Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections (NCT02591953), a randomized na study. The primary outcome is Simple Shoulder Test.

2. Clinical Question

The study was designed as a randomized comparison of injection guidance methods. Its brief summary describes the aim as prospectively determining whether either approach was superior with regard to various clinical variables. The primary outcome listed in the registry is the Simple Shoulder Test, a questionnaire assessing shoulder function through yes-or-no answers.

This is a question about the comparison between two procedures, not a registry-reported estimate of the effect of either procedure. Although the record identifies the intended endpoint and its time frame, it does not post a comparison of outcome values, an effect estimate, or an uncertainty interval. The record explains that the study was terminated after the department switched patient-reported outcome companies and access to the data was lost. Consequently, the clinical question remains unanswered by the posted primary outcome results.

3. Trial Design

The registry describes a randomized, triple-masked, parallel-group study. Participants were assigned to ultrasound-guided injection or landmark-guided injection. The landmark approach is described as injection at the point of maximal tenderness along the biceps tendon; the ultrasound-guided arm is described as injection performed with ultrasound guidance. The record does not identify which parties were masked, how randomization was generated or implemented, or whether allocation concealment was used.

The enrollment listed is 22. The study is marked terminated, with a start date of 2015-11 and a primary completion date of 2019-05. Its listed sponsor is Rush University Medical Center. The registry record gives no further account of why the trial ended beyond the loss of access to outcome data after a change in patient-reported outcome companies. It does not report whether termination was planned, when the decision was made, or whether any participants withdrew.

The interventions include ultrasound guidance, landmark guidance, methylprednisolone, and Lidocaine 1%. The arm descriptions specify the guidance procedures but do not detail which medications each arm received, doses, or other procedural features. Those details are not reported in the registry record and cannot be inferred from the intervention list alone.

The primary outcome is the Simple Shoulder Test at 1 year. The registry reports one outcome measure and no posted analyses. It states that the study was terminated and that the data could not be analyzed because access was lost. Thus, the design indicates the comparison the investigators intended, but the record does not supply an analyzed primary outcome or a statistical comparison between arms.

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:

Analysis population for the primary outcome, as defined in the registry: The study was terminated and data could not be analyzed as the department switched PRO companies. Access to the data was lost at that time.

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 Simple Shoulder Test, measured over 1 year.

The primary endpoint is the Simple Shoulder Test, assessed at 1 year. The registry describes it as a 12 question assessment of shoulder function, with yes-or-no answers. The questionnaire is therefore intended to summarize patient-reported shoulder function using responses to a set of functional questions.

In general, a prespecified endpoint gives a trial a defined outcome on which to focus its main comparison. A patient-reported measure can capture how participants describe their function, rather than relying only on an external assessment. For a two-arm study, analysis would ordinarily compare the endpoint between the randomized groups using a method suited to how the score is recorded and summarized. The registry does not report the score’s range, scoring procedure, direction of benefit, or planned summary measure, so these cannot be described.

The record identifies the endpoint and time frame but reports no analyzed Simple Shoulder Test values. It states that the trial was terminated and access to the data was lost after the department switched patient-reported outcome companies. No arm-level results, comparison, or estimate of uncertainty are posted. The endpoint therefore describes what the trial intended to measure, not an observed finding that can be interpreted as favoring either guidance method.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, parallel-group comparison, but it does not report the statistical analysis plan or any completed analysis. The explanations below describe general statistical concepts relevant to interpreting this type of study; they are not claims about methods actually used by the investigators.

What randomization contributes

In general, random assignment is intended to make the comparison between treatment groups less dependent on participants’ starting characteristics. If implemented successfully, it supports a comparison that can be interpreted as an effect of assignment to the study approaches, subject to adherence, outcome measurement, and missing-data issues. Randomization does not guarantee that groups will be alike in every respect, especially in a small study. The registry says the trial was randomized but does not describe the sequence generation, allocation concealment, or implementation. Those details are not reported in the registry record.

What masking can and cannot tell us

The record labels the study triple-masked. In general, masking can reduce the influence of expectations or knowledge of assignment on care, reporting, or assessment. The registry does not say which three parties were masked, how masking was maintained, or whether masking could be distinguished between the ultrasound and landmark procedures. The label alone does not establish how masking worked in practice.

How an endpoint comparison is usually interpreted

For a continuous or score-based endpoint, an analysis often estimates a difference between groups and reports an interval expressing uncertainty. A confidence interval is a range of values compatible with the data under the analysis assumptions; its width helps convey precision. A hypothesis test can also summarize how inconsistent the data are with a specified null hypothesis, but a p-value does not measure the size or clinical importance of an effect. These are general explanations, not methods reported for this trial.

The Simple Shoulder Test is described as a set of yes-or-no questions. The registry does not state how responses were combined into a score, whether the outcome was treated as a total score or another summary, or what comparison method was planned. It also does not report a baseline measurement or adjustment strategy. Without these details and without analyzed outcome values, there is no basis for reproducing or evaluating a primary endpoint analysis.

Why precision matters

In general, an effect estimate is more informative when accompanied by uncertainty. A narrow interval can indicate greater precision, while a wide interval can leave a broad range of possible effects compatible with the data. Neither can be assessed because no estimate or confidence interval is posted. The absence of a p-value is not a nonsignificant result; it reflects that no analysis is reported.

Over-dispersion and model choice

General statistical models rely on assumptions about how observations vary. Over-dispersion refers to variability greater than a model assumes. When relevant, failing to account for it can make standard errors and uncertainty estimates too small. Whether over-dispersion is relevant depends on the outcome and model. The registry does not report a model, the distributional assumptions, or any diagnostic assessment, so there is no basis for saying whether this issue arose in the study.

Planning calculations are not trial findings

In general, sample-size planning calculations use assumptions about the effect to detect, variability, significance level, allocation, and analysis method. They describe a hypothetical design scenario; they do not demonstrate that a trial had a particular chance of detecting an effect after the fact. The record describes its planning illustration as based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also says the effect to detect is a stated fraction of the observed effect. The posted record contains no analyzed primary effect to interpret, and any planning figures should not be mistaken for observed power or an outcome result.

The trial’s reported design and the missing analysis must remain distinct. The randomized structure describes how the comparison was intended to be conducted. It does not substitute for outcome data, an estimate, an uncertainty interval, or a documented statistical method. Those elements are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome measure, the Simple Shoulder Test at 1 year, and describes the study aim as examining various clinical variables. It does not report a statistical plan for handling multiple outcomes or comparisons. No adjustment strategy, hierarchy of secondary outcomes, or distinction between confirmatory and exploratory analyses is described. These details are not reported in the registry record.

In general, examining multiple outcomes or time points can increase the chance of finding an apparently notable result by chance if analyses are interpreted without accounting for multiplicity. A prespecified hierarchy or adjustment method can help make the interpretation clearer. That is a general consideration; the record does not establish that multiple statistical tests were performed. It lists one outcome measure and no analyses.

The missing-data issue is explicit but not quantified. The record says the study was terminated and data could not be analyzed because the department switched patient-reported outcome companies and access to the data was lost. It does not state how many participants had completed the Simple Shoulder Test, whether any data remained available, or whether partial outcome data could be recovered. The reason and extent of missingness are therefore only partly described.

The registry also does not report the analysis population, such as whether a planned analysis would include all randomized participants or only participants with available endpoint data. It gives no method for handling missing responses, withdrawals, or incomplete questionnaires. In general, results can depend on which participants are included and how missing outcomes are addressed. Since no analysis is posted, the consequences of those choices cannot be evaluated.

These gaps do not imply that a particular method was or was not used outside the posted record. They mean that the public record does not document a multiplicity strategy, an analysis population, or a missing-data procedure, and that the stated loss of data prevented the reported primary analysis.

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.

The posted safety figures list 12 participants at risk in the ultrasound-guided injection group and 10 in the landmark-guided injection group. For each group, the registry records zero serious adverse events, zero other adverse events, and zero deaths. These are the counts shown in the registry record.

In general, an adverse-event count is interpreted in relation to the participants included in the safety record and the period and methods used to collect events. The registry does not describe the safety observation period, event definitions, or ascertainment procedures. The posted figures therefore do not tell us how long participants were followed for safety or how events were sought and classified.

Zero recorded events should not be read as proof that no event could occur, nor as a complete comparative safety analysis. The record does not provide an estimate of between-group uncertainty or additional detail on event severity beyond the serious-event category. These figures also do not resolve the missing primary outcome analysis. They describe what was recorded in the safety section, not a conclusion about the relative safety of the procedures.

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

This record documents a randomized trial intended to compare ultrasound-guided and landmark-guided biceps corticosteroid injections. It identifies the Simple Shoulder Test at 1 year as the primary outcome and gives a reason the study’s outcome data could not be analyzed: after the department switched patient-reported outcome companies, access to the data was lost. The registry lists no analyses.

What the record does show is the intended comparison, the endpoint description, the study status, enrollment, and the posted adverse-event counts. What it does not show is a primary outcome estimate, a comparison between arms, or the precision of any such comparison. It therefore cannot establish that one guidance approach produced better, worse, or similar shoulder-function scores in this study.

This is not the same as a finding of no difference. To support a conclusion of similarity, a study would need an appropriate estimate and sufficient precision relative to a defined threshold for meaningful differences. The registry provides neither a comparison estimate nor such a threshold. Likewise, the record cannot support a conclusion of superiority because no analyzed outcome result is posted.

The safety counts should also be kept in scope. The registry records no serious or other adverse events and no deaths in either group, but it does not provide the observation period or safety collection details. Those counts are descriptive and do not establish that risks were absent or that the groups had equivalent safety.

In general, a trial’s design can be scientifically informative even when its result is unavailable, because it records a question that was intended to be tested. But the design cannot replace an outcome analysis. The most defensible interpretation is that the posted registry record leaves the primary clinical comparison unresolved and offers only limited descriptive safety information.

13. Why This Trial Matters Statistically

This trial matters statistically because it illustrates the difference between a planned randomized comparison and an interpretable trial result. Randomization and a defined primary outcome can provide a framework for comparing groups, but that framework depends on outcome data being retained, analyzed, and reported. In this record, the study was terminated and the primary data could not be analyzed after access was lost.

The case also shows why a registry entry should be read in layers. The design information says what was intended: a comparison of ultrasound-guided and landmark-guided injections, with the Simple Shoulder Test at 1 year. The results information says what can be learned from the completed record: no primary analysis is listed. Those are different kinds of information and should not be conflated.

From a statistical perspective, an absent estimate cannot be treated as evidence for the null hypothesis. It gives no effect size, no confidence interval, and no basis for assessing precision. Similarly, a planning illustration is not a substitute for observed data, and safety event counts do not answer the primary efficacy question. Each evidence component answers a different question.

Finally, the explanation for the missing analysis highlights the practical importance of data continuity for patient-reported outcomes. The registry records that a change in outcome-data systems resulted in loss of access. It does not provide further operational detail, so the implications should not be generalized beyond this record. The statistical lesson is narrower: a trial’s intended design can be clear while its treatment comparison remains unavailable because the data needed for analysis are not accessible.

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.

The most consequential limitation is stated in the registry: the study was terminated and the data could not be analyzed after the department switched patient-reported outcome companies and access to the data was lost. No primary outcome analysis is posted. This prevents interpretation of the intended comparison on the Simple Shoulder Test.

The record lists enrollment of 22 but does not report the number of participants with endpoint data, the number completing follow-up, or the extent of missingness by group. It also does not provide arm-level outcome summaries. Thus, the enrollment figure cannot be used to infer the analyzed sample or the completeness of follow-up.

Other design and analysis details are not reported in the registry record. These include eligibility criteria, participant characteristics, the randomization procedure, the identities of the masked parties, the planned statistical model, the scoring and summary of the Simple Shoulder Test, and the analysis population. The registry does not describe how missing questionnaire data would have been handled or whether other clinical variables were prespecified as secondary outcomes.

The intervention descriptions are brief. Although the record lists methylprednisolone and Lidocaine 1%, it does not specify their use by arm, doses, or other procedural details. The adverse-event section also does not describe the safety follow-up period or ascertainment methods. These omissions limit the detail with which the interventions and safety counts can be interpreted.

These limitations concern what the registry record makes available; they do not establish that information was absent from all study documents. The posted record supports a description of the intended trial and its reported data-access problem, but not an estimate of comparative clinical outcomes.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections — NCT02591953.
• Registry record last updated 2022-07-18; status last verified 2022-07.
• Results first posted 2022-07-18.
• 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

This registry record describes NCT02591953, a randomized, triple-masked, parallel-group study sponsored by Rush University Medical Center. It compares ultrasound-guided injection with landmark-guided injection for biceps tendonitis. Enrollment is listed as 22, the start date as 2015-11, and primary completion as 2019-05; the study status is terminated.

The primary outcome is the Simple Shoulder Test at 1 year, described as a 12 question yes-or-no assessment of shoulder function. The record states that the study was terminated and the data could not be analyzed after a switch in patient-reported outcome companies led to loss of access. It lists one outcome measure and no analyses.

The safety record lists 12 participants at risk in the ultrasound-guided group and 10 in the landmark-guided group, with zero serious adverse events, zero other adverse events, and zero deaths in each group. No primary outcome comparison is posted, so the record does not resolve the intended clinical question.