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TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)

NCT05250830 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-06-06

Study results available
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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.

Conditions

  • Post-cesarean Pain

Interventions

DEVICE

TrueRelief device

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.

DEVICE

Sham TrueRelief device

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

Sponsors & Collaborators

  • TrueRelief, LLC

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-18
Primary Completion
2023-03-16
Completion
2023-04-16
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05250830 on ClinicalTrials.gov