baseline, 8 weeks
Population: Facial Pain - Visual Analogue Scale (VAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic Group | Change in Facial Pain Visual Analogue Scale (VAS) | 2.4 score on a scale | Standard Deviation 1.6 |
| Sham Group | Change in Facial Pain Visual Analogue Scale (VAS) | 3.9 score on a scale | Standard Deviation 2.6 |
Secondary
Change in Nasal Obstruction Symptoms
The Nasal Obstruction Symptom Evaluation (NOSE) Score is a 5-item, self-reported survey that assesses the impact of nasal obstruction on quality of life over the past month; each item is rated from 0 (not a problem) to 4 (severe problem). These five items form a single subscale (i.e., nasal obstruction symptom severity). The responses to all 5 items are summed to yield a raw total score ranging from 0 to 20. Raw scores are scaled to a total score out of 100, by multiplying by 5. Nasal Obstruction Severity Classification categories: Mild (5-25), Moderate (30-50), Severe (55-75), Extreme (80-100). A score of 0 means that there are no problems with nasal obstruction and a score of 100 means that they are experiencing the worst possible problems with nasal obstruction. NOSE scores will be obtained at 'Baseline' and 'Week 8,' to measure obstruction changes with device use (sham vs real).
Time frame: Baseline, 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic Group | Change in Nasal Obstruction Symptoms | 61.1 score on a scale | Standard Deviation 22.7 |
| Sham Group | Change in Nasal Obstruction Symptoms | 67.7 score on a scale | Standard Deviation 21.9 |
Secondary
Subjects Reporting Epistaxis
Number of subjects reporting epistaxis
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SinuSonic Group | Subjects Reporting Epistaxis | 0 Participants |
| Sham Group | Subjects Reporting Epistaxis | 0 Participants |
Secondary
Subjects Reporting Pain With Device Use
Number of subjects reporting pain with device use
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SinuSonic Group | Subjects Reporting Pain With Device Use | 0 Participants |
| Sham Group | Subjects Reporting Pain With Device Use | 0 Participants |