ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction (NCT03255733), a na na study. The primary outcome is Percentage of Patients Reporting at Least 25% Overall Pain Reduction.

2. Clinical Question

The clinical question concerns the proportion meeting a specified threshold for reported pain improvement after treatment. It is not a question about whether ultrasound is better than another treatment, because the registry record describes no randomized or other control group. Patients also received Standard of Care treatments, so the record does not isolate the ultrasound treatment from those accompanying treatments.

The study summary describes physical examinations at follow-up visits and patient-reported surveys specific to the treated anatomy. Follow-up was described at 4, 8 and 12 weeks, with a phone follow-up at 26 weeks after the first treatment. The primary endpoint is tied to the 12-week time point, not to every follow-up. The registry record does not report the primary endpoint's observed percentage or the number of patients who met its threshold. Thus, the clinical question is clear, but its answer cannot be read from the posted results.

3. Trial Design

This completed study evaluated Intense Therapeutic Ultrasound for chronic, subcutaneous lateral epicondylitis musculoskeletal pain reduction. The registry lists 29 enrolled participants and a single-group model. Allocation is recorded as NA, and there is no listed parallel control arm. The record therefore describes an intervention cohort rather than a randomized comparison.

The treatment description says ultrasound was applied along the length and width of the Common Extensor Tendon. It specifies 80, 1 Joule pulses applied twice, four weeks apart. The brief summary says patients received 2 treatments, four weeks apart, alongside Standard of Care treatments prescribed by the Principal Investigator. Because usual care could accompany the device treatment, changes observed after treatment would not by themselves distinguish the contribution of ultrasound from other care or from changes over time.

The registry status is COMPLETED. The study start date is 2015-07-14, and the primary completion date is 2017-03-13. The summary describes follow-up for up to 6 months after the first treatment, with physical examinations and patient-reported measures at 4, 8 and 12 weeks, plus phone follow-up at 26 weeks. The primary endpoint is specified at 12 weeks after the first treatment.

The brief summary calls the study single-blinded, while the registry masking entry is NONE. The specific blinding procedures, if any, are not reported in the registry record. The phase is listed as NA. A protocol-level explanation of the study's design choices and sample-size rationale is 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:

Analysis population for the primary outcome, as defined in the registry: Percentage of Patients reporting at least 25% improvement in Pain at 12 Weeks after the first treatment

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 Percentage of Patients Reporting at Least 25% Overall Pain Reduction, measured over 12 weeks after 1st Treatment.

The primary endpoint is the percentage of patients reporting at least 25% overall pain reduction at 12 weeks after the first treatment. The description defines this as at least 25% improvement compared with baseline, measured with the Universal Visual Analog Scale (VAS) Pain Score. The record describes the VAS as a 10-point pain scale, where 0 means no pain, 1 means slight pain and 10 means the patient's worst imaginable pain. Intermediate scale points are described as representing 10% increments of pain, with a stated range of 1 - 10.

This threshold-based endpoint turns a patient-reported pain measure into a proportion: the numerator would be patients meeting the specified improvement criterion, and the denominator would be the patients included in the endpoint assessment. The registry record does not report either the observed percentage or the underlying count for this endpoint. It also does not report how missing endpoint assessments were handled, so the analysis denominator cannot be established from the record.

As a general statistical point, a threshold can make an endpoint easier to interpret as a responder outcome, but it does not show the full pattern of individual pain scores. Patients just above and just below the threshold may have similar reported changes while being classified differently. The registry also lists a secondary outcome concerning change in average pain score during normal activities using the Patient Rated Tennis Elbow Evaluation. That is a distinct measure from the primary VAS responder endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation depends on the design, the outcome definition, the analysis population and the uncertainty around estimates. For this study, the registry record describes a single-group intervention cohort, a threshold-based primary endpoint and a 12-week assessment time. It does not report outcome analyses, endpoint counts or uncertainty estimates. The explanations below describe general statistical concepts and how they relate to the information recorded.

What does a single-group design estimate?

In general, a single-group study can describe what happened among participants who received the intervention, such as the proportion meeting a stated outcome definition at follow-up. Without a separate comparison group, it does not directly estimate the difference between outcomes under the intervention and outcomes under an alternative. A baseline measurement can provide a within-person reference, but it does not replace a concurrent control group: changes over time can have explanations other than the intervention.

That distinction matters in this study because the summary states that Standard of Care treatments were given alongside ultrasound. A change from baseline, if reported, would reflect the experience of participants receiving the combined care described, not an isolated ultrasound-versus-control contrast. The registry record does not report an adjusted or causal analysis intended to separate these contributions.

How is a responder proportion interpreted?

For a binary responder endpoint, each assessed participant is classified according to whether the endpoint criterion was met. The proportion is the number meeting the criterion divided by the number included in that assessment. Here, the criterion is at least 25% pain reduction from baseline on the Universal Visual Analog Scale at 12 weeks after the first treatment. This definition is reported, but the responder count, assessment denominator and resulting percentage are not reported in the registry record.

As a general matter, a proportion should be read together with its denominator. The denominator affects the precision of the estimate, and exclusions or unobserved outcomes can affect who the estimate represents. Enrollment of 29 does not establish that all 29 contributed a 12-week response. The registry record does not report the number assessed at that time or the rules used to classify participants without a measurement.

What would a confidence interval add?

In general, a confidence interval expresses the uncertainty associated with an estimate under a stated statistical procedure. For a responder proportion, it would communicate a range of values compatible with the observed data and method. It is not a guarantee that the true value falls in that particular interval, and it does not address biases caused by study design, missing observations or outcome measurement. No confidence interval is reported for the primary endpoint in the registry record, and the data needed to calculate one are not posted.

A p-value, if one were reported, would answer a different statistical question under specified assumptions. It would not measure the size or practical importance of an effect, nor would it correct the lack of a control group. The record lists zero analyses, and no primary-endpoint p-value or formal hypothesis test is reported in the registry record.

Why does over-dispersion matter?

As a general concept, over-dispersion occurs when variability in data exceeds what a chosen statistical model expects. It can make standard errors too small if the model does not account for the extra variation. This issue is more often considered for count or clustered data than for a simple binary outcome, but model choice still needs to match the data structure and analysis question. The registry record does not describe a model, an over-dispersion assessment or an adjustment for clustering, so none can be attributed to this study.

What do the planning illustrations mean?

Sample-size calculations are planning tools, not observed results. The described illustrations use a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. They are explicitly not the trial's own design. This is particularly important because the actual study is listed as single-group; hypothetical two-arm planning assumptions do not create a control group in the completed study.

Such illustrations describe how many participants per arm might be needed under their assumed comparison and effect. They are not evidence that the completed study had a particular power, and they are not a substitute for its observed outcome estimates. The observed effect needed to anchor those illustrations is not reported in the registry record, and the illustrations should not be read as observed power. The protocol's sample-size justification is not reported in the registry record.

10. Exact Estimates for Each Arm

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

R code and output

arm    <- c("Intense Therapeutic Ultrasound Treatment")
n      <- c(25)
events <- c(22)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Intense Therapeutic Ultrasound Treatment  25  22  88.0  68.8  97.5  70.0  95.8  69.8  95.6

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and a secondary outcome, and records 2 outcome measures. The primary outcome is the proportion reporting at least 25% pain reduction at 12 weeks after the first treatment. The secondary outcome concerns average pain score change during normal activities using the Patient Rated Tennis Elbow Evaluation. The registry lists zero analyses, and no analysis results are reported for either outcome.

When a study examines multiple outcomes or time points, multiplicity can arise because repeated statistical tests increase the chance of at least one apparently notable result by chance. As a general statistical practice, a prespecified primary outcome helps focus interpretation; adjustment or other approaches may be used depending on the analysis plan. Whether any multiplicity adjustment or hierarchy was prespecified or used is not reported in the registry record. The number of outcome measures alone does not reveal how many tests were performed.

The record describes follow-up at 4, 8 and 12 weeks, with phone follow-up at 26 weeks after the first treatment. The primary endpoint is associated with the 12-week assessment. The registry record does not report the analysis population, the number of participants assessed at each time, or whether outcomes at multiple visits were analyzed together.

Missing-data procedures are also not reported in the registry record. It is not stated how absent surveys, incomplete follow-up, or other unavailable outcome values were handled. This matters because the denominator for a responder percentage depends on the analysis rules and available observations. The enrolled total of 29 should not be assumed to be the denominator for every endpoint or visit.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry lists 29 participants at risk for both serious and other adverse events. The posted counts are 0 serious adverse events, 0 other adverse events and 0 deaths. These are event counts as entered in the registry record; they do not provide a detailed account of how events were sought, classified or followed.

A zero count in a study cohort is not proof that an event is impossible or that no event could occur in a larger or differently observed population. As a general statistical point, estimates based on a limited number of participants can be imprecise, especially when events are uncommon. The record does not provide a confidence interval or other uncertainty estimate for these safety counts.

The adverse-event follow-up period and detailed safety monitoring procedures are not reported in the registry record. The study summary describes follow-up for up to 6 months after the first treatment, but does not specify how the adverse-event counts relate to each visit or the phone follow-up. The counts should therefore be read as the registry's posted safety figures, not as a complete characterization of risk.

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

The record documents a completed, single-group study of Intense Therapeutic Ultrasound for chronic lateral epicondylitis and defines a primary patient-reported pain endpoint. The planned endpoint asks what percentage of patients reported at least 25% overall pain reduction at 12 weeks after the first treatment, compared with baseline. The record also describes the treatment schedule and follow-up.

What it does not provide is the primary endpoint result. No response percentage, responder count, confidence interval or analysis result is reported in the registry record. The listed enrollment of 29 cannot serve as a substitute for a reported outcome, and it does not establish how many participants had usable 12-week measurements.

The study structure also limits what any within-group change could mean. There is no listed control group, allocation is recorded as NA, and participants received Standard of Care treatments alongside ultrasound. As a general interpretive principle, changes observed in a treated group do not establish that the intervention caused those changes. The design does not provide a direct estimate of how outcomes would differ under another treatment or under no ultrasound.

The record's safety counts list zero serious adverse events, zero other adverse events and zero deaths among 29 at risk. Those counts are useful as a description of the entries in the registry, but they do not establish that adverse events cannot occur or fully characterize safety beyond the recorded observations.

Overall, the registry record supports an account of the study's question, design and recorded safety counts, but not a conclusion about the magnitude or precision of the primary pain outcome. The protocol's statistical plan, missing-data approach and detailed analysis methods are not reported in the registry record. Conclusions should remain bounded by those omissions and by the absence of a comparison group.

14. Why This Trial Matters Statistically

This study illustrates why a clear endpoint definition and a posted endpoint result are both necessary for statistical interpretation. The primary outcome specifies a threshold for patient-reported pain improvement and an assessment time of 12 weeks after the first treatment. That makes the intended measurement question identifiable, but without a responder count or percentage, the endpoint cannot be quantified from the registry record.

It also demonstrates the distinction between describing outcomes in a treated group and estimating a comparative treatment effect. The study is listed as single-group, with allocation recorded as NA. Participants received Standard of Care treatments alongside ultrasound. These features mean that any reported change from baseline would need careful interpretation and would not alone identify the contribution of ultrasound.

The entry further highlights the importance of denominators and missing-data reporting for responder outcomes. Enrollment was 29, but the registry does not state how many participants contributed to the 12-week endpoint. Without that information, readers cannot determine the analysis population or assess how incomplete follow-up might affect the reported proportion.

Finally, registry fields can be incomplete or internally different in emphasis. The brief summary calls the study single-blinded, while the masking entry is NONE. Recording that distinction avoids presenting a specific blinding procedure as established. The record also lists no analyses, leaving outcome estimates and statistical uncertainty unavailable. These are practical examples of why design descriptions, analysis details and numerical results each matter for a balanced statistical reading.

15. Limitations

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

Several limitations arise from the study information recorded. The single-group design offers no concurrent control comparison, and no random allocation is listed. The registry record therefore does not support a between-group estimate. In addition, participants received Standard of Care treatments along with ultrasound, so the contribution of the device cannot be separated from accompanying care using the design information reported.

The primary result is absent. The registry record does not report the number of participants meeting the endpoint, the percentage, an uncertainty interval or a test result. It also does not state how many participants were assessed at 12 weeks, how missing outcomes were handled, or which analysis population was used. These omissions prevent assessment of the endpoint's numerical result and its precision.

The record lists a secondary outcome and follow-up at multiple times, but detailed analyses and multiplicity procedures are not reported in the registry record. The protocol and statistical analysis plan, including any sample-size justification, are not reported in the registry record. The sample-size illustrations use hypothetical two-arm assumptions and are not the completed study's design.

There is also a discrepancy in the description of masking: the brief summary calls the study single-blinded, whereas the registry masking entry is NONE. The specific procedures are not reported in the registry record. Finally, the adverse-event entries give counts but do not describe event ascertainment, follow-up duration for safety, or uncertainty around those counts. These limitations concern what can be interpreted from the registry entry and do not establish that unreported procedures were or were not carried out.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction — NCT03255733.
• Registry record last updated 2017-11-17; status last verified 2017-10.
• Results first posted 2017-11-17.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry record describes a completed, single-group study of Intense Therapeutic Ultrasound for chronic lateral epicondylitis, with 29 enrolled participants. The treatment was given twice, four weeks apart, alongside Standard of Care treatments. The primary endpoint was the percentage reporting at least 25% pain reduction from baseline on the Universal Visual Analog Scale at 12 weeks after the first treatment.

The study summary describes follow-up through 26 weeks after the first treatment. The registry lists a secondary pain-score outcome, but records zero analyses. The primary endpoint result and analysis details are not reported in the registry record. Safety entries list 0 serious adverse events, 0 other adverse events and 0 deaths among 29 at risk.