CompletedNot Applicable

Microcurrent Device (TIVIC Health)

United States60 participantsStarted 2022-03-30

Plain-language summary

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 range18 Years

SexALL

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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)

What they're measuring

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

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

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

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

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

Sino-Nasal Outcome Test (SNOT 22)

Timeframe: Baseline and 2 weeks Post-Op

Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score

Timeframe: Baseline and 2 weeks Post-Op

Trial details

NCT IDNCT05198518

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-19

Results submitted2025-03-19

View on ClinicalTrials.gov More Chronic Rhinosinusitis trials