TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)

• Sponsor: Ohio State University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05250830
• Collaborator: TrueRelief, LLC (Other)
• Enrollment: 134
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.4
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Post-cesarean Pain	Device: TrueRelief device; Device: Sham TrueRelief device	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blind, randomized, sham-controlled trial parallel arm study using TrueRelief as the experimental treatment and a TrueRelief device with sham capabilities as a placebo.Double blind, randomized, sham-controlled trial parallel arm study using TrueRelief as the experimental treatment and a TrueRelief device with sham capabilities as a placebo.
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Non-invasive bioELEctroniC Treatment foR pOst-cesarean paiN (ELECTRON)
• Actual Study Start Date: Apr 18, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TrueRelief device Patients receive an experimental procedure using a TrueRelief device.	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.
Sham Comparator: Sham TrueRelief device 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.	Device: Sham TrueRelief device; The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.

Outcome Measures

Primary Outcome Measures

1. 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. [For primary day of cesarean to day of discharge (3 days)]

Secondary Outcome Measures

1. Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in decreasing the number of opioid refill prescriptions. [After discharge through study completion, an average of six weeks]

2. Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in decreasing the total number of opioid tablets prescribed at discharge. [At the discharge up to 24 hours]

3. 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). [At the discharge up to 24 hours.]

4. Evaluating incidence of opioid related side effects. [After cesarean delivery until six weeks postpartum]

   Evaluating incidence of opioid related side effects (nausea and constipation).

5. Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in wound disruption rates. [After cesarean delivery until six weeks postpartum]

6. Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in breastfeeding rates. [After cesarean delivery until six weeks postpartum]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) Singleton, or twin gestation

Exclusion Criteria:

• Known history of opioid use disorder, by medical record review

• Contraindication to opioids

• Contraindications to both acetaminophen and ibuprofen

• Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different

• Fetal or neonatal death prior to randomization

• Inability to randomize on postoperative day 0

• Inability to participate in twice daily use of non-invasive bioelectronic treatment during inpatient stay as assessed by research staff

• Language barrier (non-English or Spanish speaking)

• Participation in another intervention study that influences the primary outcome in this trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University
• TrueRelief, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kara M Rood, MD, Assistant Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT05250830
• Other Study ID Numbers: 2022H0046
• First Posted: Feb 22, 2022
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Kara M Rood, MD, Assistant Professor, Ohio State University: Post-cesarean pain; Non-opioid; Non-invasive device

Study Results

No Results Posted as of Jun 2, 2022