Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-9/11 Veterans: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-9/11 Veterans (NCT02657317), a randomized na study. The primary outcome is Change in Oswestry Disability Index (ODI).

2. Clinical Question

The clinical question concerns pain-related disability, rather than pain intensity alone. The ODI is a self-report measure of limitations in life domains attributed to pain. The study description also identifies opioid medication use and pain coping as topics of interest, but the registered primary outcome is change in ODI score.

The registry record lists 103 participants enrolled and describes the study as completed. The participant group is specific: veterans with chronic musculoskeletal pain related to military service and one or more of the listed comorbid symptoms or conditions. The record identifies chronic pain, traumatic brain injury, posttraumatic stress disorder, depression, and opioid use disorder among the conditions.

The comparison is between a structured, time-limited program and usual VA care, which may include different kinds of services. The registry record does not report a single comparative ODI estimate for the scheduled assessments. It therefore does not establish from the posted primary outcome results whether or how the groups differed in disability change over time.

3. Trial Design

The registry record describes a randomized, double-masked, parallel-group study. Participants were allocated to FORT-A or VA Treatment as Usual. Enrollment is listed as 103. The record identifies the trial as completed, with a phase listed as NA. Further details about the randomization procedure, allocation concealment, and who was masked are not reported in the registry record.

FORT-A was delivered on an outpatient basis. Its group component consisted of 12 daily pain-management and physical-therapy sessions spanning three weeks, supplemented by individual psychotherapy, biofeedback, and case staffings. The description also says CBT sessions were decreased in favor, but the remaining description of that change is incomplete in the registry record, so its intended meaning cannot be determined from the record.

The comparator was usual VA care based on appointments and referrals from VA providers. The registry description allows that care to include active medical interventions, psychosocial intervention, and other rehabilitation strategies. This means that the comparator is routine care rather than a single standardized treatment protocol; the specific care received by each participant is not reported in the registry record.

The primary outcome schedule includes pre-treatment, post-treatment three weeks after pre-treatment, and follow-up six and twelve months after post-treatment. This schedule distinguishes change during the treatment period from later follow-up assessments. The registry record does not provide enough result detail to compare the arms at each time point or to establish a trajectory of between-group differences.

The study start date is 2016-04-04 and the primary completion date is 2020-02-18. The sponsor is The University of Texas Health Science Center at San Antonio. These registry entries describe the study’s administrative record; they do not substitute for information about the trial’s statistical procedures or the results of 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent to treat

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 Oswestry Disability Index (ODI), measured over Pre-Treatment, Post-Treatment 3 weeks after Pre-Treatment, Follow-Up 6 Months After Post-Treatment, Follow-Up 12 Months After Post-Treatment.

The registered primary endpoint is change in the Oswestry Disability Index (ODI), a self-report measure of perceived limitation in different life domains due to pain. The ODI contains ten items. Each item is scored from 0-5, and the item scores are combined and converted to a total from 0 to 100. The registry describes this total as a percentage disability score, with categories ranging from Minimal through Bed Bound/Exaggerating.

The ODI is used because pain-related disability includes the effect pain has on everyday functioning, not merely the experience of pain itself. A score change can therefore describe a change in reported functional limitation. It remains a patient-reported measure: the score reflects an individual’s answers and does not by itself identify the cause of any change.

The planned assessments are pre-treatment, post-treatment three weeks after pre-treatment, and follow-ups six and twelve months after post-treatment. Those occasions can address different questions: immediate change over the program period and the pattern of scores at later follow-up. The registry record lists a mean as the outcome parameter and a 95% confidence interval as the dispersion measure.

Although the outcome title refers to change, the registry record does not present a single comparison of ODI change between groups. It lists several categories or time points, and the posted result is not reduced to one comparison. The specific group estimates and their confidence intervals are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, double-masked, parallel-group design. Random allocation is intended, in general, to make treatment groups comparable on average at the time of assignment. That benefit depends on how allocation is generated and implemented. The specific randomization and concealment procedures are not reported in the registry record. The record says double masking, but does not identify which participants, clinicians, assessors, or analysts were masked, or how masking was maintained.

What does the mean represent?

The primary outcome parameter is the mean of a continuous measure. In general, a mean is the arithmetic average of the scores in a group. For ODI, the score ranges from 0 to 100, with larger values corresponding to greater reported disability according to the registry description. A mean can provide a compact summary of the group’s scores, but it does not show how widely individual scores vary or whether distributions are uneven. The registry record does not report the primary outcome means.

The outcome is described as change, with assessments before treatment, after the three-week treatment interval, and at later follow-up. Change can be summarized in different ways, such as change within each group or a contrast between groups in their changes. Those are not interchangeable quantities. The registry record does not report the exact estimand or a single between-group contrast, so the precise target of the registered analysis cannot be established from the record.

How should a confidence interval be read?

The outcome dispersion is specified as a 95% confidence interval. In general, a confidence interval conveys statistical uncertainty around an estimate under the assumptions of the calculation. A narrower interval indicates greater precision than a wider interval for the same type of estimate. It is not a measure of the spread of individual participants’ scores; standard deviations or other distribution summaries serve different purposes. No numeric confidence interval for ODI is reported in the registry record.

A confidence interval is most informative when the estimate and the comparison it describes are clear. For a two-group trial, readers need to know whether an interval refers to each group’s mean, a within-group change, or a between-group contrast. The registry gives the confidence-interval format but not the numeric result or the particular contrast needed for interpretation.

What does the repeated assessment schedule imply?

Multiple assessments can be analyzed in ways that account for the fact that measurements from the same person are related. In general, repeated-measures methods can model within-person correlation and use information across scheduled visits. The method chosen affects the interpretation of the estimates and the assumptions required. The registry record does not report the model, covariance structure, or other details of the analysis. It is therefore not possible to say which repeated-measures approach, if any, was used.

Time also matters to the clinical interpretation. A post-treatment result concerns a different point in the course of care from follow-up six or twelve months after post-treatment. A difference at one assessment would not automatically describe a difference at another. The registry record does not provide separate numeric results for these occasions, so neither the short-term pattern nor the later pattern can be assessed.

Why can over-dispersion matter?

In general, over-dispersion means that the observed variability is greater than a statistical model expects. It is particularly relevant to count outcomes, where ignoring extra variability can make standard errors too small and confidence intervals too narrow. ODI is a continuous score, so over-dispersion is not automatically the central issue for this endpoint; the choice of model still needs to reflect the score’s distribution and the repeated assessments. The analysis details needed to evaluate those choices are not reported in the registry record.

For adverse-event counts, a simple count model can also be inadequate if events vary more than expected under its assumptions. The posted safety information gives counts, but does not report a formal statistical comparison or modeling strategy. General considerations about count-data models should not be mistaken for evidence that any particular model was used in this trial.

What do planning sample sizes mean?

A sample-size illustration is a planning calculation, not an observed trial result and not observed power. The registry description of the illustration says it uses a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect defined as a stated fraction of the observed effect. It also distinguishes participant counts per arm for non-time-to-event outcomes from total event counts for time-to-event outcomes. Such an illustration does not establish that the trial was originally designed using those assumptions, and the registry record does not report the trial’s own sample-size justification.

Planning calculations depend on assumptions about the effect to detect, variability, allocation, and analysis. If the assumptions differ from the trial’s actual circumstances, the illustration may not describe the study’s operating characteristics. No numerical sample-size result is needed to interpret the primary endpoint, and no planning illustration can replace the missing ODI estimates or confidence intervals.

Overall, the statistical methods identifiable from the registry are limited to the randomized, double-masked, parallel-group design, the continuous mean outcome, the stated confidence-interval format, and the assessment schedule. The model, estimand, handling of baseline scores, missing-data method, and details of multiplicity control are not reported in the registry record. Those omissions limit a detailed assessment of the analysis.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is assessed at pre-treatment, post-treatment three weeks after pre-treatment, and follow-ups six and twelve months after post-treatment. Multiple times can create multiple opportunities to test or emphasize differences. In general, multiplicity refers to the increased chance of a false-positive finding when several statistical hypotheses are tested without appropriate planning or adjustment. It can be managed through a prespecified hierarchy, adjusted testing, or a clearly designated primary time point, among other approaches.

The registry record does not report which time point, if any, was intended as the single primary comparison, nor does it describe a multiplicity adjustment or testing hierarchy. Because the posted outcome is not reduced to a single comparison, the results cannot be interpreted as one definitive time-specific estimate from the registry record. The record also does not report the analysis plan needed to judge whether multiplicity was addressed.

The primary outcome population is listed as intent to treat. In general, an intent-to-treat analysis aims to analyze participants according to their assigned groups, regardless of treatment received. The label alone does not specify how missing measurements, withdrawal, or other incomplete outcome data were handled. The registry record does not report the number of missing ODI observations, reasons for missingness, imputation method, or sensitivity analyses.

Missing data matter because follow-up measurements may be unavailable for reasons related to health, treatment experience, or other factors. In general, different assumptions about why observations are missing can lead to different estimates. Without the missing-data methods and the amount and pattern of missingness, readers cannot assess the robustness of the primary outcome analysis.

The registry lists one analysis, but does not provide enough detail to establish the model or its relation to the several assessment occasions. These limitations do not show that the analysis was inappropriate; they mean the relevant procedures are not reported in the registry record.

11. 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 reports serious adverse events and other adverse events separately for the two groups. For FORT-A, 50 participants are listed as at risk for serious events and 0 as affected; 50 are listed as at risk for other adverse events and 15 as affected. For VA Treatment as Usual, 53 are listed as at risk for serious events and 0 as affected; 53 are listed as at risk for other adverse events and 13 as affected. Deaths are listed as 0 in both groups.

These are counts as recorded, not estimates of a comparative treatment effect. The registry record does not provide event-level descriptions for the other adverse events or a statistical comparison between groups. The serious-event terms list is empty. A zero count in the registry should be understood as no affected participants recorded in that category, not as proof that a risk is absent.

The at-risk counts are the denominators displayed in the safety record. The figures do not by themselves describe severity, timing, relatedness to treatment, or whether participants experienced more than one event. The record does not report those details. Safety counts also do not answer the primary question about change in ODI, and should not be used as a substitute for primary-outcome results.

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

The registry record establishes that a randomized comparison of FORT-A and VA Treatment as Usual was conducted, with 103 participants enrolled and ODI change registered as the primary outcome. It also describes the intervention schedule, comparator, intended population, and outcome assessment times. Those details define the clinical question and provide context for interpreting any results that may be available elsewhere.

The record does not report a single ODI comparison across the scheduled time points. It does not provide the group means, changes, between-group estimates, confidence intervals, or p-values needed to describe the direction, size, or precision of the primary outcome findings. Consequently, it cannot support a conclusion that one group had greater or lesser disability change based on the registry’s posted primary results.

That absence does not mean that the outcome was unchanged, or that no analysis was performed. It means the registry record does not report the information required to determine the result. Study completion and enrollment are administrative or design details, not evidence of the direction or magnitude of an outcome.

Even with numeric results, interpreting an ODI difference would require attention to its measurement scale, uncertainty, assessment time, and clinical context. Statistical significance alone would not establish clinical importance, and an estimate from one assessment would not necessarily describe later follow-up. The registry record does not report a clinical-importance threshold for interpreting ODI change.

The safety counts offer a separate, limited description of recorded adverse events. They do not establish a complete safety profile or a balance of benefits and harms. The absence of recorded serious events in the listed groups should be read as a count, not as proof of no possible serious risk.

The appropriate conclusion is therefore narrow: the registry describes a randomized trial and its planned disability outcome, but the posted outcome information is insufficient to quantify or interpret a comparative ODI result. It does not, on its own, establish whether FORT-A differed from usual VA care on the primary endpoint.

13. Why This Trial Matters Statistically

This trial addresses a practical statistical challenge: comparing an intensive, structured interdisciplinary program with routine care that can vary across participants. The intervention is described as a three-week outpatient program with group sessions and additional individual services, while usual VA care can include medical, psychosocial, and rehabilitation approaches. This context makes it important to distinguish the effect of assignment to a program from the effect of any single treatment component.

The primary endpoint focuses on disability related to pain, an outcome that captures reported functional limitation rather than pain alone. Using a patient-reported measure can make the endpoint relevant to participants’ experiences, while also requiring careful interpretation of score changes and uncertainty. The ODI’s scheduled use before treatment, after the program, and at later follow-ups reflects interest in both short-term and longer-term outcomes.

Statistically, multiple time points require a clear definition of the principal comparison and an analysis that accounts for repeated observations. The registry record does not report those details or a single comparative result. That absence is itself important for evidence interpretation: a study’s design and registered endpoint can be informative, but without estimates and uncertainty, readers cannot assess the magnitude or precision of a treatment contrast.

The trial also illustrates why enrollment totals and planning calculations should not be treated as outcome evidence. Enrollment describes how many participants entered the study; a planning illustration concerns assumptions for sample-size calculations. Neither indicates whether a difference was observed or how precisely it was estimated.

Careful reporting would permit readers to distinguish the findings at each assessment, evaluate uncertainty, and understand missing-data and multiplicity decisions. For this registry record, the clinical question is identifiable, but the posted primary outcome results are not sufficiently detailed for those evaluations. That distinction helps prevent design information from being mistaken for evidence of an effect.

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 main trial-specific limitation for interpretation is the absence of a single reported primary-outcome comparison. The ODI is listed across several assessment occasions, but the registry record does not provide arm-specific means, changes, between-group contrasts, or confidence intervals. As a result, the size, direction, and precision of the comparative disability findings cannot be assessed.

The intervention description is incomplete at the point where it states that CBT sessions were decreased in favor. The rest of that description is not reported in the registry record. The specific treatment content beyond the described group sessions and supplemental services therefore cannot be fully characterized from the record.

The comparator is usual VA care and may include medical, psychosocial, and rehabilitation services. The particular services received by participants and their variation are not reported in the registry record. This limits the ability to describe the contrast in actual care received, even though the assigned groups are clearly named.

The registry states that the study was double-masked, but does not identify who was masked or provide details about implementation. The randomization procedures, allocation concealment, analysis model, and handling of baseline ODI are also not reported. These details would help evaluate possible sources of bias and understand the statistical estimand.

Although the outcome population is listed as intent to treat, the record does not report missing ODI data, reasons for missingness, or methods used to address incomplete follow-up. Multiplicity procedures for the several assessment occasions are not reported either. These omissions restrict assessment of whether the estimates, if available, are robust to missing data and multiple comparisons.

Finally, the safety record provides counts but not detailed event descriptions, relatedness, or statistical comparisons. These registry limitations do not establish that the trial lacked suitable procedures; they indicate that the procedures and primary-outcome results needed for a fuller evaluation are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-9/11 Veterans — NCT02657317.
• Registry record last updated 2024-07-29; status last verified 2024-07.
• Results first posted 2024-07-29.
• 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

NCT02657317 is a completed randomized, double-masked, parallel-group study sponsored by The University of Texas Health Science Center at San Antonio. Enrollment is listed as 103, and the phase is listed as NA. The record describes a comparison of outpatient FORT-A with VA Treatment as Usual among post-9/11 veterans with chronic musculoskeletal pain related to military service and specified comorbid conditions.

The primary outcome is change in ODI score, assessed before treatment, three weeks after the pre-treatment assessment, and at follow-ups six and twelve months after post-treatment. The record identifies an intent-to-treat outcome population and a mean with a 95% confidence interval, but does not report a single primary-outcome comparison across the listed time points.

Safety entries list zero serious adverse events affected and zero deaths in each group, with 15 other adverse events affected in FORT-A and 13 in VA Treatment as Usual. Further details about the statistical analysis, missing data, and adverse-event descriptions are not reported in the registry record.