Microcurrent TENS device for Chronic Sinusitis

Faculty Practice Associates - Mount Sinai Doctors, New York, NY
Chronic SinusitisMicrocurrent TENS device - Device
All Sexes

Study Summary

This trial is to see if using a small electrical current on the forehead and face region can help reduce pain after sinus surgery.

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: postoperative visit 2 (day 14)

Day 14
Postoperative pain medication usage
Week 2
Change in pain visual analog score
Day 14
Debridement associated pain visual analog score

Trial Safety

Trial Design

3 Treatment Groups

Microcurrent TENS device
1 of 3
Active study device
1 of 3
Sham device
1 of 3

Experimental Treatment

Non-Treatment Group

60 Total Participants · 3 Treatment Groups

Primary Treatment: Microcurrent TENS device · Has Placebo Group · N/A

Microcurrent TENS device
Experimental Group · 1 Intervention: Microcurrent TENS device · Intervention Types: Device
Active study device
Experimental Group · 1 Intervention: Microcurrent TENS device · Intervention Types: Device
Sham device
ShamComparator Group · 1 Intervention: Sham Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: postoperative visit 2 (day 14)

Who is running the clinical trial?

Tivic Health SystemsIndustry Sponsor
2 Previous Clinical Trials
102 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
800 Previous Clinical Trials
509,456 Total Patients Enrolled
1 Trials studying Chronic Sinusitis
100 Patients Enrolled for Chronic Sinusitis
Alfred-Marc Iloreta, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
165 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an upcoming functional nasal or endoscopic sinus surgery scheduled.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

What is the aggregate participant count of this clinical experiment?

"Affirmative. Clinicaltrials.gov states that this trial is currently recruiting, having been published on January 1st and most recently updated on June 1st of 2022. The study aims to enroll 60 individuals at a single site location." - Anonymous Online Contributor

Unverified Answer

Is there still room for individuals to join the trial?

"Affirmative. According to material available on clinicaltrials.gov, this study is actively looking for participants. The trial was initially introduced on January 1st 2022 and tweaked most recently on June 1st 2022. In total, 60 patients are needed from a single medical facility." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.