Remote Participation (Within USA) Trial of Sana Pain Reliever: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Remote Participation (Within USA) Trial of Sana Pain Reliever (NCT04280562), a randomized na study. The primary outcome is Change in Neuropathic Pain Symptom Inventory (NPSI).

2. Clinical Question

3. Trial Design

The registry describes a randomized, double-masked, parallel-group trial comparing the Sana Pain Reliever with a sham SPR device. The trial status is completed, and the listed enrollment is 75. The record does not report how enrollment was divided between the groups, or whether every enrolled participant completed each assessment.

The trial was designed for remote participation within the USA. Its brief description states that study visits took place by teleconferencing and that devices were mailed to participants for home use over 8-14 weeks. The record describes four study visits. The “real” SPR group used the real device protocol, while the sham group used a sham protocol; both arm descriptions mention a tablet application for pain levels and other questionnaires.

The registry lists the start date as 2020-01-31 and the primary completion date as 2023-02-21. The sponsor is Icahn School of Medicine at Mount Sinai. The phase is listed as NA. Details such as the randomization procedure, allocation concealment, masking procedures, and any changes made during the trial are not reported in the registry record.

The registry lists 15 outcome measures, including the primary NPSI measure and secondary measures of depression, sleep, anxiety, quality of life, global impression of change and pain. It lists 0 analyses. The primary outcome has multiple categories or time points and was not reduced to a single comparison in the posted results. Consequently, the design description establishes the intended comparison, but the registry results do not provide an analyzed primary endpoint estimate.

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.

Baseline Screening

Study

Reasons for not completing this period:

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 Neuropathic Pain Symptom Inventory (NPSI), measured over Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14).

The primary endpoint is change in the Neuropathic Pain Symptom Inventory, or NPSI. The registry describes it as a measure of quantitative and qualitative aspects of neuropathic pain. Its 12 items assess spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. The full scale runs from 0-100, with higher scores indicating greater symptom intensity.

The endpoint is intended to capture change in pain symptoms over time, rather than only a score at a single assessment. The registry specifies comparisons with baseline at Week 2, Week 10 and Week 14. It also identifies Baseline 1 at Week 0 and Baseline 2 at Week 2, followed by a post-assessment at Week 10 and follow-up at Week 14. The record does not explain how the two baseline measurements were used to define the reported change or which baseline was used for each comparison.

Repeated symptom assessments can describe whether scores shift during the study and whether any change is still present at follow-up. That interpretation depends on the actual scores, the analysis method and the amount of missing data. Numerical NPSI results and an analysis of change are not reported in the registry record, so the size and precision of any difference between groups cannot be evaluated from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary measure as a continuous score summarized by a mean, with standard deviation as the stated measure of dispersion. These labels describe the intended form of the outcome summary. They do not provide the actual score distributions or the result of a comparison. In the absence of posted group summaries and analysis estimates, no effect size or uncertainty can be interpreted.

What does a mean describe?

In general, a mean is a measure of the central location of numerical observations. For a symptom score, it can give a compact description of the group’s average score at an assessment or of average change, depending on what was analyzed. A mean alone does not show how participant scores vary, whether the distribution is strongly skewed, or whether a small number of observations have a large influence. The registry identifies the mean as the parameter of interest, but does not report the actual means.

What does a standard deviation describe?

In general, a standard deviation describes the spread of individual observations around their mean. It is not the same as the uncertainty in a group mean or in a difference between groups. A confidence interval for an estimated treatment contrast would express uncertainty about that contrast; it would be interpreted alongside the estimate, not as a measure of individual variability. No standard deviations, confidence intervals or group-level NPSI estimates are reported in the registry record.

Why do repeated assessments matter?

The endpoint description includes baseline and later assessments, with changes specified for Week 2, Week 10 and Week 14 compared with baseline. Repeated measurements can be analyzed in different ways. For example, an analysis might compare change scores at specified visits or model scores across visits while accounting for repeated observations from the same participant. These are general possibilities, not methods established for this trial. The statistical model, the precise change calculation and the handling of the two baseline assessments are not reported in the registry record.

Multiple assessment times also create a question about which comparisons are intended to carry the main inferential claim. Testing multiple time points can increase the chance of a chance-positive finding if results are interpreted without accounting for the multiplicity. A prespecified primary time point, an adjustment procedure, or a clearly defined hierarchy can help clarify interpretation. The record says the primary outcome has multiple categories or time points and was not reduced to one comparison; it does not report a multiplicity procedure or a selected primary time-point contrast.

What can randomization and masking contribute?

In general, random assignment is intended to make comparison groups similar in expectation with respect to measured and unmeasured characteristics. It does not guarantee balance in a particular trial, especially when the amount of outcome data available for analysis is unknown. Masking is intended to limit influences on participant reports, care or assessment that could arise from knowing the assigned intervention. The registry labels the trial randomized and double-masked, but details of sequence generation, concealment and masking implementation are not reported. The design labels therefore should not be mistaken for evidence that bias was absent.

What do the planning assumptions mean?

The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms and a normal approximation. It also describes planning for fractions of the observed effect. These are assumptions for an illustration, not confirmation of the trial’s original design or its statistical plan. The registry record does not report the trial’s own sample-size justification, and the listed planning assumptions do not constitute observed power. Sample-size illustrations concern hypothetical future planning and cannot fill the gap left by missing primary-outcome estimates.

More generally, power is a design-stage probability calculation tied to an assumed effect, variability, significance level and analysis. It is not a measure of whether a completed trial has proved an effect. Retrospective power calculations based on an observed estimate do not replace confidence intervals, and they cannot recover information that is absent from the posted results. No numerical planning results are stated in the registry record.

Finally, a p-value, if reported, would quantify how compatible the data are with a specified null model under the chosen analysis. It would not measure the probability that the intervention is effective, the probability that the null hypothesis is true, or the clinical importance of a difference. Because no primary analysis or p-value is posted, those interpretations cannot be made for this trial from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 15 outcome measures and identifies the NPSI change measure as primary. It describes secondary measures covering depression, sleep, anxiety, quality of life, global impression of change and pain. The primary endpoint itself includes multiple assessment times: change at Week 2, Week 10 and Week 14 compared with baseline. The posted results state that this primary outcome was not reduced to a single comparison, and the registry lists 0 analyses.

When a study evaluates multiple outcomes or time points, the number of opportunities for a chance-positive finding can increase. Statistical approaches such as adjustment for multiple comparisons, a prespecified hierarchy, or emphasis on a clearly defined primary contrast can help control or explain that issue. These are general methodological options; the registry record does not report which, if any, were used. Without an analysis plan or reported contrasts, readers cannot identify which tests were intended to be confirmatory or how multiplicity was handled.

Missing-data information is also not reported in the registry record. There are no posted NPSI results by assessment time, no analyzed denominators, and no description of missing observations or the methods used to handle them. The listed enrollment does not establish how many participants contributed data at each visit. The record also does not specify whether the primary analysis used an intention-to-treat population, a per-protocol population or another analysis set. Consequently, the extent to which missing data or analysis-population choices could affect the estimate cannot be assessed from the posted results.

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.

Most frequent non-serious adverse event terms

The registry lists serious adverse event counts separately for the two arms. In the “real” SPR arm, 0 serious adverse events were reported among 34 participants at risk; in the sham SPR arm, 0 were reported among 41 participants at risk. Deaths are listed as 0 in both arms. These entries describe the posted counts and denominators; they do not establish that an event was impossible or that the chance of a rare event is zero.

For other adverse events, the registry lists 4 affected participants among 34 at risk in the real SPR arm and 1 among 41 at risk in the sham SPR arm. These are counts, not a statistical comparison. The record does not provide an analysis of the difference, event-level descriptions for these other events, or information sufficient to determine whether the events were related to the device.

No serious adverse event terms are listed. The registry record does not report additional details about event definitions, monitoring, timing, severity classification or completeness of ascertainment. Safety counts should therefore be read as the reported entries for this record, not as a comprehensive estimate of comparative risk.

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

The registry record describes a randomized comparison of a real SPR protocol with a sham protocol, with change in NPSI specified as the primary outcome. It also describes remote home use and a set of questionnaire-based secondary outcomes. These details clarify the intended research question and the measurements selected to address it.

However, the record does not post an analyzed primary outcome. It lists 0 analyses and notes that the primary outcome has multiple categories or time points and was not reduced to a single comparison. No NPSI effect estimate, group summary, confidence interval or p-value is reported. The posted information therefore cannot show whether the groups differed, in which direction any difference went, or how precise an estimated difference would be.

The absence of a reported analysis is not evidence that there was no effect, and it is not evidence that an effect was present. It means the relevant result cannot be evaluated from the registry record. Similarly, the enrollment entry and the listed outcome schedule do not establish how many observations were available for analysis or whether the planned assessments were completed.

The adverse-event entries provide counts for serious and other events, but do not answer the primary pain question. Nor do these counts alone establish that the device is safe or unsafe: interpretation depends on event definitions, follow-up, completeness of reporting and appropriate comparison. Those details are not reported in the registry record.

Thus, the record is informative about the study’s design, intended measures and posted safety counts, but it does not support a conclusion about the intervention’s effect on neuropathic pain symptoms. Such a conclusion would require analyzable outcome results and sufficient information to assess uncertainty, missing data and the prespecified comparison.

13. Why This Trial Matters Statistically

This trial raises several important statistical issues for readers of clinical research. First, the primary outcome is measured repeatedly, with changes specified at Week 2, Week 10 and Week 14. Repeated measurements can describe the time course of symptoms, but they also require clarity about which visit or overall pattern is the primary target of inference. Without that clarity, readers may not know which comparison should anchor interpretation.

Second, the registry lists 15 outcome measures. A broad set of measures can capture different aspects of participants’ experience, but multiple outcomes and assessment times make prespecification and multiplicity handling important. The record does not report a statistical plan or an adjustment approach, and it lists 0 analyses. This makes it impossible to distinguish planned confirmatory analyses from other possible comparisons.

Third, remote participation and home device use make the completeness of repeated self-reported measurements especially relevant to interpretation. The registry describes teleconferencing visits and tablet-based questionnaires, but it does not report outcome availability by visit or how missing observations were handled. Without those details, the potential influence of incomplete follow-up cannot be assessed.

Finally, this record illustrates the distinction between a trial’s design and its results. Randomization and masking describe intended protections against bias, but they do not replace estimates, measures of uncertainty or transparent reporting. The posted safety counts also need context and do not answer the primary efficacy question. A clear analysis of the planned endpoint would be needed to assess the size and precision of the comparison.

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 central limitation for interpreting this trial from its registry record is the absence of reported primary-outcome analyses. Although the registry identifies NPSI change as the primary endpoint and gives its assessment schedule, it does not report the group scores or a comparison between groups. The record explicitly lists 0 analyses and says that the primary outcome has multiple categories or time points that were not reduced to a single comparison.

The endpoint description names two baseline assessments, at Week 0 and Week 2, and later assessments at Week 10 and Week 14. The record does not explain how those baseline measurements were used to calculate change. It also does not report how the repeated observations were analyzed, whether the analysis adjusted for baseline values, or which assessment time was intended to be most important for the primary conclusion.

Important participant-flow and analysis details are absent. The registry lists enrollment as 75 but does not report group-specific analyzed numbers or outcome completion at each assessment. Missing-data frequency, reasons for missingness, imputation or other handling methods, and the analysis population are not reported in the registry record.

Although the design is labeled randomized and double-masked, implementation details are not reported. The record also does not report a statistical analysis plan, a sample-size justification for the trial, or a multiplicity approach for the listed outcomes and time points. The planning assumptions described in the record are illustrations and do not supply those missing design details.

The safety entries are limited to counts of affected participants and do not include fuller event descriptions or additional context for interpreting exposure and follow-up. Taken together, these reporting gaps prevent assessment of the primary treatment contrast, its precision, and the robustness of any conclusion from this registry record alone.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Remote Participation (Within USA) Trial of Sana Pain Reliever — NCT04280562.
• Registry record last updated 2025-11-04; status last verified 2025-07.
• Results first posted 2025-07-09.
• 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 a completed, randomized, double-masked, parallel-group trial of the Sana Pain Reliever against a sham SPR device for chronic neuropathic pain. Listed enrollment is 75. The trial was remote, with teleconferencing visits and mailed devices for home use over 8-14 weeks. The primary measure was change in NPSI, assessed at Week 2, Week 10 and Week 14 compared with baseline.

The record lists 15 outcome measures and 0 analyses. It does not report numerical primary-outcome results, a between-group estimate or its precision. Safety entries list 0 serious adverse events and 0 deaths in each arm; other adverse events affected 4 participants in the real SPR arm and 1 in the sham SPR arm. The registry record therefore describes the intended comparison and reported safety counts, but does not provide an analyzed primary result.