Overview
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.
Eligibility
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)