Microcurrent Device (TIVIC Health): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Microcurrent Device (TIVIC Health) (NCT05198518), a randomized na study. The primary outcome is Change in Pain Visual Analog Score After First Use of Device.

2. Clinical Question

The trial addresses an immediate postoperative symptom in a defined surgical context. It compares use of an active microcurrent device with a sham device, rather than comparing device use with no device. Because the sham was designed to look like the active device, the comparison is intended to help separate the effect associated with the device’s microcurrent from effects associated with using a device or expecting treatment. The registry describes the study as randomized and quadruple masked. Details of who was masked and how masking was maintained are not reported in the registry record.

The key statistical question is about the pattern of pain scores around the first device use, not simply whether a score was recorded at one time. The outcome description lists baseline and three later timepoints. A complete interpretation would need the change at those times in each group, an appropriate between-group contrast, and information about uncertainty. Those results are not reported in the registry record. Thus, the trial question is identifiable, but the posted record does not establish the magnitude, precision, or direction of a treatment-group difference.

3. Trial Design

The registry describes a prospective, randomized controlled study of a microcurrent device following FESS. It lists a parallel-group model and quadruple masking. Participants were described as randomized 1:1 to receive either an active neuromodulation device or a sham device. The planned enrollment was 60. The record lists the study as completed, with a start date of 2022-03-30 and a primary completion date of 2024-03-19. The phase is listed as NA.

The active intervention is described as a handheld micro-current TENS emitter that applies a small current to the forehead and maxillary region. The sham device appears identical but emits no therapeutic microcurrent. Participants were to self-treat at home and be followed for 2 weeks after FESS. They were instructed to use the device for 14 days and recommended to use it at least 3x a day. These are descriptions of the study instructions, not evidence that every participant followed them as intended.

The primary outcome is change in a visual analog pain score after the first use of the device, with assessments at baseline, 10 min, 2 hour, and 4 hour. The scale runs from 0-10, with higher scores indicating more pain. The registry also lists secondary outcomes concerning pain associated with debridement at multiple stages and postoperative pain medication usage. It lists 13 outcome measures in total.

The reported safety groups list 27 people at risk in the Microcurrent TENS Device group and 33 in the Sham Device group. The registry’s brief study description says allocation was 1:1, but an explanation for the difference between the group counts in the safety record and the planned allocation is not reported in the registry record. Participant flow, withdrawals, adherence, and the analysis population are also not reported in the registry record. The record lists no analyses, and it does not provide a primary-outcome result. Randomization and masking describe design features; neither alone supplies evidence about the observed treatment contrast.

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.

Screening Visit

Reasons for not completing this period:

Enrolled Participants

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.

6. Primary Endpoint

The registry lists the primary outcome as Change in Pain Visual Analog Score After First Use of Device, measured over baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure.

The primary endpoint is the change in postoperative pain score around the first use of the device. Pain is recorded on a visual analog scale from 0-10, where higher scores indicate more pain. The listed measurement times are baseline, 10 min, 2 hour, and 4 hour. The endpoint description says participants record pain before and after device use and identifies the assessment as occurring at first use within 14 days after the procedure.

A repeated set of measurements can describe both the initial pain level and how scores vary over the hours following device use. Baseline provides a within-participant reference for the later scores. The later observations can characterize whether a change is sustained, short-lived, or different across measurement times. These are general reasons to collect repeated pain ratings; they do not establish that a particular change occurred in this trial.

Because pain is recorded as a numerical score, the registry identifies the outcome parameter as a mean and the dispersion as a standard deviation. A mean summarizes the average score in a group, while a standard deviation describes variation among individual scores around that mean. For a treatment comparison, the clinically and statistically relevant quantity would need to make clear how the groups differ in change over time. The registry does not specify a single timepoint as the sole primary comparison, nor does it provide group means, changes, a contrast, or uncertainty estimates. The primary endpoint’s numerical result and analysis are therefore not reported in the registry record.

The endpoint is a patient-reported measure, which captures the experience the trial is designed to assess. At the same time, interpretation depends on complete and timely recordings and on knowing how missing observations were handled. Those details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical methods that generated a primary-outcome estimate are not reported in the registry record. The general concepts below explain what would be needed to interpret the planned type of outcome, without implying that any particular method was used in this trial.

What does a mean describe?

For a continuous measure such as a pain score, the mean is the arithmetic average of the recorded values in a group. It gives a compact description of the group’s central score, but it does not describe every participant’s experience. The registry identifies the primary parameter as a mean and the dispersion as a standard deviation. In general, the standard deviation indicates how spread out individual scores are around the group mean. It is not the same as the uncertainty in the estimated mean, and it is not itself a treatment comparison.

To compare randomized groups, a result would usually need to state a contrast, such as a difference between group averages or a difference between average changes. Which contrast is appropriate depends on the prespecified question and analysis. The registry does not report the chosen contrast or a numerical estimate, so no treatment difference can be interpreted.

Why are repeated measurements important?

The primary outcome lists measurements at baseline, 10 min, 2 hour, and 4 hour around first device use. Repeated measurements can show how a score changes over time and can account for the fact that measurements from the same person are related. General approaches for repeated data include modeling measurements jointly or defining change from baseline at specified times. Those approaches can answer somewhat different questions. A joint model may describe a time course, while a single-timepoint contrast focuses on one moment. The registry does not report which approach was used, whether time was modeled categorically or otherwise, or whether one timepoint was designated as the primary treatment comparison.

A within-group change is not by itself evidence of a difference between treatments. In a randomized trial, the comparison of interest ordinarily concerns whether outcome changes differ between the assigned groups. Pain may change after surgery over time in both groups, whether or not the device has an effect. The sham group is relevant because it provides a comparator under the trial’s device-use and masking arrangements. The posted record gives no outcome values with which to make this comparison.

What does a confidence interval add?

In general, a confidence interval expresses statistical uncertainty around an estimated quantity. Its width is affected by factors such as the amount of information in the data and variability in the outcome. A narrow interval indicates greater precision than a wide interval, under the assumptions of the analysis. An interval for a between-group effect can show which effect sizes are compatible with the data and model. It does not guarantee that the model is correct, and it does not by itself determine clinical importance. No confidence interval for the primary outcome is reported in the registry record.

A p-value, if reported, would address how compatible the observed data are with a specified null hypothesis under an analysis model. It would not measure the size or importance of an effect, and it would not be the probability that the null hypothesis is true. The registry does not report a primary-outcome p-value or analysis. Without a defined comparison and estimate, statistical significance cannot be assessed.

How should several times and outcomes be considered?

Multiple outcome measures and timepoints create more than one possible opportunity to observe a result that appears notable. In general, multiplicity methods can control the chance of false-positive findings across a family of comparisons, or an analysis can identify a primary comparison in advance and treat other analyses as secondary or exploratory. The registry lists 13 outcome measures, and the primary outcome itself includes several timepoints. The method for handling multiple outcomes or timepoints is not reported in the registry record. It would be inappropriate to infer that a particular adjustment or hierarchy was used.

What do planning sample sizes mean?

In general, a sample-size calculation for a future study depends on assumptions about the effect to detect, outcome variability, significance level, power, allocation, and the statistical model. The record describes a planning illustration based on a fraction of an observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also states that participant counts are per arm for non-time-to-event outcomes. However, no calculated planning values are reported in the registry record, and the underlying observed effect is not reported there. Any such illustration is a planning exercise, not a measure of the probability that this completed trial found an effect. Sample-size assumptions cannot replace reported estimates and uncertainty.

Over-dispersion is a general concern when observed variability is greater than a model assumes. If a method assumes less variability than is present, uncertainty can be understated. For continuous pain scores analyzed with a mean-based method, the distribution and repeated-measure structure still matter to the validity of standard errors and intervals. The registry does not report diagnostics, model assumptions, or whether over-dispersion was relevant to the analysis.

Other important method details include whether the analysis followed randomized assignment, how incomplete records were handled, how adherence was considered, and whether any covariates were used. None of these details is reported in the registry record. The absence of those details limits assessment of how a result would have been produced, independently of the absence of a posted result itself.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 13 outcome measures. The primary outcome contains observations at baseline, 10 min, 2 hour, and 4 hour, and several secondary outcomes also refer to repeated stages of debridement. When many outcomes or timepoints are examined, general statistical practice distinguishes the primary comparison from secondary or exploratory comparisons and may use a prespecified strategy to address multiplicity. The multiplicity strategy for this trial is not reported in the registry record. The record also does not identify a single timepoint as the sole primary comparison.

Missing-data handling is not reported in the registry record. The described outcome depends on participants recording pain scores around device use, and the study description says participants were to self-treat at home. The record does not state how many participants posted each measurement, whether missingness differed by group or time, or how incomplete series were treated. In general, missing scores can affect estimates if the likelihood of a score being absent is related to the score itself, treatment, or other participant characteristics. The impact depends on both the pattern of missingness and the method used to handle it; neither is described.

The analysis populations are also not reported in the registry record. There is no statement about whether participants were analyzed according to randomized assignment, whether only participants who used the device were included, or how withdrawals and protocol deviations were handled. The enrollment is listed as 60, while the safety groups have 27 and 33 participants at risk. The record does not give a participant-flow account explaining these figures or the number contributing to the primary endpoint.

These omissions matter because an estimate is interpretable only in relation to the observations and analysis rules that produced it. The registry lists zero analyses and does not provide primary-outcome results, so there is no reported estimate whose missing-data or multiplicity handling can be evaluated.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The safety record lists two groups. For the Microcurrent TENS Device group, 27 participants are listed at risk, with zero serious adverse events, zero other adverse events, and zero deaths. For the Sham Device group, 33 participants are listed at risk, also with zero serious adverse events, zero other adverse events, and zero deaths. These are the event counts recorded in the registry.

In general, an adverse-event count is interpreted alongside the number of people at risk, the period over which events were sought, and the procedures used to collect and classify them. The registry does not report details of event definitions, ascertainment, follow-up completeness, or whether events were actively solicited. It also does not report a statistical comparison between groups. The different numbers at risk should not be interpreted as evidence of a safety difference by themselves.

Zero recorded events does not establish that no event could occur, nor does it demonstrate equivalence between the groups. It means only that the posted safety counts contain no events in the listed categories. The record does not provide further serious-event terms or narrative details. Safety interpretation is therefore limited to the reported counts and denominators, without a basis for estimating comparative risk or assessing how completely events were captured.

12. What the Result Does, and Does Not, Mean

The registry record establishes that a randomized, quadruple-masked, parallel-group trial was registered as completed, with an intended comparison between a microcurrent device and a sham device after FESS. It describes a patient-reported pain outcome around first use and lists safety counts. It does not provide a primary-outcome analysis. The central statistical result needed to answer whether pain scores differed between the groups, and by how much, is not reported in the registry record.

Consequently, the record does not establish the direction of any treatment-group difference, its magnitude, or its precision. It does not provide evidence that scores were higher or lower with either device, and it does not support a conclusion about the size or clinical relevance of a possible effect. Those limits apply regardless of the randomized design: randomization describes how the comparison was assigned, while outcome estimates describe what was observed.

The listed zero adverse-event counts likewise have a narrow meaning. They indicate zero recorded serious events, zero recorded other events, and zero deaths in each group’s safety listing. They do not show that the event risk is zero, that the safety profiles are equivalent, or that all events were captured. The record does not describe the safety follow-up and ascertainment needed to evaluate those possibilities.

General statistical interpretation separates the estimate, its uncertainty, and the assumptions behind the analysis. Here, the estimate and uncertainty for the primary outcome are absent, and analysis details such as missing-data handling and the analysis population are not reported in the registry record. It is therefore not possible to assess whether any estimated difference would be compatible with no difference, how precise it would be, or how robust it would be to analysis choices.

The absence of a posted result should not be mistaken for a finding of no effect. It is also not evidence of an effect. The appropriate conclusion is that the registry record describes the intended clinical question and design but does not report the numerical outcome evidence needed to answer that question.

13. Why This Trial Matters Statistically

This trial is statistically interesting because its primary outcome is not a single isolated pain rating. It is described as change around first device use, with scores at baseline, 10 min, 2 hour, and 4 hour. That structure raises familiar issues in clinical-trial analysis: how to compare groups over time, how to account for repeated measurements from the same participant, and how to define the principal contrast when several timepoints are recorded.

The active and sham devices also make the comparison conceptually specific. The sham is described as identical in appearance while emitting no therapeutic microcurrent. In general, a sham comparator can help distinguish effects associated with the active component from effects associated with device use and expectations. Interpreting that design still depends on masking and implementation. The registry does not report who was masked, whether masking was maintained, or how adherence was assessed.

The trial illustrates why a design description and an outcome result answer different questions. Randomization and masking describe planned safeguards for the comparison. Means, between-group contrasts, uncertainty estimates, and analysis details would show what the data indicate. The registry record provides the former but not the latter for the primary endpoint. Its completed status does not fill that gap.

The record also lists multiple secondary outcomes and repeated measurements. In general, these create decisions about which comparisons are confirmatory and how to interpret multiple findings. Since the multiplicity plan is not reported in the registry record, any future interpretation of several outcome results would need to consider that uncertainty. Reporting the prespecified contrast, analysis population, missing-data approach, and confidence interval would make the statistical evidence more transparent.

Finally, the safety listing shows why denominators and ascertainment matter. It reports zero events in groups with different numbers at risk, but provides no event-collection details or comparative analysis. The counts are informative as registry entries while remaining insufficient to characterize comparative safety. Together, these features make the trial a useful example of the distinction between registered methods, posted counts, and a fully interpretable statistical result.

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 largest limitation for statistical interpretation is that the registry does not report the primary-outcome result. There are no group summaries, changes, treatment contrasts, confidence intervals, or p-values. The registry lists zero analyses. Without an estimate and its uncertainty, the primary question cannot be answered from the posted record.

The outcome is described across multiple timepoints, but the record does not state how those repeated observations were analyzed or identify one timepoint as the sole primary comparison. The method for addressing multiplicity across timepoints and the 13 listed outcome measures is not reported in the registry record. These details would be important in distinguishing a prespecified principal analysis from exploratory comparisons.

Participant flow and outcome completeness are not reported. Although enrollment is listed as 60, the safety groups list 27 and 33 participants at risk. The registry does not explain these denominators, identify the number randomized to each group, or state how many participants contributed primary-outcome data. Adherence to home device use, withdrawals, and protocol deviations are also not reported in the registry record.

The analysis population, treatment of missing pain scores, model specification, covariate adjustment, and handling of repeated measurements are not reported in the registry record. The record describes quadruple masking but does not say who was masked or whether masking was assessed. These gaps prevent appraisal of key assumptions and possible sources of bias.

Safety information is limited to the posted counts. Event definitions, ascertainment procedures, follow-up completeness, and comparative safety analyses are not reported. The record’s completed status and stated dates describe the trial’s registry status and timing, but do not remedy these outcome-reporting limitations.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Microcurrent Device (TIVIC Health) — NCT05198518.
• Registry record last updated 2025-06-12; status last verified 2025-05.
• Results first posted 2025-06-12.
• 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.

18. Record Summary

The registry record describes NCT05198518, titled “Microcurrent Device (TIVIC Health),” a randomized, quadruple-masked, parallel-group trial of an active microcurrent device versus a sham device following FESS. The listed condition is chronic rhinosinusitis, planned enrollment is 60, and the record lists the study as completed. The primary completion date is 2024-03-19.

The primary outcome is change in pain visual analog score around first use, measured at baseline, 10 min, 2 hour, and 4 hour on a 0-10 scale. Secondary outcomes include debridement-associated pain and postoperative pain medication usage. The safety listing reports zero serious adverse events, zero other adverse events, and zero deaths in each group, with 27 and 33 participants at risk, respectively.

The registry lists no analyses and does not report a primary-outcome estimate, uncertainty interval, or p-value. Details of participant flow, missing-data handling, analysis populations, and multiplicity methods are not reported in the registry record. The design and intended outcome are described, but the posted information does not provide the numerical evidence needed to assess the primary treatment comparison.