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 Effects of 12-week Digital Treatment in Patients With Hand OA on Pain and Function (NCT05499559), a registered phase not stated study. The primary outcome is Change in Pain Intensity (Numerical Rating Scale NRS, Discrete Boxes 0-10, Higher Score Mean Worse Pain).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05499559 |
| Phase | Phase not stated |
| Condition | Hand Osteoarthritis, Wrist Osteoarthritis, Thumb Osteoarthritis |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 846 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Joint Academy |
| Results posted | Yes |
2. Clinical Question
The study asks how pain intensity changes between baseline and 3 months of digital treatment among participants with hand osteoarthritis. The program combined exercises with educational sessions about the disease, its natural course, and recommended treatment strategies. The registry record also describes assessment of hand function and health-related quality of life.
Population
Participants in Joint Academy’s digital treatment for hand osteoarthritis. The registry lists hand, wrist, thumb, and finger osteoarthritis as conditions. Enrollment is recorded as 846.
Intervention
A digital treatment program consisting of exercises and education. Participants received Joint Academy’s digital treatment, according to the arm description.
Comparator
No randomized comparator is described. The record characterizes the study as an observational longitudinal cohort study; allocation is not stated.
Primary question
What is the mean change in self-reported hand pain intensity, measured with the Numeric Rating Scale, from baseline to 3 months of treatment?
This is a within-cohort change question, not a randomized estimate comparing treatment with a control condition. A change after starting a program can describe participants’ reported outcomes over time, but by itself it cannot separate changes associated with treatment from other influences. The registry record does not report the numerical mean change, its confidence interval, or an analysis result. It therefore does not establish the size, direction, or precision of the observed change.
3. Trial Design
The registry identifies this as an observational longitudinal cohort study. Participants took part in the Joint Academy digital treatment program, and the study planned to assess outcomes at baseline and again after 3 months of treatment. The program included exercises and educational sessions. Its educational content concerned hand osteoarthritis, its natural course, and recommended treatment strategies.
The listed enrollment is 846, and the study status is COMPLETED. The recorded start date is 2021-07-07, and primary completion is dated 2022-07-31. These registry entries describe the study record; they do not establish how many participants completed both assessments or contributed to each outcome analysis. Those analysis-population counts are not reported in the registry record.
The primary outcome is change in pain intensity on a 0–10 Numeric Rating Scale, with higher scores indicating worse pain. The description says participants were asked to rate hand pain over the past week. Self-assessment questionnaires were mandatory at baseline and at 3 months, and responses were self-reported through the digital program interface. Functional Index for Hand OsteoArthritis and EQ-5D-5L are also described among the outcomes. The record lists 7 outcome measures.
No randomized comparison is described, and allocation is not stated. A control group or a like-for-like comparison is not established by the registry record. The number of analyses is recorded as 0, and numerical outcome estimates are not reported in the registry record. Thus, the design description identifies the follow-up framework and measures, but does not supply a results-based estimate of change or its uncertainty.
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.
Before assignment: Patients who did not complete 3 months of treatment was excluded from the study.
Overall Study
| Stage | Joint Academy |
|---|---|
| STARTED | 846 |
| COMPLETED | 379 |
| NOT COMPLETED | 467 |
Reasons for not completing this period:
| Reason | Joint Academy |
|---|---|
| Lost to Follow-up | 467 |
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.
Population: Participants who enrolled in the digital treatment
| Characteristic | Unit | Included Participants | Excluded Participants | Total |
|---|---|---|---|---|
| Participants analysed | 379 | 467 | 846 | |
| Age, Continuous: All participants | years | 64.6 (SD 9.3) | 62.7 (SD 10.6) | 63.6 (SD 10.1) |
| Age, Customized: Participants included in analysis – 28-59 years old | Participants | 108 | — | 108 |
| Age, Customized: Participants included in analysis – 60-69 years old | Participants | 147 | — | 147 |
| Age, Customized: Participants included in analysis – 70 years old or older | Participants | 124 | — | 124 |
| Sex: Female, Male: Female | Participants | 285 | 374 | 659 |
| Sex: Female, Male: Male | Participants | 94 | 93 | 187 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: Sweden | Participants | 379 | 467 | 846 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Pain Intensity (Numerical Rating Scale NRS, Discrete Boxes 0-10, Higher Score Mean Worse Pain), measured over Change in pain intensity from baseline to 3 months of treatment..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in pain intensity from baseline to 3 months of treatment. Pain was assessed with a Numeric Rating Scale made up of discrete boxes from 0 to 10. Participants were instructed to mark how much pain they had in their hand over the past week. A score of 0 represents no pain, while 10 represents the maximum pain imaginable; higher scores indicate greater pain intensity.
Pain is the study’s main outcome because the registry identifies change in pain as the primary outcome of interest. Repeating the same self-reported measure at baseline and follow-up allows a within-participant change to be described. In general, a continuous scale can retain information about different levels of a symptom rather than reducing the outcome to a simple improved/not-improved category. The interpretation still depends on how the change is calculated and which participants contribute measurements at both time points.
The endpoint is reported as a mean with a 95% confidence interval. In general, the mean describes the average change in the analyzed group, while the confidence interval conveys statistical uncertainty around that estimate under the analysis assumptions. Neither statistic is a causal treatment effect in an observational cohort without a suitable comparison. The registry record does not report the mean change or confidence interval, so the direction, magnitude, and precision of the endpoint cannot be evaluated from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically relevant question: whether participants’ self-reported hand pain changed between baseline and 3 months while they took part in a digital exercise and education program. However, it does not report the numerical primary outcome estimate. There is no reported mean change, 95% confidence interval, or inferential result. Consequently, the posted record does not show whether the average score increased, decreased, or remained similar, nor how precisely any change was estimated.
The design is observational and longitudinal. A baseline-to-follow-up change describes what happened over time among the participants included in the analysis. Without a randomized comparator or another credible comparison strategy, the change cannot be attributed uniquely to the program. In general, symptoms may change over time for reasons other than an intervention, and participants’ characteristics or concurrent experiences may also be related to change. These are design considerations, not claims that any particular influence occurred in this cohort.
The questionnaire responses were self-reported through the digital program interface, and assessments were scheduled at baseline and 3 months. Self-report is appropriate for reporting a person’s own pain experience, but interpretation depends on complete and comparable measurement across the assessment times. The registry record does not report completion counts, missing-data handling, or the analysis population. It is therefore not possible to determine from the record how missing assessments affected the estimates.
The scale ranges from 0 to 10, with higher values indicating worse pain. That direction helps interpret a reported change, but no change value is present in the registry record. Nor is a threshold for clinically important pain change reported there. The record mentions analyses of minimally clinical important changes as planned outcomes, but does not provide their results or definitions. Statistical uncertainty and clinical importance therefore cannot be assessed from the posted results described in the record.
The record lists 7 outcome measures, including pain, function, and health-related quality of life, but records 0 analyses. The numerical results for these outcomes are not reported in the registry record. The adverse-event fields list 0 at risk and 0 affected for serious and other events, and deaths are recorded as 0. Since the at-risk counts are also recorded as 0, these fields do not provide an informative estimate of event frequency among participants.
Any planning illustration based on an observed effect should be read as a hypothetical sample-size scenario, not as observed power or evidence that a treatment effect was demonstrated. The registry record does not report the observed effect needed to interpret such an illustration. Overall, the record describes the cohort, intervention, and planned outcome framework, but does not provide numerical results from which to judge the amount or precision of change.
9. Statistical Methods Explained
The registry describes the primary outcome as a mean change in a continuous pain score, accompanied by a 95% confidence interval. The study’s stated measurement times are baseline and 3 months of treatment. The numerical estimate and interval are not reported in the registry record, so the statistical methods can be explained in general terms without drawing conclusions about this cohort’s results.
What does a mean change represent?
In general, a mean change summarizes the average difference between an outcome measured at follow-up and the same outcome measured at baseline for the participants included in the analysis. Its interpretation depends on the subtraction order. For this scale, a lower pain score indicates less reported pain, while a higher score indicates more. The registry record describes the endpoint as change but does not state the calculation order or provide the result. The sign of a reported change therefore cannot be interpreted from the record alone.
A mean can give a concise account of the group’s average experience, but it does not show how individual participants’ scores were distributed. Participants may have different baseline scores and different follow-up changes. A group average can conceal that variation, so it should not be taken to mean that every participant experienced the average change. The record does not report a distribution of individual changes.
How should a confidence interval be read?
In general, a confidence interval describes the statistical uncertainty around an estimate under the assumptions of the method used. A narrower interval indicates greater precision than a wider interval, while the interval’s location conveys the range of estimates compatible with the data and method. A 95% confidence interval is not a guarantee that the true value lies within the particular interval, nor does it describe the range of individual participants’ changes. Because neither the estimate nor the interval is reported, precision cannot be judged for this outcome.
Confidence intervals also do not resolve design limitations. An interval around an observational pre-post change can quantify uncertainty about that change under its analysis assumptions, but it does not account automatically for the absence of a suitable comparison. Greater statistical precision would not, by itself, establish that a change was caused by treatment.
Why does the cohort design matter?
In general, observing the same cohort at two time points can describe change over time, but a before-and-after comparison is vulnerable to alternative explanations. Without a randomized comparator, changes may reflect influences other than the program. Potential concerns in observational follow-up include natural fluctuation in symptoms, changes in participants’ circumstances, and differences between people who complete follow-up and those who do not. These are general methodological possibilities; the registry record does not report whether or how they affected this study.
The registry says baseline and 3-month questionnaires were mandatory, but this does not establish that every participant completed both assessments or that every response was included in the analysis. The numbers contributing to the primary endpoint, the handling of incomplete records, and the analysis population are not reported in the registry record. Those details matter because a mean change based on complete cases can represent a different subset from the enrolled cohort if follow-up completion is selective.
What can be inferred from planning illustrations?
The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. Such calculations are hypothetical planning scenarios; they are not observed power and do not establish that the study was designed or conducted as a randomized two-arm trial. The record characterizes this study as an observational cohort, and the planning assumptions do not change that design.
Sample-size calculations depend on assumptions about the effect to detect, variability, allocation, and statistical procedure. In general, changing those assumptions changes the number of participants required for a target level of power. The observed effect used for the illustration and the resulting planning values are not reported in the registry record. The illustration therefore cannot be independently interpreted from the registry entries, and it should not be treated as a retrospective measure of whether the study had adequate power.
Why do analyses and outcome definitions matter?
The registry lists 7 outcome measures but records 0 analyses. Multiple outcomes can raise questions about which measures were prespecified as primary, how secondary outcomes were interpreted, and whether multiplicity was addressed. The primary outcome is identified as change in pain, but a detailed statistical analysis plan, model specification, and multiplicity procedure are not reported in the registry record. It would be inappropriate to infer these details.
The record also mentions minimally clinical important changes, but does not report their operational definition or numerical findings. In general, a clinically meaningful threshold answers a different question from a mean estimate or a confidence interval: it concerns the size of change considered important under a specified definition. Without the threshold and outcome results, neither the proportion meeting that threshold nor its uncertainty can be interpreted.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 7 outcome measures, including pain, hand function, and health-related quality of life, and records 0 analyses. Pain is identified as the primary outcome. The registry record does not report a statistical analysis plan, a procedure for handling multiple outcomes, or a hierarchy for interpreting the secondary measures. It is therefore not possible to determine whether multiplicity was considered in the analyses or how any multiplicity adjustment would have been applied.
In general, examining multiple outcomes can increase the chance of finding an apparently notable result by chance if each is tested separately. A prespecified primary outcome can help focus interpretation, but it does not reveal what statistical procedures were used. Since numerical analyses are not reported in the registry record, there are no reported estimates or inferential results to assess for the listed outcomes.
Missing-data handling and analysis populations are also not reported in the registry record. Although the description says questionnaires were mandatory at baseline and 3 months, the record does not say how many participants completed each assessment, whether all records were analyzed, or how missing responses were handled. Mandatory questionnaires do not establish complete follow-up. In general, excluding participants with incomplete measurements can affect an estimate if follow-up completion is related to pain or other participant characteristics; the registry record does not provide information to assess that possibility.
The registry record does not report whether an intention-to-treat, complete-case, or other analysis population was used. It also does not report an imputation method, sensitivity analysis, or reasons for missing data. These omissions limit assessment of both the representativeness of the analyzed cohort and the robustness of the results.
11. What the Result Does, and Does Not, Mean
The record describes an observational study of a digital program and a plan to measure pain before treatment and at 3 months. It also describes assessment of function and health-related quality of life. These details establish the research question and measurement framework, but the registry record does not report numerical outcome results. No conclusion about the direction, size, or precision of pain change can be drawn from the record.
Even if a within-cohort change were reported, it would describe change over time among participants included in that analysis. Without a randomized comparison or another suitable approach to causal inference, it would not by itself show that the program caused the change. General factors such as natural symptom variation or changes in circumstances can affect a pre-post comparison; the record does not state whether such factors influenced this cohort.
The endpoint is self-reported pain on a scale from 0 to 10, with higher scores indicating worse pain. It represents participants’ reports of hand pain over the past week, not an objective measure of disease progression. The registry record mentions minimally clinical important changes, but does not report a threshold or results for that analysis. Statistical and clinical interpretations therefore cannot be made from the posted record.
The adverse-event fields record 0 at risk and 0 affected for serious and other events, with deaths recorded as 0. Because the at-risk fields are also 0, those entries should not be read as showing that no participants experienced adverse events. They do not establish a safety rate for the cohort.
Planning illustrations are hypothetical calculations based on assumptions, not observed power and not evidence of efficacy. They do not compensate for the absence of numerical outcome estimates or a comparator. The record’s completion status indicates that the study is marked completed; it does not supply the missing outcome findings or resolve the design limitations.
12. Why This Trial Matters Statistically
This study is statistically notable for the contrast between a clearly described longitudinal question and the limited results detail in the registry record. The record specifies a primary pain measure, its scale direction, the assessment times, and the self-reported nature of the data. Those features help readers understand what change was intended to be measured. Without the numerical estimate and its confidence interval, however, readers cannot evaluate the size or precision of that change.
The observational cohort design also matters for interpretation. Repeated measurement can describe participants’ outcomes over time, but it does not supply the counterfactual comparison needed to isolate what would have happened without the program. Keeping descriptive change distinct from causal effect is essential when communicating results from a non-randomized study.
The registry lists pain alongside functional and quality-of-life outcomes and mentions minimally clinical important changes. These measures can address different aspects of participants’ experience, but each requires clearly reported definitions, estimates, and uncertainty for useful interpretation. The record does not report those numerical findings, analysis details, or the handling of missing measurements.
The record’s planning assumptions also illustrate why sample-size calculations need to be read in context. A hypothetical calculation based on an observed effect and two-arm allocation assumptions is not the same as evidence from the study’s observational cohort. It is not observed power and cannot establish a treatment effect. Overall, the study description makes the intended measurement question understandable, while the missing results and analysis details sharply limit statistical conclusions.
13. 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 this study from the registry record is the absence of numerical outcome results. The record describes mean change in pain with a 95% confidence interval, but does not report the estimate or interval. It also does not provide numerical results for the other listed outcomes. The direction, magnitude, and precision of the outcomes therefore cannot be assessed.
The observational longitudinal design does not establish a causal comparison. No randomized comparator is described, and allocation is not stated. The record describes participants receiving the digital program, but does not report a comparison group suitable for separating change associated with the program from change over time or other influences.
All responses for the primary pain measure were self-reported through the digital interface. The registry record describes mandatory questionnaires at baseline and 3 months, but does not report completion by time point, the number included in each analysis, or reasons for incomplete data. Missing-data methods, analysis populations, and sensitivity analyses are not reported in the registry record.
The record lists 7 outcome measures and records 0 analyses. It does not report a detailed statistical analysis plan, model specification, or approach to multiplicity. Although minimally clinical important changes are mentioned, their definition and results are not reported. These omissions constrain interpretation of both statistical and clinical importance.
Safety information is also limited: the registry fields list 0 at risk and 0 affected for serious and other events, and deaths are recorded as 0. With no participants recorded as at risk in those fields, the entries do not provide an interpretable event rate. The planning illustration’s assumptions are not a substitute for observed results and do not resolve these limitations.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Effects of 12-week Digital Treatment in Patients With Hand OA on Pain and Function — NCT05499559.
- Registry record last updated 2026-08-25; status last verified 2026-08.
- Results first posted 2025-08-27.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
17. Record Summary
The registry record identifies NCT05499559 as an observational longitudinal cohort study of Joint Academy’s digital treatment for osteoarthritis of the hand, wrist, thumb, or fingers. The program consisted of exercises and educational sessions. Enrollment is recorded as 846. The study is marked COMPLETED, with a start date of 2021-07-07 and primary completion dated 2022-07-31.
The primary outcome is mean change in self-reported pain intensity on a 0–10 Numeric Rating Scale from baseline to 3 months. Higher scores indicate worse pain. The record also describes outcomes for hand function and health-related quality of life and lists 7 outcome measures.
Numerical outcome estimates, confidence intervals, analysis-population details, and missing-data methods are not reported in the registry record. The record identifies no randomized comparison, and allocation is not stated. It records 0 analyses. These omissions mean that the record describes the study question and design but does not allow evaluation of the observed outcome changes or their precision.