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.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis
• Intervention / Treatment: Device: Microcurrent TENS device; Device: Sham Device

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10028
      • Faculty Practice Associates - Mount Sinai Doctors

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham device; The sham device appears identical to the active device while emitting no therapeutic microcurrent.	Device: Sham Device; The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.
Experimental: Microcurrent TENS device; A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region	Device: Microcurrent TENS device; The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.; Other Names: Microcurrent neuromodulation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Visual Analog Score After First Use of Device	Change in postoperative pain score in first use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the first time they use the device.	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	Change in postoperative pain score after second use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the second time they use the device.	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	Change in postoperative pain score after third use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the third time they use the device.	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	Change in postoperative pain score after fourth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fourth time they use the device.	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	Change in postoperative pain score after fifth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fifth time they use the device.	baseline, 10 min, 2 hour, 4 hour at fifth use within 14 days after procedure
Sino-Nasal Outcome Test (SNOT 22)	The possible range of Total SNOT scores is between 0 to 110. Higher scores indicate greater rhinosinusitis-related health burden.	Baseline and 2 weeks Post-Op
Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score	Full scale from 0-100. Higher score indicates more severe symptoms	Baseline and 2 weeks Post-Op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Debridement Associated Pain Visual Analog Score Before Use of Device	Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.	baseline, 10 min, 2 hour, 4 hour on POD14
Debridement Associated Pain Visual Analog Score After First Use of Device	Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the first use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.	baseline, 10 min, 2 hour, 4 hour on POD14
Debridement Associated Pain Visual Analog Score After Second Use of Device	Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the second use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.	baseline, 10 min, 2 hour, 4 hour on POD14
Debridement Associated Pain Visual Analog Score After Third Use of Device	Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the third use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.	baseline, 10 min, 2 hour, 4 hour on POD14
Debridement Associated Pain Visual Analog Score After Fourth Use of Device	Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the fourth use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.	baseline, 10 min, 2 hour, 4 hour on POD14
Postoperative Pain Medication Usage	Participants will record their postoperative pain medication daily usage (opioids and acetaminophen). Number of Acetaminophen 325mg or Number of Oxycodone 5 mg taken across 2 weeks post-op	Daily until 2nd postoperative visit (day 14)

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Tivic Health Systems
• Investigators: Principal Investigator: Alfred-Marc Iloreta, MD, Icahn School Of Medicine At Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Actual): March 19, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: microcurrent; postoperative pain; chronic rhinosinusitis
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Sinusitis; Paranasal Sinus Diseases; Rhinosinusitis
• Other Study ID Numbers: STUDY-21-01392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No additional clinically relevant information will be collected from subjects in the course of the study beyond what is routinely collected and communicated to patients in their standard course of care. Study subjects will not be notified of results until the final analysis of study data is complete. The study results will be submitted for publication and/or presentation at national conferences/journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No