Microcurrent Device (TIVIC Health)

Chronic Rhinosinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198518
• Other study ID #: STUDY-21-01392
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 2024

Study information

• Verified date: October 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Chanel Rojas
• Phone: (347) 962-6630
• Email: Chanel.Rojas[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Rhinosinusitis

Intervention

Device:
• Microcurrent TENS device
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 Device
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.

Locations

Country	Name	City	State
United States	Faculty Practice Associates - Mount Sinai Doctors	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Tivic Health Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Postoperative pain medication usage	Participants will record their postoperative pain medication daily usage (opioids and acetaminophen)	Daily until 2nd postoperative visit (day 14)