Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain (NCT02356783), a non-randomized na study. The primary outcome is Percentage of Patients With Available Step Count Data at Baseline..

2. Clinical Question

The clinical motivation recorded for the study is that step count might offer a way to monitor activity around a pain intervention. The registry summary describes usability and compliance as aims and identifies step count as a possible measure for evaluating interventions. Those aims are broader than the posted primary endpoint: availability of pre-procedure step data addresses whether monitoring generated data during the specified period, rather than whether step counts changed after injection or whether a change was caused by treatment.

The record describes two injection approaches, with pedometers used in both arms. It therefore does not describe a comparison of pedometer use against no pedometer use. Nor does it establish that any observed difference between approaches would be attributable to the injection approach, because assignment was non-randomized and the registry record gives no adjustment or analysis details. The primary question remains a practical measurement question: whether the intended baseline step-count record was available.

3. Trial Design

This completed study is titled Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain. It is registered as NCT02356783 and was sponsored by Hospital for Special Surgery, New York. The registry classifies allocation as non-randomized, masking as none, and the model as parallel. The listed phase is NA. Enrollment is 43.

The parallel arms are described by lumbar epidural steroid injection approach: interlaminar and transforaminal. Each arm description says that a wireless pedometer would be implemented to measure primary and secondary outcomes. Each description also refers to 15 patients in that group. In the serious adverse event record, the number at risk is 15 for the interlaminar group and 14 for the transforaminal group. These entries are not the same as a report of the number contributing to the primary endpoint, which is not given.

The registry lists the study start as 2015-02 and primary completion as 2016-08, with status completed. The record lists two outcome measures, but the details describe the primary outcome as the percentage of patients with available step-count data at baseline. It specifies a week before the procedure and says daily step count would be obtained for 7 days using a wireless pedometer. A second outcome measure's details are not reported in the registry record.

Because allocation was non-randomized, comparisons between the interlaminar and transforaminal groups are observational rather than randomized contrasts. Differences between groups could reflect features other than the approach, and the registry record does not report methods to address that possibility. The record also does not report a masking procedure or a control group without pedometer monitoring. Both described groups received the monitoring device.

The registry record gives no further description of recruitment, eligibility, allocation decisions, adherence definitions, or participant flow. It also does not report the rationale for the planned enrollment. Consequently, the page can describe the structure recorded in the registry, but cannot reconstruct operational details that are not recorded there.

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: Forty-three patients were enrolled in study and received FitBit prior to their steroid injection appointment. Only 33 patients returned to have the steroid injection (16 interlaminar, 17 transforaminal). Three transforaminal and 1 interlaminar patient stopped using/syncing the FitBit, so data were not available to analyze.

Overall Study

Reasons for not completing this period:

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 With Available Step Count Data at Baseline., measured over A week pre-procedure..

The primary endpoint is the percentage of patients with available step-count data at baseline, defined as the week before the procedure. The description says step count would be obtained daily for 7 days using a wireless pedometer. In plain terms, the endpoint asks whether the planned pre-procedure monitoring produced step-count data that could be used for the baseline period.

This kind of endpoint is relevant to the stated usability and compliance aim. If data are unavailable, it may not be possible to characterize activity over the intended period or use that measurement in a later analysis. However, availability alone does not show why data are missing, how many days each participant contributed, whether readings were accurate, or whether participants consistently wore the device. Those details are not reported in the registry record.

The endpoint is also distinct from a clinical efficacy outcome. A percentage with available baseline data is a measure of data capture, not a measure of pain relief, functional improvement, or change in walking activity. The study summary describes a broader hypothesis about using step count to measure efficacy of pain interventions, but the posted primary endpoint does not itself test that claim. The registry record does not report the observed percentage for this endpoint, so its level of data availability cannot be assessed.

General: a clearly specified measurement window helps define which observations count toward an endpoint. It does not, by itself, establish that all participants had complete records, that the device measured activity accurately, or that the resulting measure is a valid substitute for a clinical outcome. These are separate questions from whether data were available.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies the primary endpoint as a percentage of patients with available step-count data. This is a binary-per-participant kind of outcome: for the purpose of a defined availability rule, each participant would contribute as having or not having available data. The record does not state the exact rule used to classify availability, such as whether a single recorded day would count or whether a complete set of daily measurements was required. That operational definition is not reported in the registry record.

What does a percentage describe?

General: a percentage summarizes the fraction of an analysis group meeting a defined condition. Its interpretation depends on both the condition and the denominator. For this endpoint, the condition concerns availability of step-count data during the stated baseline period. The registry record does not report the observed percentage, the numerator, or the denominator used in an analysis. It is therefore not possible to tell whether the analysis counted all enrolled participants, participants assigned to an arm, or another group.

The endpoint description specifies daily measurement for 7 days before the procedure. That time window gives the intended period for baseline monitoring, but it does not tell readers how missing days were handled. For example, the record does not say whether partial data were treated differently from no data, or whether device non-use and technical failure were distinguished. These distinctions matter for interpreting a usability or compliance measure because the same overall availability classification can arise for different reasons.

Why does non-randomized allocation matter?

Allocation is recorded as non-randomized, and the study has parallel interlaminar and transforaminal groups. General: random allocation is used to reduce systematic differences between treatment groups at the point of assignment. In a non-randomized comparison, group membership may be related to participant characteristics, clinical decisions, or other factors. A difference between groups cannot automatically be attributed to the injection approach. The registry record does not report the factors guiding assignment, a covariate-adjustment plan, or a comparative statistical analysis.

Both arm descriptions include pedometer monitoring. This means the described groups are not a device-versus-no-device comparison. The study may address whether step data can be collected in the context of these procedures, but the record does not describe a design that isolates the effect of using a pedometer against not using one. Similarly, the primary endpoint is an availability measure rather than a between-arm contrast in clinical outcome.

What can uncertainty quantify?

General: a confidence interval communicates the statistical uncertainty around an estimate under a specified analysis. For a percentage, it can help show how precisely the observed data estimate the underlying availability rate in a relevant population. A confidence interval does not account automatically for every source of bias, and it cannot repair an unclear endpoint definition or a missing denominator. No confidence interval or other uncertainty estimate for the primary endpoint is reported in the registry record.

A significance test, when used, evaluates compatibility between data and a specified null hypothesis under its assumptions. The registry record does not report a primary hypothesis test, a test statistic, or a p-value. It also does not report the statistical model used for the primary endpoint. Readers should not infer these details from the fact that the page includes statistical displays elsewhere.

How should the planning illustration be read?

The page includes a sample-size planning illustration computed from an observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The illustration varies the effect to detect as a stated fraction of the observed effect. It is a planning exercise, not a report of the trial's original design justification and not a measure of observed power. The registry record does not report the trial's own sample-size justification or statistical plan. The illustration's calculated sample sizes are displayed elsewhere on the page and should be read as hypothetical planning quantities, not as observed participant counts or results.

General: a normal approximation uses a reference distribution to estimate uncertainty or plan a study. Its adequacy depends on features of the data and analysis. The registry record does not report enough information about the endpoint analysis to evaluate those assumptions for a primary result. The assumptions stated for the planning illustration should not be mistaken for evidence that the same approach was used in the study's own analysis.

What does the record leave unresolved?

The registry lists two outcome measures, but the primary endpoint description alone does not specify the analysis population, missing-data procedure, multiplicity strategy, or handling of repeated daily measurements. It also does not report whether the primary endpoint was analyzed overall or separately by arm. These elements affect what an estimate would mean and how precisely it could be interpreted. Because the record does not post the endpoint result or analysis details, the statistical interpretation must remain descriptive and limited to the design and endpoint definition.

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("Interlaminar", "Transforaminal")
n      <- c(15, 14)
events <- c(14, 10)
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  Interlaminar  15  14  93.3  68.1  99.8  70.2  98.8  69.8  98.4
ARM  Transforaminal  14  10  71.4  41.9  91.6  45.4  88.3  44.9  88.2

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists two outcome measures, but the details describe only the primary endpoint. The other outcome's definition, analysis, and result are not reported in the registry record. A multiplicity strategy for handling more than one outcome or statistical comparison is also not reported in the registry record. There is no basis to state whether tests were adjusted, prioritized in a hierarchy, or interpreted descriptively.

The primary endpoint refers to available step-count data across the week before the procedure. The record does not define how much data were required for a participant to count as having available data. It does not report the number of missing days, reasons for missingness, or whether partial monitoring records were included. Nor does it describe imputation, exclusion, or sensitivity analyses for missing observations. These details are not reported in the registry record.

The study enrollment is 43, while arm descriptions and safety entries contain separate group counts. The registry record does not specify the analysis population for the primary endpoint or provide participant flow from enrollment to analysis. It is therefore not possible to infer how many participants contributed to the reported endpoint, and no such endpoint result is posted.

General: missing data can affect both the apparent availability rate and the interpretation of any measured activity. A complete-case analysis, an analysis that uses partial records, and an analysis that imputes missing values can answer different questions. These are general possibilities, not methods that can be attributed to this study. The registry record does not report which approach, if any, was used.

12. Safety Results

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

Other (non-serious) adverse events

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

The registry's serious adverse event entries report zero serious adverse events among 15 participants at risk in the interlaminar group and zero among 14 participants at risk in the transforaminal group. The entries for other adverse events also report zero among 15 and 14 participants at risk, respectively. These figures describe the registry's recorded counts for the stated groups.

Deaths are not reported in the registry record: the death entries are null, which should not be interpreted as a reported count of zero. The registry record also does not provide a narrative description of adverse event collection, event definitions, follow-up duration, or the relationship of any event to the procedure or device. The absence of reported events in these entries does not establish that no events occurred outside the recorded information.

General: adverse-event counts are most interpretable when the population at risk, observation period, and collection methods are clear. Here, the listed at-risk counts are not a substitute for the primary endpoint denominator, and the adverse-event figures do not answer whether the pedometer produced usable step-count data. They should be read as registry entries, not as a full safety assessment or a comparison demonstrating that one approach is safer.

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

The registry record supports a narrow description of the study's purpose and measurement plan. It describes use of a wireless pedometer in two groups receiving different lumbar epidural steroid injection approaches and identifies baseline step-data availability as the primary endpoint. The intended baseline window is the week before the procedure, with daily step-count measurement for 7 days.

The posted record does not report the primary endpoint result. As a result, it cannot show how often baseline data were available, how complete the data were, or how precisely an availability rate was estimated. It also cannot establish from the endpoint entry whether monitoring was usable or compliant in practice. The study summary's broader hypothesis that step count can measure efficacy of pain interventions remains a stated hypothesis, not a reported finding in the record.

The endpoint does not directly measure pain, function, or the effect of an injection. It concerns availability of measurements intended to characterize activity. Even if a data-availability result were reported, that result alone would not demonstrate that step count is a valid measure of clinical benefit or that a change in step count was caused by treatment.

Likewise, the two arms do not constitute a randomized control comparison. Both descriptions include a pedometer, and assignment was non-randomized. Any contrast between the interlaminar and transforaminal groups would need to be interpreted cautiously, particularly because the registry record does not report an adjustment plan or comparative result. The statistical displays and planning illustration cannot substitute for a missing primary result.

General: a study can contribute information about whether a measurement procedure is feasible without establishing that the measurement is clinically meaningful or that an intervention changes it. Those are distinct claims requiring distinct evidence. Here, the registry record describes an intended feasibility-related endpoint but does not report its value. No conclusion about treatment benefit or lack of benefit follows from the information recorded.

14. Why This Trial Matters Statistically

This study raises a useful statistical question about measurement before it raises a question about treatment effect: can daily activity data be captured around a clinical procedure in a way that could support later analysis? For activity measures such as step count, the existence, timing, and completeness of observations are prerequisites for interpreting changes. A carefully specified data-availability endpoint can make that practical issue visible.

The record also illustrates why an endpoint's wording matters. The primary endpoint is a percentage with available baseline data, while the registry summary describes a broader interest in using step counts to assess intervention efficacy. These are related but not interchangeable objectives. Data capture concerns whether an observation exists; efficacy concerns a clinical effect and requires an outcome analysis that addresses the relevant comparison and uncertainty.

From a design perspective, the non-randomized parallel groups make the distinction between description and causal comparison important. The interlaminar and transforaminal approaches are both represented, but a group difference would not by itself identify an effect of approach. A clear analysis plan and information about group differences would be needed to interpret such a contrast, and those details are not reported in the registry record.

The record's limitations also show the value of complete reporting. An endpoint definition without its result, denominator, missing-data rules, or uncertainty leaves readers unable to judge the observed level of data availability. Similarly, listing a hypothesis does not establish that it was supported. The tables and plots can organize the information that is posted, but cannot fill gaps in the registry record.

General: transparent reporting of endpoint definitions, analysis populations, missingness, estimates, and uncertainty allows readers to distinguish what was planned from what was observed. That distinction is central in biostatistics, especially when a study's measurement objective and clinical objective are not the same. This record makes the planned measurement question identifiable, while leaving its empirical answer unreported.

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.

The most important trial-specific limitation for interpretation is that the registry record does not report the primary endpoint result. Without the observed percentage of participants with available baseline step-count data, the central data-capture question cannot be answered from the posted results. No estimate or confidence interval is available to show the magnitude or precision of data availability.

The endpoint description does not state the rule for considering data available. Although it specifies daily measurement for 7 days before the procedure, the record does not say whether partial records counted, how many days were required, or how technical problems and non-use were classified. Those missing definitions limit the interpretation of the endpoint even apart from the absence of a result.

Enrollment is reported as 43, but the registry record does not identify the primary endpoint analysis population or provide participant flow. The arm descriptions refer to 15 patients in each group, while the safety entries list 15 and 14 at risk. These figures should not be treated as an endpoint denominator, and the record does not explain their relationship to the primary analysis.

Non-randomized allocation limits any causal interpretation of differences between the interlaminar and transforaminal groups. The registry record does not report how participants were assigned, what characteristics differed between groups, or whether statistical adjustment was planned or performed. Both groups are described as using a wireless pedometer, so the record does not offer a no-device comparison.

The registry does not report the primary analysis method, missing-data handling, multiplicity strategy, or the detailed result for the other listed outcome measure. It also does not report a sample-size justification for the study. The sample-size material is a planning illustration, not evidence about the original design rationale or observed power. These reporting gaps restrict both statistical and clinical interpretation.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain — NCT02356783.
• Registry record last updated 2019-10-15; status last verified 2019-10.
• Results first posted 2018-04-09.
• 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

NCT02356783 is a completed, non-randomized, parallel study sponsored by Hospital for Special Surgery, New York. The registry lists enrollment of 43, no masking, and a study start of 2015-02 with primary completion in 2016-08. It concerns chronic low back pain and monitoring around lumbar epidural steroid injection for radicular pain.

The two described groups use interlaminar and transforaminal approaches, and both include wireless pedometer monitoring. The primary endpoint is the percentage of patients with available step-count data during the week before the procedure, with daily measurement intended for 7 days. The registry record does not report the observed primary endpoint result, its analysis population, or its uncertainty.

The record lists two outcome measures and no posted analyses. Serious and other adverse event entries are zero for the stated at-risk counts; deaths are not reported in the registry record. Because allocation was non-randomized, the groups are not a like-for-like randomized control comparison. The posted record describes the study question and measurement plan but does not establish a result about baseline data availability or clinical efficacy.