Preoperative Acupuncture for Total Knee or Hip Arthroplasty: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Preoperative Acupuncture for Total Knee or Hip Arthroplasty (NCT06099223), a randomized na study. The primary outcome is Perioperative Anxiety.

2. Clinical Question

The registry describes a randomized controlled trial intended to assess whether preoperative acupuncture affects anxiety before surgery and pain after surgery. Its stated hypothesis also includes postoperative nausea and vomiting, opioid consumption, and patient satisfaction. The posted primary endpoint, however, is anxiety measured only in the acupuncture group before and after the procedure. It therefore describes a within-group change over time, rather than a comparison of anxiety outcomes between the randomized acupuncture and no-acupuncture groups.

This distinction matters when interpreting the clinical question. A before-and-after change can show that scores differed at the two measurement times among participants who received acupuncture. Without a reported control-group anxiety score at matching times, it cannot establish how much of that change is attributable to acupuncture rather than to other influences or the passage of time. The registry record does not report a between-group primary anxiety estimate.

3. Trial Design

The registry identifies NCT06099223 as a completed, randomized, open-label, parallel-group trial sponsored by Hartford Hospital. Enrollment was 60. The study began on 2022-03-21, and primary completion was recorded as 2023-04-03. The phase is listed as NA. Participants were assigned to preoperative acupuncture or no acupuncture; masking was none.

The trial concerned patients undergoing total knee or hip arthroplasty who were described in the brief summary as having high anxiety. The intervention is listed as acupuncture needles. The registry’s primary outcome is perioperative anxiety, assessed with a Visual Analog Scale before acupuncture and 30 minutes after acupuncture. Its description says the scale is a 10 centimeters line from 0-100, with higher scores indicating worse anxiety. Only participants in the acupuncture group completed this measure, and the outcome description gives n=30 for that group.

The registry lists 19 outcome measures and 17 analyses. Secondary outcomes include preoperative pain, opioid consumption, midazolam use, satisfaction measures, nausea and vomiting, antiemetic medications, and hospital length of stay. Numerical results are posted for some secondary measures, but the registry record does not report numerical results for every listed outcome in the registry record for this analysis.

The completed status and randomized allocation describe the trial’s overall design, but they do not by themselves establish that each outcome was analyzed according to randomized assignment. The analysis populations, handling of missing observations, allocation concealment, and the trial’s original sample-size assumptions are not reported in the registry record. Those omissions limit how fully the design and analysis can be evaluated from the posted information.

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: Of 123 screened patients, 60 met the inclusion criteria and were randomized to treatment. 31 patients declined participation, 26 patients did not meet the eligibility criteria, 5 patients consented but had surgery cancellation, and 1 patient withdrew consent.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Only participants in the acupuncture group (n=30) completed the Visual Analog Scale to reflect the level of anxiety they had before and 30 minutes after receiving the acupuncture procedure.

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 Perioperative Anxiety, measured over Prior to acupuncture and 30 minutes after acupuncture.

The primary endpoint is perioperative anxiety measured with a Visual Analog Scale. Participants mark a line to indicate how anxious they feel at the time of assessment. The registry describes the line as 10 centimeters long and scored from 0-100, with 0 meaning not at all anxious and 100 meaning very anxious. A higher score represents worse anxiety.

Anxiety is relevant to the stated research question because the trial concerns an intervention administered before surgery and specifically aims to assess preoperative anxiety. Measuring the score before acupuncture and again 30 minutes after it allows the investigators to describe whether the acupuncture group’s reported anxiety changed over that interval. The posted group means are 60.73 before acupuncture and 28.9 after acupuncture, with standard deviations of 21.28 and 21.54, respectively.

The endpoint’s measurement schedule and population constrain its interpretation. The registry says only participants in the acupuncture group completed the scale. The two means therefore describe that group at two time points; they do not show what anxiety would have been over the same interval without acupuncture. The record does not report an anxiety score for the control group at corresponding times. Nor does the outcome description report a threshold for a clinically important change. The score is a measure of reported anxiety, not a direct measure of postoperative recovery or a substitute for the trial’s other planned outcomes.

7. Results Posted in the Registry

• Preoperative Post-acupuncture: mean 28.90 versus 60.73 on control; difference -31.83 (95% CI -42.66 to -21.00), standardized effect d = -1.49; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Preoperative Pain

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Preoperative Post-acupuncture: mean 2.90 versus 4.97 on control; difference -2.07 (95% CI -4.67 to 0.53), standardized effect d = -0.40; z-test p = 0.119.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Preoperative Post-acupuncture and the control. The interval gives the range of effects that remain compatible with the data.

Opioid Consumption

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Acupuncture: mean 45.51 versus 52.46 on control; difference -6.95 (95% CI -22.37 to 8.47), standardized effect d = -0.23; z-test p = 0.377.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Acupuncture and the control. The interval gives the range of effects that remain compatible with the data.

Midazolam Use as Anxiolytic Medications

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Acupuncture: mean 3.96 versus 4.21 on control; difference -0.25 (95% CI -1.14 to 0.64), standardized effect d = -0.14; z-test p = 0.583.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Acupuncture and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes add context but do not provide a uniform pattern of clear statistical evidence. The numerical comparisons include preoperative pain measured before and after acupuncture, and medication use compared between acupuncture and control. The posted means move in a direction favoring lower values after acupuncture for pain and in the acupuncture group for opioid consumption and midazolam use. The recalculated intervals for these outcomes include zero. The registry-reported pain p-value differs substantially from the recalculated result, while the reported medication-use p-values are broadly similar to the recalculations.

These secondary findings do not resolve the main limitation of the primary anxiety result: anxiety is reported only for the acupuncture group. Nor do the secondary outcomes establish a common effect across pain, medication use, satisfaction, nausea and vomiting, antiemetic use, and length of stay. Numerical results for all the listed outcomes are not reported in the registry record details available for this analysis. Secondary results should therefore be treated as supporting or exploratory context rather than as a single coherent confirmation of the primary finding.

There are 17 analyses and 19 outcome measures listed. When many outcomes or comparisons are examined, the chance of obtaining apparently persuasive results by chance can increase. Adjusting for multiplicity is one way to address that issue, but the registry record does not report whether an adjustment was planned or applied. Unadjusted p-values for secondary outcomes consequently carry less weight than results from a clearly prespecified analysis with an explicit strategy for multiple comparisons. The record also does not report which outcomes were designated as key secondary outcomes or how the analyses were prioritized.

In practical statistical terms, the secondary results are compatible with uncertainty rather than a definitive pattern. They can help identify questions for better-described studies, but the posted summaries do not establish the effects of acupuncture on the broad range of outcomes named in the trial hypothesis.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Patient Satisfaction With Acupuncture Procedure
• Preoperative Pain
• Opioid Consumption
• Midazolam Use as Anxiolytic Medications
• Patient Satisfaction Scale With Overall Care
• Occurrence of Nausea and Vomiting at First Postoperative Hour
• Antiemetic Medications
• Hospital Length of Stay

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a numerical anxiety score on a scale. The registry reports means and standard deviations for the two measurement times. A mean describes the average score in a group. A standard deviation describes how spread out individual scores are around that mean; it is not the same as the uncertainty around the mean or the uncertainty around a treatment effect.

The posted primary comparison is expressed as a mean difference of -31.83, calculated from the pre-acupuncture mean of 60.73 and post-acupuncture mean of 28.9. The negative direction indicates that the later group mean is lower. The registry reports a two-sided t-test and p < 0.001. A two-sided test evaluates evidence for a difference in either direction, rather than prespecifying only an increase or only a decrease. A p-value describes how incompatible the observed data are with a specified no-difference model under the test’s assumptions; it is not the probability that the null hypothesis is true, nor does it measure clinical importance.

There is an important design distinction between a paired measurement and an independent-group comparison. The primary description says the same acupuncture participants completed the anxiety scale before and after receiving acupuncture. In a paired analysis, each participant’s change contributes to the estimate, and the variability of those changes is relevant. The registry record does not report the individual changes, their standard deviation, or the covariance between the two measurements. It names a t-test but does not report whether the primary test was paired. The posted group means and standard deviations alone do not recover all the information needed to evaluate a paired analysis.

The recalculated comparison uses the posted summary statistics to describe the difference in means and its uncertainty. It is a simple, unadjusted recalculation, not a replacement for the sponsor’s analysis. Because the two anxiety measurements come from the same group at different times, the recalculated interval should be interpreted with the missing paired information in mind. It is not a randomized treatment contrast: the control group’s corresponding anxiety data are not reported.

Confidence intervals express a range of values compatible with the data and the analysis assumptions. For a mean difference, an interval entirely below zero indicates that the compatible differences are negative under that calculation; an interval crossing zero includes no difference as a compatible value. The interval does not account for sources of uncertainty that the analysis has not modeled, such as unreported missing data or an unreported multiplicity strategy. Its coverage level is not stated in the registry record, so no particular level should be assumed from the registry entries.

The secondary outcomes use the same general distinction between a group summary and an inferential comparison. Preoperative pain is reported as a mean and standard deviation before and after acupuncture. Opioid consumption and midazolam use are reported as means and standard deviations for acupuncture and control. The registry reports two-sided t-tests for these comparisons. The recalculations give an unadjusted mean difference, confidence interval, and p-value from the posted summaries. Such calculations are useful for checking the direction and approximate precision of the posted group summaries, but they do not incorporate participant-level covariates, a repeated-measures correlation, or any adjustment that might have been used in an analysis that is not fully described.

Over-dispersion is a general concern for count data when variability exceeds what a simple model assumes. These posted outcomes are described as continuous means with standard deviations, rather than as counts, so over-dispersion is not the central issue for the comparisons presented. More generally, a statistical model should reflect how the outcome was measured and how observations are related. Repeated measurements from one participant are related; treating them as independent can misstate uncertainty. Whether that issue affected the sponsor’s test cannot be determined because the method is described only as a two-sided t-test.

Randomization is intended to make groups comparable on average at baseline, supporting causal comparisons when the randomized groups are analyzed appropriately. It does not transform a pre-to-post comparison within only one randomized group into a randomized contrast. For the anxiety endpoint, the missing control-group measurement prevents a direct comparison of changes across randomized groups. For outcomes reported across acupuncture and control, the arm summaries allow comparisons, but the registry record does not report detailed adjustment, covariates, or analysis populations.

The trial’s original statistical plan, including any prespecified primary analysis details, sample-size justification, interim analyses, and multiplicity strategy, is not reported in the registry record. The displayed recalculations are unadjusted and based on posted summary statistics. They should be read as descriptive analytical checks alongside, not in place of, the registry’s own reported analyses.

11. Confidence Intervals and Precision

For the primary anxiety outcome, the recalculated mean difference is -31.83, and its confidence interval extends from -42.66 to -21.0. Because the entire interval is below zero, the summary-statistic calculation is consistent with a lower average score after acupuncture. The interval’s width conveys uncertainty around that estimated difference under the calculation used. It does not establish that the change was caused by acupuncture, because a matching control-group anxiety outcome is not reported.

The reported standard deviations, 21.28 before acupuncture and 21.54 afterward, describe variation in scores at each measurement time. They are not a direct description of the spread of within-person changes. Since the record does not report the paired changes or the covariance between pre- and post-acupuncture scores, the available summaries do not show how much individual participants’ scores moved together across the two measurements. That missing information limits interpretation of the precision of a paired change estimate.

For preoperative pain, the recalculated interval runs from -4.672 to 0.532 and includes zero. The corresponding recalculated p-value is 0.119. For opioid consumption, the interval is -22.37 to 8.471, and for midazolam use it is -1.143 to 0.643; both include zero. These intervals indicate that the recalculations do not pin down a nonzero difference at the displayed precision. They do not demonstrate equivalence or rule out potentially meaningful differences.

Confidence intervals describe statistical uncertainty conditional on the data and method, not every uncertainty in the evidence. The registry record does not report the confidence-interval level or enough detail to assess all analysis assumptions. Precision should therefore be considered alongside the limited endpoint reporting, missing paired information for anxiety, and unreported handling of missing outcomes.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm for 80% power and participants per arm for 90% power. They are planning illustrations based on the observed effect, not the trial’s original design assumptions. The registry record does not report the original sample-size justification or its assumptions.

The listed illustration assumes a two-sided significance level 0.05, equal allocation between the two arms, and a normal approximation. It considers detecting the stated fraction of the observed effect: 100%, 75%, or 50%. The power columns express the chance, under those planning assumptions and an effect of the specified size, of detecting a difference at the stated significance level. The 90% column targets a higher chance of detection than the 80% column, and therefore requires more participants for the same assumed effect.

The general pattern is that smaller effects require more participants. Detecting 50% of the observed effect takes a larger planned sample than detecting the full observed effect, because a smaller signal is harder to distinguish from variability. The illustrations are not observed power and do not describe the probability that the trial’s actual result is correct.

These figures should be treated cautiously because they are based on effects observed in a small trial and use a simplified normal approximation. They do not establish what the original investigators planned, whether the planned assumptions were met, or whether a future study should use the same effect size. The figures for the continuous outcomes are per arm, not total events. Time-to-event planning displays, if present, use total events, but the outcomes discussed in these recalculations are continuous.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -31.830; pooled standard deviation σ = 21.410.
2. n = 2 × (1.96 + 0.842)² × 21.410² / -31.830² = 7.1, rounded up to 8 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -31.83                      # observed difference in means
sigma <- 21.4103946717476                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(6099223)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 8 (80% power), 10 (90% power)
 75% of observed effect: n per arm = 13 (80% power), 17 (90% power)
 50% of observed effect: n per arm = 29 (80% power), 39 (90% power)
power.t.test: 8.2 
Simulated power at n = 8 per arm: 0.787 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

For perioperative anxiety, the registry reports a two-sided t-test with p < 0.001. The recalculation from the posted means also gives p < 0.001, with a mean difference of -31.83 and an interval from -42.66 to -21.0. The direction and broad evidence against no difference are aligned. The recalculation adds an estimate and interval based on the summary statistics, while the registry’s reported analysis remains the sponsor’s own analysis. The outcome is still a before-and-after comparison in the acupuncture group, rather than a randomized anxiety comparison against control.

For preoperative pain, the registry reports p < 0.001, whereas the unadjusted recalculation from the posted summary statistics gives p=0.119 and an interval from -4.672 to 0.532. These do not tell the same statistical story. The registry reports p=0.38 for opioid consumption and p=0.61 for midazolam use; the corresponding recalculated p-values are 0.377 and 0.583. Those values are similar in broad interpretation, although they are not identical.

The record does not provide enough detail to determine why the pain result differs, including participant-level data or a fuller description of the sponsor’s analysis. The registry’s stated test is a two-sided t-test, but further details about pairing, analysis populations, and adjustments are not reported in the registry record. The recalculations are simple unadjusted checks of the posted summaries and cannot resolve that discrepancy. They should not be presented as the sponsor’s analysis or as a correction to it.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists 19 outcome measures and 17 analyses, spanning anxiety, pain, medication use, satisfaction, nausea and vomiting, and hospital length of stay. Examining multiple outcomes creates a multiplicity concern: even when there is no true effect, a collection of tests can produce a small p-value by chance. Prespecifying a primary endpoint and limiting or adjusting secondary comparisons can help readers distinguish confirmatory evidence from exploratory findings.

The record identifies perioperative anxiety as the primary outcome and lists several secondary outcomes, but a multiplicity strategy is not reported in the registry record. It is therefore not possible to tell whether the reported secondary p-values were adjusted, whether a testing hierarchy was used, or whether additional analyses were conducted but not posted. The unadjusted recalculations should not be interpreted as multiplicity-controlled evidence.

Missing-data handling is also not reported in the registry record. The posted primary description states that participants in the acupuncture group completed the anxiety measure, but it does not explain whether all randomized participants contributed data, how incomplete assessments were handled, or whether any imputation was used. The analysis populations are not reported in the registry record, so the extent to which analyses followed randomized assignment cannot be evaluated from these registry entries.

The registry record does not report the original sample-size justification, interim analyses, or a detailed statistical analysis plan. These omissions do not prove that such procedures were absent; they mean that their use cannot be assessed from the posted record. In particular, the planning illustrations based on observed effects do not answer whether the original trial was designed around the endpoint, effect, and analysis ultimately reported.

These gaps matter because selective outcome reporting, missing observations, and multiple testing can affect how much confidence to place in a result. They do not invalidate the posted values, but they limit the ability to judge whether the reported analyses were prespecified, complete, and appropriately controlled.

16. 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 zero serious adverse events among 30 participants in the acupuncture group and zero among 30 participants in the control group. It also reports zero deaths in both groups. These figures describe the serious-event counts posted in the record; they do not show that the risk of a rare or unobserved event is zero.

For other adverse events, the registry reports 13 affected participants among 30 at risk in the acupuncture group and zero among 30 at risk in control. The record does not list serious adverse event terms. The other-adverse-event figures should be kept separate from the serious-event figures: the presence of other reported events does not mean they were serious, and the record does not provide enough detail to characterize their type or severity.

Event counts in a trial of this size are descriptive and should be interpreted cautiously. They do not by themselves establish that the intervention caused an event or that the groups had equivalent safety. Further information on event definitions, timing, severity, relatedness, and completeness of reporting is not reported in the registry record.

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

The clearest numerical observation is that the acupuncture group’s mean anxiety score was lower 30 minutes after acupuncture than before it. The recalculated difference is -31.83, with a confidence interval from -42.66 to -21.0 and p < 0.001. The registry’s reported two-sided test also gives p < 0.001. This result describes change across measurement times in the group receiving acupuncture.

It does not establish that acupuncture caused the change. The primary anxiety scale was completed only by participants in the acupuncture group, so there is no reported control-group anxiety trajectory for comparison. Changes over time can reflect influences other than the intervention. The randomized design would support a causal comparison if the outcome were reported across randomized groups in a suitable analysis, but the primary anxiety result as posted is not such a comparison.

The result also does not establish that acupuncture reduces postoperative pain, opioid use, or other outcomes. The secondary results are limited, include uncertainty in the recalculations, and include a notable disagreement between the registry-reported and recalculated pain p-values. Numerical results for every outcome named in the trial’s hypothesis are not reported in the registry record. The serious adverse event counts are zero in each group, while other adverse events are reported in the acupuncture group; those counts do not establish overall safety or causation.

A small p-value is not a measure of the practical importance of a score change. The registry does not report a threshold for a clinically important difference on this anxiety scale. Nor does the posted material provide the paired participant-level changes needed to fully assess the uncertainty of the before-and-after measure. The most defensible reading is therefore narrow: reported anxiety scores were lower after acupuncture among the acupuncture participants measured, while the comparative effect and broader clinical consequences remain uncertain from this record.

18. Why This Trial Matters Statistically

This trial raises a useful statistical question about the relationship between randomization and outcome measurement. Randomized assignment can support a comparison between intervention groups, but only when the relevant outcome is measured and analyzed in those groups. Here, the primary anxiety result is a before-and-after description among acupuncture participants. The distinction between a within-group change and a randomized between-group contrast is central to interpreting the result.

The record also illustrates why effect estimates and uncertainty are more informative than a p-value alone. The primary recalculation provides a mean difference and confidence interval, allowing readers to see the estimated direction and precision under the summary-statistic calculation. Secondary comparisons show that reported means and test results need to be considered together, especially when the sponsor’s pain p-value does not match the unadjusted recalculation from the posted summaries.

Finally, the record highlights how transparent reporting supports appraisal. Details about paired analyses, missing observations, multiplicity, analysis populations, and the original sample-size plan would help readers assess the statistical evidence more fully. Their absence does not negate the posted observations, but it limits the conclusions that can be drawn from them. For clinical researchers, this is a reminder to align the endpoint, randomized comparison, analysis method, and reporting so that the intended treatment question can be evaluated directly.

19. 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 primary anxiety outcome is reported only for participants in the acupuncture group, with measurements before and 30 minutes after acupuncture. No corresponding control-group anxiety results are reported. As a result, the primary finding is a within-group time comparison rather than an estimate of the effect of assignment to acupuncture versus no acupuncture.

The registry does not report participant-level paired changes or the covariance between anxiety measurements. Without these details, the precision of the change cannot be independently assessed using a paired analysis. The registry names a two-sided t-test but does not specify whether the primary test accounted for the repeated measurements.

The pain result presents an additional limitation: the registry-reported p-value is < 0.001, whereas the recalculation from posted summary statistics gives p=0.119 and an interval that includes zero. The available record does not explain the difference. The secondary outcomes are also numerous, and a multiplicity strategy is not reported. Results for several listed outcomes are not included in the numerical details available for this analysis.

Missing-data procedures, analysis populations, allocation concealment, and the original sample-size justification are not reported in the registry record. The trial is open-label, and masking is listed as none. These features and reporting gaps limit assessment of potential bias, analysis choices, and generalizability. The registry describes a high-anxiety surgical population, but further eligibility details are not reported in the registry record.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Preoperative Acupuncture for Total Knee or Hip Arthroplasty — NCT06099223.
• Registry record last updated 2025-03-26; status last verified 2025-03.
• Results first posted 2025-03-26.
• 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.

23. Record Summary

NCT06099223 is a completed, randomized, open-label, parallel-group trial of preoperative acupuncture versus no acupuncture for patients undergoing total knee or hip arthroplasty. Enrollment was 60, and the sponsor was Hartford Hospital. The registry lists perioperative anxiety as the primary outcome, measured before and 30 minutes after acupuncture in the acupuncture group.

The acupuncture group’s mean anxiety score was 60.73 before treatment and 28.9 afterward. The recalculated mean difference was -31.83, with a confidence interval from -42.66 to -21.0 and p < 0.001. Because the control group’s anxiety outcome is not reported, this is not a randomized comparison of anxiety outcomes.

Selected secondary outcomes and adverse-event counts are posted, but their interpretation is limited by uncertainty, a mismatch between the registry and recalculated pain p-values, and unreported details about multiplicity, missing data, and analysis populations. The record supports a pre-to-post anxiety score change in the acupuncture group; it does not establish the comparative effect of acupuncture on anxiety or the broader outcomes in the trial hypothesis.