This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for TrueRelief Efficacy for Post-cesarean Pain (ELECTRON) (NCT05250830), a randomized na study. The primary outcome is Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05250830 |
| Phase | NA |
| Condition | Post-cesarean Pain |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 134 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Ohio State University |
| Results posted | Yes |
2. Clinical Question
Population
People having a cesarean delivery and experiencing post-cesarean pain. The registry describes 134 individualized post-cesarean participants enrolled in the trial. Further eligibility details, such as age limits or exclusions, are not reported in the registry record.
Intervention
Twice-daily use of the TrueRelief device, described as a non-invasive bioelectronic treatment. The primary outcome concerns opioid intake during the hospital stay after cesarean delivery.
Comparator
Twice-daily use of an identical-appearing sham TrueRelief device. The sham is described as looking and operating like the experimental device but not emitting high-frequency current.
Primary question
How did the median total inpatient oral opioid consumption, converted to morphine milligram equivalents, compare between the TrueRelief and sham groups from the day of cesarean delivery to hospital discharge?
The trial addresses a comparative question about opioid consumption during the inpatient postoperative period. It does not, through this primary endpoint alone, answer broader questions about pain relief, recovery after discharge, or outcomes in populations beyond those enrolled. Those topics require separate outcomes and evidence.
Random assignment is intended to make the groups comparable on average, while masking can reduce the influence of expectations on care or outcome assessment. The registry labels the trial triple-masked, but which people or roles were masked is not reported in the registry record. The sham description indicates that the devices appeared and operated identically, while their delivery of high-frequency current differed.
3. Trial Design
The registry describes ELECTRON as a randomized, parallel-group trial of the TrueRelief device and a sham device for post-cesarean pain. Enrollment is recorded as 134. The primary outcome results list 67 participants in the TrueRelief group and 66 in the sham group. The adverse-event record uses group denominators of 67 for each group; the record does not explain the difference in denominators across these outcome records.
The experimental group received a procedure using the TrueRelief device. The comparator group received a placebo procedure using an identical-appearing sham that would not emit high-frequency current. Participants were to use the assigned device twice daily. The record labels allocation as randomized, masking as triple, and the model as parallel. It does not identify the specific roles included in the triple masking.
The condition is listed as post-cesarean pain, and the study status is completed. The recorded study start date is 2022-04-18, and the primary completion date is 2023-03-16. The phase is listed as NA. Ohio State University is the named sponsor.
The main outcome covers total postoperative oral opioid intake through hospital discharge, with the time frame described as the day of cesarean delivery to discharge, noted as 3 days. The secondary outcomes address post-discharge opioid refill prescriptions, opioid tablets prescribed at discharge, pain scores at discharge, wound infection or separation, and breastfeeding. The registry record does not report the trial setting, recruitment locations, detailed eligibility criteria, or a fuller schedule of study visits.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | TrueRelief Device | Sham TrueRelief Device |
|---|---|---|
| STARTED | 67 | 67 |
| COMPLETED | 67 | 66 |
| NOT COMPLETED | 0 | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | TrueRelief Device | Sham TrueRelief Device | Total |
|---|---|---|---|---|
| Participants analysed | 67 | 67 | 134 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 67 | 67 | 134 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 30.5 (SD 4.9) | 31.4 (SD 4.8) | 30.95 (SD 4.85) |
| Sex: Female, Male: Female | Participants | 67 | 67 | 134 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: United States | participants | 67 | 67 | 134 |
6. Primary Endpoint
The registry lists the primary outcome as Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups., measured over For primary day of cesarean to day of discharge (3 days).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | Morphine milligram equivalents |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is total oral opioid consumption during the hospital stay after cesarean delivery. The registry says that opioid doses were converted to equianalgesic doses of morphine sulfate, expressed as morphine milligram equivalents (MME), using standard ratios. This conversion places different opioid medicines on a common scale for describing total opioid intake.
The outcome is reported as a median for each group, with an interquartile range (IQR). The posted median is 19.75 MME for the TrueRelief group, with an IQR from 0.0 to 52.5. For the sham group, the median is 37.5 MME, with an IQR from 7.5 to 67.5. A median describes the middle of the ordered observations; the IQR describes the range containing the middle half of observations. These summaries convey both a typical value and the spread of individual values without assuming that the distribution is symmetric.
In general, inpatient opioid consumption is one measurable aspect of postoperative care. Comparing consumption can be informative alongside other outcomes, but it does not by itself measure pain relief, functional recovery, or the balance of benefits and harms. Interpretation also depends on the statistical comparison and the context of the outcome. A formal inferential analysis for this primary endpoint is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome has a lower median inpatient opioid consumption in the TrueRelief group than in the sham group: 19.75 MME compared with 37.5 MME. The corresponding IQRs are 0.0 to 52.5 and 7.5 to 67.5. These are descriptive summaries. The ranges overlap, and the registry does not report a confidence interval, p-value, or other formal comparison for this primary outcome. The posted medians therefore describe the observed groups but do not establish how precisely the group difference has been estimated.
A median is not an average difference between groups, and the difference between the two medians should not be treated as a treatment effect estimate with known uncertainty. The IQRs show substantial spread in observed opioid consumption within both groups. A distribution may contain individual values well away from its median; the summaries do not reveal each participant's experience or the full shape of the data.
The registry also posts secondary results on opioid refill prescriptions, pain scores above the stated threshold at discharge, and wound infection or separation. Their displayed unadjusted comparisons point in different degrees toward fewer events in the TrueRelief group, but the amount of uncertainty varies. For the refill outcome, the risk-difference interval does not include zero; for pain scores and wound outcomes, the intervals include zero. These secondary comparisons are not a substitute for an inferential analysis of the primary endpoint, and their unadjusted nature matters when several outcomes are examined.
The registry lists additional secondary outcomes concerning opioid tablets prescribed at discharge and breastfeeding. Results for those outcomes are not reported in the registry record. Consequently, the full pattern across all planned secondary outcomes cannot be assessed from the posted results.
There are no reported analyses listed for the trial, and the record does not provide the primary endpoint's analysis method or a sponsor-reported inferential result. The primary result should therefore be read as a descriptive comparison of group medians and IQRs, not as evidence that a prespecified statistical test met or failed a threshold. No conclusion about treatment efficacy or lack of efficacy follows from these summaries alone.
9. Statistical Methods Explained
What does the design contribute? Random allocation is a method for assigning participants to groups by chance. In general, it can reduce systematic differences between groups at the outset, although it does not guarantee that every characteristic will be balanced in a particular trial. A parallel design means participants are assigned to one group rather than cycling through both conditions. The registry labels this study triple-masked. In general, masking can limit the influence of expectations on participant reports, clinical decisions, and outcome assessment; the particular roles masked are not reported in the registry record.
Why report a median and IQR? The primary outcome is a non-negative measure of consumption and is summarized using a median and IQR. In general, these summaries can be useful when measurements are skewed or include observations far from the center. The median is the central observation after ordering values, while the IQR covers the central half of the observations. Neither summary alone gives a standard error or confidence interval for a between-group contrast. The record does not describe why this summary was selected or how the primary comparison was tested.
What does a risk difference mean? For binary secondary outcomes, the posted comparisons use a risk difference, expressed as the proportion with an outcome in the TrueRelief group minus the proportion in the sham group. In general, a negative risk difference means the observed proportion is lower in the first group under that orientation; a positive value means it is higher. A confidence interval describes uncertainty around an estimate under the assumptions of the calculation. For a risk difference, an interval including zero is compatible with no group difference as well as with differences in either direction. The interval does not assign probabilities to particular true effects.
The registry also posts unadjusted p-values for two secondary comparisons and an unadjusted p-value for the wound outcome. In general, a p-value measures how incompatible the observed data are with a specified null model, under the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of an effect. Because no multiplicity adjustment is reported, these values should be interpreted as unadjusted results rather than as confirmatory tests across a family of outcomes.
What do the planning illustrations represent? The sample-size illustrations use the observed effects as a starting point and consider planning for 100%, 75%, or 50% of those effects. Their stated assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation. In general, planning calculations estimate the number of participants that might be needed under specified assumptions to detect an effect at a chosen power level. They are not the trial's observed power, do not show that an effect is real, and should not be mistaken for the original design justification. The original sample-size justification is not reported in the registry record.
The registry's planning description says that binary-outcome values are participants per arm. Such illustrations depend on the assumed effect and other design inputs; a smaller target effect generally requires a larger study under otherwise unchanged assumptions. The displayed planning quantities do not resolve uncertainty in the observed trial results. Nor do they establish whether the trial was adequately sized for its primary endpoint, since the design assumptions and planned primary analysis are not reported.
What is absent from the statistical record? The registry does not report a formal analysis for the primary endpoint, the specific statistical test or model, any adjustment variables, or an analysis population such as intention-to-treat or per-protocol. It also does not report an interim-analysis plan, a missing-data method, or a multiplicity strategy. General statistical guidance cannot fill those gaps: the choice of method should be assessed against a prespecified plan and the data structure, neither of which is fully described in this record.
In general, skewed or over-dispersed count-like measurements can make methods based on simple distributional assumptions less suitable. Over-dispersion means that the observed variability exceeds what a particular model expects; it can affect standard errors and confidence intervals if not handled appropriately. The posted primary summaries do not indicate whether the underlying distribution was assessed or what inferential method, if any, was used. The registry record does not report enough detail to evaluate those choices.
10. Multiplicity, Missing Data and Analysis Populations
The record does not report a multiplicity strategy for the primary and secondary outcomes. Several outcomes are listed, and three secondary outcomes have posted results. When several statistical tests are conducted, the chance of at least one apparently notable result can increase. In general, a prespecified testing hierarchy or an adjustment can address some of that concern. Without a reported plan, the unadjusted secondary p-values should not be read as if they controlled the error rate across all outcomes.
The record also does not report whether any interim analyses were planned or conducted. The absence of a reported interim analysis is not evidence that one did or did not occur; the relevant information is not reported in the registry record. The statistical analysis plan and original sample-size justification are likewise not reported, so it is not possible to determine which analyses were intended to be confirmatory or how the trial's size was selected.
Missing-data handling is not reported. The registry does not state whether all randomized participants contributed to every outcome, how missing measurements were treated, or whether sensitivity analyses were conducted. The primary result lists group denominators of 67 and 66, while the adverse-event record lists 67 participants at risk in each group. The record does not explain the denominator difference across these outcome records. No assumption about the reason for the difference is warranted.
The analysis populations are not reported. In general, an intention-to-treat analysis retains participants in their randomized groups, while a per-protocol analysis may restrict analysis according to adherence or other criteria. These approaches answer somewhat different questions, and the record does not identify which approach was used for the posted summaries. It also does not report whether outcome assessors were masked or how deviations from assigned device use were handled. These omissions limit appraisal of the analysis and the robustness of the results.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| TrueRelief Device | 0 | 67 | 0.0% |
| Sham TrueRelief Device | 0 | 67 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| TrueRelief Device | 0 of 67 |
| Sham TrueRelief Device | 0 of 67 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| TrueRelief Device | 0 of 67 |
| Sham TrueRelief Device | 0 of 67 |
The adverse-event record lists zero serious adverse events in the TrueRelief group and zero in the sham group, with 67 participants at risk in each group. It also lists zero other adverse events in both groups and zero deaths in both groups. No serious adverse-event terms are listed.
These figures describe the events recorded in the registry for the stated groups. A zero count is not proof that an event is impossible or that no unrecorded event occurred. The registry does not provide further detail about event definitions, collection procedures, severity grading, attribution, or completeness of follow-up. Those details are needed to assess how the safety data were collected and classified.
The adverse-event counts should be interpreted in the context of the trial's recorded group sizes and follow-up information. The record does not establish that the study was designed or sized to detect uncommon harms. These figures are a limited description of reported events, not a comprehensive safety conclusion.
12. What the Result Does, and Does Not, Mean
The primary summaries show that the observed median inpatient opioid consumption was lower in the TrueRelief group than in the sham group. The groups' IQRs indicate variation in consumption, and the registry does not report a confidence interval or formal statistical test for the primary comparison. As a result, the size and precision of any underlying group difference cannot be established from the primary summaries alone.
The result does not by itself show that the device caused a difference. Randomization supports a comparative design, but interpretation also depends on implementation, follow-up, missing data, adherence, and analysis choices. Several of those details are not reported in the registry record. Nor does an inpatient opioid-consumption summary measure pain relief or recovery in full; those require their own outcomes and interpretation.
The posted secondary comparisons provide additional observations but are unadjusted, and results are not reported for every listed secondary outcome. A pattern of results across a limited set of outcomes cannot replace a prespecified analysis or resolve uncertainty in the primary outcome. The reported adverse-event counts likewise should not be interpreted as showing that harms cannot occur.
General statistical interpretation distinguishes an observed estimate from the uncertainty around it. A formal comparison and an interval would help characterize how compatible the data are with a range of group differences. Those primary inferential results are not reported. The posted median values remain useful descriptive information, but they should not be turned into a claim of established efficacy, lack of efficacy, or a definitive safety profile.
The registry record is one source of trial information and does not report the full protocol, analysis plan, or detailed methods. Further conclusions would require those details and a complete account of outcomes and analyses. The available results support a careful description of the observed trial groups, not medical advice or an individual treatment recommendation.
13. Why This Trial Matters Statistically
This trial illustrates why an outcome's scale and summary matter. Total opioid consumption is expressed in MME so opioid doses can be represented on a common scale, while the median and IQR describe the center and spread without implying that the values follow a symmetric distribution. Readers can see that the observed group medians differ, but cannot infer the precision of that difference without a reported inferential comparison.
It also shows the distinction between a primary outcome and secondary outcomes. The primary endpoint captures inpatient opioid use, while the secondary outcomes address post-discharge prescriptions, pain, wound outcomes, and breastfeeding. These outcomes can provide complementary perspectives, but they are not interchangeable. The registry's lack of a reported multiplicity plan makes it especially important to avoid treating each unadjusted secondary result as confirmatory evidence.
The study also offers an example of the limits of registry reporting. A randomized, masked design is informative, but the record does not describe the statistical analysis plan, missing-data approach, analysis population, or primary inferential result. Those details are essential for understanding how descriptive outcomes were converted, or were not converted, into formal evidence about group differences.
Finally, the planning illustrations emphasize that sample-size requirements depend on assumptions about the effect to detect and the desired power. They are design exercises based on observed effects, not retrospective evidence that the completed study had a particular probability of detecting an effect. Keeping descriptive summaries, inferential results, and planning calculations distinct is central to responsible statistical interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary endpoint is reported only through group medians and IQRs. The registry does not report a confidence interval, p-value, or formal statistical comparison for this endpoint, and no sponsor-reported primary analysis is listed. This prevents assessment of the precision of the primary group contrast using the registry results alone.
Important analysis details are not reported, including the prespecified statistical methods, missing-data handling, analysis population, and any adjustment for covariates. The registry also does not report how adherence to twice-daily device use was measured or handled analytically. The roles included in triple masking are not identified.
Five secondary outcomes are listed, but results are posted for only three. The registry does not report results for opioid tablets prescribed at discharge or breastfeeding. The available secondary p-values are unadjusted, and no multiplicity strategy is reported. These features limit the strength of conclusions drawn from secondary patterns.
The primary outcome is restricted to inpatient opioid consumption through discharge, with the stated time frame of 3 days. Follow-up time frames vary across secondary outcomes. The registry does not provide detailed information about the care setting, participant characteristics, eligibility criteria, or opioid prescribing practices, which could help readers judge the applicability of the results.
Adverse-event reporting is limited to the posted counts; the record does not describe event definitions, collection, attribution, or completeness. The group denominators differ between the primary and adverse-event records, and no explanation is given. These reporting limitations do not establish that the data are incorrect, but they constrain independent appraisal of the results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: TrueRelief Efficacy for Post-cesarean Pain (ELECTRON) — NCT05250830.
- Registry record last updated 2024-06-06; status last verified 2024-05.
- Results first posted 2024-06-06.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
ELECTRON (NCT05250830) is a completed randomized, triple-masked, parallel-group trial sponsored by Ohio State University. The registry describes 134 enrolled participants and compares twice-daily TrueRelief device use with an identical-appearing sham after cesarean delivery.
The primary outcome is median total inpatient oral opioid consumption, converted to MME, from the day of cesarean delivery to discharge. The posted median is 19.75 MME in the TrueRelief group and 37.5 MME in the sham group. No formal primary comparison is reported in the registry record.
Results are also reported for three secondary outcomes, with unadjusted comparisons, while two listed secondary outcomes have no posted results. Serious adverse events, other adverse events, and deaths are recorded as zero in both groups. Missing-data methods, analysis populations, and the statistical analysis plan are not reported.