NCT05250830

TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-04-18
• Primary completion: 2023-03-16
• Completion: 2023-04-16
• First posted: 2022-02-22
• Last updated: 2024-06-06
• Results posted: 2024-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study