This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis (NCT02388646), a randomized na study. The primary outcome is Assessment of Pain Using the Visual Analog Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02388646 |
| Phase | NA |
| Condition | Knee Osteoarthritis, Arthritis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 60 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Orthopaedic Research Foundation |
| Results posted | Yes |
2. Clinical Question
The study asks whether knee pain changes differently with a commercially available brace, home exercises, or both together. Its three groups are Exercise Only, Brace Only, and Bracing + Exercises. The record describes the brace as a Reaction Web brace and the exercise intervention as a home program.
Population
People with knee osteoarthritis; the registry record also lists arthritis. The record lists enrollment 60, but does not describe participant characteristics or the numbers assigned to each group in the posted results.
Intervention
A Reaction Web brace worn during normal activities, with home quadriceps-strengthening exercises in the combined group. The brief description says exercises were to be done twice daily, every day.
Comparator
The study includes exercise alone and brace alone as separate comparison groups. The registry record does not specify which pairwise comparisons were designated as the primary comparison.
Primary question
How does change in Visual Analog Scale pain score from baseline to the 3-month visit compare between study arms? The registry describes the outcome, but does not report the arm-level estimates or comparison results.
The brief description says functional and subjective outcomes were to be collected at baseline and at 6 and 12 weeks. The primary outcome timeframe is separately recorded as baseline and the 3-month visit. These descriptions are retained as recorded rather than assumed to be interchangeable. The study is framed as an exploration of bracing alone, a home exercise program, and their combination, not as a registry-reported demonstration that one option is superior.
3. Trial Design
The registry describes a randomized, single-masked, parallel-group study. Participants were assigned to one of three approaches: Exercise Only, Brace Only, or Bracing + Exercises. In a parallel design, each participant receives one assigned approach during the study rather than moving through all approaches. Random allocation is intended to reduce systematic differences between groups at assignment, although the record does not describe the randomization sequence or allocation concealment.
The record lists enrollment 60 and status COMPLETED. The enrollment figure does not establish how many participants were included in each outcome analysis. Group-specific analysis counts are not reported in the registry record. The record does not say who was masked, whether masking was maintained, or how it was implemented. Those details matter because participants may recognize whether they are wearing a brace or doing exercises, while outcome assessment or analysis could potentially be masked separately.
The intervention descriptions distinguish an exercise program, a Reaction Web brace, and the brace together with home exercises. The brief summary says that participants in the brace groups were fitted with a brace and instructed to wear it during normal activities; those assigned exercises were given instructions for quadriceps strengthening. The registry record does not report adherence or the amount of brace use or exercise actually completed.
The study is identified as COMPLETED, with a start date of 2015-03 and a primary completion date of 2016-12-31. The posted results identify pain assessed with a Visual Analog Scale as the primary outcome and change in quadriceps force as a secondary outcome. They do not provide arm-level pain estimates or a reported statistical comparison. The registry record does not report a detailed statistical analysis plan, the primary pairwise contrast, or analysis-population definitions.
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
| Stage | Exercise Only | Brace Only | Bracing + Exercises |
|---|---|---|---|
| STARTED | 20 | 20 | 20 |
| COMPLETED | 16 | 19 | 14 |
| NOT COMPLETED | 4 | 1 | 6 |
Analysis population for the primary outcome, as defined in the registry: Change from baseline reported in table
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.
| Characteristic | Unit | Exercise Only | Brace Only | Bracing + Exercises | Total |
|---|---|---|---|---|---|
| Participants analysed | 16 | 19 | 14 | 49 | |
| Age, Continuous | years | 67 (56 to 76) | 64 (50 to 76) | 66 (51 to 78) | 66 (50 to 78) |
| Sex: Female, Male: Female | Participants | 7 | 8 | 6 | 21 |
| Sex: Female, Male: Male | Participants | 9 | 11 | 8 | 28 |
| Race and Ethnicity Not Collected | Participants | — | — | — | 0 |
| Laterality: Right | Participants | 8 | 9 | 7 | 24 |
| Laterality: Left | Participants | 8 | 10 | 7 | 25 |
6. Primary Endpoint
The registry lists the primary outcome as Assessment of Pain Using the Visual Analog Scale, measured over Baseline and 3-month Visit.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in pain score on the Visual Analog Scale between baseline and the 3-month visit. The scale is a 100mm horizontal line anchored by “No Pain” at 0 and “Pain as bad as it could possibly be” at 100. A participant marks the point that represents their pain, and the distance from the left-hand end is reported as a score out of 100.
A change score expresses how a participant’s measured pain differs from their own baseline measurement. Comparing such changes between study arms can help describe whether pain trajectories differ across the assigned approaches. The registry says the difference between baseline and the 3-month score was compared between arms, but does not report the direction or size of any arm-specific changes or between-arm contrasts.
The endpoint is recorded as a mean with full-range dispersion. In general, a mean describes the average score in a group, while the full range describes the lowest and highest observed values. These summaries answer different questions: an average gives a central summary, and the range conveys the spread from the most extreme observations. No actual mean, range, or confidence interval for this endpoint is reported in the registry record.
The brief study description also mentions functional and subjective outcomes collected at 6 and 12 weeks. The primary outcome timeframe is recorded as baseline and the 3-month visit. The registry record does not explain how these timing descriptions correspond, so they should not be silently treated as identical. The listed secondary outcome is change in quadriceps force; numerical results for it are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes the clinical comparison being investigated: exercise alone, a brace alone, and the combination of bracing and exercises. It also specifies a pain measure and a baseline-to-follow-up contrast. It does not, however, provide the primary endpoint values by group, an estimated between-group difference, a confidence interval, or a statistical test result. Therefore, the posted results do not establish the direction, magnitude, or precision of any difference in pain change.
Randomization is relevant to interpretation because it aims to make assigned groups comparable on average at the start of a trial. It does not guarantee that groups are identical, and it does not resolve problems such as missing outcomes, deviations from assigned treatment, or differences in adherence. The registry record does not report baseline group summaries, participant flow through the outcome assessment, or adherence information, so these aspects cannot be evaluated from the posted results.
The primary outcome is a change score on a bounded pain scale. A between-arm estimate would quantify how much the average change differs between the groups being compared. A confidence interval would describe the range of effects compatible with the data and the analysis assumptions; its width would indicate precision. Neither those estimates nor their uncertainty are reported in the registry record. Statistical significance, clinical importance, and precision cannot be inferred from the existence of a completed trial or from its enrollment figure.
There are three assigned approaches, but the record does not state which pairwise comparisons were prespecified or how the overall comparison was handled. A finding for one contrast would not automatically answer every comparison among the three approaches. The registry record also does not report whether any multiplicity adjustment was planned or used. No primary analysis result is available to interpret against a significance threshold.
The safety entries record zero serious adverse events and zero other adverse events in each group’s at-risk count as listed. Those entries are descriptive registry reports, not evidence that no events occurred outside the recorded categories or observation period. The deaths field is null for each group, so deaths are not reported in the registry record; null should not be read as a reported zero.
Overall, the registry record supports a description of the trial question, design, outcome definition, and recorded adverse-event counts. It does not support a conclusion about which approach had a larger or smaller pain change, whether any difference was statistically distinguishable from chance, or how precise an effect estimate would be.
9. Statistical Methods Explained
The record identifies a randomized, parallel-group design with single masking. Randomization assigns participants to study groups using a chance-based procedure. In general, this reduces the risk that treatment assignment is systematically linked to participant characteristics, but it cannot ensure exact balance in every characteristic. Parallel-group means each person is assigned to one study approach, rather than receiving all approaches in sequence. The meaning and implementation of single masking are not described in the registry record; it does not identify who was masked.
What does a change score represent?
The primary outcome is the change in Visual Analog Scale pain score from baseline to the 3-month visit. In general, a change score is calculated by comparing a later measurement with the starting measurement for the same participant. A group mean change can then describe the average change among participants included in that group’s analysis. A comparison between groups focuses on the difference in those changes, not simply on whether one group’s score changed from baseline.
The scale ranges from 0, labeled “No Pain,” to 100, labeled “Pain as bad as it could possibly be.” The participant marks a position on a 100mm line, and the distance from its left-hand end is recorded as a score out of 100. A higher or lower score has meaning relative to those anchors, but a change estimate must still be interpreted in the context of its uncertainty and the population assessed. The registry record does not report the observed scores or changes.
The outcome is specified as a mean with full-range dispersion. Generally, the mean is the arithmetic average, and the full range runs from the smallest observed value to the largest. A range can be sensitive to extreme observations and does not, by itself, describe the distribution of values between its endpoints. Since no actual summary values are reported, the distribution and variability of pain scores cannot be assessed.
How should an estimated effect be read?
In general, a between-group estimate gives the size and direction of the contrast as defined by the analysis. A confidence interval expresses uncertainty around that estimate under the statistical model and assumptions used. A narrow interval indicates greater precision than a broad interval, while an interval compatible with effects in different directions may leave the direction uncertain. A p-value, when reported, summarizes how unusual data at least as incompatible with a specified null hypothesis would be under that hypothesis and model. It does not measure the probability that the null hypothesis is true, the importance of an effect, or its clinical value.
None of these primary comparison statistics is reported in the registry record. There is no estimate, confidence interval, or p-value to interpret. General explanations of these statistics cannot substitute for missing trial results.
Why do group comparisons and multiplicity matter?
With three study arms, more than one pairwise contrast is possible. In general, if several hypotheses are tested, the chance of at least one chance-positive result can rise unless the analysis accounts for the set of comparisons. A prespecified primary contrast or an appropriate multiplicity procedure can make interpretation more coherent. The registry record does not identify the primary pairwise comparison, report a multiplicity strategy, or provide an analysis result. It is therefore not possible to determine how comparisons were selected or interpreted.
The record’s illustrative sample-size calculations are described as planning illustrations based on an observed effect, not as the trial’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. Such calculations, in general, ask how many participants per arm would be needed under selected assumptions. They are not observed power, do not describe the number actually analyzed, and do not show that the trial had a particular probability of detecting an effect. The posted illustrations should not be confused with a reported protocol justification or a primary analysis. A trial-specific sample-size justification is not reported in the registry record.
What can be assessed about the analysis?
Statistical interpretation depends on more than the endpoint definition. It also depends on which participants were analyzed, how missing measurements were handled, whether the planned comparison was adjusted for baseline values, and how departures from assigned treatment were treated. These details can affect both the estimate and its uncertainty. The registry record does not report these methods, and it lists no analyses. It does not state whether the primary analysis was based on all randomized participants, participants who completed follow-up, or another population.
In general, a comparison adjusted for baseline measurements may account for starting differences and can be more efficient than an unadjusted comparison under suitable assumptions. A change-score analysis instead compares within-person changes, as the endpoint description indicates. The record does not say whether the reported comparison used a particular model, whether covariates were included, or how any assumptions were checked. No claim about these procedures can be made from the registry record.
Over-dispersion is a general issue for count outcomes when observed variability exceeds what a simple count model assumes. It is not a reported feature of this pain endpoint, which is described as a score summarized by a mean and full range. There is no basis in the registry record to say that over-dispersion was assessed or affected the analysis. More broadly, method choice should follow the outcome type and study question; the registry record does not give enough analysis detail to evaluate those choices for this trial.
10. Multiplicity, Missing Data and Analysis Populations
The three-arm design permits multiple possible comparisons: each approach could be contrasted with either of the other approaches. The record does not identify which contrast was designated primary, whether all pairwise contrasts were intended, or whether an overall test preceded any pairwise tests. It also does not report whether a multiplicity adjustment was planned or applied. Without those details, the scope of any intended statistical claim is unclear.
The record lists pain as the primary outcome and change in quadriceps force as a secondary outcome. It does not report results for either outcome or explain how inference across outcomes and follow-up times was managed. The brief description mentions collection at 6 and 12 weeks, while the primary outcome timeframe is stated as baseline and the 3-month visit. The relationship between those schedules and any multiplicity strategy is not reported in the registry record.
Missing-data methods are not reported in the registry record. The record does not provide the numbers with outcome measurements at each time point, reasons for missing measurements, or whether missing outcomes were imputed or otherwise addressed. It also does not report the analysis population or say whether participants were analyzed according to assigned group, actual treatment received, or another rule.
The registry lists enrollment 60, but that does not reveal the number included in each outcome analysis or the completeness of follow-up. No analysis results are listed. Consequently, the effects of missing data, analysis-population choices, and multiplicity on the trial’s statistical conclusions cannot be evaluated from the posted results.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Exercise Only | 0 | 16 | 0.0% |
| Brace Only | 0 | 19 | 0.0% |
| Bracing + Exercises | 0 | 14 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Exercise Only | 0 of 16 |
| Brace Only | 0 of 19 |
| Bracing + Exercises | 0 of 14 |
The registry’s adverse-event entries list zero serious adverse events and zero other adverse events for each of the three groups. The at-risk counts are listed separately for Exercise Only, Brace Only, and Bracing + Exercises. These are counts recorded in the registry, not a complete account of every possible health event or a comparison adjusted for differences in exposure or follow-up.
The deaths field is null for all groups. A null entry means deaths are not reported in the registry record; it is not equivalent to a reported count of zero. The record does not provide event definitions, collection procedures, observation duration, or information about whether adverse events were actively solicited. Those details affect how confidently zero recorded events can be interpreted.
Zero recorded events in a group does not establish that the underlying event risk is zero. Rare events may not occur in a study, and incomplete reporting or limited observation may also affect what appears in a registry. The recorded entries should therefore be read narrowly: the registry reports no events in the listed serious and other adverse-event categories, while deaths and additional context are not reported.
12. What the Result Does, and Does Not, Mean
This registry record describes a randomized comparison of three conservative approaches for knee osteoarthritis and defines a pain outcome based on change from baseline to a 3-month visit. It also identifies change in quadriceps force as a secondary outcome. These details make the research question understandable, but they do not provide the results needed to judge the size or direction of any treatment-group difference.
The record does not report group-level pain changes, between-group estimates, confidence intervals, or p-values. It also lists no analyses. Therefore, it cannot establish whether pain scores changed within any group, whether changes differed between groups, or how precisely any difference was estimated. A completed status and a listed enrollment figure do not replace outcome results.
Even if a numerical difference were available, statistical evidence and practical importance would be separate considerations. In general, a small estimate can be precise, while a larger estimate can be uncertain; neither description alone establishes whether a difference matters to participants. This record contains no estimates or uncertainty intervals to assess in that way. The registry record also does not define a threshold for a clinically important change.
The safety entries report zero serious and zero other adverse events for each group, while deaths are not reported in the registry record. These entries should not be interpreted as proof of no risk, nor do they establish comparative safety. The record does not supply enough information about event monitoring, follow-up, or analysis to support broader safety conclusions.
The most defensible reading is limited to the design and reported fields: the study set out to compare a brace, exercises, and their combination, using a specified pain scale and a quadriceps-force outcome. The posted results do not show which approach had the best outcome or whether any approach differed from another. No treatment recommendation follows from these registry entries.
13. Why This Trial Matters Statistically
This study is statistically interesting because it has three active approaches addressing related but distinct questions. Comparing exercise alone with bracing alone differs from comparing the combined approach with either component. A clear primary contrast is important in a multi-arm study because each contrast answers a different question. The registry record does not identify which contrast was primary, so the intended hierarchy of claims cannot be reconstructed.
The pain endpoint is based on repeated measurement: a baseline score and a later score are used to describe change. Such outcomes can be analyzed in more than one way, and the chosen method affects interpretation and precision. The record says that baseline-to-3-month change was compared between arms, but does not report the statistical model or the resulting estimates. This illustrates why an endpoint definition alone is not a full analysis description.
The study also highlights the difference between trial completion and availability of interpretable results. The record lists COMPLETED, yet the posted results do not include arm-level pain estimates or analysis results. Without those quantities, readers cannot assess effect magnitude, uncertainty, or the extent to which findings might be compatible with different effects.
Finally, the adverse-event entries demonstrate the need to distinguish zero recorded events from missing information. Counts are reported for serious and other adverse events, but deaths are not reported, and the event-collection context is not described. Careful statistical reading keeps those categories distinct and avoids treating absent information as evidence of no events.
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 limitation for interpreting efficacy is that the registry record does not report primary outcome estimates or results of statistical comparisons. Without arm-level change summaries, contrast estimates, uncertainty intervals, or p-values, the direction, magnitude, and precision of pain differences cannot be evaluated.
The record lists enrollment 60 but does not provide group-specific outcome-analysis counts, participant flow, or the amount of missing follow-up data. It does not report the analysis population or methods for handling missing measurements. Thus, the relationship between enrollment and the data contributing to the primary comparison is unclear.
Important design and analysis details are also not reported in the registry record. These include the randomization procedure, allocation concealment, who was masked, adherence to the brace and exercises, the prespecified primary contrast, the statistical model, and any multiplicity strategy. The registry does not describe baseline group characteristics or the criteria used to interpret a clinically important difference.
The primary timeframe is described as baseline and the 3-month visit, while the brief summary refers to outcome collection at 6 and 12 weeks. The record does not explain how these descriptions align. The secondary outcome is named, but numerical results are not reported. Safety entries have limited context, and deaths are not reported in the registry record. These gaps restrict what can be inferred from the posted information and should not be filled by assumptions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis — NCT02388646.
- Registry record last updated 2021-04-12; status last verified 2021-04.
- Results first posted 2021-04-12.
- 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.
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18. Record Summary
The registry record describes a randomized, single-masked, parallel-group study of Exercise Only, Brace Only, and Bracing + Exercises for knee osteoarthritis. It lists enrollment 60 and status COMPLETED. The primary outcome is change in Visual Analog Scale pain score from baseline to the 3-month visit; change in quadriceps force is listed as a secondary outcome.
Arm-level primary outcome estimates, statistical comparisons, and analysis methods are not reported in the registry record. The record lists zero serious and zero other adverse events in each group; deaths are not reported. The design and outcome definition are available, but the posted results do not permit an assessment of comparative pain outcomes or their precision.