Microcurrent Device (TIVIC Health)

Not Applicable

Completed

Conditions: Chronic Rhinosinusitis

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

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

Primary Outcome Measures

Name	Time	Method
Change in Pain Visual Analog Score After First Use of Device	baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure	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.
Change in Pain Visual Analog Score After Second Use of Device	baseline, 10 min, 2 hour, 4 hour at second use within 14 days after procedure	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.
Change in Pain Visual Analog Score After Third Use of Device	baseline, 10 min, 2 hour, 4 hour at 3rd use within 14 days after procedure	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.
Change in Pain Visual Analog Score After Fourth Use of Device	baseline, 10 min, 2 hour, 4 hour at fourth use within 14 days after procedure	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.
Change in Pain Visual Analog Score After Fifth Use of Device	baseline, 10 min, 2 hour, 4 hour at fifth use within 14 days after procedure	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.
Sino-Nasal Outcome Test (SNOT 22)	Baseline and 2 weeks Post-Op	The possible range of Total SNOT scores is between 0 to 110. Higher scores indicate greater rhinosinusitis-related health burden.
Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score	Baseline and 2 weeks Post-Op	Full scale from 0-100. Higher score indicates more severe symptoms

Secondary Outcome Measures

Name	Time	Method
Debridement Associated Pain Visual Analog Score After Third Use of Device	baseline, 10 min, 2 hour, 4 hour on POD14	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.
Debridement Associated Pain Visual Analog Score After Fourth Use of Device	baseline, 10 min, 2 hour, 4 hour on POD14	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.
Debridement Associated Pain Visual Analog Score After First Use of Device	baseline, 10 min, 2 hour, 4 hour on POD14	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.
Postoperative Pain Medication Usage	Daily until 2nd postoperative visit (day 14)	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
Debridement Associated Pain Visual Analog Score Before Use of Device	baseline, 10 min, 2 hour, 4 hour on POD14	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.
Debridement Associated Pain Visual Analog Score After Second Use of Device	baseline, 10 min, 2 hour, 4 hour on POD14	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.

Trial Locations

Locations (1): Faculty Practice Associates - Mount Sinai Doctors
🇺🇸
New York, New York, United States
Faculty Practice Associates - Mount Sinai Doctors
🇺🇸New York, New York, United States