Exercise Application in the Treatment of Patients With Subacromial Pain Syndrome: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Exercise Application in the Treatment of Patients With Subacromial Pain Syndrome (NCT02695524), a randomized na study. The primary outcome is Change in Functionality Evaluated With Specific Questionnaire.

2. Clinical Question

3. Trial Design

The registry describes a randomized, double-masked, parallel-group trial with an enrollment of 60. The study is marked completed, was sponsored by the University of Sao Paulo, and has a listed start date of 2016-03 and primary completion date of 2017-07. The meaning of masking in practice, including which participants or study personnel were masked and how masking was maintained, is not reported in the registry record.

The listed exercise descriptions include scapula-focused movements such as side lying external rotation, prone horizontal abduction, scapular punch, knee push, full can and D1 diagonal. The motor control exercise description includes towel slide, scapular clock, PNF scapular, inferior glide modified, scapular orientation exercise, and protraction and retraction of the scapula. Both descriptions specify three times a week for 8 weeks and 3x10 repetitions. Adherence, progression, supervision and any deviations from the stated regimen are not reported in the registry record.

The registry summary describes the study as evaluating the addition of neuromuscular exercises with tactile, visual and auditory feedback to scapula-focused treatment, compared with a strengthening exercise protocol alone. The intervention and arm descriptions do not fully clarify how the listed exercise components map to each randomized group, so the treatment contrast should be read as described in the summary rather than reconstructed beyond it.

Functionality was scheduled for assessment at baseline, four and eight weeks, and sixteen weeks after randomization. The exercise program is described as lasting 8 weeks, while outcome follow-up extends to sixteen weeks. The statistical analysis plan and sample-size justification 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 Change in Functionality Evaluated With Specific Questionnaire, measured over baseline, four and eight weeks and sixteen weeks after randomization.

The primary endpoint is change in functionality measured with the Brazilian version of the Shoulder Pain and Disability Index. The registry describes the instrument as ranging from 0 to 100 points, with lower scores indicating better functionality. The measure is reported in units on a scale, and the listed summary statistic is the mean with a 95% confidence interval.

Functionality is relevant to this trial because the registry summary focuses on disability in people with subacromial pain syndrome. A patient-reported disability measure can capture how shoulder symptoms affect function, rather than describing only a physical measurement such as strength or range of motion. This is a general explanation of the role of such an endpoint, not a claim about what the trial found.

The registry schedules the primary measure at baseline, four and eight weeks, and sixteen weeks after randomization. That schedule allows the question to concern both change during the stated 8-week exercise program and the status at a later follow-up. However, no group means, changes, confidence intervals or statistical comparisons are reported in the registry record. Therefore, the endpoint’s definition and timing are available, but the size and precision of any observed difference are not.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as a continuous measure summarized by a mean and 95% confidence interval. The following concepts explain how such statistics are generally used; they do not describe analyses confirmed to have been performed in this trial. The registry record lists zero analyses, and the primary outcome is not reduced to a single comparison because it has several categories or time points.

What does a mean represent?

For a continuous measure, a mean is the arithmetic average of the observed values in the group or analysis set being described. In a trial, a group mean can describe the level of functionality at a specified assessment time, while a mean change can describe movement from a baseline measurement. Those are different quantities: a follow-up score and a change score should not be treated as interchangeable. The registry identifies the primary outcome as change in functionality, but does not report the observed means or clarify an analyzed change contrast.

The scale ranges from 0 to 100 points, and lower scores indicate better functionality. This direction is important when interpreting any future or separately reported estimates: the numerical direction of a difference must be read alongside the scale’s scoring rule. Without outcome values, the direction of the trial’s result cannot be established.

What does a 95% confidence interval convey?

In general, a confidence interval gives a range of values compatible with an estimate under the statistical model and its assumptions. It communicates uncertainty about the estimate; it is not a range containing the results of individual participants, and it does not by itself establish clinical importance. The interval’s width is informative about precision, while its position relative to a relevant reference value informs the interpretation of the estimate.

For a group difference, the reference value is commonly no difference. For a change within one group, the relevant reference may be no change. The exact estimand and comparison must be clear before interpreting an interval. The registry lists a 95% confidence interval as the dispersion measure but gives no endpoints, so neither the estimate nor its precision can be evaluated.

Why do repeated assessment times matter?

Functionality is scheduled at baseline, four and eight weeks, and sixteen weeks after randomization. Repeated measurements on the same participants are related rather than independent observations. As a general statistical matter, an analysis of repeated outcomes should account for that within-participant relationship and should make clear whether the target is change at a particular time, an average pattern over time, or a group-by-time contrast. Different choices answer different questions.

A single result selected from several assessment times can also give an incomplete picture. A prespecified primary time point or an explicitly defined repeated-measures analysis can help clarify which contrast is central. The record says the primary outcome has several categories or time points and was not reduced to one comparison. The intended model, contrast, handling of baseline values and any time-point selection are not reported in the registry record.

Why can over-dispersion matter?

Over-dispersion is a general issue for count outcomes when observed variability exceeds what a chosen probability model assumes. It can make standard errors too small if the model does not allow for the extra variability. The listed primary endpoint is continuous and summarized by a mean, not a count, so over-dispersion is not an identified issue for this primary measure. This general concept should not be mistaken for a method reported in this trial.

What do the planning illustrations mean?

The registry’s planning assumptions describe illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The target effect is described as a stated fraction of the observed effect. Such calculations ask how many participants per arm might be needed under those assumptions to detect a chosen effect with a specified power. They are planning illustrations, not observed power, and they do not establish that the trial was designed around those assumptions.

Because the registry does not report the underlying outcome estimate or the trial’s sample-size justification, the illustrations should not be read as a substitute for the sponsor’s design rationale. More generally, planning calculations depend on assumptions about the outcome’s variability, the target effect, allocation and analysis. If those assumptions differ from the eventual data or intended analysis, the calculation may not describe the study’s actual precision.

What cannot be reconstructed?

The record does not report the statistical model, the exact treatment-effect estimand, covariate adjustment, confidence interval calculation, test procedure or analysis population. It also lists zero analyses. Thus, the registered design and endpoint definition can be explained, but the analysis method and comparative findings cannot be reconstructed from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists eight outcome measures and schedules the primary functionality measure at baseline, four and eight weeks, and sixteen weeks after randomization. Considering several outcomes or time points raises a general multiplicity issue: the more comparisons examined, the greater the chance that at least one may appear unusual by chance if each is interpreted without regard to the others. Statistical plans may address this through prespecification, adjustment or a clearly defined hierarchy. Which approach was used, if any, is not reported in the registry record.

The registry notes that the primary outcome has several categories or time points and was not reduced to one comparison. It does not identify a preferred primary follow-up contrast, report any p-values or confidence intervals, or describe a multiplicity strategy. The record lists zero analyses, so it does not establish that a particular set of hypothesis tests was conducted. The eight listed outcomes should not be treated as eight confirmed positive or negative findings.

Missing-data methods are also not reported in the registry record. There is no information about how missing assessments were handled, whether any imputation was used, or whether sensitivity analyses were conducted. These details matter because participants may not contribute measurements at every follow-up, and the assumptions used to handle absent values can affect estimates.

The analysis population is not reported in the registry record. It is therefore not possible to determine whether the reported analyses, if any, followed random assignment regardless of adherence, included only participants with available measurements, or used another population definition. Intention-to-treat analysis, per-protocol analysis and other analysis-set choices should not be presumed. These omissions limit assessment of how robust a treatment comparison would be to missing observations, adherence and analysis choices.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: cardiac arrest (3.3%).

The registry reports serious adverse event figures for two groups, each with 30 participants at risk. It records zero serious adverse events in the scapula-focused exercises group and one in the motor control exercises group. The listed number of deaths is zero in the scapula-focused group and one in the motor control group. The record also lists cardiac arrest at 3.3% among the top serious adverse event terms. It does not state whether the death and the listed serious event refer to the same event, so that relationship should not be inferred.

The registry records zero other adverse events in each group. These figures are descriptive counts from the registry record; they do not by themselves establish a causal relationship between an intervention and an event. A single event in a group provides limited information about the range or frequency of possible harms, and an absence of recorded events is not proof that no adverse events occurred outside the recorded categories or reporting period.

Further details, including event timing, participant characteristics, adjudication, relatedness to exercise, and the period used for safety monitoring, are not reported in the registry record. The safety figures should therefore be read as the recorded counts, not as a complete account of comparative safety.

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

The registry record establishes that a randomized, double-masked, parallel-group study was conducted in patients with subacromial pain syndrome, with an enrollment of 60. It identifies a primary functionality measure, describes the scale’s direction and lists four assessment occasions. These details define the question the study was intended to address, but they do not reveal the outcome of the comparison.

No primary outcome values, group changes, treatment-effect estimate, confidence interval or test result are reported in the registry record. The record lists zero analyses and states that the primary outcome was not reduced to one comparison because of its several categories or time points. Consequently, it is not possible to say whether functionality changed, whether groups differed, how large any difference was, or how precisely it was estimated. Nor is the absence of an estimate evidence that no difference existed.

The measure’s direction provides a framework for interpreting results if they are reported elsewhere: lower Shoulder Pain and Disability Index scores indicate better functionality. But this scoring rule does not substitute for the missing scores or comparisons. The listed secondary outcomes likewise define other domains of interest without showing their results.

Safety entries describe one serious adverse event and one death in the motor control exercises group, compared with none recorded in the scapula-focused exercises group; other adverse events are listed as zero in both groups. Those counts are small descriptive observations and should not be turned into a causal claim. The record does not provide the details needed to interpret event attribution or context.

In general, a randomized design can support a comparative estimate when the trial’s outcomes and analysis are reported with adequate detail. Here, the registry record supports description of the planned question and recorded safety counts, but not a conclusion about comparative functionality or a treatment effect.

13. Why This Trial Matters Statistically

This trial is statistically notable for the distinction between a defined primary endpoint and a reported primary result. The registry identifies functionality as the primary outcome, specifies the scale and its direction, and sets out repeated follow-up at baseline, four and eight weeks, and sixteen weeks after randomization. Yet it lists zero analyses and does not provide an estimate for the primary comparison. This makes clear that a well-described endpoint is not itself evidence of an observed treatment effect.

The repeated-measure schedule also illustrates why the estimand matters. A comparison at one follow-up, a difference in change from baseline, and an overall group-by-time pattern can answer different questions. The registry says the outcome has several categories or time points and was not reduced to one comparison, but does not report which contrast was intended to carry the primary interpretation. Without that detail, even an isolated numerical value would be difficult to interpret fully.

The study also lists multiple secondary outcome domains, from pain and strength to range of motion and satisfaction. In general, multiple outcomes and assessment occasions call for a transparent analysis plan so readers can distinguish primary inference from exploratory findings and understand how multiplicity was handled. That plan is not reported in the registry record.

Finally, the record’s safety counts demonstrate a different interpretive task from efficacy analysis: event counts can be stated plainly, while causal meaning remains uncertain without context and fuller reporting. The registry is useful for identifying the study design, treatment descriptions, outcome schedule and recorded adverse events, but its lack of outcome analyses limits what can be learned about the trial’s comparative results.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations specific to interpreting this trial follow from the information not reported in the registry record. The primary outcome is scheduled at multiple times, but no primary comparison, estimate or confidence interval is given. The registry also lists zero analyses and explains that the primary outcome was not reduced to one comparison. As a result, the central result cannot be assessed for direction, magnitude or precision.

The registry summary describes adding motor control exercises with sensory feedback to scapula-focused treatment, while the intervention and arm descriptions list the exercise types separately. The exact mapping of each exercise component to each randomized group is not fully clear from the record. The duration and frequency are stated, but adherence, supervision, progression and treatment fidelity are not reported in the registry record.

Other design and analysis details are also unavailable, including eligibility criteria, recruitment setting, allocation concealment, the practical masking procedures, the statistical model, analysis populations, missing-data handling and multiplicity methods. The registry does not report a sample-size justification, so the enrollment cannot be evaluated against a stated target effect or precision goal. Planning illustrations based on an observed effect do not resolve that gap.

The recorded safety information is limited to counts and a listed serious-event term. Event timing, relatedness, monitoring period and the relationship between the reported death and serious event are not reported in the registry record. These omissions prevent a fuller assessment of safety context. Together, these limitations mean the record is useful for describing the study question and design, but insufficient for evaluating comparative efficacy or making a complete safety assessment.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Exercise Application in the Treatment of Patients With Subacromial Pain Syndrome — NCT02695524.
• Registry record last updated 2019-08-19; status last verified 2019-08.
• Results first posted 2019-08-19.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry describes a completed randomized, double-masked, parallel-group trial sponsored by the University of Sao Paulo, with enrollment of 60. It concerns patients with subacromial pain syndrome and compares exercise approaches described as scapula-focused and motor control exercises. The listed regimen is three times a week for 8 weeks, with 3x10 repetitions.

The primary outcome is change in functionality on the Brazilian version of the Shoulder Pain and Disability Index, a 0 to 100 point scale on which lower scores indicate better functionality. Assessments are scheduled at baseline, four and eight weeks, and sixteen weeks after randomization. The registry lists eight outcome measures and zero analyses; comparative outcome estimates are not reported in the registry record.

For safety, the record lists one serious adverse event and one death in the motor control exercises group, and none in the scapula-focused exercises group. Other adverse events are listed as zero in both groups. Event context and a comparative primary result are not reported.