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

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

Contacts and Locations

• Study Contact: Name: Chanel Rojas; Phone Number: (347) 962-6630; Email: Chanel.Rojas@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10028
      • Recruiting
      • Faculty Practice Associates - Mount Sinai Doctors
      • Contact: Mabel Korley, MPH; Email: mabel.korley@mountsinai.org
      • Contact: Evan Kominsky; Email: evan.kominsky@mountsinai.org
      • Principal Investigator: Alfred-Marc Iloreta

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	Change in postoperative pain score 10 minutes 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.	daily for 2 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Debridement associated pain visual analog score	Participants will use the device at their postoperative debridement visits on POD7. Their pain levels will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.	postoperative visit 1 (day 7)
Debridement associated pain visual analog score	Participants will use the device at their postoperative debridement visits on POD14. Their pain levels will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.	postoperative visit 2 (day 14)
Postoperative pain medication usage	Participants will record their postoperative pain medication daily usage (opioids and acetaminophen)	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): February 1, 2022
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 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): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: microcurrent; postoperative pain; chronic 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