Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD (NCT01060553), a randomized na study. The primary outcome is SF-36.

2. Clinical Question

The study asked whether acupuncture could improve post-traumatic stress disorder symptoms among veterans who participated in Operations Enduring Freedom and Iraqi Freedom, and also examined veterans’ acceptance of acupuncture. The primary outcome recorded in the registry was the SF-36, which measures mental and physical health functioning. However, the registry’s primary-outcome description focuses on changes in SF-36 component scores, rather than reporting a numerical estimate of change or a direct comparison between randomized groups.

The registry does not report numerical SF-36 results, so the size and precision of any change cannot be assessed from the record. It also does not report numerical findings about acceptance or the secondary Pittsburgh Sleep Index outcome. The question that can be evaluated from the record is therefore primarily about the study’s design and what its analysis was intended to measure, rather than the magnitude of a treatment effect.

3. Trial Design

The study is listed as completed, with a start date of 2010-07 and primary completion in 2011-12. It was randomized and unmasked. Although randomization and a wait-list control are described, the registry classifies the analysis model as single-group. That distinction matters: the primary outcome description says that, because of very small numbers of completers in the acupuncture and wait-list groups, wait-list participants who completed at least 6 weeks of treatment were combined with participants initially assigned to treatment for a single-group pre/post analysis.

The acupuncture program consisted of 24 semi-individualized treatments over 12 weeks. The registry says front and back treatments were combined to avoid point fatigue, described as tolerance due to frequent use. The arm description also provides details of front treatment, including needle placement. These are descriptions of the intervention, not evidence about adherence or the amount of treatment actually received by each participant.

The study’s stated purpose included examining post-traumatic stress disorder symptoms and veterans’ acceptance of acupuncture. The primary outcome was the SF-36, while the Pittsburgh Sleep Index is listed as a secondary outcome. The registry records 2 outcome measures and 5 analyses. It does not describe the methods used for each analysis or identify which analyses were considered primary beyond naming the SF-36 primary outcome.

Because the reported primary analysis combines participants across their original assignments after treatment completion, it does not preserve the randomized wait-list comparison for that analysis. A pre/post analysis can describe change over time among those included, but by itself it cannot separate change associated with treatment from change due to other influences, including time or participant selection. The registry does not report a randomized between-group estimate for the primary outcome.

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.

Before assignment: 34 subjects were interviewed for consent. 15 were assigned to immediate treatment. 15 were assigned to wait list treatment. 2 did not meet inclusion criteria. 2 were assigned to case study.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis.

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 SF-36, measured over baseline, 6 or 12 weeks (latest available is used).

The SF-36 is a measure of health functioning. The registry identifies its Mental component (MCS) and Physical component (PCS) subscales as the primary outcome. Each subscale ranges from 0 to 100, with 100 representing better functioning; 50 is the expected population average. These reference points help explain the scale, but they do not indicate the scores observed in this study.

A continuous score can be summarized using a mean, and the registry identifies the primary outcome parameter as a mean with standard deviation as the dispersion measure. The planned observation points are baseline and 6 or 12 weeks, using the latest available measurement. This approach describes change in reported functioning over the study period, rather than the occurrence of a discrete event.

SF-36 mental and physical components capture different aspects of functioning, so they should not be treated as interchangeable measures. The registry does not report separate numerical results for MCS or PCS, nor does it state which component, if either, was the principal basis for an overall conclusion. It also does not report a clinically important difference threshold or explain how such a threshold would be applied. Thus, while the scale and measurement schedule are described, the registry record does not provide enough outcome information to judge the magnitude, precision, or practical importance of any observed change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a continuous measure summarized by a mean and standard deviation. It describes baseline and follow-up measurement at 6 or 12 weeks, with the latest available measurement used. The record does not report the statistical model or test used to analyze those measurements. The explanations below describe general concepts relevant to this type of outcome, not confirmed details of the study’s analysis.

What does a mean describe?

General explanation: a mean is a measure of the center of a set of scores. For a continuous outcome such as an SF-36 subscale, it gives a concise description of the average score among the observations included in the calculation. It does not show the full distribution. Different distributions can have the same mean, and an average can conceal substantial variation between participants. The registry names the mean as the outcome parameter but does not report the actual means at baseline or follow-up.

What does the standard deviation describe?

General explanation: the standard deviation describes how spread out individual observations are around their mean. It is not the same as the uncertainty in the mean. Uncertainty in an estimated mean depends on both variability and the amount of information available, as well as the analysis method. The registry lists standard deviation as the measure of dispersion but does not provide observed standard deviations or confidence intervals. Precision therefore cannot be assessed from the record.

What does a pre/post analysis estimate?

General explanation: a pre/post analysis compares measurements taken from participants at different times. When the same participants contribute both measurements, the analysis may focus on within-person change. A change estimate describes how scores differed over time in the analyzed participants. Without a concurrent comparison group analyzed according to randomized assignment, that change cannot by itself establish what would have happened over the same period without the intervention.

In this trial, the registry explicitly describes a single-group pre/post analysis and says that eligible wait-list completers were combined with those initially assigned to treatment. This means the primary analysis, as described, does not preserve a contrast between the randomized groups. The record does not specify whether the pre/post calculation used paired observations, how it handled participants with only one measurement, or whether any adjustment was made. These details are not reported in the registry record.

Why does randomization matter, and what changes when groups are combined?

General explanation: random assignment is intended to create groups that are comparable on average at the time of assignment, so a comparison by original assignment can help estimate the effect of being assigned to an intervention rather than a comparator. That interpretation depends on the analysis retaining the randomized comparison and on appropriate handling of outcomes and missing data. Combining participants based on later treatment completion is a different analysis. Completion is a post-assignment event, and the resulting group may differ from the original randomized groups. A within-group change in that combined set does not have the same interpretation as a randomized between-group contrast.

The record gives a reason for combining data—very small numbers of completers in both groups—but does not report the numbers completing in each group or the analysis details that followed. It therefore does not permit assessment of the magnitude of any selection introduced by the combination.

How should confidence intervals and p-values be read?

General explanation: a confidence interval expresses uncertainty around an estimate under a specified statistical method. A narrow interval indicates more precision than a wide interval, though precision does not determine whether a difference matters clinically. A p-value measures how compatible the observed data are with a specified null model, assuming the model and its assumptions. It is not the probability that the null hypothesis is true, and it does not quantify the size or importance of an effect.

Neither confidence intervals nor p-values for the primary outcome are reported in the registry record. No numerical primary estimate is reported either. It is thus not possible to assess statistical uncertainty or distinguish a small estimate from a large but imprecise one.

What do the planning assumptions mean?

The registry’s planning description specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. General explanation: a sample-size calculation uses assumptions about the effect, variability, allocation, and analysis to illustrate how much information a future study might need to detect a specified effect under a statistical model. Changing the assumed effect changes the planning result.

These are planning illustrations based on an observed effect, not evidence of the power achieved in this trial. The record does not give the trial’s original sample-size justification, nor does it report the analysis that produced the observed effect used for illustration. The planning assumptions cannot supply the missing primary outcome results or establish that the randomized comparison was sufficiently informative.

Why can over-dispersion matter?

General explanation: over-dispersion occurs when the variability in data is greater than a statistical model assumes. If a model underestimates variability, uncertainty estimates may be too small and inferential results may appear more precise than warranted. This concern is especially relevant when the chosen outcome model makes a particular variance assumption. The primary SF-36 outcome is described as continuous, and the registry does not report a model that would establish whether over-dispersion was relevant or how variability was handled. No conclusion about over-dispersion in this trial can be drawn from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists SF-36 as the primary outcome and the Pittsburgh Sleep Index as a secondary outcome. It records 2 outcome measures and 5 analyses, but does not describe the hypotheses attached to each analysis, identify all comparisons, or state whether any adjustment was made for multiple testing. It also does not report an analysis hierarchy or a plan for prioritizing results if analyses differed.

General explanation: when several outcomes, time points, or statistical tests are examined, the chance of at least one apparently unusual result can increase if each test is interpreted separately without accounting for the set of tests. Multiplicity procedures can address that issue, but they require a defined family of comparisons and a stated method. The registry does not report whether such a procedure was used, so it is not possible to judge how multiple analyses were handled.

The primary-outcome timeframe uses baseline and 6 or 12 weeks, with the latest available measurement. This indicates that follow-up timing could vary according to availability, but the registry does not explain how the choice of measurement was operationalized or how incomplete follow-up was handled. It does not report missing-data methods, imputation, sensitivity analyses, or the number of participants contributing paired SF-36 observations.

The record says that very small numbers of completers in the acupuncture and wait-list groups led to combining wait-list participants who completed at least 6 weeks of treatment with those initially assigned to treatment. It does not provide group-specific completion numbers or reasons for missing data. The analysis population is therefore described in broad terms, but the record does not fully specify participant flow or the rules determining inclusion in each outcome analysis. These gaps limit assessment of both missing-data bias and the applicability of the reported analysis to the originally randomized groups.

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 registry’s adverse-event entry lists Arm 1 with 30 participants at risk for serious adverse events and 0 affected. It also lists 30 at risk for other adverse events and 0 affected. These figures describe the safety counts recorded for that listed group; they should not be read as counts for every participant enrolled in the study, because the record does not explain the relationship between the safety population and the enrollment figure.

General explanation: a count of zero reported events means that no affected participants are recorded in that category for the listed group. It does not establish that an event is impossible, and it does not show how likely an event might be in a wider population. The amount of information available to assess uncommon harms depends on the number observed, follow-up, definitions, and completeness of reporting. The registry does not provide additional detail about event ascertainment or follow-up for safety.

The record lists no serious adverse-event terms. The death count is not reported in the registry record. These entries should remain distinct: zero affected is reported for the serious and other event categories, while the death field has no reported count. The registry’s safety figures alone cannot establish comparative safety, because the record does not provide a safety comparison by randomized assignment.

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

This registry record is informative about the study’s intended question and its analysis structure. It describes a randomized, unmasked pilot of acupuncture for veterans with post-traumatic stress disorder, with SF-36 mental and physical component scores as the primary outcome. It also records a wait-list control and explains that the primary analysis combined qualifying wait-list completers with participants initially assigned to treatment after the study encountered very small numbers of completers in both groups.

The record does not report numerical SF-36 findings. Without means, changes, variability, confidence intervals, or test results, there is no basis in the registry record for describing the direction or magnitude of a pre/post change or its precision. The same limitation applies to the secondary Pittsburgh Sleep Index and the study’s stated interest in acceptance of acupuncture: numerical findings for those questions are not reported in the registry record.

Even if a pre/post change estimate were available, a single-group analysis would describe change among the included participants rather than isolate the effect of acupuncture from other explanations for change over time. A randomized comparison can address a different question, but the primary analysis described in the record combines participants across their original assignment rather than reporting a between-group estimate.

The intervention description and safety counts provide context, not proof of benefit or harm. The safety record lists 0 serious and 0 other adverse events among 30 at risk in Arm 1, while the death count is not reported in the registry record. Those entries do not constitute a comparison of safety between randomized groups.

The most defensible reading is therefore about what the study set out to assess and how the recorded primary analysis was structured. The registry does not contain enough outcome results to quantify an effect, evaluate its uncertainty, or draw a treatment-effect conclusion.

13. Why This Trial Matters Statistically

This trial is statistically instructive because randomization and analysis population are not the same thing. The registry identifies random allocation and a wait-list control, but the primary outcome description specifies a single-group pre/post analysis after combining some wait-list completers with those initially assigned to treatment. A study can begin with randomized groups while a particular analysis no longer estimates a randomized group contrast.

The reason recorded for combining participants is important context: the registry cites very small numbers of completers in both groups. That practical constraint can make a planned comparison difficult to estimate, but changing the analysis does not make the resulting estimate answer the same question. A pre/post analysis describes change in the analyzed group; a randomized comparison asks how outcomes differ by assignment. Keeping those estimands distinct is essential when interpreting pilot studies.

The record also illustrates why outcome estimates need measures of uncertainty. A continuous scale, its range, and a reference value help readers understand what is measured, but they cannot substitute for observed results. Without numerical scores and precision estimates, the magnitude of change cannot be judged. Planning illustrations based on an observed effect likewise do not establish observed power or make an unreported result interpretable.

Finally, the safety entries demonstrate the importance of reading denominators and missing fields literally. The registry reports zero affected for the listed serious and other adverse-event categories, but the death count is not reported. Neither should be expanded into a broader claim than the record supports.

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 principal limitation for interpretation is that numerical primary-outcome results are not reported in the registry record. There are no SF-36 means, changes, standard deviations, confidence intervals, or test results from which to assess effect size or precision. Numerical findings for the secondary Pittsburgh Sleep Index and acceptance objective are also not reported in the registry record.

The analysis described for the primary outcome is single-group and combines wait-list completers who completed at least 6 weeks of treatment with those initially assigned to treatment. As a result, the registry does not report a primary randomized comparison by original assignment. The record gives the reason for this approach but does not provide group-specific completion counts or explain how the combination affected the analysis population.

Important details about missing data are not reported in the registry record. These include reasons for non-completion, the number contributing measurements at each time, how observations at 6 or 12 weeks were selected, and how participants with incomplete measurements were handled. The statistical model, test, and any adjustment for baseline values are also not reported in the registry record.

The registry lists 5 analyses but does not describe multiplicity procedures or clarify the relationship between each analysis and the outcome measures. It does not report a sample-size justification for the trial; the stated planning assumptions are illustrations based on an observed effect rather than a report of the original design rationale. The safety record gives counts for a listed group but does not describe comparative safety by randomized assignment, and the death count is not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD — NCT01060553.
• Registry record last updated 2015-04-28; status last verified 2014-08.
• Results first posted 2014-11-19.
• 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 describes a completed, randomized, unmasked pilot sponsored by the US Department of Veterans Affairs. It lists enrollment of 34 and identifies post-traumatic stress disorders as the condition. The intervention was a semi-individualized acupuncture program described as 24 treatments over 12 weeks; a wait-list control was also included.

The primary outcome was the SF-36 Mental and Physical component subscales, measured at baseline and at 6 or 12 weeks using the latest available measurement. The registry says that wait-list participants who completed at least 6 weeks of acupuncture were combined with those initially assigned to treatment for a single-group pre/post analysis because there were very small numbers of completers in both groups. The Pittsburgh Sleep Index was listed as a secondary outcome.

The record does not report numerical outcome findings or the statistical details needed to evaluate precision, missing-data handling, or multiplicity. Its safety entry lists 0 serious and 0 other adverse events among 30 at risk in Arm 1; the death count is not reported in the registry record.