High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy (NCT05483517), a randomized na study. The primary outcome is Change in Pain Visual Analogue Scale(VAS).

2. Clinical Question

3. Trial Design

The registry record describes a randomized, parallel-group clinical trial of high energy density pulse electromagnetic field therapy for rotator cuff tendinopathy. It lists enrollment of 24 and a completed status. The listed start date is 2023-01-31, and the primary completion date is 2024-04-08. The record identifies Tri-Service General Hospital (TSGH) as the sponsor and gives the phase as NA.

The two arm descriptions differ in whether participants receive high-PEMF therapy or sham high-PEMF therapy. Both arms also receive physiotherapy under a physiotherapist’s guidance for three weeks, following two sessions a week. This design makes the comparison relevant to the additional contribution of the active device treatment in the setting of physiotherapy; it is not a comparison of physiotherapy with no physiotherapy.

The registry lists allocation as randomized, the model as parallel, and masking as triple. The official title calls the study double-blinded, so the title and the masking field use different descriptions. Which people were masked, how masking was maintained, and whether its success was assessed are not reported in the registry record. The randomization sequence, allocation concealment, and any stratification procedures are also not reported.

The listed primary outcome is change in VAS pain score, with assessments at baseline, immediately after treatment, 4 weeks, and 12 weeks. The record also lists changes in SPADI total score and active shoulder flexion, abduction, and internal rotation. It does not report the protocol’s planned analysis details or the outcome results. Thus, the design can be described, but the treatment contrast cannot be quantified from 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

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 Pain Visual Analogue Scale(VAS), measured over baseline, immediate after treatment, 4 weeks, 12 weeks.

The primary endpoint is change in pain measured with the Visual Analogue Scale (VAS). The record describes a score from 0 to 10: 0 indicates no pain, and 10 represents the worst possible pain. Higher scores indicate worse outcomes. A change score expresses how the measured pain rating differs from its baseline value at a later assessment; the registry does not specify the sign convention used for reporting change.

Pain intensity is a patient-reported experience, so a scale gives participants a structured way to rate it and enables the trial to compare average scores across randomized groups. The endpoint is listed as a mean, with standard deviation as its measure of dispersion. A mean describes the group’s average score, while a standard deviation conveys how spread out individual scores are around that average. These summaries would help readers understand both the average pain rating and the variation among participants.

The specified assessment times are baseline, immediately after treatment, 4 weeks, and 12 weeks. Multiple times can describe the course of scores, but they also create several possible contrasts. The record does not report scores, changes, confidence intervals, or tests at any of these times. It therefore defines what was intended to be measured without showing the observed primary endpoint results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design is a randomized parallel-group comparison. In general, randomization assigns participants to study groups using a chance-based process. Its purpose is to reduce systematic differences in known and unknown participant characteristics between groups at the start of a trial. Whether that benefit is achieved depends on how the sequence is generated, concealed, and implemented. Those procedural details are not reported in the registry record, so the allocation method cannot be independently assessed from this information.

A parallel-group design assigns participants to one arm rather than having each participant receive both conditions in sequence. Here, the arm descriptions specify physiotherapy plus high-PEMF or physiotherapy plus sham high-PEMF. Because physiotherapy is included in both arms, the intended comparison is the active device treatment against its sham in the context of the shared physiotherapy. The record does not describe the sham’s appearance or operation, or report whether participants or staff could distinguish it from active treatment.

The registry lists masking as triple, while the official title describes the trial as double-blinded. Masking is intended to limit the influence of expectations or knowledge of assigned treatment on experiences, clinical care, and outcome assessment. The precise roles masked and the procedures used to keep assignments concealed are not reported in the registry record. The difference in terminology cannot be resolved from the record alone.

What does a mean and standard deviation describe?

The primary outcome is a continuous pain score, and the listed summary is the mean with standard deviation. The mean describes the average score in a group. The standard deviation describes dispersion among individual scores; it is not a measure of uncertainty in the group mean. A standard error or confidence interval would address uncertainty in an estimated mean or contrast, but neither is reported for the primary endpoint.

For a randomized comparison, an effect estimate should make clear which groups and time point are being contrasted, and how change is defined. A confidence interval communicates the precision of that estimate: a narrower interval generally indicates greater precision, while a wider interval indicates more uncertainty. It does not, by itself, guarantee that the estimate is unbiased or that the analysis choices were appropriate. No effect estimate or confidence interval is reported in the registry record.

Why do multiple assessment times matter?

The primary outcome is scheduled at baseline, immediately after treatment, 4 weeks, and 12 weeks. Repeated measurements can describe how scores change over time. They also create multiple opportunities to compare the groups. If many comparisons are examined, the chance of finding an apparently notable result by chance can increase. Statistical approaches to multiplicity can address that issue, but the registry record does not report a multiplicity procedure or designate which post-baseline time point anchors the primary comparison.

Repeated observations from the same participant are related rather than independent. A longitudinal analysis can account for that relationship, but the chosen model, assumptions, covariates, and handling of incomplete measurements are not reported in the registry record. It is not possible to infer which analytical approach was used from the listed outcome schedule.

What role does dispersion play?

Variation matters because participant scores may differ even when they receive the same assigned treatment. Standard deviation describes that variation in the recorded scale. In general, over-dispersion means that the observed variation is greater than a statistical model expects. When a model assumes less variation than the data contain, it can understate uncertainty and make results appear more precise than they are. The registry record does not report a fitted model or evidence of over-dispersion for this continuous outcome; this is a general statistical consideration, not a finding about this trial.

What can planning calculations establish?

Sample-size planning illustrations are not observed trial results. The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect defined as a fraction of the observed effect. Such illustrations explore how many participants per arm might be required under those assumptions. They do not show the trial’s observed power, establish that the trial was adequately sized, or replace a confidence interval around an observed effect. The registry record does not report the trial’s own sample-size justification, target effect, or planning calculation.

10. Multiplicity, Missing Data and Analysis Populations

The primary VAS outcome is scheduled at baseline, immediately after treatment, 4 weeks, and 12 weeks. The record does not say which post-baseline time point was designated as the main inferential comparison, whether each time point was tested separately, or whether a longitudinal model was planned. It also does not report any adjustment for multiple comparisons. When several outcomes or time points are examined, multiplicity can make chance findings more likely; prespecifying a primary contrast or using an appropriate adjustment can help control that risk. Which approach, if any, was used is not reported in the registry record.

The record lists SPADI total score and changes in active flexion, active abduction, and active internal rotation as secondary outcomes. It does not describe a hierarchy among these outcomes, how their tests were to be interpreted, or whether secondary analyses were exploratory. Without the analysis plan and results, readers cannot determine how multiplicity was handled across outcomes and assessment times.

Missing-data handling and analysis populations are also not reported in the registry record. The record does not state how many participants contributed primary-outcome data at each time, why any observations might be missing, or whether the analysis used an intention-to-treat, per-protocol, or other population. Nor does it describe imputation, a sensitivity analysis, or assumptions about missingness. These details matter because incomplete follow-up can affect both the estimate and its uncertainty, especially if missingness is related to participants’ outcomes or treatment assignment.

Enrollment is reported as 24, but that does not establish how many observations were available for any particular analysis. The record lists n analyses as 0, so no outcome analysis is reported in the registry record.

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 5% reporting threshold.

The registry reports no serious adverse events in the listed safety groups: Physiotherapy and High-PEMF, with 0 events among 11 at risk, and Physiotherapy and Sham High-PEMF, with 0 among 10 at risk. It also reports 0 other adverse events in each group, using the same at-risk counts, and 0 deaths in each group.

These figures describe the events recorded in the registry, not proof that no adverse events occurred outside the recorded categories or observation period. The record does not explain how adverse events were defined, collected, or monitored, nor does it specify the safety follow-up period. It also does not report event severity apart from the serious-versus-other categories shown.

The at-risk counts differ from the enrollment figure. The reasons for that difference, and whether it reflects the safety population, follow-up, or another convention, are not reported in the registry record. These safety denominators should not be treated as the denominators for the pain outcome analyses, which are not reported.

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

This record establishes that a randomized, parallel-group trial was registered for people with rotator cuff tendinopathy. It describes a comparison of physiotherapy plus high-PEMF with physiotherapy plus sham high-PEMF and identifies pain change on the VAS as the primary outcome. It also lists secondary shoulder pain and function or range-of-motion outcomes, a treatment schedule, and safety counts.

It does not establish the observed effect of high-PEMF relative to sham. The registry record does not report primary or secondary outcome estimates, their uncertainty, or statistical tests. As a result, it cannot show whether the groups’ pain scores differed, how large any difference was, or whether a difference persisted at the later assessment times. The absence of reported outcome analyses is not evidence that the treatments had the same effect, and it is not evidence that one treatment was better.

Nor does the record show whether the observed data were complete, whether the randomized groups remained comparable in the analyzed population, or how the outcome data were modeled. The enrollment figure alone cannot answer those questions. Sample-size planning illustrations based on an observed effect, where available, are planning exercises rather than evidence about this trial’s results or observed power.

The zero adverse-event counts are limited to the categories and denominators reported in the registry. Without details about ascertainment and follow-up, they cannot establish that the treatment was free of risk. Overall, the registry record describes the research question and trial structure but does not provide the results needed to draw a statistical conclusion about the primary outcome or the safety profile.

13. Why This Trial Matters Statistically

This trial’s design addresses a focused comparative question: whether high-PEMF adds a measurable difference in pain outcomes when both groups receive physiotherapy and one receives sham device treatment. A sham comparison can help distinguish the contribution of the active device treatment from the shared care and the experience of receiving a device intervention. The registry describes that structure, although it does not report enough detail to assess how masking was implemented.

The trial also illustrates why an outcome schedule is not a results report. Measuring pain immediately after treatment and again at 4 weeks and 12 weeks could describe both near-term scores and later scores. But multiple time points require a clear analysis plan so readers know which contrast is primary and how other comparisons are treated. Those choices are not reported in the registry record.

Statistically, the key information needed to interpret a randomized comparison is the between-arm estimate, its precision, the number of observations analyzed, and the assumptions behind the analysis. These are not reported for the primary outcome. Without them, readers cannot distinguish a precise estimate from an uncertain one or judge how compatible the data are with a range of possible effects.

The record is therefore useful for identifying the intended population, comparison, endpoints, and schedule, while also demonstrating the limits of registry-only interpretation when outcome analyses are absent. Its completed status does not itself supply evidence about efficacy or precision. A complete statistical account would need the outcome summaries and analysis details, including how repeated measurements, missing data, and multiple comparisons were handled.

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 main trial-specific limitation for interpretation is that the registry record does not report outcome results or analyses. Although the primary VAS endpoint and its assessment times are specified, the group-level scores, changes, between-arm estimates, and uncertainty measures are absent. The primary comparison therefore cannot be evaluated statistically from the record.

The record gives limited detail about participant selection and trial conduct. Eligibility criteria, recruitment setting, participant characteristics, randomization procedures, allocation concealment, and the roles included in masking are not reported in the registry record. The official title describes a double-blinded trial, while the registry masking field says triple; the record does not explain the difference.

Analysis details are also missing. The record does not specify the primary analysis time point, the model for repeated outcome measurements, adjustment for baseline values or other covariates, a multiplicity strategy, or the analysis population. It does not report the number of participants with outcome data at each assessment, missing-data reasons, or the approach to incomplete observations. These omissions prevent assessment of how robust a result would be to analytical choices or missing follow-up.

The safety record is limited to the reported event categories and at-risk denominators. Definitions, ascertainment methods, and safety follow-up are not reported. The difference between enrollment and the listed safety denominators is not explained, and those counts do not establish outcome-specific follow-up.

Finally, the registry lists a completed trial but does not report its sample-size justification or outcome findings. Completion alone does not resolve these uncertainties. The information supports a description of the intended trial, not an assessment of its clinical effect or statistical precision.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy — NCT05483517.
• Registry record last updated 2025-02-25; status last verified 2025-02.
• Results first posted 2025-02-25.
• 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

NCT05483517 is a completed randomized, parallel-group trial sponsored by Tri-Service General Hospital (TSGH), with enrollment listed as 24. The record gives a start date of 2023-01-31 and a primary completion date of 2024-04-08. Its listed condition is Rotator Cuff Tendinosis.

The arms compare physiotherapy plus high-PEMF with physiotherapy plus sham high-PEMF. Both descriptions specify three weeks of treatment, following two sessions a week. The primary outcome is change in pain VAS score at baseline, immediately after treatment, 4 weeks, and 12 weeks. Secondary outcomes include SPADI total score and changes in active shoulder flexion, abduction, and internal rotation.

Although the registry defines the primary measure and lists safety counts, outcome analyses and results are not reported in the registry record. The reported design and endpoint therefore identify the intended comparison but do not quantify its outcome.