Pain in Traumatic Brain Injury - Basile, MD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pain in Traumatic Brain Injury - Basile, MD (NCT01136486), a registered phase not stated study. The primary outcome is Assessment of Pain Severity.

2. Clinical Question

3. Trial Design

This is an observational study, not a randomized trial. The registry describes chart review concerning persistent pain, neuropsychological functioning, and community integration after traumatic brain injury. Participants were seen at one time point, when they were referred to the neuropsychology service. The primary measure, pain severity, is specified for that referral time point.

The registry lists an enrollment of 56 and the condition Head Trauma. The study is associated with Northwell Health. Its recorded start is 2003-04, its primary completion is 2009-12, and its status is TERMINATED. These administrative details do not establish when each participant was assessed or how long the chart-review period covered; those details are not reported in the registry record.

No assigned treatment or randomized allocation is described. Allocation is listed as not stated, and the registry cautions that the arms are not a like-for-like control comparison. The record names a grouping concerning severity of pain by severity of injury, but does not describe the group definitions or provide an analysis of that grouping. It therefore cannot support a causal treatment comparison or a clear between-group interpretation.

The record lists one outcome measure and zero analyses. It does not report the statistical plan, an analysis population, the number of participants with recorded pain assessments, or results for the primary measure. The listed enrollment should not be taken as evidence that every enrolled participant contributed to an endpoint analysis. These features make the registry entry most useful for identifying the study question and measurement timing, rather than for evaluating a reported statistical result.

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 Assessment of Pain Severity, measured over Referral.

The primary endpoint is titled Assessment of Pain Severity. It is a continuous measure summarized using a mean and standard deviation, with the unit described as units on a scale. The scale is defined as 1 for no pain and 10 for severe pain. Assessment took place at referral to the neuropsychology service, the single time point at which participants were seen according to the registry description.

The measure is relevant to the study’s focus on persistent pain after traumatic brain injury: a pain-severity score can describe the reported intensity of pain at the assessment. A mean can summarize the center of the recorded scores, while a standard deviation describes their spread around that mean. These summaries do not, by themselves, show how pain relates to neuropsychological functioning or community integration. Such a relationship would require suitable measurements and a reported analysis, neither of which is presented as a result in the registry record.

The record gives no observed mean, standard deviation, confidence interval, or other endpoint result. It also does not report information about scale administration beyond the stated range and referral timing. Consequently, the endpoint’s intended measurement is identifiable, but its observed distribution and precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous primary measure, summarized as a mean and standard deviation. It also identifies the study as observational, describes chart review, and states that participants were seen at one time point at referral. The statistical meaning of these choices can be explained, but the record does not report the detailed analysis plan or any completed analysis results.

What does a mean describe?

In general, the mean is an average that summarizes the center of a set of numerical observations. For pain scores on the stated scale, it would provide a single summary of the recorded scores at referral. That summary does not show whether scores cluster closely around the mean or are spread across the scale. It may also conceal differences between subgroups or an uneven distribution of scores. No observed mean is reported in the registry record.

What does the standard deviation describe?

In general, the standard deviation describes how dispersed observations are around their mean. A smaller standard deviation indicates that observations lie more closely together, while a larger one indicates more spread. It is not the same as the uncertainty in the estimated mean: uncertainty depends on factors including the amount of usable data and the variability of the observations. The record specifies standard deviation as the dispersion measure but reports no value for it. The number of participants with endpoint data is also not reported in the registry record.

What can a one-time assessment establish?

A measurement at one time point can describe the recorded status at that assessment. It cannot, by itself, describe change over time. Here, the specified assessment was at referral to the neuropsychology service. The registry does not describe repeated pain assessments or a follow-up endpoint. A single assessment also cannot establish whether pain preceded, followed, or changed alongside neuropsychological functioning or community integration. The record’s topic raises those relationships, but their analysis is not reported.

How should group comparisons be understood?

In general, a comparison between groups requires a clear definition of each group, an outcome summary for each group, and an analysis that accounts for the design and data. The registry names a grouping by pain severity and injury severity, but does not report group definitions, group-specific results, or an analysis. It states that allocation was not given and that the arms are not a like-for-like control comparison. As a result, the record does not support interpreting a group contrast as a randomized comparison or as a causal effect.

For observational data, differences between groups may reflect differences in their characteristics as well as the grouping of interest. Statistical adjustment can sometimes address measured differences, but it cannot automatically remove bias from unmeasured factors. Whether adjustment was planned or performed is not reported in the registry record. No adjusted or unadjusted estimates are reported.

What do confidence intervals and tests contribute?

In general, a confidence interval communicates uncertainty around an estimated quantity under the assumptions of a statistical method. A narrow interval indicates greater precision than a wide interval, though precision does not establish that an estimate is unbiased or important. A hypothesis test and its p-value address compatibility with a specified null hypothesis under the model; neither substitutes for an estimate and its uncertainty. The registry reports no confidence interval, hypothesis test, or p-value for the primary endpoint, so these aspects of the evidence cannot be assessed.

What do the planning assumptions mean?

The registry describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. For non-time-to-event outcomes, the planning quantity is participants per arm for a chosen power level; time-to-event calculations instead use a total number of events. These are planning assumptions, not results about participants in the study. No observed effect or sample-size illustration values are reported in the registry record, so no planning figure can be interpreted from this entry. A planning calculation is not observed power, and it does not establish that the study was designed to detect a particular effect.

The registry does not report the statistical model, data-handling rules, treatment of missing scores, or a detailed prespecified analysis plan. These omissions limit reproducibility: readers cannot determine exactly how the investigators intended to summarize or compare the observations. The listed endpoint type and summary statistics identify a broad approach, not the complete statistical method.

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("Severity of Pain by Severity of Injury")
n   <- c(56)
m   <- c(7)
sp  <- c(1.4)
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  Severity of Pain by Severity of Injury  56  7.000  1.400  6.625  7.375

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure, Assessment of Pain Severity, and zero analyses. It does not report a multiplicity strategy. With only one listed measure, the record does not identify a family of reported endpoint tests for which an adjustment can be evaluated. The absence of reported analyses also means there are no posted p-values or confidence intervals to assess for selective reporting or multiplicity.

Missing-data handling is not reported in the registry record. It does not state how many of the 56 enrolled participants had an available pain score, whether any records were incomplete, or how missing observations were handled. Enrollment is not the same as the endpoint analysis sample. Without the number and pattern of available observations, readers cannot assess whether the recorded endpoint data represent all enrolled participants or whether missingness could affect the summaries.

The analysis population is not reported in the registry record. There is no description of eligibility for the endpoint analysis or of exclusions from any analysis set. The record also does not provide a participant flow for the chart review. The study’s observational design does not make these details unnecessary: knowing which records contributed to a summary is important for understanding its scope.

The registry does not report a statistical analysis plan, whether the endpoint or analyses were prespecified, or any interim analyses. These details should not be inferred from the study title, the one listed outcome, or the TERMINATED status. Without them, the record supports a description of the planned measurement but not a full evaluation of analysis choices, missing data, or multiplicity.

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

The registry record establishes that the study concerned persistent pain and neuropsychological functioning after traumatic brain injury, and that pain severity was specified as the primary measure at referral to a neuropsychology service. It defines the score range from 1 for no pain to 10 for severe pain and identifies the mean and standard deviation as the intended summary. Those details explain what investigators intended to measure and when.

They do not establish what pain scores participants actually recorded. The primary endpoint’s observed mean and standard deviation are not reported in the registry record. Nor are there reported results linking pain severity to neuropsychological functioning or community integration. The record therefore cannot show the direction, magnitude, or precision of such a relationship.

The observational design also limits what any association could establish. In general, an observed relationship between two measures does not by itself establish that one caused the other. The registry describes one assessment time point and does not report a randomized intervention or a like-for-like control comparison. It explicitly notes that allocation was not stated and that the arms are not a like-for-like control comparison. The listed grouping by pain and injury severity is not accompanied by definitions or an analysis.

These limits do not mean that there was no pain, no association, or no difference. They mean that the registry record does not report evidence that would support those conclusions. The enrollment of 56 is a study-level detail, not an endpoint result, and the status TERMINATED does not explain the study’s findings or reason for termination.

In practical terms, the registry can inform readers about the study’s subject, design description, and intended outcome measurement. It cannot be used to estimate the prevalence or severity distribution of pain in the enrolled participants, quantify an association, or assess statistical significance. Any such conclusion would require results not reported in the registry record.

13. Why This Trial Matters Statistically

This study is statistically relevant because its stated subject spans pain, neuropsychological functioning, and community integration, while its recorded primary endpoint is a single continuous pain-severity measure at referral. That distinction matters: a clearly defined measurement is only one part of answering a research question. Results and an analysis connecting the measurement to the broader outcomes are also needed to evaluate the question.

The observational chart-review design is another important feature. Such a design can describe information recorded in clinical records, but the interpretation depends on how participants and measures were defined and how available data were analyzed. A one-time assessment can characterize scores at referral; it does not show change over time. A group label or association, if reported, would not by itself establish a causal relationship.

The registry record also illustrates why enrollment and analysis counts should not be treated as interchangeable. Enrollment is listed as 56, but the number of participants with usable primary-outcome data is not reported. The record lists one outcome measure and zero analyses, so readers do not receive endpoint estimates or measures of uncertainty. Without those, there is no basis for judging precision or for distinguishing a small estimated association from an imprecise one.

Finally, a study’s stated topic and administrative status are not substitutes for results. The title and summary describe the intended area of inquiry, while the status is TERMINATED. Neither indicates whether the primary measure was high or low, whether relationships were found, or why the study ended. Clear reporting of analysis populations, outcome summaries, uncertainty, and planned methods would be necessary for statistical interpretation beyond the study description recorded.

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 registry entry gives limited detail about how the chart review was conducted. It does not report the source records, the period covered by the review, inclusion or exclusion criteria, or how traumatic brain injury and persistent pain were defined. Without those details, readers cannot determine precisely which records were eligible or how well the enrolled group represents the population of interest.

The timing information is broad. The primary measure is specified at referral, and participants are described as seen at one time point, but the record does not report when individual assessments occurred or how long symptoms had been present. It does not report repeated measurements. Thus, the specified endpoint describes a single assessment rather than a documented trajectory of pain severity.

The scale is described as ranging from 1 for no pain to 10 for severe pain, but further details about how scores were elicited, recorded, or checked are not reported in the registry record. There is also no endpoint result, group-specific summary, or analysis. The listed sample enrollment cannot resolve these gaps: the number with completed endpoint data and the characteristics of any missing records are unknown.

The study’s observational design and the lack of a like-for-like control comparison constrain interpretation of group differences. The registry does not define the injury-severity groups or report which factors were considered in any analysis. Whether confounding, selection, or measurement issues were evaluated is not reported in the registry record. These are limitations of what can be learned from the registry entry; they do not establish that any particular bias occurred.

Finally, the status TERMINATED is recorded, but the reason for termination and whether it affected data collection or analysis are not reported. No statistical plan, analysis population, missing-data approach, or endpoint findings are available in the entry. These omissions prevent a detailed appraisal of the study’s execution and the reliability of any proposed relationship among pain, functioning, and community integration.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Pain in Traumatic Brain Injury - Basile, MD — NCT01136486.
• Registry record last updated 2016-05-24; status last verified 2016-05.
• Results first posted 2016-05-24.
• 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.

18. Record Summary

The registry record describes an observational chart review concerning persistent pain and neuropsychological functioning after traumatic brain injury, with community integration also named in the study description. It lists Head Trauma as the condition, Northwell Health as sponsor, and enrollment of 56. The recorded start is 2003-04, primary completion is 2009-12, and status is TERMINATED.

The primary measure is Assessment of Pain Severity, a continuous score on a scale from 1 for no pain to 10 for severe pain. The intended summary is a mean and standard deviation, assessed at referral to the neuropsychology service. Participants were described as seen at one time point. The record lists one outcome measure and zero analyses.

No observed endpoint summary, association analysis, missing-data handling, or analysis population is reported in the registry record. Allocation is not stated, and the registry notes that the arms are not a like-for-like control comparison. The entry therefore describes the study question and measurement but does not provide results from which to assess the primary outcome or its relationship to functioning or community integration.