The purpose of this study is to investigate whether daily use of a microcurrent neuromodulation device, which applies a small current of electricity to the forehead and maxillary region, will decrease the pain experienced by patients in the days following functional endoscopic sinus surgery (FESS). This study is a prospective randomized controlled study. Enrolled subjects will be randomized (1:1) to receive either an active neuromodulation study device or a sham device that appears identical to the active device while emitting no therapeutic microcurrent. Subjects will self-treat with the device at home and will be followed for 2 weeks after FESS.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Scheduled for FESS functional nasal or endoscopic sinus surgery
* Possessing an American Society of Anesthesiologists physical status classification of I or II
* Age ≥ 18
* Possess the capacity to give informed consent
* Able to read, write and understand English or Spanish
* Able to attend follow up visits at postop days 7 and 14 Visit 1 (within 0 - day 14) and post-op Visit 2 (within 10 - 21 days)
* Postop pain VAS ≥ 5 in PACU phase II
Exclusion Criteria:
* Age \< 18
* Does not understand English or Spanish
* Does not meet inclusion criteria
* History of chronic pain
* Experiencing chronic pain requiring opioids at baseline and/or who are under the care of pain management specialists
* Neurologic disorders (including seizure disorders)
* Undergoing planned or unplanned additional procedures at the time of FESS surgery
* In custody of the state
* Prisoners
* Known to be pregnant
* Implanted cranial metallic components or devices including deep brain stimulators or cochlear implants
* Has an implanted or external worn cardiac device including pacemakers, automated implantable cardioverter defibrillator (AICD), or any other cardiac electric devices (including non-implanted devices, e.g. defibrillator vest)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Visual Analog Score After First Use of Device
Timeframe: baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure
2
Change in Pain Visual Analog Score After Second Use of Device
Timeframe: baseline, 10 min, 2 hour, 4 hour at second use within 14 days after procedure
3
Change in Pain Visual Analog Score After Third Use of Device
Timeframe: baseline, 10 min, 2 hour, 4 hour at 3rd use within 14 days after procedure
4
Change in Pain Visual Analog Score After Fourth Use of Device
Timeframe: baseline, 10 min, 2 hour, 4 hour at fourth use within 14 days after procedure
5
Change in Pain Visual Analog Score After Fifth Use of Device
Timeframe: baseline, 10 min, 2 hour, 4 hour at fifth use within 14 days after procedure