Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot (NCT05546749), a randomized na study. The primary outcome is Change in Pain Intensity.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group pilot study comparing RelieVRx with Sham Virtual Reality. The record identifies the allocation as randomized and masking as none. It lists the study as completed and describes the purpose as assessing feasibility of a virtual reality device for patients with co-morbid chronic pain and opioid use disorder. The study was conducted in a methadone maintenance treatment program. The registry lists the phase as NA.

The intervention was designed for at-home use and consisted of daily immersive experiences. Participants were scheduled for 20-30 minute sessions twice per week over the course of 6 weeks. The sham device was also by RelieVRx but lacked the immersive nature of the interventional virtual reality. Sham participants were scheduled for sessions of the same stated duration and frequency over 6 weeks. Actual adherence to the sessions, reasons for missed sessions, and treatment exposure by participant are not reported in the registry record.

The registry records enrollment of 18. For the primary outcome, the registry states that 8 participants in the RelieVRx arm and 6 in the Sham Virtual Reality arm completed the study. The posted outcome summaries use those arm-specific participant counts. How the participants who did not complete the study were handled in the analysis, and whether the analysis followed an intention-to-treat principle, are not reported in the registry record.

The primary outcome was change in pain intensity from baseline to 6 weeks. Secondary outcomes listed in the record were changes in pain interference, sleep, cognitive function, social function, physical function, depression, and anxiety. Further operational details for these outcomes, including their measurement instruments and analysis time points, are not reported in the registry record.

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: 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the 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 Change in Pain Intensity, measured over From baseline to 6 weeks.

The primary endpoint was change in pain intensity from baseline to 6 weeks. Pain intensity was assessed using a single item from the Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity scale. Participants were asked to rate their average pain over the past 7 days on an 11-point Likert scale ranging from 0-10, where 0 means no pain and 10 means worst pain imaginable.

The outcome is a continuous measure: it can take values along a numerical scale rather than placing participants into categories. The registry summarizes the change using a mean and standard deviation for each arm. As described in the record, positive mean change scores indicate increased pain intensity from baseline, while negative mean change scores indicate decreased pain intensity from baseline. The arm-level means were -1.38 for RelieVRx and 0.33 for Sham Virtual Reality; the corresponding standard deviations were 1.69 and 2.66. The reported participant counts were 8 and 6, respectively.

A pain-intensity measure gives a direct, patient-reported account of the symptom targeted by the intervention. The single-item format focuses on average pain over a defined recent period. The registry does not report a threshold for interpreting the size of a change as clinically important, nor does it provide further information about the scale's measurement properties in this study. The endpoint therefore describes change on the recorded scale; the registry record alone does not establish how large a change would matter to an individual participant.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is continuous, and the record reports an arm-specific mean and standard deviation. In general, a mean describes the central tendency of numerical observations, while a standard deviation describes their spread around the mean. The mean change was -1.38 with a standard deviation of 1.69 for RelieVRx, and 0.33 with a standard deviation of 2.66 for Sham Virtual Reality. The registry reports 8 and 6 participants, respectively, for these summaries. These statistics describe the recorded participants; they do not show how each participant's score changed.

A between-group comparison asks how the outcomes differ across randomized groups, rather than whether a group's mean changed from its own baseline. The registry reports a mixed models analysis with a mean difference in final values of -1.28. A mixed model is a modelling approach that can account for relationships among repeated observations, depending on how it is specified. The precise model structure, covariates, handling of repeated measures, and contrast coding are not reported in the registry record. The label alone does not establish those details.

The reported 95% confidence interval runs from -3.1 to 0.54. In general, a confidence interval conveys uncertainty around an estimate under the assumptions of the analysis. A wider interval indicates less precision than a narrower interval. Here, the reported interval includes zero and reaches both negative and positive values, so the data do not pin down the direction of the modelled difference with high precision. A confidence interval is not a guarantee that the true effect lies within its bounds, and its interpretation depends on the statistical model and study conduct.

The registry reports p = 0.17 for the mixed models analysis. In general, a p-value describes how compatible the observed data are with a specified null hypothesis under the model assumptions. It is not the probability that the null hypothesis is true, and it does not quantify clinical importance. The registry's threshold for statistical significance, if any, is not reported in the registry record. The p-value should be considered alongside the estimate, confidence interval, study size, and pilot purpose, rather than read as a standalone verdict.

The registry record also states that values were missing or not estimable for a two-arm comparison of the continuous endpoint. Therefore, no recalculated comparison based on posted summary statistics is available. In general, recalculation from arm-level means and standard deviations would be an unadjusted calculation and might not reproduce a model-based result. A mixed models estimate may depend on participant-level observations and model specifications not captured by summary statistics. Since no recalculated comparison is available in this case, there is no second inferential estimate to set against the sponsor's analysis.

Over-dispersion is a general concern when observed variability is greater than a statistical model assumes. If a model understates variability, its uncertainty estimates may be too narrow. The registry record does not report a dispersion assessment or enough model detail to determine whether over-dispersion was relevant. The arm-level standard deviations show the observed spread within each group, but they do not, on their own, diagnose model fit.

The record's sample-size assumptions describe planning illustrations based on the observed effect, two-sided significance level 0.05, equal allocation, and a normal approximation; the stated effect to detect is a fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the trial had a particular probability of detecting an effect. Their interpretation depends on the assumed effect and model. The registry does not report its original sample-size justification or a protocol-based target for power. No numerical planning result is stated in the registry record.

Randomization can support a fair comparison by making group assignment independent of participant characteristics on average, but in a small pilot chance differences in baseline characteristics can remain. The record does not report baseline characteristics, the randomization procedure, concealment of allocation, or stratification factors. The study was unmasked, so participants and study personnel were not recorded as masked. The registry does not describe whether outcome assessment or statistical analysis was masked. These details matter when evaluating the potential influence of expectations, conduct, and analytic choices.

General statistical interpretation also depends on how missing observations and repeated measures are handled. Mixed models can use data under particular assumptions about missingness, but the method's name alone does not establish which assumptions or implementation applied. The missing-data mechanism, imputation approach, and sensitivity analyses are not reported in the registry record. These omissions prevent a fuller assessment of how incomplete outcome data could affect the estimated difference.

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("RelieVRx", "Sham Virtual Reality")
n   <- c(8, 6)
m   <- c(-1.38, 0.33)
sp  <- c(1.69, 2.66)
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  RelieVRx  8  -1.380  1.690  -2.793  0.033
CARM  Sham Virtual Reality  6  0.330  2.660  -2.461  3.121

11. Analyses Reported by the Sponsor

The registry reports the sponsor's mixed models analysis as a mean difference in final values of -1.28, with a 95% confidence interval from -3.1 to 0.54 and p = 0.17. The estimate is an inferential comparison reported by the study record. Its confidence interval includes zero and reflects uncertainty about the between-group difference under the stated analysis.

The posted arm summaries give mean changes from baseline of -1.38 for RelieVRx and 0.33 for Sham Virtual Reality. However, the registry does not provide a recalculated two-arm comparison from those summary statistics: the record marks the continuous comparison as missing or not estimable. Thus there is no separate unadjusted recalculation to compare directly with the mixed models estimate. The endpoint summaries and the model result are also labelled differently: change from baseline versus a mean difference in final values. Further detail on the model and its contrast is not reported in the registry record.

The record identifies no discrepancy between the sponsor analysis and an independently recalculated comparison. Because no recalculated comparison is available, the reported mixed models result remains the only posted inferential comparison for the primary endpoint. The registry does not report additional model specifications, assumptions, or sensitivity analyses that would allow a fuller review of that result.

12. Multiplicity, Missing Data and Analysis Populations

The registry lists 7 secondary outcomes: change in pain interference, sleep, cognitive function, social function, physical function, depression, and anxiety. It also records 15 outcome measures and 3 analyses. The record does not identify how the primary and secondary outcomes were ordered for confirmatory inference, whether the secondary outcomes were exploratory, or whether any adjustment was made for multiple comparisons. A multiplicity strategy is not reported in the registry record.

In general, testing many outcomes can increase the chance of obtaining an apparently notable result by chance if each is interpreted separately. Adjustments and prespecified outcome hierarchies are possible ways to address that issue, but the record does not say whether either was used. The listed secondary outcomes should therefore be read as outcomes recorded for the study, not as a set of independently confirmed findings. Results for the secondary outcomes are not included in the registry record for this analysis, so their estimates and uncertainty cannot be described.

The primary outcome population is described as study completers: 8 in the RelieVRx arm and 6 in the Sham Virtual Reality arm. The registry does not report the outcome availability for other randomized participants, reasons for non-completion, or whether missing observations were imputed. It also does not specify whether the primary analysis used all randomized participants, completers, or another defined analysis population. The analysis population and missing-data assumptions are not reported in the registry record.

These details matter because incomplete outcome data can affect both the estimated effect and its uncertainty, depending on why data are absent and how the analysis handles them. General approaches include analysing available observations under stated assumptions, using imputation, or conducting sensitivity analyses; no such approach can be attributed to this study from the registry record. The distinction between enrollment, endpoint completion, and the analysis population should remain explicit when interpreting the estimate. No additional information about interim analyses or a prespecified statistical analysis plan is reported in the registry record.

13. 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 adverse-event record lists serious adverse events for 0 of 10 participants at risk in the RelieVRx group and 0 of 8 at risk in the Sham Virtual Reality group. It lists 1 other adverse event among 10 at risk in RelieVRx and 0 among 8 at risk in the sham group. The record lists 0 deaths in each group. No serious adverse-event terms are listed.

These are counts recorded in the registry, not a complete characterization of every possible safety outcome. The adverse-event denominators differ from the primary endpoint completion counts: the safety record lists 10 and 8 at risk, while the primary outcome description gives 8 and 6 study completers. The registry does not explain the relationship between these populations, the adverse-event collection period, event definitions, or whether the other adverse event was considered related to the device or study procedures.

Zero recorded serious adverse events does not establish that serious events cannot occur, particularly in a pilot study. The small recorded groups and the absence of further event detail limit safety interpretation. The figures should be read as the events and at-risk counts reported in the registry record, without inferring causation or making comparisons beyond those counts.

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

The record documents a randomized pilot comparison of RelieVRx with Sham Virtual Reality for people with chronic pain and opioid use disorder. Its primary endpoint was change in pain intensity from baseline to 6 weeks, assessed using a single self-reported item about average pain over the past 7 days. The recorded arm means were -1.38 for RelieVRx and 0.33 for sham. The sponsor's mixed models analysis reported a mean difference in final values of -1.28, with a 95% confidence interval from -3.1 to 0.54 and p = 0.17.

These results describe the observed outcomes and the uncertainty in the reported model estimate. The confidence interval includes zero and covers negative and positive values. The result therefore does not precisely establish the direction or size of the modelled difference. It also does not demonstrate equivalence: showing equivalence requires a prespecified margin and an analysis designed for that question, neither of which is reported in the registry record.

The pilot purpose and the outcome counts are important context. The primary outcome summaries refer to study completers, and the registry does not explain how other randomized participants were handled. The study was unmasked, and key details about missing data, model specification, and the analysis population are not reported. These uncertainties limit how far the result can be generalized beyond the recorded study participants and setting.

The findings do not establish whether RelieVRx is effective or ineffective for chronic pain, whether it changes opioid use disorder outcomes, or whether it is safe in broader populations. Opioid use outcomes are not listed among the secondary outcomes reported in the record. The registry describes this as a feasibility pilot, not as a definitive clinical effectiveness trial. No medical decision should be based on this statistical summary alone.

15. Why This Trial Matters Statistically

This trial illustrates the difference between a feasibility pilot and a conclusive comparison. The record describes a randomized study of a virtual reality device in a specific clinical setting, with an active sham device that lacked the immersive nature of the intervention. It also records a patient-reported continuous primary outcome and a sponsor-reported model estimate. That combination makes it possible to discuss design, outcome measurement, and statistical uncertainty even when the available evidence is limited.

The main statistical lesson is that an arm-level change and a between-group model estimate are not interchangeable. The registry reports separate means and standard deviations for the outcome, as well as a mixed models comparison labelled in terms of final values. The model's interval is broad and includes zero. Because no recalculated two-arm comparison is estimable from the posted summaries, the arm means should not be used to manufacture a substitute inferential result.

The study also highlights why analysis populations and missing-data reporting matter. The primary outcome counts are given for completers, while the safety record uses different at-risk counts. Without information about non-completion and the handling of incomplete observations, readers cannot fully judge the representativeness of the estimate. Similarly, a list of secondary outcomes does not establish a multiplicity plan or show how each result should be interpreted.

For biostatisticians and clinical researchers, the record is a useful reminder to separate descriptive findings, model-based inference, and planning illustrations. A small pilot can inform questions for further study, but its estimates may remain uncertain and its registry record may not contain all analytic detail. The appropriate reading is therefore careful and bounded: describe what was measured and estimated, identify uncertainty, and avoid treating a single p-value as a complete account of evidence.

16. 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.

Several details needed to assess the primary analysis are not reported in the registry record. These include the randomization procedure, allocation concealment, baseline characteristics, the precise mixed-model specification, covariate adjustment, contrast coding, and model diagnostics. The reported result is labelled a mean difference in final values, while the endpoint description and arm summaries concern change from baseline. The record does not explain this difference in parameter labels or provide enough information to reconcile them.

The primary outcome population is described through the study completers, but the record does not give the reasons participants did not complete the study or explain which participants contributed to the model. Missing-data methods, assumptions, and sensitivity analyses are not reported. This prevents an assessment of how incomplete observations may have influenced the reported estimate. The adverse-event counts use different at-risk counts from those reported for primary outcome completion, and the relationship between those populations is not explained.

The study was unmasked. The registry does not report whether outcome assessors or analysts were masked, nor does it provide details about expectations, adherence, or actual session exposure. The session schedule is described, but completion of scheduled virtual reality sessions is not reported. These details are relevant for understanding exposure and potential sources of bias.

The record lists secondary outcomes and analyses but does not report a multiplicity approach, a statistical analysis plan, or an original sample-size justification. The registry also does not specify a clinically important difference for pain intensity. Consequently, statistical uncertainty cannot be translated into a threshold-based judgment about clinical importance using this record alone. These are limitations of the information available in the registry record; they do not show that particular methods were or were not used outside what the record reports.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot — NCT05546749.
• Registry record last updated 2025-03-05; status last verified 2025-02.
• Results first posted 2025-03-05.
• 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.

20. Record Summary

NCT05546749 is a completed randomized, parallel-group pilot study titled “Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot.” The official title describes virtual reality treatment in a methadone maintenance treatment program for chronic pain and opioid use disorder. The sponsor is Albert Einstein College of Medicine. The study start date is 2023-02-08, and the primary completion date is 2023-07-12. The registry lists the phase as NA and masking as none.

The comparison was RelieVRx versus Sham Virtual Reality. The primary outcome was change in pain intensity from baseline to 6 weeks, measured with a single PROMIS pain intensity item. The registry reports arm-level change summaries and a mixed models analysis with a mean difference in final values of -1.28, a 95% confidence interval from -3.1 to 0.54, and p = 0.17. The primary outcome description gives completion counts of 8 for RelieVRx and 6 for sham.

The registry lists 7 secondary outcomes and reports no serious adverse events in either group. Key details on the statistical plan, missing data, analysis population, and model specification are not reported in the registry record.