Pain and Sensory Changes Assessment in HIV+ Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pain and Sensory Changes Assessment in HIV+ Patients (NCT00422695), a registered phase not stated study. The primary outcome is Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome.

2. Clinical Question

3. Trial Design

The registry record describes a completed assessment study titled “Pain and Sensory Changes Assessment in HIV+ Patients.” The sponsor is the University of Medicine and Dentistry of New Jersey. The study start is recorded as 2007-01, and primary completion as 2008-02. Enrollment is listed as 143. The record does not explain how enrollment was determined or provide a sample-size justification.

The group descriptions identify HIV-positive participants, divided according to CD4 counts, and healthy controls described as HIV-negative subjects. The record does not state that participants were randomly assigned; the allocation method is not reported in the registry record. These groups are not a like-for-like randomized control comparison. Differences between groups could reflect differences in characteristics other than HIV status, and the record does not describe an adjustment strategy that would address such differences.

The planned work includes routine dental clinical assessment and Quantitative Sensory Testing. The registry says testing was performed during a regular clinical visit and took about an hour. Its stated aims also include assessing psychological condition and nutrition status among people with HIV and examining associations between inherited traits and neuropathic pain. The record does not describe the detailed procedures, recruitment setting, eligibility criteria, or timing of each assessment beyond the stated visit timeframe.

The study status is COMPLETED, but completion does not establish that all planned analyses or outcomes are reported. The primary outcome is named, yet its group counts and comparative estimates are not reported in the registry record. The registry record lists 2 outcome measures and 2 analyses, but does not give enough detail to determine how each analysis maps to the outcomes.

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

Analysis population for the primary outcome, as defined in the registry: Comparisons of categorical variables were performed with Fischer's exact test. Trends in ordered categorical variables were tested with the chi square test.

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 Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome, measured over Tests were performed during regular clinical visit. The test duration was about an hour.

The primary endpoint is titled “Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome.” It is a count-based endpoint: the intended measure is how many participants meet the criteria for the named pain conditions. The registry gives the unit as participants and the parameter as NUMBER. The title’s spelling of “Disoder” is retained only when quoting it; TMJ disorder is used in the description.

A count of participants meeting a condition can describe how frequently that condition was identified in the assessed group. When group-specific counts and denominators are available, categorical methods can be used to examine whether the observed distributions differ. Such a comparison does not by itself establish that group membership caused a difference, particularly when allocation is not randomized.

The endpoint is relevant to the stated aim of investigating orofacial pain in people with HIV during routine dental clinical assessment. The record also describes sensory testing and broader aims, but those aims should not be mistaken for the primary endpoint. It does not provide diagnostic criteria, thresholds, or details on how chronic myogenic pain, TMJ disorder, or Burning Mouth Syndrome were classified. Most importantly, endpoint counts and any comparison between the HIV-positive group and healthy controls are not reported in the registry record. The measure therefore cannot be interpreted as evidence about the prevalence or relative frequency of these conditions from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record states that comparisons of categorical variables were performed with Fischer's exact test and that trends in ordered categorical variables were tested with the chi square test. It does not provide the analysis results or enough information to reproduce them. The distinctions below explain these methods generally; they do not imply that any particular result was found in this study.

Why use a categorical test?

A categorical variable records membership in a group or category rather than a measured quantity on a continuous scale. The primary endpoint is expressed as the number of participants with named pain conditions, so a comparison of condition status across groups is categorical in form. For such data, an analysis typically compares the observed category counts with the pattern expected under a null hypothesis of no association. The registry’s method description does not state the exact contingency tables, category definitions, or null hypotheses used for each analysis.

What does Fischer's exact test assess?

In general, Fischer's exact test evaluates whether categorical distributions are associated, using the observed margins of a contingency table to calculate the probability of results at least as incompatible with the null hypothesis as those observed. It is often useful when cell counts are small, because it does not rely on the same large-sample approximation used by a chi-square test. A p-value from such a test, if reported, would describe compatibility of the observed data with a specified null model; it would not measure the size or importance of an association. The registry record does not report a p-value for the primary outcome.

What does a chi-square trend test assess?

In general, a test for trend can be used when categories have a meaningful order. It asks whether the observed pattern changes systematically across that order, rather than treating all categories as unrelated labels. The record says trends in ordered categorical variables were tested with the chi square test, but does not identify the ordered variables, their categories, or the trend results. CD4 counts are mentioned in the description of the HIV-positive group, but the record does not specify how they were categorized for analysis or whether they were included in a trend test.

What can the methods tell the reader?

A named test identifies an analysis approach, not its result. Interpretation also depends on the outcome definition, the counts entering the analysis, how missing observations were handled, and whether the analysis population was defined in advance. Those details are not reported in the registry record. The lack of group-specific endpoint counts also prevents readers from checking the test calculation or judging the scale of any difference.

Statistical significance and effect size answer different questions. A p-value does not communicate the magnitude of a difference; an effect estimate and its confidence interval are needed to describe the direction, size, and precision of a comparison. In general, a confidence interval gives a range of effect values reasonably compatible with the data and the analysis assumptions. A narrow interval indicates greater precision than a wide interval, but neither guarantees that the endpoint was measured without bias. No effect estimate or confidence interval for the primary endpoint is reported in the registry record.

The record also describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. It characterizes this as an illustration rather than the study’s own design. Such calculations are planning scenarios, not observed power and not evidence that the study was designed around a particular target. The registry record does not report a prospective sample-size justification or enough outcome results to assess the assumptions behind the illustration.

In general, over-dispersion matters when count data vary more than the statistical model expects: standard errors can then be too small, making intervals too narrow and tests too optimistic. That issue cannot be evaluated from this record because the primary outcome counts and any count-model specification are not reported. The listed categorical tests do not, by themselves, document how sensory measurements or any other continuous data were analyzed. Methods for those outcomes are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The study description contains several aims: assessing orofacial pain, characterizing sensory phenotype, examining psychological condition and nutrition status, and exploring inherited traits in relation to neuropathic pain. The registry record lists 2 outcome measures and 2 analyses, but does not report a complete mapping of outcomes to analyses or identify which outcomes were primary or secondary beyond the named primary endpoint.

When researchers examine multiple outcomes or conduct multiple tests, the chance of at least one apparently unusual result can increase. In general, a statistical plan may address this issue by defining a primary comparison in advance, adjusting inference across selected tests, or treating additional analyses as exploratory. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or whether any adjustment was applied. It is therefore not possible to tell how the analyses were prioritized or how to interpret any unreported collection of tests.

Handling of missing data is also not reported in the registry record. The record does not say how many observations were missing for the primary outcome or other measures, why data might be missing, whether participants with incomplete assessments were excluded, or whether any imputation was used. Missingness can affect both the estimated group pattern and the interpretation of a comparison, especially if the likelihood of missing data differs between groups or relates to pain status.

The analysis populations are not defined beyond the group descriptions. The record does not state whether all enrolled participants were included in each analysis, whether exclusions occurred, or how participants were classified if outcome information was incomplete. It also does not give a prespecified statistical analysis plan or interim-analysis information; these details are not reported in the registry record. Without those details and the endpoint results, readers cannot assess whether analyses followed a plan established before results were known.

11. Safety Results

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

Other (non-serious) adverse events

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

The adverse-event record lists the HIV-positive group with 105 participants at risk and the healthy-control group with 38 at risk. It reports 0 serious adverse events and 0 other adverse events in each group. No serious adverse-event terms are listed. These are the figures recorded for the adverse-event categories; they are separate from the primary pain endpoint, for which results are not reported in the registry record.

A recorded count of 0 means that no events were entered in that category for the group in this record. It does not establish that no symptoms or health events occurred outside the reporting definitions or observation procedures. The registry record does not describe the event definitions, the method of collecting adverse events, or the period over which they were monitored. It also does not report death counts; those values are not reported in the registry record, rather than being presented as zero.

These safety figures should be read descriptively. They do not compare treatment effects, since the study is not described as a randomized treatment comparison. Nor do the zero counts establish that the assessments themselves had no risks. The available safety record supports only the narrow statement that the listed serious and other adverse-event counts are 0 for both groups.

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

The study record addresses a relevant descriptive question: whether orofacial pain and sensory changes are present among people with HIV assessed in a dental clinical setting, and how those findings might be characterized alongside healthy controls. It describes routine dental assessment and Quantitative Sensory Testing as part of the planned work. The named primary endpoint concerns the number of participants with chronic myogenic pain, TMJ disorder, and Burning Mouth Syndrome.

However, the registry record does not report the primary endpoint counts, a group comparison, or estimates of precision. It therefore cannot show how common the named conditions were in the assessed groups or whether their recorded frequency differed. It also cannot establish that the groups were similar: missing results are not equivalent to evidence of no difference. The broader study aims likewise do not establish findings about sensory aberrations, nerve types, pain classification, psychological condition, nutrition status, or inherited traits.

Even if group-specific results were available, the comparison would require caution because allocation is not stated and the groups are not described as randomized. Differences between the groups could reflect characteristics other than HIV status. A cross-group association would not, on its own, demonstrate that HIV status caused a pain or sensory outcome. The record does not report an adjustment approach that would support a stronger causal interpretation.

The posted adverse-event counts are 0 for serious events and 0 for other events in each group, but those counts do not answer the primary pain question. The record does not provide event definitions or monitoring details, and it does not report death counts.

In general, a clinical result is most informative when the outcome definition, group counts, effect estimate, uncertainty interval, analysis population, and handling of missing data can be evaluated together. Several of these elements are not reported in the registry record. The defensible interpretation is therefore about the study’s stated objectives and documented methods, not about an unreported clinical result.

13. Why This Trial Matters Statistically

This study is statistically notable for bringing together a count-based clinical outcome and a broader sensory-assessment question. Its aims include routine assessment of orofacial pain and Quantitative Sensory Testing, alongside questions about psychological condition, nutrition status, and inherited traits. Such a combination illustrates why a registry record needs to distinguish a primary endpoint from additional objectives: each may require a different definition, analysis, and interpretation.

The record also illustrates the importance of reporting observed data, not only naming an endpoint or test. Fischer's exact test and a chi square test for trends are identified, but the primary outcome counts, effect estimate, confidence interval, and p-value are not reported in the registry record. Without those results, readers cannot assess the magnitude or precision of the primary comparison or reproduce its analysis.

Group structure matters as well. The record identifies people with HIV and healthy controls, but does not state that allocation was randomized. This limits how strongly a difference, if one were reported, could be attributed to HIV status. Describing how groups were formed and which characteristics were considered in analysis is essential to interpreting observational comparisons.

Finally, the record shows why missingness and multiplicity need explicit documentation. Multiple aims can produce multiple outcomes and analyses, while incomplete assessments can affect which participants contribute to each result. The registry record does not describe a multiplicity strategy, missing-data handling, or analysis populations. These omissions do not negate the study’s purpose, but they constrain what can be learned statistically from its posted information.

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 most direct limitation is that the registry record names the primary endpoint but does not report its observed counts or comparative results. Without those values, readers cannot estimate the frequency of the named conditions, evaluate a group difference, or assess its precision. The record also does not report diagnostic criteria or classification thresholds for chronic myogenic pain, TMJ disorder, or Burning Mouth Syndrome.

The group descriptions are limited. The HIV-positive group is said to be divided according to CD4 counts, but the categories and their membership are not reported. The healthy controls are described as HIV-negative subjects, but eligibility criteria and recruitment procedures are not reported in the registry record. Allocation is not stated, so the groups should not be interpreted as randomized or necessarily comparable on other characteristics.

The planned assessment includes Quantitative Sensory Testing, but the registry does not report detailed procedures, assessor methods, or results for sensory outcomes. The record also does not explain how psychological condition, nutrition status, or inherited traits were measured or analyzed. Methods for dealing with missing data, the analysis populations, and any multiplicity strategy are not reported in the registry record.

The registry gives enrollment of 143 and adverse-event counts, but enrollment alone does not establish that all enrolled participants contributed data to each endpoint. It does not report endpoint-specific denominators or participant flow. The adverse-event record does not give event definitions or monitoring procedures, and death counts are not reported. These omissions limit interpretation of both the clinical outcome and the safety record.

Finally, the stated timeframe describes testing during a regular clinical visit lasting about an hour, but it does not provide a broader follow-up schedule. The record does not report whether assessment findings were confirmed at another time. These limitations restrict conclusions to the documented study aims, methods, and recorded adverse-event counts.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Pain and Sensory Changes Assessment in HIV+ Patients — NCT00422695.
• Registry record last updated 2017-04-13; status last verified 2017-01.
• Results first posted 2017-04-13.
• 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 study of orofacial pain and sensory changes in people with HIV and healthy controls, sponsored by the University of Medicine and Dentistry of New Jersey. The recorded start is 2007-01, primary completion is 2008-02, and enrollment is 143. The HIV-positive group is described as divided according to CD4 counts; the controls are described as HIV-negative subjects.

The named primary endpoint counts participants with chronic myogenic pain, TMJ disorder, and Burning Mouth Syndrome. The record describes Fischer's exact test for categorical comparisons and a chi square test for trends in ordered categorical variables. It does not report primary endpoint counts, comparative estimates, confidence intervals, or p-values. The adverse-event counts are 0 serious events and 0 other events in each group; death counts are not reported in the registry record. Allocation, missing-data handling, analysis populations, and multiplicity procedures are not reported.