Clinical trial NCT05198518: Microcurrent Device (TIVIC Health)
Official title: Utilization of a Microcurrent Device for Postoperative Pain Following Functional Endoscopic Sinus Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis
Keywords: chronic rhinosinusitis
postoperative pain
microcurrent
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Tivic Health Systems
First posted: 2022-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Pain Visual Analog Score After First Use of Device
timeFrame: baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure
measure: Change in Pain Visual Analog Score After Second Use of Device
timeFrame: baseline, 10 min, 2 hour, 4 hour at second use within 14 days after procedure
measure: Change in Pain Visual Analog Score After Third Use of Device
timeFrame: baseline, 10 min, 2 hour, 4 hour at 3rd use within 14 days after procedure
measure: Change in Pain Visual Analog Score After Fourth Use of Device
timeFrame: baseline, 10 min, 2 hour, 4 hour at fourth use within 14 days after procedure
measure: Change in Pain Visual Analog Score After Fifth Use of Device
timeFrame: baseline, 10 min, 2 hour, 4 hour at fifth use within 14 days after procedure
measure: Sino-Nasal Outcome Test (SNOT 22)
timeFrame: Baseline and 2 weeks Post-Op
measure: Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score
timeFrame: Baseline and 2 weeks Post-Op
Secondary outcomes:
measure: Debridement Associated Pain Visual Analog Score Before Use of Device
timeFrame: baseline, 10 min, 2 hour, 4 hour on POD14
measure: Debridement Associated Pain Visual Analog Score After First Use of Device
timeFrame: baseline, 10 min, 2 hour, 4 hour on POD14
measure: Debridement Associated Pain Visual Analog Score After Second Use of Device
timeFrame: baseline, 10 min, 2 hour, 4 hour on POD14
measure: Debridement Associated Pain Visual Analog Score After Third Use of Device
timeFrame: baseline, 10 min, 2 hour, 4 hour on POD14
measure: Debridement Associated Pain Visual Analog Score After Fourth Use of Device
timeFrame: baseline, 10 min, 2 hour, 4 hour on POD14
measure: Postoperative Pain Medication Usage
timeFrame: Daily until 2nd postoperative visit (day 14)
Other outcomes:
Locations:
city: New York
country: United States
facility: Faculty Practice Associates - Mount Sinai Doctors
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Alfred-Marc Iloreta, MD
role: PRINCIPAL_INVESTIGATOR
References: