Microcurrent Device (TIVIC Health)

Study Overview
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Brief Summary
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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.

Official Title
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Utilization of a Microcurrent Device for Postoperative Pain Following Functional Endoscopic Sinus Surgery: a Randomized Controlled Trial

Conditions
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Chronic Rhinosinusitis

Intervention / Treatment
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* Device: Microcurrent TENS device
* Device: Sham Device


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomly assigned in a 1:1 ratio to receive the intervention or placebo. Randomization will be completed via a computer-generated randomization table.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microcurrent TENS device<br>A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region | Device: Microcurrent TENS device<br>* 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.<br>* Other names: Microcurrent neuromodulation device;|
| Sham Comparator: Sham device<br>The sham device appears identical to the active device while emitting no therapeutic microcurrent. | Device: Sham Device<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic rhinosinusitis, postoperative pain, microcurrent