Acupressure in Rheumatoid Arthritis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Acupressure in Rheumatoid Arthritis (NCT05412121), a na na study. The primary outcome is Feasibility of Self-performed Acupressure in Patients With Rheumatoid Arthritis Assessed by the Number of Sessions Completed.

2. Clinical Question

This is a feasibility and acceptability question, rather than a randomized comparison of acupressure with another treatment or with no intervention. The registry describes a pilot intended to better understand whether acupressure is feasible and tolerable for people with rheumatoid arthritis. Its primary outcome concerns participation and completion, not a clinical measure of disease activity.

The primary outcome description links the session-completion measure to participants who responded to all surveys administered at Day 42. That wording identifies the assessment period as up to day 42 during acupressure, but the registry does not report how many participants completed the sessions or met the survey-response criterion. It also does not report a comparison group, so the record cannot answer whether outcomes differed from those under another approach.

Secondary outcomes listed in the record include the Fibromyalgia Survey Questionnaire and PROMIS-29 +2 domains for physical functioning, anxiety, depression, fatigue, sleep disturbance, social participation, and pain interference. The results for these measures are not reported in the registry record. The central question that can be stated from the record is therefore whether the intervention could be delivered and assessed as planned; the posted information does not provide the endpoint result needed to quantify feasibility.

3. Trial Design

The registry identifies NCT05412121 as a completed study titled “Acupressure in Rheumatoid Arthritis,” with the official title “Feasibility and Acceptability of Acupressure in Patients With Rheumatoid Arthritis.” The listed condition is rheumatoid arthritis, the sponsor is the University of Michigan, and the enrollment is 14. The study began on 2022-09-15, reached primary completion on 2023-07-14, and has a status of completed.

The design is recorded as single-group, with allocation listed as NA and masking listed as none. The phase is also listed as NA. There is no like-for-like control arm in the registry record, so treatment effects cannot be estimated through a randomized between-group contrast. The acupressure group is the only intervention group described.

The intervention is classified as a device and named Acupressure. Participants were to perform self-acupressure using a modified MeTime Acupressure mobile application, alongside instruction delivered by study staff either in person or virtually. The registry does not report the number or length of instructional sessions, the specific acupressure routine, or other operational details beyond that description.

The primary outcome is described as the number of study sessions completed by participants, assessed up to day 42 during acupressure. The outcome description adds that the results reflect participants who responded to all surveys administered at the Day 42 visit. The record lists 14 outcome measures and 0 analyses. Those listings do not include an endpoint estimate, a statistical test, or a confidence interval. Results for the listed secondary outcomes are also not reported in the registry record.

Because the study has no separate comparator, its design can describe participation and outcomes within the enrolled group, if those results are reported. It cannot isolate an intervention effect from changes that might occur over time or for other reasons. The registry record does not report a protocol rationale for the design, a sample-size justification, or details of planned interim analyses.

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:

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 Feasibility of Self-performed Acupressure in Patients With Rheumatoid Arthritis Assessed by the Number of Sessions Completed, measured over up to day 42 (during acupressure).

The primary endpoint concerns feasibility of self-performed acupressure, expressed as the number of participants who completed study sessions. Its assessment period is listed as up to day 42 during acupressure. The description further specifies that results reflect participants who responded to all surveys administered at the Day 42 visit. This makes survey completion part of how the endpoint is defined or reported, so interpretation depends on knowing both the completion rule and how many participants met it.

A feasibility endpoint is used to characterize whether an intervention and its assessment procedures can be carried out in the intended setting. It differs from an endpoint designed to estimate a clinical treatment effect. Session completion can describe engagement with the intervention, while survey completion can indicate whether participant-reported measures were obtained. Neither alone establishes a change in rheumatoid arthritis symptoms or a causal effect of acupressure.

The registry title and description emphasize session completion, but the record does not give the observed number of participants meeting the completion criterion. It does not report the session-level distribution, the number of sessions expected, or the number of sessions completed by each participant. The number meeting the Day 42 survey criterion is also not reported in the registry record. Without these results, the endpoint's magnitude and precision cannot be assessed from the posted information.

The distinction between the endpoint label and the reporting rule matters: a count of participants is not the same as a count of sessions, and the description ties the reported count to complete Day 42 surveys. The registry does not provide further detail to resolve how partial survey completion or incomplete intervention participation was handled.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a single-group design allow?

In a single-group study, participants receive the described intervention and outcomes are assessed within that group. This can be useful when the question concerns whether an intervention can be delivered, whether participants complete its activities, or whether measurement procedures are workable. The design does not include a separate group serving as a concurrent comparison. As a result, a before-and-after change, if reported, cannot by itself distinguish the intervention's contribution from time trends, other care, or other influences.

Random allocation is one way to create comparable groups for estimating a between-group contrast. Allocation is listed as NA in this record, and the design is single-group. It would therefore be inappropriate to describe the study as a randomized comparison or to interpret the acupressure group as if it had a matched control. The record does not report a comparator or a between-group treatment estimate.

What does a count endpoint convey?

The primary outcome is framed as a count of participants completing study sessions, with the description tying reported results to complete survey responses at the Day 42 visit. A participant count can be straightforward to communicate, but its interpretation depends on the exact eligibility and completion rules. For example, readers need to know what qualified as completing the required sessions and whether the count includes everyone enrolled or only those with complete assessments. Those details and the observed count are not reported in the registry record.

Counts are not continuous measurements such as a score change, and they should not be interpreted as though they were. A count can be presented alone or with an appropriate denominator and uncertainty estimate. Here, enrollment is listed as 14, but the endpoint result and its uncertainty are not reported. No new completion rate can be inferred from enrollment alone.

Why are uncertainty estimates important?

Statistical estimates from a study are subject to sampling variability: a different sample of participants might yield a different result. A confidence interval is a general method for expressing uncertainty around an estimate. Its width reflects both the amount of information in the data and the analysis method. A point estimate without an uncertainty measure may give an incomplete picture, while a missing point estimate and interval provide no basis for judging the precision of the outcome.

The registry record reports neither a primary endpoint estimate nor a confidence interval. Thus, no precision assessment can be made. The enrollment figure is a description of the study, not a substitute for an outcome estimate, and it does not indicate how precisely feasibility was measured.

What is over-dispersion, in general?

Over-dispersion is a general concern in count-data analyses when observed variability exceeds what a chosen statistical model assumes. If ignored, standard errors and confidence intervals may be unreliable. Whether over-dispersion is relevant depends on the outcome's data structure and the statistical model. The registry record does not report a fitted count model, a dispersion estimate, or an analysis, so there is no basis to say whether over-dispersion was assessed or affected results in this study.

What can planning calculations tell readers?

Sample-size calculations are planning tools that describe how many participants might be needed under stated assumptions to detect a specified effect with a chosen statistical procedure. They are not outcome results and do not show what happened in the enrolled study. A planning illustration based on an observed effect is especially distinct from a prespecified design justification: it uses an effect estimate as an input to illustrate a hypothetical design. The posted assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. For time-to-event calculations, the planning quantity is total events; for other calculations, it is participants per arm. These assumptions do not describe the single-group trial's actual allocation, which is recorded as NA.

Such illustrations are not observed power. Observed power is not a substitute for an estimate and its uncertainty; after data collection, interpretation should focus on the observed result and its precision. No sample-size justification for the trial's own design is reported in the registry record. The record also does not report the effect estimate that would be needed to interpret any illustration based on an observed effect.

What does the absence of analyses mean?

The record lists 0 analyses, and no inferential result is reported for the primary or secondary outcomes. This is a statement about what the registry record contains, not a claim about the investigators' activities outside that record. It does not identify whether analyses were planned, completed, or omitted, and those details are not reported in the registry record. Readers should distinguish missing analysis results from a result showing no difference or no change. Without an analysis population, estimate, and uncertainty measure, the posted data cannot support statistical conclusions about endpoint values.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Acupressure")
n      <- c(14)
events <- c(6)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Acupressure  14  6  42.9  17.7  71.1  21.4  67.4  21.3  67.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 14 outcome measures, including the primary feasibility outcome and secondary patient-reported measures. Testing or estimating many outcomes can raise multiplicity concerns: when multiple statistical tests are used, the chance of at least one apparently notable result can increase. General approaches include prespecifying a primary outcome, organizing outcomes hierarchically, or adjusting inference for multiple comparisons. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or analysis results. No claim about adjustment or unadjusted testing can therefore be made.

Missing data are particularly relevant to the primary outcome because its description says results reflect participants who responded to all surveys administered at the Day 42 visit. The record does not report how many participants met that condition, how many had incomplete surveys, or how incomplete session information was handled. It also does not describe a missing-data method, such as imputation, or sensitivity analyses. Those details are not reported in the registry record.

An analysis population identifies which participants contribute to an estimate, for example all enrolled participants or only those with complete outcome data. The registry record does not report an analysis population for the primary or secondary outcomes. Since the endpoint description conditions results on Day 42 survey completion, the distinction between all enrolled participants and those with complete responses would be important for interpreting any eventual count.

The record's 0 analyses and the absence of outcome estimates leave these issues unresolved. The absence of reported results should not be treated as a finding that missing data were absent, that all participants completed assessments, or that multiplicity was handled in a particular way.

12. 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 records 0 participants affected by serious adverse events among 14 at risk in the Acupressure group. It records 1 participant affected by other adverse events among 14 at risk, and 0 deaths. These are event counts from the study record, not comparative estimates.

The serious-event count is a description of what was recorded in this group. It does not prove that serious events are impossible or establish a broader safety profile. With no separate control group, the counts cannot be used to compare risks between acupressure and another condition. The registry does not report the identity, timing, severity, or intervention relationship of the other adverse event; those details are not reported in the registry record.

Zero recorded deaths is likewise a descriptive count, not evidence that the intervention caused or prevented deaths. The enrollment and at-risk figures describe the study group but do not supply a comparative risk estimate. Safety interpretation should remain limited to the counts and denominators recorded, without extrapolating beyond this pilot.

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

The record establishes that this was a completed, single-group pilot of self-acupressure in people with rheumatoid arthritis, with enrollment of 14. The intervention combined use of the modified MeTime Acupressure mobile application with in-person or virtual instruction from study staff. The stated aim was to better understand feasibility and tolerability. The primary outcome was intended to assess session completion, with results tied to complete responses to surveys at the Day 42 visit.

What the posted information does not establish is how many participants completed sessions, how many met the survey-response condition, or what results were observed on the secondary patient-reported measures. The endpoint estimate, statistical uncertainty, and analysis details are not reported in the registry record. Missing results are not equivalent to a finding of no effect, no change, or failure to complete the intervention.

The single-group design also does not estimate a randomized contrast against another treatment or a control condition. It can inform a feasibility question if participation and assessment results are available, but it cannot isolate a causal treatment effect from other influences. The registry's listing of secondary measures does not supply their outcomes, and no conclusion about symptom or functioning changes can be drawn from outcome titles alone.

The safety counts show 0 serious adverse events among 14 at risk, 1 other adverse event among 14 at risk, and 0 deaths recorded. Those counts are descriptive and do not establish comparative safety or rule out events beyond the study. Taken together, the registry record describes the pilot's objective and structure, but not the results needed to determine how feasible or acceptable the intervention was.

14. Why This Trial Matters Statistically

Feasibility studies address a practical statistical question that precedes, but is distinct from, estimating treatment efficacy: can an intervention be delivered and can the intended outcomes be collected? This trial's stated focus on self-acupressure, session completion, and Day 42 survey responses fits that kind of question. The design and endpoint wording therefore matter because they define what the study could contribute if results are reported.

The primary endpoint combines an intervention-participation concept with a survey-completion condition. These are related but not identical aspects of feasibility. Clear reporting of the completion criterion, the number of participants assessed, and the handling of incomplete data would help readers understand what the count represents. Those outcome details are not reported in the registry record.

Statistically, a pilot's enrollment count should not be mistaken for evidence of precision or for a formal sample-size justification. The record lists 14 participants, but does not report an endpoint estimate or confidence interval. It also lists 0 analyses. Without those results, readers cannot judge the uncertainty around a feasibility estimate or use it to inform a later study design.

The single-group structure is also important. It is appropriate to describe the intervention as a one-group pilot, but that structure does not support a controlled estimate of treatment effect. Keeping feasibility conclusions separate from efficacy conclusions prevents the study's aim from being overstated. The registry record gives useful context about the intervention and intended assessments, while leaving the primary statistical result unavailable.

15. 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 for interpreting this trial is that the registry record does not report the primary endpoint result. It describes a count of participants completing study sessions and relates the results to Day 42 survey completion, but does not provide the number meeting either condition. The record also omits an estimate of uncertainty, so neither the magnitude nor precision of feasibility can be assessed.

The design is single-group, with allocation listed as NA and masking listed as none. There is no control comparison from which to estimate a difference attributable to the intervention. The registry does not report additional eligibility information, the number or duration of sessions, a detailed completion definition, or how partial participation was treated. These design and operational details are not reported in the registry record.

Although secondary outcomes are listed for fibromyalgia symptoms and PROMIS-29 +2 domains, their results are not reported in the registry record. The record lists 14 outcome measures and 0 analyses, but does not give an analysis population, a missing-data approach, a multiplicity plan, or interim-analysis details. It also does not report a sample-size justification for the trial's own design. These gaps prevent assessment of the planned statistical framework and the completeness of the reported outcomes.

The safety information is limited to group-level counts: 0 serious adverse events, 1 other adverse event, and 0 deaths among the recorded at-risk participants. The description of the other event and its relationship to the intervention are not reported in the registry record. These counts cannot be compared with a control group or interpreted as a complete account beyond the recorded categories.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Acupressure in Rheumatoid Arthritis — NCT05412121.
• Registry record last updated 2024-05-09; status last verified 2024-04.
• Results first posted 2024-05-09.
• 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.

19. Record Summary

NCT05412121 is a completed, single-group pilot of acupressure for people with rheumatoid arthritis, sponsored by the University of Michigan. Enrollment is listed as 14. The study began on 2022-09-15 and reached primary completion on 2023-07-14.

Participants were to use a modified MeTime Acupressure mobile application with in-person or virtual instruction from study staff. The primary outcome concerns the number of study sessions completed, with the description tying results to all surveys administered at the Day 42 visit. Secondary outcomes include the Fibromyalgia Survey Questionnaire and PROMIS-29 +2 domains.

The registry lists 14 outcome measures and 0 analyses. Primary and secondary outcome results, analysis methods, and uncertainty estimates are not reported in the registry record. Safety counts are 0 serious adverse events, 1 other adverse event, and 0 deaths among 14 at risk.