Microcurrent Device (TIVIC Health)

Utilization of a Microcurrent Device for Postoperative Pain Following Functional Endoscopic Sinus Surgery: a Randomized Controlled Trial

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.

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)