A User Study of SYNUS Pain Relief Made by Tivic Health Systems
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sinus; Inflammation
- Sponsor
- Tivic Health Systems
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Pain reduction
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be 18 years of age and older
- •Present with symptoms of sinus pain and pressure
- •Have an initial sinus pain score of 4 or more on the visual analogue scale
- •Be able to read and understand English
- •Agree to participate in the study
- •Be able and willing to provide Informed Consent
Exclusion Criteria
- •Do not meet Inclusion Criteria
- •Have currently a dental infection
- •Have currently abnormal cranial nerve or other neurological findings or symptoms that would require prompt medical attention
- •Be currently pregnant
- •Have implanted electrostimulation devices including a pacemaker, a DBS or a cochlear implant
Outcomes
Primary Outcomes
Pain reduction
Time Frame: 10 minutes
Average decrease in pain score of the SYNUS device is greater than the average decrease is pain score for the sham/placebo device.