An observational study in Sinus; Inflammation, sponsored by Tivic Health Systems. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-12-26.
Sponsored by Tivic Health Systems · Observational
Demonstrate the ability of subjects suffering from sinus pain to self-treat with the SYNUS Pain Relief device and to obtain pain relief compared to a sham/placebo device.
A prospective study of at least 58 recruited subjects suffering from sinus pain. At least 30 of the subjects will be randomly selected to use the SYNUS Pain Relief device, a device that uses micro-currents to stimulate major nerve fibers passing from the sinus passages through various foramina to the facial skin. Subjects will read manufacturer's provided Instructions-For-Use (IFU's) and without help from staff will proceed to self-perform the treatment. The other subjects will follow the same procedure but use a sham/placebo device with no stimulating current. Subjects will be blinded as to the device they use. Prior to and 10 minutes following the stimulation, subjects will score their pain level on a visual analogue scale.
417 studies on the registry are indexed under Sinusitis; 47 are open to participants now.
This study's enrollment of 72 is below the median of 100 across 77 observational studies indexed under Sinusitis.
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At least 58 subjects suffering from sinus pain
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Exclusion Criteria:
Users will use an active SYNUS Pain Relief device
Device: SYNUS Pain Relief device
Users will use a sham SYNUS Pain Relief device that is not providing treatment
SYNUS Pain Relief is a handheld micro-current TENS device used for the temporary relief of sinus pain.
Pain reduction
Average decrease in pain score of the SYNUS device is greater than the average decrease is pain score for the sham/placebo device.
Time frame: 10 minutes
Plan to share: No
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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Tivic Health Systems