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| Name | Class |
|---|---|
| TrueRelief, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TrueRelief device | Experimental | Patients receive an experimental procedure using a TrueRelief device. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrueRelief device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | For primary day of cesarean to day of discharge (3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After discharge through study completion, an average of six weeks |
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Inclusion Criteria:
• Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) Singleton, or twin gestation
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Morphine milligram equivalents | For primary day of cesarean to day of discharge (3 days) |
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From the day of cesarean until six weeks postpartum
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Rood | The Ohio State University | 440-321-0264 | Kara.Rood@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2022 | Mar 8, 2024 | Prot_SAP_000.pdf |
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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.
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| Sham TrueRelief device | Device | The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current. |
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| 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. | 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, | 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. | After cesarean delivery until six weeks postpartum |
| Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. | At hospital discharge |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
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| Secondary | 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. | Posted | Count of Participants | Participants | After discharge through study completion, an average of six weeks |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | Morphine milligram equivalents | At the discharge up to 24 hours |
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| Secondary | 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, | Posted | Count of Participants | Participants | At the discharge up to 24 hours. |
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| Secondary | 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. | Posted | Count of Participants | Participants | After cesarean delivery until six weeks postpartum |
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| Secondary | Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. | Posted | Count of Participants | Participants | At hospital discharge |
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| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | 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. | 0 | 67 | 0 | 67 | 0 | 67 |
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