A Study of Fisetin to Treat Carpal Tunnel Syndrome: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of Fisetin to Treat Carpal Tunnel Syndrome (NCT05416515), a na phase 2 study. The primary outcome is Change in Boston Carpal Tunnel Syndrome (BCTQ) Score.

2. Clinical Question

3. Trial Design

NCT05416515 is a phase 2 clinical trial titled “A Study of Fisetin to Treat Carpal Tunnel Syndrome,” with the official title “Phase 2 Clinical Trial of FIsetin to Treat CArpal Tunnel Syndrome (FITCATS).” The registry lists the study as completed and records enrollment of 40 participants. The listed sponsor is Peter C. Amadio, M.D. The recorded start date is 2022-10-09, and the primary completion date is 2024-12-31.

The design is single-group, with allocation marked NA and masking listed as none. Participants with a clinical diagnosis of CTS were assigned to the Fisetin arm described in the record; no separate comparison group is listed. Adult men and women are described as receiving Fisetin for 2 day periods for 2 months. The record does not describe a placebo, usual-care comparator, or randomized allocation.

The primary outcome is change in BCTQ score, with assessments named at baseline and 60 days. The registry also lists two secondary outcome descriptions concerning decreases in blood markers of cellular senescence, including examples of markers and additional exploratory assays. It records 3 outcome measures in total, but does not give numerical results for the BCTQ or the secondary outcomes. The number of outcome analyses recorded is 0.

This design can describe measurements made among enrolled participants over time, but it does not create a concurrent estimate of what would have happened without Fisetin. The registry record does not report further details of the intervention schedule, adherence, eligibility criteria beyond the clinical diagnosis, or how participants were included in each analysis.

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

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 Boston Carpal Tunnel Syndrome (BCTQ) Score, measured over Baseline, 60 days.

The primary endpoint is change in the Boston Carpal Tunnel Syndrome questionnaire (BCTQ) score, assessed at baseline and 60 days. The questionnaire is described as assessing symptom severity and overall function in people with CTS. It has two sections: Symptom Severity, with 11 questions, and Functional Status, with 8 questions. Each question is rated on a scale of 1 to 5; a section score is calculated as the mean of its question responses. Higher scores indicate greater symptom severity and dysfunction.

These scores are useful as patient-reported measures because the stated content concerns symptoms and function rather than a laboratory marker alone. A change over time can describe how questionnaire scores differ between the named assessment points among participants with measurements. However, the registry record does not report the observed baseline or 60-day scores, the change, its variability, or an analysis result. It also does not clarify whether the reported primary result would combine the two BCTQ sections or report them separately. The endpoint description therefore explains what was intended to be measured, but does not establish the size or precision of any observed change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods determine how measurements are summarized, how uncertainty is quantified, and what comparisons can support an interpretation. The registry record identifies a continuous primary outcome summarized by a mean and standard deviation, but does not report numerical outcome results or any outcome analyses. The explanations below describe general statistical concepts; they do not state methods as having been used in this trial unless the registry record says so.

What does a mean score describe?

For a continuous measure, a mean is an average across the observations included in a calculation. Here the endpoint description says each BCTQ section score is calculated by averaging responses to its questions. A mean change would summarize the average difference between the named baseline and 60-day measurements for the participants included in that calculation. The record does not report the BCTQ scores or mean change, so the value and direction of any average change cannot be assessed.

A standard deviation describes how dispersed individual measurements are around their mean. It is not the same as the uncertainty around the mean: a standard error or confidence interval is used to express uncertainty in an estimated mean, subject to the analysis and its assumptions. No standard deviation, standard error, or confidence interval for the primary outcome is reported in the registry record. Without those quantities, the precision of a primary outcome estimate cannot be evaluated from the posted results.

What can a baseline-to-follow-up comparison establish?

In a single-group study, measurements from the same participants may be compared over time. A paired analysis, as a general method, uses within-participant differences and accounts for the fact that measurements from one person are related. Other methods may be used depending on the data structure and analysis plan. The registry record does not report which method was used, whether an analysis was conducted, or how participants with only one measurement were handled. It would therefore be inappropriate to attribute any particular method to this trial.

Even if a within-group change is measured precisely, it does not by itself identify a causal treatment effect. The observed change combines any intervention-related change with other changes occurring during the same period. A concurrent comparison group can help distinguish those influences when the study design and analysis are appropriate. This trial is registered as single-group, so its design does not provide that direct comparison.

How should confidence intervals and significance tests be understood?

General explanation: a confidence interval gives a range of values compatible with an estimate under the assumptions of the analysis. Its width conveys precision; a wider interval reflects greater uncertainty than a narrower interval. A significance test assesses compatibility between observed data and a specified null hypothesis under a statistical model. A p-value is not the probability that a treatment works, nor does it measure the importance of an effect. The registry record does not report a confidence interval or p-value for the BCTQ outcome, and it does not report an outcome analysis from which to interpret either.

Statistical significance and clinical importance are also distinct questions. A statistical test concerns uncertainty under a model; clinical interpretation concerns whether a change is meaningful in context. The record gives the score range and indicates that higher scores reflect greater symptom severity and dysfunction, but it does not provide a threshold for an important change. It also does not report an observed change. No conclusion about clinical importance can therefore be drawn from the registered outcome description alone.

What do the planning assumptions mean?

The record describes sample-size assumptions for planning illustrations: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as a stated fraction of the observed effect. It specifies that non-time-to-event calculations are expressed as participants per arm, while time-to-event calculations use total events. These are assumptions for planning illustrations, not a description of the actual single-group trial design. The registry does not report a trial-specific sample-size justification or its assumptions.

Planning sample sizes are hypothetical quantities calculated under assumptions about the effect, variability, statistical test, and design. They are not observed results and are not “observed power.” Here, the record does not report the observed primary effect needed to understand an effect-based illustration. The hypothetical two-arm allocation also differs from the registered single-group design, so those assumptions should not be read as the actual allocation or analysis plan.

General explanation: over-dispersion means that variability in count data is greater than a model assumes. If present, it can make uncertainty estimates from a model that ignores it too small. The registry record does not identify a count outcome analysis or report whether over-dispersion was assessed; this concept is not evidence that it occurred in this study.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Carpal Tunnel Syndrome")
n   <- c(40)
m   <- c(-0.5)
sp  <- c(0.6)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Carpal Tunnel Syndrome  40  -0.500  0.600  -0.692  -0.308

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 3 outcome measures, including the primary BCTQ change outcome and two secondary descriptions concerning blood markers of cellular senescence. When a study evaluates multiple outcomes or multiple analyses, multiplicity can arise: the chance of at least one apparently unusual result may increase as more statistical tests are considered. General approaches can include prespecifying a primary outcome, adjusting tests, or treating secondary findings as exploratory. The registry record does not report a multiplicity adjustment, a hierarchy among analyses, or a statistical analysis plan, so none should be assumed.

The record lists 0 outcome analyses and does not provide numerical results for the primary or secondary outcomes. It does not report the amount or pattern of missing outcome data, reasons for missingness, imputation methods, or sensitivity analyses. Missing-data methods can affect estimates when measurements are unavailable, and their appropriateness depends on why data are missing and on the assumptions used. Those assumptions and methods are not reported in the registry record.

The record does not state which analysis population was used—for example, whether analyses included all enrolled participants, only those who completed follow-up, or participants meeting another definition. Enrollment was 40, but enrollment alone does not establish the number contributing to each outcome analysis. The reported safety counts list 40 participants at risk for each adverse-event category; this does not establish the analysis population for the questionnaire outcomes.

12. 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 record lists 0 serious adverse events among 40 participants at risk. It lists 15 participants with other adverse events among 40 at risk. No serious adverse event terms are listed. These are descriptive registry counts, not comparative estimates.

The figures do not indicate whether an event was considered related to Fisetin, how events were defined or collected, how long participants were observed for safety, or whether any event led to treatment discontinuation. Those details are not reported in the registry record. The record also does not provide descriptions of the 15 other adverse events, so their types and severity cannot be assessed from these counts.

A count of zero reported serious events does not establish that serious events cannot occur, and the count cannot be compared with a control group because no separate comparator is registered. Likewise, the count of other events does not by itself show that Fisetin caused them. The figures describe what the registry lists for this study; they do not establish comparative risk or make a treatment recommendation.

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

The registry record documents a completed phase 2, single-group study of Fisetin in participants with CTS, with BCTQ change from baseline to 60 days named as the primary outcome. It also records adverse-event counts. These details describe the study’s registered design and the safety figures posted in the record.

The primary outcome results are not reported numerically, and the record lists 0 outcome analyses. As a result, the posted information does not establish whether BCTQ scores changed, in which direction they changed, or how precise any estimate might be. The secondary blood-marker outcomes are also named without numerical findings. The record therefore does not provide an estimate of the intervention’s effect on the questionnaire or those markers.

Even a reported change in a single group would not, on its own, establish that the intervention caused that change. Without a concurrent comparator, other influences over time cannot be separated from an intervention effect using the registered design alone. The record also does not provide enough information to evaluate outcome missingness, analysis populations, or the statistical methods used.

The adverse-event counts can be read as descriptive observations, but the record does not provide event details or a comparator from which to estimate relative safety. The results should not be interpreted as proof of benefit, lack of benefit, or comparative safety. They identify what the study set out to measure and what safety counts were recorded, while leaving the primary efficacy question unanswered in the posted numerical results.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of the difference between a registered study question and a reported estimate. The record identifies a patient-reported primary outcome, its assessment timing, and the group in which it was measured. Yet it does not report the endpoint values or an outcome analysis. A study status of completed does not itself provide the results needed to estimate change or uncertainty.

The single-group structure also makes the distinction between change over time and treatment effect especially important. A baseline-to-follow-up comparison can characterize participants’ observed scores, but without a concurrent comparator it cannot isolate what would have happened in the absence of the intervention. This is a design limitation for causal interpretation, regardless of whether an observed within-group change is large or small.

The record’s planning assumptions illustrate why sample-size calculations must match the trial design and analysis. The stated illustration assumes two arms with equal allocation, whereas the registered study is single-group. Planning illustrations are not study findings, and they cannot replace a reported effect estimate with an uncertainty interval. No trial-specific sample-size justification is reported.

Finally, the gap between outcome descriptions and reported analysis details matters for reproducibility and interpretation. The record lists primary and secondary outcomes, but does not report numerical findings, missing-data handling, analysis populations, or multiplicity methods. Those omissions limit what readers can conclude from the posted record, without changing the factual description of the registered study.

15. 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 principal limitation for statistical interpretation is that numerical results for the primary BCTQ outcome are not reported in the registry record. There is no reported mean change, dispersion, confidence interval, or outcome test, and the record lists 0 outcome analyses. The secondary blood-marker outcomes are likewise described without numerical results.

The registered single-group design has no separate comparator. It can support description of outcomes over time among participants with measurements, but it cannot by itself distinguish intervention effects from other influences over time. The masking field is listed as none, and allocation is listed as NA; the record does not describe additional measures that might address expectations or other sources of bias.

Further limitations arise from unreported methods. The registry record does not describe a trial-specific sample-size justification, the statistical analysis plan, missing-data methods, analysis populations, or multiplicity handling. It also does not report the dose or route of Fisetin, outcome completion by assessment, or the numerical results for the secondary measures. These details are not reported in the registry record and cannot be inferred from the enrollment count or study status.

The safety counts are limited to the categories recorded: serious adverse events and other adverse events. No serious event terms are listed, and the types and circumstances of other events are not given. Without a comparator or event-level information, the counts cannot establish causality or comparative safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study of Fisetin to Treat Carpal Tunnel Syndrome — NCT05416515.
• Registry record last updated 2025-12-24; status last verified 2025-12.
• Results first posted 2025-12-24.
• 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.

19. Record Summary

NCT05416515 is a completed phase 2, single-group study of Fisetin for carpal tunnel syndrome, with enrollment of 40 and no separate comparator group listed. The primary outcome is change in BCTQ score from baseline to 60 days. Two secondary outcome descriptions concern blood markers of cellular senescence. The registry lists 0 outcome analyses and does not report numerical results for these outcomes.

The record lists 0 serious adverse events among 40 participants at risk and 15 participants with other adverse events among 40 at risk. No serious adverse event terms are listed. The registry does not report the primary outcome estimate, its precision, missing-data methods, analysis populations, or the statistical analysis plan. Accordingly, the record describes the trial and its posted safety counts but does not provide a numerical estimate of the primary outcome change.