Trial Outcomes & Findings for TrueRelief Efficacy for Post-cesarean Pain (ELECTRON) (NCT NCT05250830)

Results Overview

The primary outcome is the total postoperative opioid intake through hospital discharge. All opioid doses were converted to equianalgesic doses of morphine sulfate MME using standard ratios.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

134 participants

Primary outcome timeframe

For primary day of cesarean to day of discharge (3 days)

Results posted on

2024-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	TrueRelief Device Patients receive an experimental procedure using a TrueRelief 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 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. Sham TrueRelief device: The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Overall Study STARTED	67	67
Overall Study COMPLETED	67	66
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TrueRelief Device n=67 Participants Patients receive an experimental procedure using a TrueRelief 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 TrueRelief Device n=67 Participants 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. Sham TrueRelief device: The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.	Total n=134 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=67 Participants	0 Participants n=67 Participants	0 Participants n=134 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=67 Participants	67 Participants n=67 Participants	134 Participants n=134 Participants
Age, Categorical >=65 years	0 Participants n=67 Participants	0 Participants n=67 Participants	0 Participants n=134 Participants
Age, Continuous	30.5 years STANDARD_DEVIATION 4.9 • n=67 Participants	31.4 years STANDARD_DEVIATION 4.8 • n=67 Participants	30.95 years STANDARD_DEVIATION 4.85 • n=134 Participants
Sex: Female, Male Female	67 Participants n=67 Participants	67 Participants n=67 Participants	134 Participants n=134 Participants
Sex: Female, Male Male	0 Participants n=67 Participants	0 Participants n=67 Participants	0 Participants n=134 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	67 participants n=67 Participants	67 participants n=67 Participants	134 participants n=134 Participants

PRIMARY outcome

Timeframe: For primary day of cesarean to day of discharge (3 days)

The primary outcome is the total postoperative opioid intake through hospital discharge. All opioid doses were converted to equianalgesic doses of morphine sulfate MME using standard ratios.

Outcome measures

Outcome measures
Measure	TrueRelief Device n=67 Participants Patients receive an experimental procedure using a TrueRelief 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 TrueRelief Device n=66 Participants 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. Sham TrueRelief device: The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups.	19.75 Morphine milligram equivalents Interval 0.0 to 52.5	37.50 Morphine milligram equivalents Interval 7.5 to 67.5

SECONDARY outcome

Timeframe: After discharge through study completion, an average of six weeks

Additional opioid prescriptions within 6 weeks postpartum in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in decreasing the number of opioid refill prescriptions.

Outcome measures

Outcome measures
Measure	TrueRelief Device n=67 Participants Patients receive an experimental procedure using a TrueRelief 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 TrueRelief Device n=66 Participants 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. Sham TrueRelief device: The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Number of Participants Who Received Opioid Refill Prescription in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups After Discharge.	1 Participants	7 Participants

SECONDARY outcome

Timeframe: At the discharge up to 24 hours

Oral opioid prescribed at discharge as Morphine milligram equivalents (MME) in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator.

Outcome measures

Outcome measures
Measure	TrueRelief Device n=67 Participants Patients receive an experimental procedure using a TrueRelief 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 TrueRelief Device n=66 Participants 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. Sham TrueRelief device: The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Morphine Milligram Equivalents (MME) Opioid Tablets Prescribed at Discharge in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.	82.50 Morphine milligram equivalents Interval 0.0 to 90.0	90.00 Morphine milligram equivalents Interval 75.0 to 90.0

SECONDARY outcome

Timeframe: At the discharge up to 24 hours.

The Brief Pain Inventory (BPI) includes self-assessment of pain scores in the previous 24 hours using a numerical scale from 0 to 10, with 0 representing no pain and 10 the worst pain imaginable. Moderate to severe pain (BPI score \>4) in past 24 h,

Outcome measures

Outcome measures
Measure	TrueRelief Device n=67 Participants Patients receive an experimental procedure using a TrueRelief 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 TrueRelief Device n=66 Participants 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. Sham TrueRelief device: The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge.	57 Participants	61 Participants

SECONDARY outcome

Timeframe: After cesarean delivery until six weeks postpartum

Rate of wound infection or separation in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator groups.

Outcome measures

Outcome measures
Measure	TrueRelief Device n=67 Participants Patients receive an experimental procedure using a TrueRelief 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 TrueRelief Device n=66 Participants 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. Sham TrueRelief device: The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Rate of Wound Infection or Separation in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.	0 Participants	2 Participants

SECONDARY outcome

Timeframe: At hospital discharge

Outcome measures

Outcome measures
Measure	TrueRelief Device n=67 Participants Patients receive an experimental procedure using a TrueRelief 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 TrueRelief Device n=66 Participants 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. Sham TrueRelief device: The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.	59 Participants	57 Participants

Adverse Events

TrueRelief Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham TrueRelief Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kara Rood

The Ohio State University

Phone: 440-321-0264

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place