Developing and Testing a Comprehensive MS Spasticity Management Program: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Developing and Testing a Comprehensive MS Spasticity Management Program (NCT02170779), a randomized phase 2 study. The primary outcome is MS Walking Scale-12 (MSWS-12).

2. Clinical Question

This is a question about the observed score difference between randomized groups at the stated follow-up time. It is not a question about a change from baseline: the posted primary outcome is reported as a group mean at an average of 4 months, and baseline outcome values or a baseline-adjusted comparison are not reported in the registry record. The registry describes the trial as a pilot intended to evaluate acceptance and efficacy of education and stretching for MS-related spasticity. Acceptance results are not reported in the registry record.

The primary outcome is patient-reported walking impact rather than a direct measure of walking speed or distance. Other posted outcomes include timed walking tests, fatigue, quality of life, spasticity, and depression measures, but the primary question concerns the MSWS-12. The randomized comparison can describe how the groups’ posted scores differed; interpreting that difference also requires attention to its uncertainty, the small numbers contributing outcome data, and the analysis methods recorded for the trial.

3. Trial Design

The registry record describes a randomized, parallel-group Phase 2 trial with no masking. The study was completed, and enrollment was 40. The listed study dates are 2015-10 for the start and 2016-05 for primary completion. The sponsor is the VA Office of Research and Development.

One group received Spasticity: Take Control, a behavioral intervention focused on education and specific lower-extremity stretches. Its arm description lists four visits: baseline, viewing and discussing DVDs, stretching practice, and outcome measures. The other group received usual care; its description lists two visits, with baseline, a brochure for stretching, and outcome measures. The visit schedules therefore differed between arms, as did the amount of described contact. The registry record does not report whether this difference was accounted for in the analysis.

The posted primary outcome is the MS Walking Scale-12 at an average of 4 months. The primary outcome summaries include 19 participants in each arm. For the posted secondary timed walking outcomes, the program group has 19 participants and the usual-care group has 18. Enrollment and the outcome-specific numbers are distinct pieces of information; the registry record does not explain why the numbers contributing to these summaries differ from total enrollment.

Random allocation supports a between-group comparison, but the record does not report details such as the randomization sequence, allocation concealment, or stratification. Masking is listed as none. The trial is identified as a randomized controlled pilot trial in the study summary. The original sample-size rationale, prespecified analysis plan, and any interim-analysis procedures 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

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 MS Walking Scale-12 (MSWS-12), measured over at average of 4 months.

The primary endpoint is the MS Walking Scale-12 (MSWS-12), reported in units on a scale at an average of 4 months. The registry describes it as a clinically validated and reliable tool intended for clinical and research use. It captures participants’ perspectives on ambulatory disability across activities and experiences such as standing, running, walking around the home, maintaining balance, climbing stairs, walking distance, and the effort needed to walk.

Each of the 12 items uses a five-point response scale, from “Not at all” to “Extremely.” The item responses are combined and transformed to a 0 to 100 scale. Higher values represent worse outcome and greater disability. That direction matters when reading the group means: a lower mean is a lower reported level of walking-related disability on this scale, but the group summaries alone do not establish why the scores differ.

A patient-reported measure complements timed walking tests because it represents the participant’s view of how walking affects daily function, rather than only performance on a specified test. The registry’s description says the measure is responsive to changes in patient performance over time. In this trial, however, the posted primary summaries are group means at the stated follow-up time. Change-from-baseline results, a threshold for a clinically important difference, and a separate analysis of responsiveness are not reported in the registry record.

7. Results Posted in the Registry

• B Usual Care: mean 82.20 versus 72.60 on control; difference 9.60 (95% CI -8.91 to 28.11), standardized effect d = 0.33; z-test p = 0.309.

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.

Timed 25 Foot Walk

• 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:
  • B Usual Care: mean 9.40 versus 7.60 on control; difference 1.80 (95% CI -3.94 to 7.54), standardized effect d = 0.20; z-test p = 0.539.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between B Usual Care and the control. The interval gives the range of effects that remain compatible with the data.

Timed up and go Test

• 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:
  • B Usual Care: mean 13.82 versus 11.23 on control; difference 2.59 (95% CI -5.02 to 10.20), standardized effect d = 0.22; z-test p = 0.505.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between B Usual Care and the control. The interval gives the range of effects that remain compatible with the data.

2 Minute Walk Test

• 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:
  • B Usual Care: mean 412.50 versus 462.80 on control; difference -50.30 (95% CI -150.07 to 49.47), standardized effect d = -0.33; z-test p = 0.323.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between B Usual Care and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary numerical results cover the Timed 25 Foot Walk, Timed up and go Test, and 2 Minute Walk Test. Their mean differences are imprecise, and each recalculated confidence interval includes zero. The registry’s reported rank-based p-values for these comparisons are 0.738, 0.843, and 0.638. Taken together, these results do not provide a consistently precise secondary-outcome estimate that would resolve the uncertainty in the primary comparison.

The secondary measures assess aspects of walking performance that complement the participant-reported MSWS-12. They are not interchangeable with the primary scale: a timed test records performance on a defined task, while the MSWS-12 summarizes reported walking-related disability across several experiences. Similarity or difference in their numerical patterns should not be treated as proof that one measure confirms or contradicts another, particularly when the estimates are imprecise and measure different constructs.

The registry lists other secondary measures, including fatigue, multiple sclerosis impact, spasticity, and depression measures. Numerical results for those measures are not reported in the registry record. This limits the extent to which the broader secondary-outcome pattern can be assessed. In particular, the listed outcomes should not be assumed to have results that match the three posted timed walking outcomes.

Secondary findings generally carry less weight when several outcomes are examined without a reported multiplicity strategy. Testing many outcomes increases the opportunity for apparently notable findings to arise by chance, while unadjusted p-values do not account for that broader set of comparisons. The registry record does not report whether adjustment, outcome hierarchy, or selective reporting safeguards were prespecified. Accordingly, the secondary results are most appropriately treated as supportive descriptive information rather than independent confirmation of the primary result.

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

• Timed 25 Foot Walk
• Timed up and go Test
• 2 Minute Walk Test
• Modified Fatigue Impact Scale (MFIS)
• Multiple Sclerosis Impact Scale (MSIS-29)
• Spasticity Measured by the Modified Ashworth Scale
• Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)
• Beck Depression Inventory II (BDI II)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a numerical scale score summarized with a mean and standard deviation. A mean describes the center of the observed scores, while the standard deviation describes their spread around that mean. The MSWS-12 group means are 72.6 and 82.2, with standard deviations of 27.3 and 30.8. The corresponding outcome summaries include 19 participants in each group. These summaries do not show the individual scores or the shape of their distributions.

What does a mean difference represent?

A mean difference subtracts one group’s mean from the other’s. The recalculated primary comparison is expressed as usual care minus Spasticity: Take Control, giving 9.6 units. With that ordering, a positive estimate means the usual-care mean is numerically higher. Because higher MSWS-12 scores indicate worse outcome, the direction of this estimate is consistent with a lower mean score in the program group. The estimate is not a measure of change from baseline, and the registry does not report an adjustment for other variables.

A confidence interval accompanies the estimated difference. In general, it conveys uncertainty around an estimate under the assumptions of the statistical method used. The primary interval runs from -8.906 to 28.11. Since it contains zero, the data are compatible with no mean difference as well as with differences in either direction. An interval is not a guarantee that the true effect lies within its limits, and its interpretation depends on the method and coverage level. The registry record does not report the confidence-interval level or the calculation method for the posted sponsor analysis.

Why are there two kinds of comparison?

The registry reports a Wilcoxon (Mann-Whitney) analysis for the primary outcome and the listed timed walking outcomes. In general, this is a rank-based comparison: it uses the ordering of observations rather than directly testing a difference between arithmetic means. Its interpretation concerns the distributions or relative ordering of observations, and it is not automatically a test of a difference in means. The registry gives p = 0.84 for the primary comparison but does not report a test statistic, confidence interval, or further details for that analysis.

The recalculated mean differences and confidence intervals are simple, unadjusted calculations from the posted group summaries. They summarize mean differences and do not reproduce the registry’s rank-based test. The recalculated primary p-value is 0.309. The difference between that p-value and the registry-reported p-value reflects the distinction between the analysis based on summary means and the reported Wilcoxon (Mann-Whitney) method; it does not by itself establish an error in either result. The registry does not report an analysis plan that would clarify which result was designated for interpretation beyond listing the reported test.

What does a p-value tell the reader?

In general, a p-value measures how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the test assumptions were correct. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. A p-value also does not express precision as directly as an interval estimate. For this trial, the registry-reported primary p-value is 0.84, while the recalculated mean-based p-value is 0.309. Neither number should be read in isolation from the estimated difference, confidence interval, outcome scale, and small outcome-group counts.

All posted p-values are unadjusted in the information available for these comparisons. Whether the trial planned a multiplicity adjustment, a hierarchy among outcomes, or a particular approach to multiple testing is not reported in the registry record. Unadjusted secondary p-values do not account for the fact that several outcomes were assessed, so they warrant more caution than a single prespecified primary comparison.

What information is missing about the analysis?

The registry record does not report the statistical analysis plan, the handling of missing observations, the analysis population, or whether the primary comparison was adjusted for baseline values. It also does not state whether the reported means are based on all randomized participants or another analysis set. These omissions limit the ability to assess how the reported outcome summaries relate to the original protocol and how sensitive they might be to analysis choices.

The primary comparison is based on posted summary statistics, not participant-level data. Consequently, it is not possible from these summaries to inspect distributions, assess outliers, verify assumptions, or reproduce the rank-based analysis. The recalculation is useful as a transparent mean-based description, while the sponsor-reported test remains a separate analysis with a different statistical basis. Neither should be treated as a substitute for unreported protocol and analysis details.

11. Confidence Intervals and Precision

The primary estimated mean difference is 9.6 MSWS-12 units, with a confidence interval from -8.906 to 28.11. The interval includes zero and extends to estimates on both sides of zero. This means the posted data do not precisely distinguish a positive mean difference from no difference or a difference in the opposite direction. The registry’s direction convention for the recalculated estimate is usual care minus the program group, so the positive point estimate corresponds to the higher observed mean in usual care.

In general, a confidence interval communicates the uncertainty in an estimate under a specified statistical procedure. A narrow interval indicates greater precision than a wide interval, but precision is not the same as clinical importance or absence of bias. The primary interval is wide relative to the point estimate, and the registry record does not report the confidence level or the method used to construct the sponsor’s analysis. The mean-based interval is a recalculation from posted summary statistics, not the interval from the registry’s Wilcoxon analysis.

The secondary mean-difference intervals are also broad and include zero. For the Timed 25 Foot Walk, the interval is -3.944 to 7.544 seconds; for the Timed up and go Test, it is -5.022 to 10.2 seconds; and for the 2 Minute Walk Test, it is -150.1 to 49.47 feet. These ranges illustrate that the observed group means do not yield highly precise estimates of between-group differences. They should not be interpreted as defining all plausible clinical consequences, and the registry does not report thresholds for clinical importance.

Precision is affected by the amount of outcome information and variability in the observations. The primary summaries have 19 participants per arm, and the secondary timed walking summaries have 19 in the program group and 18 in usual care. The reported standard deviations indicate substantial spread in the primary scores and timed walking measures. The available aggregate information cannot show whether distributions are skewed, whether individual observations strongly influence the means, or how missing outcomes may have affected precision.

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 sample-size figures are planning illustrations, not a description of the trial’s original design calculation. For continuous outcomes such as these, the figures refer to participants per arm, not total events. The listed planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set to the stated fraction of the observed effect.

The 80% power column represents a planning scenario in which the assumed effect would be detected by the specified test in 80% of repeated studies under those assumptions. The 90% column uses a higher target probability of detection under the same general planning framework. These are prospective planning probabilities conditional on the assumed effect and statistical model; they are not probabilities that the observed trial result is correct. The original trial’s sample-size assumptions and justification are not reported in the registry record.

Planning scenarios use 100%, 75%, and 50% of the observed effect. The smaller-effect scenarios require more participants per arm than the larger-effect scenario, because a smaller difference is harder to distinguish from random variation while holding the other assumptions fixed. For the primary endpoint, the illustration gives 145 participants per arm for 80% power and 194 for 90% power when planning for 100% of the observed effect. The corresponding requirements are 257 and 344 when planning for 75%, and 578 and 773 when planning for 50%.

These figures are not observed power. They should be read as conditional planning illustrations based on the observed estimate, rather than as evidence that the completed study had a particular probability of finding an effect or that a future study would necessarily need exactly those numbers. Different design assumptions or a different target effect would lead to different planning estimates. The registry record does not report the trial’s own original sample-size rationale.

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 = 9.600; pooled standard deviation σ = 29.103.
2. n = 2 × (1.96 + 0.842)² × 29.103² / 9.600² = 144.3, rounded up to 145 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 <- 9.60000000000001                      # observed difference in means
sigma <- 29.1026631083824                     # 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(2170779)
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 = 145 (80% power), 194 (90% power)
 75% of observed effect: n per arm = 257 (80% power), 344 (90% power)
 50% of observed effect: n per arm = 578 (80% power), 773 (90% power)
power.t.test: 145.2 
Simulated power at n = 145 per arm: 0.800 (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

The registry reports a Wilcoxon (Mann-Whitney) comparison for the primary outcome, with p = 0.84. It does not report a sponsor-derived mean difference or confidence interval for that analysis. The recalculated comparison uses the posted group means and standard deviations to describe the unadjusted difference in means: 9.6 units, with a confidence interval from -8.906 to 28.11 and an unadjusted p-value of 0.309.

These are not identical analyses. The registry’s rank-based test compares the groups using the ordering of observations, whereas the recalculation summarizes the difference between arithmetic means from aggregate data. Different methods can produce different p-values because they use the data differently and answer related but distinct statistical questions. The recalculated values should therefore be understood as supplementary, mean-based descriptions rather than replacements for the registry-reported test.

The registry record does not give enough detail to reproduce the sponsor’s analysis, including participant-level data or a fuller statistical specification. It also does not report the analysis plan that would clarify the intended relationship between the rank-based test and the mean summaries. No discrepancy between a reported estimate and recalculation is flagged in the registry information. The distinct p-values are best read in light of their different methods, and neither alone establishes the clinical importance of the observed score pattern.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies the MSWS-12 as the primary outcome and lists multiple secondary outcomes. It reports a rank-based p-value for the primary comparison and for the posted timed walking outcomes. The record does not report a multiplicity procedure, such as an adjustment to account for testing several outcomes, or a hierarchy specifying how primary and secondary results were to be interpreted. The reported p-values should therefore be understood as unadjusted in the information available.

Multiplicity matters because each additional statistical comparison creates another opportunity to observe an apparently unusual result by chance, even when there is no corresponding underlying difference. In general, adjustment procedures or prespecified outcome hierarchies can help control how a collection of tests is interpreted. Without reported details, it is not possible to determine whether any such approach was planned or used. This is particularly relevant to secondary outcomes, which are often interpreted as exploratory when the analysis strategy is not documented.

The registry record also does not report how missing outcome data were handled, whether any imputation was used, or whether the analysis was restricted to participants with observed data. The posted primary summaries include 19 participants per arm, while the posted secondary timed walking summaries include 19 in the program group and 18 in usual care. The record does not explain the difference between these outcome counts and total enrollment of 40, or whether the counts reflect missing data, exclusions, or another analysis decision. No reason should be inferred from the counts alone.

The analysis population is not reported in the registry record. It is therefore unclear whether results follow an intention-to-treat approach, a per-protocol approach, or another definition. Baseline adjustment, handling of protocol deviations, and sensitivity analyses are also not reported. These omissions make it harder to assess the robustness of the estimates and how closely the posted summaries reflect the original randomized comparison.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The adverse-event information reports zero serious adverse events among 19 participants at risk in the Spasticity: Take Control group and zero among 19 at risk in usual care. For other adverse events, 1 participant is reported affected in the program group and 5 in usual care, with 19 at risk in each group. These are the registry’s reported affected-participant counts; they are not a complete description of event types or severity.

No serious adverse-event terms are listed. Death counts are not reported in the registry record. The record does not provide additional detail about how adverse events were defined, how they were collected, or whether the groups had comparable follow-up for safety reporting. The observed counts should be read descriptively, especially in a small pilot trial. They do not establish that an event is caused by an intervention, and the difference in reported counts alone does not establish a reliable comparative safety estimate.

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

The posted primary results show that the mean MSWS-12 score at an average of 4 months was numerically lower in the Spasticity: Take Control group than in usual care. Because higher scores indicate worse walking-related disability, the direction of the observed means is toward a lower reported disability score in the program group. The estimated mean difference is 9.6 units, but its confidence interval ranges from -8.906 to 28.11 and includes zero.

These data do not provide a precise estimate of the primary group difference. They are compatible with no mean difference and with estimates in either direction. The registry-reported rank-based p-value is 0.84, while the mean-based recalculation gives a different unadjusted p-value because it uses a different statistical comparison. The posted results should not be reduced to a single p-value or treated as a binary verdict.

The findings also do not establish whether any observed difference is clinically important. A threshold for a meaningful MSWS-12 difference is not reported in the registry record. Nor do the reported endpoint means establish change from baseline, because baseline scores and change estimates are not reported. The secondary timed walking results have broad intervals that include zero, and numerical outcomes for several other listed measures are not reported in the registry record.

This is a randomized pilot trial with outcome summaries based on small group counts. Randomization is an important design feature, but the record does not report details of allocation concealment, the analysis population, missing-data handling, or a full statistical plan. Those limitations affect how confidently the estimates can be interpreted and generalized. The results are best viewed as preliminary comparative evidence with substantial uncertainty, not as definitive proof for or against the program.

Nothing in these posted statistical results alone determines an individual’s care. They describe group-level outcomes in this trial and do not replace clinical judgment or establish that the intervention caused a particular participant’s experience.

18. Why This Trial Matters Statistically

This trial illustrates why statistical interpretation requires more than comparing group means or checking whether a p-value crosses a threshold. The primary means differ numerically, but the confidence interval is broad and includes zero. The estimate’s direction, uncertainty, outcome scale, and analysis method all matter to the interpretation. A single summary number cannot convey all of those features.

The registry also makes the distinction between a rank-based sponsor analysis and a mean-based recalculation important. These methods use different aspects of the outcome data, and they can yield different p-values without representing a simple arithmetic disagreement. Clear reporting of the analysis plan, estimand, and confidence-interval method would help readers understand how each result was intended to inform the trial’s main question.

The pilot setting highlights the limits of small studies for estimating effects precisely. The posted outcome counts are modest, and the observed variation in scores is substantial. Planning illustrations can show how required sample sizes depend on the effect a study aims to detect, but they are not evidence about the probability that the completed study found a true effect. The original sample-size justification is not reported.

Finally, the registry lists a range of secondary outcomes, while numerical results are available for only some measures. A clearly reported multiplicity plan, missing-data approach, and analysis population would make the full pattern easier to evaluate. These considerations are broadly relevant in clinical research: statistical conclusions depend not only on the observed results, but also on which outcomes were planned, how analyses were conducted, and how uncertainty is communicated.

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.

This is a small pilot comparison: enrollment was 40, and the primary outcome summaries include 19 participants per arm. The registry does not explain the relationship between enrollment and outcome-specific counts. The secondary timed walking summaries include 19 participants in the program group and 18 in usual care. Without reported reasons or missing-data methods, readers cannot determine why these counts differ.

The study is listed as unmasked. Participants and study staff therefore were not masked according to the registry entry. For a behavioral education and stretching program, the registry does not report whether outcome assessment was separately masked. The arm descriptions also indicate different numbers of visits and different materials or activities. Any effects of contact, attention, or expectations cannot be separated from the specific program elements using the information reported.

The primary results are endpoint means at an average of 4 months. Baseline scores, changes from baseline, and baseline-adjusted estimates are not reported in the registry record. The record does not give the analysis population, missing-data approach, allocation-concealment details, or full statistical plan. It also does not report the confidence-interval level or a clinical-importance threshold for the primary scale.

Only some of the listed secondary measures have numerical results in the registry record. Results for the other listed measures, a reported multiplicity approach, and details of adverse-event definitions and collection are not available. These limitations constrain assessment of the overall outcome pattern, the robustness of estimates, and the degree to which the findings apply beyond the participants and follow-up described in this pilot study.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Developing and Testing a Comprehensive MS Spasticity Management Program — NCT02170779.
• Registry record last updated 2017-03-28; status last verified 2017-02.
• Results first posted 2017-03-28.
• 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

NCT02170779 is a completed randomized, parallel-group Phase 2 pilot trial titled “Developing and Testing a Comprehensive MS Spasticity Management Program,” sponsored by the VA Office of Research and Development. It enrolled 40 participants and compared Spasticity: Take Control with usual care for multiple sclerosis-related spasticity.

The primary outcome was the MSWS-12 at an average of 4 months. The reported group means were 72.6 for the program and 82.2 for usual care. The recalculated unadjusted mean difference was 9.6, with a confidence interval from -8.906 to 28.11; the registry-reported Wilcoxon (Mann-Whitney) p-value was 0.84.

Posted secondary numerical findings include three timed walking measures. Their recalculated confidence intervals include zero. The trial’s original sample-size rationale, multiplicity strategy, analysis population, and handling of missing data are not reported in the registry record.