Microcurrent Device (TIVIC Health)

Not Applicable

Completed

• Conditions: Chronic Rhinosinusitis
• Interventions: Device: Microcurrent TENS device; Device: Sham Device

• Registration Number: NCT05198518
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-20
• Study Start: 2022-03-30
• Primary Completion: 2024-03-19
• Study Completion: 2024-04-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microcurrent TENS device	Microcurrent TENS device	A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region
Sham device	Sham Device	The sham device appears identical to the active device while emitting no therapeutic microcurrent.

Primary Outcome Measures

Name	Time	Method
Change in pain visual analog score	daily for 2 weeks after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Debridement associated pain visual analog score	postoperative visit 2 (day 14)	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 pain medication usage	Daily until 2nd postoperative visit (day 14)	Participants will record their postoperative pain medication daily usage (opioids and acetaminophen)

Trial Locations

Locations (1)

Faculty Practice Associates - Mount Sinai Doctors; 🇺🇸 New York, New York, United States