A User Study of SYNUS Pain Relief Made by Tivic Health Systems

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03466879

Enrollment

Registered

2018-03-15

Start date

2018-02-02

Completion date

2018-07-21

Last updated

2018-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinus; Inflammation

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.

Interventions

DEVICESYNUS Pain Relief device

SYNUS Pain Relief is a handheld micro-current TENS device used for the temporary relief of sinus pain.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pain reduction	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026