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 Chest Pain Perception and Capsaicin Sensitivity (NCT02346903), a na na study. The primary outcome is Capsaicin Sensitivity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02346903 |
| Phase | NA |
| Condition | Chest Pain |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 99 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bassett Healthcare |
| Results posted | Yes |
2. Clinical Question
Population
People undergoing clinical elective balloon angioplasty of a coronary stenosis were the intended participants. The registry reports enrollment of 99, but the number with both pain assessments available is not reported in the registry record. Further eligibility details are not reported in the registry record.
Intervention
The study included topical application of a capsaicin-containing cream to the forearm. The stated purpose was to measure sensitivity to capsaicin by asking participants to rate the intensity of cutaneous discomfort. The registry describes an application of Capzasin-HP Cream (0.1%) to the non-dominant forearm.
Comparator
There was no separate control group or randomized treatment comparison. The registry identifies a single-group model and no allocation. The central comparison is between two measurements in the same participant: chest pain during a coronary balloon occlusion and discomfort following topical capsaicin application.
Primary question
The study asks whether people who report greater chest pain during a standardized episode of myocardial ischemia also report greater discomfort from topical capsaicin. This is an association question, not a question about whether capsaicin changes chest pain or whether either measure causes the other. The registry record does not report an estimated association or a test of this question.
The proposed clinical interest is whether a cutaneous response could be related to a person's perception of ischemic chest pain. The registry describes a one-minute coronary balloon occlusion during angioplasty, with chest pain rated using a previously validated numeric rating scale. It then describes a capsaicin cream application and a rating of the resulting discomfort. The aim is to compare subjective pain measures, not to compare randomized treatments or evaluate a clinical outcome over follow-up. The actual chest pain score results, capsaicin scores, and any association between them are not reported in the registry record. Consequently, the clinical question is identifiable from the protocol description, but its answer cannot be determined from the posted record.
3. Trial Design
This is a completed, single-group study sponsored by Bassett Healthcare. The registry lists enrollment of 99 and identifies the condition as chest pain. The listed phase and allocation are NA, and masking is listed as none. Those design details mean that the record does not describe a randomized, masked comparison between treatment arms. Instead, participants were to undergo the capsaicin assessment and have chest pain perception assessed during coronary balloon occlusion as part of elective angioplasty.
The registry gives a start date of 2013-04 and a primary completion date of 2015-08. The study status is completed. These dates describe the recorded study timeline; they do not establish when analyses were completed or when results became available. The registry record does not report a detailed protocol, recruitment flow, or the number of participants who completed each assessment.
The procedural description places the chest pain rating during a standardized one-minute coronary balloon occlusion. The primary outcome is capsaicin sensitivity, described as a discomfort score on a scale; the assessment timeframe is 30 minutes. A secondary outcome is listed as chest pain score during PCI. The registry’s arm description is truncated, so further procedural detail beyond the stated application cannot be established from the record.
Because both pain measures concern the same participant, the intended statistical question concerns whether the two scores vary together. This differs from an intervention trial asking whether one treatment produces a different outcome from a control treatment. The single-group design has no separate comparator arm, and it cannot by itself isolate the effect of capsaicin application from other influences on reported discomfort. Detailed eligibility criteria, the analysis population, missing-data procedures, and the prespecified statistical analysis are not reported in the registry record. Although the status is completed, no outcome estimates or analysis results are posted.
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 | Cardiac Catheterization Patients |
|---|---|
| STARTED | 99 |
| COMPLETED | 99 |
| NOT COMPLETED | 0 |
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 | Cardiac Catheterization Patients |
|---|---|---|
| Participants analysed | 99 | |
| Age, Continuous | Years | 64.80 (SD 8.38) |
| Sex: Female, Male: Female | Participants | 24 |
| Sex: Female, Male: Male | Participants | 75 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 99 |
6. Primary Endpoint
The registry lists the primary outcome as Capsaicin Sensitivity, measured over 30 minutes.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is capsaicin sensitivity, measured as a participant’s rating of cutaneous discomfort at the application site. The registry describes a 10 point numerical rating scale running from 0, “no discomfort,” to 10, “the worst discomfort imaginable.” It identifies the endpoint as a mean of a continuous measure, with standard deviation as the planned measure of dispersion, and gives a timeframe of 30 minutes.
A numerical rating scale turns a subjective experience into a score that can be compared across participants and related to another reported measure. In general, a mean describes the average score in a group, while a standard deviation describes how much individual scores vary around that average. The registry record does not report the observed mean or standard deviation, nor does it state whether the endpoint was analyzed using the full scale or another scoring approach.
The reason for collecting this endpoint is to assess whether cutaneous response to capsaicin is associated with chest pain perception during balloon occlusion. The capsaicin score is therefore one part of a paired-assessment question; it is not itself a measurement of myocardial ischemia. No endpoint result or estimate of its relationship with chest pain is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a study designed to examine an association between cutaneous capsaicin discomfort and chest pain reported during coronary balloon occlusion. It does not report the observed capsaicin scores, observed chest pain scores, or any estimate of the association. It also lists zero analyses. Therefore, the record establishes what investigators intended to measure, but it does not provide statistical evidence with which to judge the stated association.
The enrolled population is reported as 99, but the number contributing to either outcome analysis is not reported in the registry record. Enrollment should not be treated as proof that all participants completed both assessments or were included in an analysis. Without an analyzed sample size and summary results, readers cannot assess the precision of an estimate, the extent of variation among participants, or whether the observed pattern was consistent across participants.
In general, an association estimate would describe how the two scores relate across participants. Its direction would indicate whether higher scores on one measure tend to accompany higher or lower scores on the other; its magnitude would describe the strength of that pattern under the chosen statistical measure. A confidence interval, if reported, would show the range of values compatible with the data under the analysis assumptions and would convey precision. Neither an association estimate nor a confidence interval is reported in the registry record. A p-value or other inferential result is also not reported.
The single-group design is appropriate to describe paired measurements but does not create a randomized comparison. Any observed association would not, by itself, show that capsaicin sensitivity causes a difference in chest pain perception, or that changing the capsaicin response would change chest pain. Both scores are subjective ratings and may share influences unrelated to a direct biological relationship. The posted record does not describe how such influences were measured or addressed.
The study status is completed, but completion is not equivalent to a posted analysis. The record identifies no analysis results and does not provide information about missing observations, exclusions, or the population used for analysis. As a result, neither a positive nor a null association can be inferred from the registry entry. The appropriate statistical reading is that the research question and intended endpoints are described, while the evidence needed to answer that question is not reported in the registry record.
9. Statistical Methods Explained
What kind of comparison was intended?
This is a single-group study with paired measurements rather than a randomized comparison between groups. Each participant was intended to provide a chest pain rating during a coronary balloon occlusion and a cutaneous discomfort rating after capsaicin application. In general, paired data retain the connection between observations from the same individual. An analysis can then ask whether participants with higher values on one measure tend to have higher or lower values on the other.
The record does not identify the statistical measure used to quantify that relationship. A correlation coefficient is one general way to describe the direction and strength of a linear association between two quantitative measures. Other measures may be appropriate depending on the score distributions and analysis objectives. Which measure, model, or test was prespecified is not reported in the registry record. No analysis is posted, so no method can be matched to a reported result.
What do a mean and standard deviation describe?
The primary outcome is specified as a mean of a continuous measure, with standard deviation as its dispersion measure. In general, the mean gives a location summary: it represents the arithmetic average of the included scores. The standard deviation expresses the degree to which individual scores vary around that average. These summaries answer different questions. A mean does not indicate whether responses are tightly clustered or widely spread, while a standard deviation does not tell the reader where the average score lies.
The endpoint uses a bounded numerical rating scale from 0 to 10. A mean can be a useful summary, but it may not fully describe a distribution, especially if ratings cluster near a scale boundary or take only a limited set of values. In general, inspecting the distribution and considering whether the assumptions of an analysis fit the outcome are important. The registry record does not report score distributions, observed summary statistics, or a rationale for a particular analysis.
How should uncertainty be assessed?
In general, a confidence interval communicates uncertainty around an estimated quantity. Its width reflects statistical precision under the analysis assumptions; it does not guarantee that the assumptions are correct or that the estimate applies to other populations. A p-value, when used, addresses compatibility of the data with a specified null hypothesis under a statistical model. It does not measure the size or clinical importance of an association. The registry record does not report a confidence interval, p-value, or other uncertainty measure for the primary outcome or the association question.
The enrollment count alone cannot supply that missing precision information. The number of participants with paired measurements, the variability in those measurements, and the selected statistical method all matter to an association estimate. The analysis population and the number with complete measurements are not reported in the registry record. No estimate should be reconstructed from enrollment alone.
What does the record say about sample-size planning?
In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability, significance level, power, and analysis design. It is not a description of observed evidence. The registry record does not report the study’s own sample-size justification or planned target effect. No numerical planning illustrations are available in the record for interpretation. Thus, there is no basis to characterize enrollment as adequate or inadequate for detecting the intended association, and no observed-power claim can be made.
A planning illustration based on an observed effect, if available elsewhere, would not establish that the study was designed around that effect. It would also not be a substitute for an estimate and confidence interval. Here, the registry does not post a numerical effect estimate to interpret, and the details of any prespecified sample-size plan are not reported in the registry record.
What can be concluded from an association?
In general, association is not causation. Even if two ratings were correlated, that pattern could reflect shared influences, measurement characteristics, or features of the study population. A single-group association study does not randomize participants to different levels of capsaicin sensitivity, and it does not establish that one subjective response produces the other. The registry’s stated goal is to determine whether an association can be demonstrated; it does not establish a causal effect.
Subjective scales also depend on how participants interpret and use response categories. The chest pain scale is described as previously validated, while the capsaicin outcome is described as a numerical rating scale. The record does not report validation details for the capsaicin measure, reliability estimates, or procedures to harmonize the two ratings. The scales assess different experiences, so a relationship between their scores would need to be interpreted as a relationship between those measured responses, rather than as proof that the experiences are interchangeable.
The registry does not report an analysis plan, distributional checks, adjustment variables, missing-data methods, or sensitivity analyses. These omissions limit reproducibility and make it impossible to assess whether the intended analysis accounted for features of the paired scores. Since no analysis results are posted, the methods discussion remains general: the intended design supports an association question, but the statistical answer and its precision are not reported in the registry record.
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.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| Cardiac Catheterization Patients | 98 | 2.470 | 2.150 | 2.039 to 2.901 |
R code and output
arm <- c("Cardiac Catheterization Patients")
n <- c(98)
m <- c(2.47)
sp <- c(2.15)
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 Cardiac Catheterization Patients 98 2.470 2.150 2.039 2.90111. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome of capsaicin sensitivity and a secondary outcome of chest pain score during PCI. It also describes an overarching aim to examine an association between these measures. However, the relationship between the listed outcomes and the association analysis is not detailed. The statistical analysis plan, including any control for multiple comparisons or selection among analyses, is not reported in the registry record. The record lists zero analyses, so there are no posted estimates or tests from which to assess multiplicity in practice.
Missing-data information is also not reported in the registry record. The enrollment count is 99, but the record does not state how many participants provided each rating, how many had paired observations, or whether any participants were excluded. It does not describe reasons for missing measurements or any imputation, complete-case, or sensitivity-analysis approach. These details matter because an association analysis depends on having usable measurements for both variables, and the analyzed participants may differ from those enrolled.
The analysis population is not reported in the registry record. It is therefore not possible to determine whether reported results, if any, would be based on all enrolled participants, participants completing both procedures, or another defined group. No outcome estimates are posted, so the effects of missingness and analytic selection cannot be evaluated. The completed status does not resolve these reporting gaps.
12. 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 |
|---|---|---|---|
| Cardiac Catheterization Patients | 0 | 99 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cardiac Catheterization Patients | 0 of 99 |
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 |
|---|---|
| Cardiac Catheterization Patients | 0 of 99 |
The registry reports that 99 participants were at risk for serious adverse events and that 0 were affected. It also reports 99 at risk for other adverse events and 0 affected. Deaths are reported as 0. These are the safety counts recorded for the listed cardiac catheterization patient group.
These figures are counts, not estimates of how likely an event would be in another population or setting. A report of 0 affected participants means that no events are recorded in these fields; it does not demonstrate that the risk is absent. Interpretation also depends on how events were defined, collected, and followed. The registry record does not report further detail about safety definitions, monitoring procedures, duration of safety follow-up, or the completeness of event capture.
The zero counts should not be used to infer anything about the study’s primary association question. Safety-event reporting and the capsaicin and chest pain ratings address different outcomes. The record’s safety figures can be stated as recorded, while the limits of the available reporting remain relevant.
13. What the Result Does, and Does Not, Mean
The study’s stated question is whether capsaicin-related cutaneous discomfort is associated with reported chest pain during a standardized episode of myocardial ischemia in people undergoing elective balloon angioplasty. The registry record provides enough design information to identify the intended measurements and the type of question. It does not provide the outcome results needed to answer that question.
No capsaicin mean, standard deviation, chest pain score summary, association estimate, confidence interval, or inferential result is reported in the registry record. It is therefore not possible to say whether the posted data show a positive association, a negative association, or little association. Nor can the precision of any estimate be described. The status marked completed does not substitute for posted analyses.
Even if an association were reported, it would describe how measured ratings vary together in the analyzed participants. It would not establish that sensitivity to capsaicin causes a particular level of chest pain perception, or that the capsaicin measure can predict an individual’s response in another clinical setting. Predictive usefulness would require evidence about prediction performance and validation beyond a simple association; such evidence is not reported in the registry record.
The scale scores are subjective reports of different experiences. Any interpretation would need to consider the instruments, participant selection, measurement timing, and missing observations. The record does not provide enough information to assess those issues in detail. The most defensible conclusion is limited: this completed study was designed to examine a relationship between two pain ratings, but the posted registry record does not report the results needed to judge whether such a relationship was observed.
14. Why This Trial Matters Statistically
Statistically, this study illustrates the distinction between a study question and a study result. The registry describes a paired-measurement question: whether individual differences in capsaicin-related discomfort correspond to individual differences in chest pain perception during balloon occlusion. That is a different design and estimand from a randomized trial comparing outcomes across treatment groups. Recognizing this distinction helps prevent a single-group association from being misread as a treatment effect.
The design also highlights why summary statistics need context. A mean capsaicin score alone would describe the average response, while the association question requires information about how paired scores relate across participants. In general, the relationship depends on the joint distribution of the two measures, not just on the separate averages. The registry record does not report the joint data or a relationship estimate, so the stated aim cannot be assessed statistically from the posted information.
Precision and analysis transparency matter as much as the headline question. The registry reports enrollment of 99 but does not report the analyzed sample, missing-data handling, statistical method, or uncertainty around any estimate. These omissions prevent readers from evaluating how stable or reproducible a result might be. The record’s completed status and the presence of a planned endpoint do not supply those missing details.
Finally, the study raises a measurement issue: two subjective ratings may capture related but distinct experiences. A statistical association, if established, would need interpretation in light of the scales and the way the assessments were conducted. Because no association result is posted, the statistical importance lies in the design and in the information needed to interpret it, rather than in a numerical finding.
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 of the available registry record is the absence of outcome results. Although the study is marked completed and reports enrollment of 99, no primary or secondary outcome values are posted, and the record lists zero analyses. The intended association between capsaicin sensitivity and chest pain perception therefore cannot be evaluated.
The analysis population and the number of participants with both measurements are not reported in the registry record. Without those details, it is not possible to determine whether the enrolled participants all contributed to the intended comparison or whether missing assessments could affect the results. Reasons for missing measurements and missing-data procedures are also not reported.
The registry does not report the statistical analysis plan, the method for quantifying association, uncertainty estimates, or any adjustment strategy. The study’s own sample-size justification is not reported. This limits assessment of whether the analysis was prespecified, how precise it could be, and whether the enrollment target was tied to a defined objective.
The arm description is truncated, and full eligibility criteria and assessment procedures are not reported in the registry record. Further, the design is single-group and unmasked, with no separate randomized control group. The intended comparison is between subjective ratings collected from the same participants, so any association would not by itself demonstrate causality or show that either measure predicts clinical outcomes. The registry does not report validation or reliability information for the capsaicin rating beyond the scale description. These limitations concern what can be established from the record; they do not establish that the study procedures or analyses had any particular deficiency.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Chest Pain Perception and Capsaicin Sensitivity — NCT02346903.
- Registry record last updated 2021-03-04; status last verified 2021-02.
- Results first posted 2021-03-04.
- 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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19. Record Summary
The record describes a completed, single-group study sponsored by Bassett Healthcare, with enrollment of 99 and the condition listed as chest pain. It reports a study start of 2013-04 and primary completion of 2015-08. Participants undergoing elective balloon angioplasty were to rate chest pain during a one-minute coronary balloon occlusion and discomfort after topical capsaicin application.
The primary outcome is capsaicin sensitivity, measured on a 0 to 10 discomfort scale, with a 30 minute timeframe. A chest pain score during PCI is listed as a secondary outcome. The stated goal is to assess whether the two subjective measures are associated. No outcome estimates or statistical analyses are reported in the registry record, so the association cannot be judged from the posted results. The safety fields report 0 serious adverse events, 0 other adverse events, and 0 deaths among the listed group.