Post-cesarean PainELECTRONNCT05250830
TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)
A study testing TrueRelief device in people with Post-cesarean Pain, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Post-cesarean Pain
- What is being tested?
- TrueRelief device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 16 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) Singleton, or twin gestation
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210
About this study
Official title: Non-invasive bioELEctroniC Treatment foR pOst-cesarean paiN (ELECTRON)
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
- Being tested
- TrueRelief device, Sham TrueRelief device
- Keywords
- Post-cesarean pain, Non-opioid, Non-invasive device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| TrueRelief device | Experimental | Patients receive an experimental procedure using a TrueRelief device. Receives: Device: TrueRelief device |
| Sham TrueRelief device | Sham comparator | 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. Receives: Device: Sham TrueRelief device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups.
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.
Measured: For primary day of cesarean to day of discharge (3 days)
Secondary outcomes (5)
Number of Participants Who Received Opioid Refill Prescription in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups After Discharge.
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.
Measured: After discharge through study completion, an average of six weeks
Morphine Milligram Equivalents (MME) Opioid Tablets Prescribed at Discharge in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.
Oral opioid prescribed at discharge as Morphine milligram equivalents (MME) in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator.
Measured: At the discharge up to 24 hours
Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge.
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,
Measured: At the discharge up to 24 hours.
Rate of Wound Infection or Separation in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.
Rate of wound infection or separation in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator groups.
Measured: After cesarean delivery until six weeks postpartum
Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.
Measured: At hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start18 Apr 2022
- Primary completion16 Mar 2023
- Study completion16 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-cesarean PainStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- TrueRelief, LLC
- Responsible party
- Principal investigator, Kara M Rood, MD, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250830
- Sponsor's protocol ID
- 2022H0046
- Acronym
- ELECTRON
- Status last verified
- May 2024
- First submitted
- 25 Jan 2022
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive bioELEctroniC Treatment foR pOst-cesarean paiN (ELECTRON)
- ClinicalTrials.gov ID
- NCT05250830
- Acronym / sponsor ID
- ELECTRON / 2022H0046
- Conditions
- Post-cesarean Pain
- Keywords
- Post-cesarean pain, Non-opioid, Non-invasive device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- TrueRelief, LLC
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Apr 2023 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TrueRelief device | Experimental | Device: TrueRelief devicePatients receive an experimental procedure using a TrueRelief device. |
| Sham TrueRelief device | Sham comparator | Device: Sham TrueRelief devicePatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) Singleton, or twin gestation
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrueRelief deviceTrueRelief 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 | TrueRelief device |
| Sham TrueRelief deviceThe placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current. | Device | Sham TrueRelief device |
Primary outcome
Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups.
Time frame: 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.
5 secondary outcomes
Number of Participants Who Received Opioid Refill Prescription in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups After Discharge.
Time frame: After discharge through study completion, an average of six weeks
Morphine Milligram Equivalents (MME) Opioid Tablets Prescribed at Discharge in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.
Time frame: At the discharge up to 24 hours
Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge.
Time frame: At the discharge up to 24 hours.
Rate of Wound Infection or Separation in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.
Time frame: After cesarean delivery until six weeks postpartum
Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.
Time frame: At hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TrueRelief device in people with Post-cesarean Pain, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups. (time frame: For primary day of cesarean to day of discharge (3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.