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Microcurrent Device (TIVIC Health)

CompletedNot applicableNCT05198518
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Utilization of a Microcurrent Device for Postoperative Pain Following Functional Endoscopic Sinus Surgery: a Randomized Controlled Trial
Conditions
  • Chronic Rhinosinusitis
Interventions
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Tivic Health Systems
Start date
2022-03-30
Primary completion
2024-03-19
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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)

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05198518