Microcurrent Device (TIVIC Health)

N/ACompletedNCT05198518

Icahn School of Medicine at Mount Sinai60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Rhinosinusitis

Interventions

Microcurrent TENS deviceDEVICE

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.

Sham DeviceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Faculty Practice Associates - Mount Sinai Doctors

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Secondary Outcomes

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.