← Back to Search

Sham Device

TrueRelief device for Post-cesarean Pain (ELECTRON Trial)

N/A

Waitlist Available

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after discharge through study completion, an average of six weeks

Awards & highlights

ELECTRON Trial Summary

This trial is testing whether a bioelectronic device can help with post-cesarean pain management.

ELECTRON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after cesarean delivery until six weeks postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after cesarean delivery until six weeks postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and after cesarean delivery until six weeks postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in decreasing opioid consumption in morphine milligram equivalents in inpatient post-cesarean population.

Secondary outcome measures

Evaluating incidence of opioid related side effects.

Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in breastfeeding rates.

Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in decreasing post-cesarean pain intensity pain scores based on the Brief Pain Inventory (worst, average, current).

+3 more

ELECTRON Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TrueRelief deviceExperimental Treatment1 Intervention

Patients receive an experimental procedure using a TrueRelief device.

Group II: Sham TrueRelief devicePlacebo Group1 Intervention

Patients receive a placebo procedure using a sham TrueRelief device that looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TrueRelief device

2022

N/A

~140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

827 Previous Clinical Trials

502,617 Total Patients Enrolled

TrueRelief, LLCUNKNOWN

1 Previous Clinical Trials

Frequently Asked Questions

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

How many participants are benefiting from this healthcare experiment?

"Affirmative. Clinicaltrials.gov reveals that this medical experiment, which was first posted on April 18th 2022, is actively seeking participants. One centre needs to register 134 patients for the trial.."

Answered by AI

Is there an age limitation for participants in this clinical research?

"This medical trial is accepting participants that are of the age range between 18 and 50."

Answered by AI

Are additional participants currently being enrolled in this experiment?

"Right. According to clinicaltrials.gov, the trial which debuted on April 18th 2022 is now open for recruitment with a goal of 134 participants from 1 site. This information was last updated on May 31st 2022."

Answered by AI

To whom does this medical experiment extend eligibility?

"134 post-partum people in the 18-50 age bracket can be included in this research. It is essential that they had a cesarean delivery, either with one or two fetuses, and not combined vaginal/cesarean births."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)

Kara M Rood, MD 2022. "TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05250830.