What side effects are associated with this type of intervention?

Common treatments for chronic sinusitis involving electrical stimulation, such as transcutaneous electrical nerve stimulation (TENS) and percutaneous electrical nerve stimulation (PENS), have been studied for their efficacy in pain relief. Known side effects of these treatments can include skin irritation at the site of electrode placement, discomfort during the stimulation, and, less commonly, muscle twitching or pain. While these treatments are generally considered safe, their effectiveness can vary, and some studies have shown inconsistent results regarding pain relief and functional improvement.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic sinusitis, including medications like corticosteroids and antibiotics, as well as surgical interventions such as functional endoscopic sinus surgery (FESS). While specific FDA approvals for microcurrent neuromodulation devices for chronic sinusitis are not detailed, similar neuromodulation techniques, such as vagus nerve stimulation and transcranial magnetic stimulation, have been explored for other conditions. These treatments aim to reduce inflammation and pain through electrical stimulation, offering a potential alternative for patients with chronic sinusitis.

What other types of research exist?

Promising alternatives to Microcurrent Neuromodulation Device for chronic sinusitis patients include: 1) Transcutaneous Electrical Nerve Stimulation (TENS), which has shown efficacy in pain management for various conditions. 2) High-frequency Spinal Cord Stimulation (SCS), which has been effective in managing neuropathic pain. 3) Non-invasive Vagus Nerve Stimulation (nVNS), which has been used for migraine prevention and could potentially be adapted for sinusitis-related pain. These alternatives offer different mechanisms of action and have shown promise in clinical trials for pain management.

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Neuromodulation Device

Microcurrent Therapy for Post-Sinus Surgery Pain

N/A

Waitlist Available

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)

Summary

This trial is testing a small device that sends tiny electrical currents to the face to see if it can reduce pain in patients who have had 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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative visit 2 (day 14)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pain visual analog score

Secondary study objectives

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Microcurrent TENS device

2022

N/A

~60

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chronic Sinusitis treatments aim to promote sinus drainage, reduce inflammation, and eradicate pathogens. Electrical stimulation treatments, such as the Microcurrent Neuromodulation Device, work by applying small electrical currents to targeted areas, which can help reduce pain and inflammation. This method is particularly relevant for Chronic Sinusitis patients as it offers a non-invasive option to manage symptoms and improve quality of life, especially when traditional treatments like antibiotics and nasal sprays are insufficient. The electrical currents may enhance blood flow and stimulate nerve activity, contributing to symptom relief and faster recovery.