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Neuromodulation Device

Microcurrent Therapy for Post-Sinus Surgery Pain

N/A
Recruiting
Led By Alfred-Marc Iloreta, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative visit 2 (day 14)
Awards & highlights

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.

Who is the study for?
This trial is for adults over 18 with chronic sinusitis who are scheduled for sinus surgery (FESS) and have a pain score of at least 5 post-surgery. They must be able to understand English or Spanish, give consent, and attend follow-up visits. People with cardiac devices, neurologic disorders, chronic pain management needs, or metallic cranial implants cannot participate.Check my eligibility
What is being tested?
The study tests if a microcurrent TENS device can reduce pain after sinus surgery compared to a sham device that looks the same but does nothing. Participants will use the real or fake device daily at home and their progress will be tracked for two weeks post-surgery.See study design
What are the potential side effects?
Since this trial involves a non-invasive microcurrent device, side effects may include mild discomfort or skin irritation where the device is applied. There's no mention of severe side effects as it's not drug-related.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative visit 2 (day 14)
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative visit 2 (day 14) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in pain visual analog score
Secondary outcome measures
Debridement associated pain visual analog score
Postoperative pain medication usage

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Microcurrent TENS deviceExperimental Treatment1 Intervention
A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region
Group II: Sham devicePlacebo Group1 Intervention
The sham device appears identical to the active device while emitting no therapeutic microcurrent.

Find a Location

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
858 Previous Clinical Trials
524,226 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
162 Total Patients Enrolled

Media Library

Microcurrent Device (TIVIC Health) (Neuromodulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05198518 — N/A
Chronic Sinusitis Research Study Groups: Microcurrent TENS device, Sham device
Chronic Sinusitis Clinical Trial 2023: Microcurrent Device (TIVIC Health) Highlights & Side Effects. Trial Name: NCT05198518 — N/A
Microcurrent Device (TIVIC Health) (Neuromodulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05198518 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Microcurrent Device (TIVIC Health)
Alfred-Marc Iloreta 2022. "Microcurrent Device (TIVIC Health)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05198518.
~19 spots leftby Apr 2025
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