CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 134 enrolled
Drug / intervention
TrueRelief device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05250830
NCT05250830N/ACompleted
CompareCT.gov

Non-invasive bioELEctroniC Treatment foR pOst-cesarean paiN (ELECTRON)

Ohio State University·interventional·Posted Feb 22, 2022·Updated Jun 6, 2024

In Brief

A clinical study evaluating TrueRelief device and Sham TrueRelief device for Post-cesarean Pain. Completed, enrolled 134 participants across 1 site.

Detailed Summary

This is a randomized trial of 134 individualized post-cesarean delivery who will be randomized to twice daily use of non-invasive bioelectronic treatment with TrueRelief device or identical appearing sham device for post-cesarean pain management.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-cesarean Pain
CountriesUnited States
CollaboratorsTrueRelief, LLC

Timeline

N/ACompletedFinished
2023202420252026
First PostedFeb 22, 2022
Enrollment StartApr 18, 2022
Primary CompletionMar 16, 2023
Study CompletionApr 16, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.4 years ago

Interventions

TrueRelief devicedevice

TrueRelief is an FDA-cleared treatment for chronic intractable pain, and as an adjunctive procedure in the management of post-surgical and post-traumatic acute pain. This 20,000 Hz high frequency electrical procedure is provided by clinicians trained in the use of the device and delivered via handheld steel-tipped probes to the source of pain and where pain is experienced.

Sham TrueRelief devicedevice

The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.