Thera-Band® HEP for LBP Secondary Prevention: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Thera-Band® HEP for LBP Secondary Prevention (NCT02355275), a na na study. The primary outcome is Oswestry Disability Index.

2. Clinical Question

The registry record describes a study of a Thera-Band® based home exercise program (HEP) for people with low back pain (LBP). Its stated purpose was to determine the program’s effectiveness on LBP and disability 4 weeks after treatment discharge. The primary outcome was disability measured with the Oswestry Disability Index (ODI); Numeric Pain Rating Scale (NPRS) was listed as a secondary outcome.

This is therefore a question about change over time within a group, not a randomized comparison of the home program with another treatment or with no program. Without reported ODI values or an estimated change, the direction, size, and precision of any change cannot be described. The record also does not report how the NPRS results were analyzed.

3. Trial Design

The study is registered as a single-group study with enrollment of 22 and status recorded as terminated. Allocation is listed as NA, and masking is listed as NONE. The registry record gives the study start as 2015-01 and primary completion as 2016-01. The phase is listed as NA. These entries describe the registered design and status; they do not explain why the study was terminated or what led to its enrollment and completion status.

The intervention is named Home Exercise Program and classified as a procedure. The study title and brief summary describe a Thera-Band® based home exercise program intended for low back pain secondary prevention. No additional intervention details or arm description are reported in the registry record. Since the design is single group, the record does not identify a concurrent control arm. The registry’s own notes characterize it as not a randomized comparison and caution against treating arms as a like-for-like control comparison.

The primary outcome is the Oswestry Disability Index, with a stated timeframe of 4 weeks. Its description says the outcome was reported at baseline (T1) and 4 weeks later (T2). The brief summary frames the study purpose as assessing LBP and disability 4 weeks post treatment discharge. The record does not clarify how the baseline and post-discharge timing relate for each participant, or report further visit procedures.

The registry lists Numeric Pain Rating Scale as a secondary outcome and reports 2 outcome measures. It lists 0 analyses. No outcome estimates, analysis populations, or statistical methods for an efficacy analysis are reported in the registry record. Consequently, the design details support a description of the study question, but not an estimate of treatment effect.

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 Oswestry Disability Index, measured over 4 weeks.

The primary endpoint is the Oswestry Disability Index (ODI), a self-report measure of disability. The registry describes each section as having a possible score of 5: marking the first statement gives a section score of 0, while marking the last gives a score of 5. The described total is calculated by totaling the marked values, dividing by 50, and multiplying by 100. The registry states that a greater score indicates greater disability.

The measure is used to describe how low back pain affects a person’s reported functioning. That makes disability a relevant outcome for a study whose stated purpose includes assessing disability after treatment discharge. The record gives minimal disability as 0% to 20% and bed-bound as 81%-100%, as examples of how the score can be interpreted. These are descriptions of the scale, not results from the participants in this study.

The ODI is specified as a mean outcome with full range dispersion and a timeframe of 4 weeks. Its description refers to measurements at baseline (T1) and 4 weeks later (T2). However, no baseline or follow-up scores, mean change, or range values are reported in the registry record. The endpoint’s measurement definition is available, but the trial’s observed disability results and their precision are not.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a mean ODI endpoint and a single-group design, but lists 0 analyses. It does not report the statistical methods used to analyze the primary or secondary outcomes. The explanations below describe general statistical concepts relevant to interpreting these outcomes; they are not claims about methods actually used in this study.

What would a within-group change represent?

In a single-group study, an analysis might describe the difference between participants’ measurements at baseline and follow-up. Such a summary can show the pattern of change over time in the observed group. It is not equivalent to a randomized treatment contrast. Without a separate group representing what might have happened without the home exercise program, the change cannot be attributed uniquely to the program. Other changes over time, differences in participant circumstances, and measurement variation may also contribute. This is a general feature of single-group designs.

The registry identifies baseline (T1) and 4 weeks later (T2) for the ODI description, but it does not report paired observations or an estimated change. A paired analysis, in general, uses the fact that the two measurements come from the same participants. An analysis that treats the two sets of measurements as unrelated would not represent that pairing. The registry record does not state which approach, if any, was used.

What do a mean and range convey?

A mean is a measure of the average value in a group. It can help describe the central level of ODI scores, but it does not show how scores are distributed across participants. A range describes the span from the lowest to highest observed value and can help indicate how widely the recorded scores extend. General statistical interpretation of a mean and range depends on seeing their actual values and knowing how many observations contributed. The registry specifies mean and full range dispersion, but reports neither the summary values nor the number contributing to each time point.

For a change estimate, a confidence interval would describe the uncertainty associated with that estimate under the assumptions of the analysis. A narrow interval generally indicates greater precision than a wide interval, while an interval that includes values compatible with no change does not establish that the true change is zero. These are general interpretations; the registry record does not report an estimate or confidence interval for the ODI.

Why is the comparator relevant?

Random assignment to a comparator group can, under appropriate implementation and analysis, help distinguish an intervention effect from changes that would also occur without the intervention. This study is registered as single group, with allocation listed as NA. The registry notes that it is not a randomized comparison. An analysis of change within this group would thus answer a different question from a comparison of outcomes between randomized groups. It could describe change among enrolled participants, but it would not by itself provide a controlled estimate of the home program’s effect.

Masking is listed as NONE. The record does not explain which people, if any, knew the intervention assignment or how outcomes were collected. Since the study has no separate comparison arm, masking should not be interpreted as evidence about assessor procedures or participant expectations. The registry does not report such details.

What can be inferred from the analysis listing?

The registry lists 0 analyses. This means no statistical analysis results are reported in the record; it does not supply an estimate that can be interpreted as positive, negative, or inconclusive. In general, estimates and their uncertainty are more informative than a statement that a study was intended to assess an outcome. The endpoint definition alone describes what was meant to be measured, not what participants scored or what happened over time.

The record says the study purpose was to determine the effectiveness of a Thera-Band® based home exercise program on LBP and disability 4 weeks post treatment discharge. Purpose statements explain the motivation for a study, but do not replace outcome data. Without reported results, it is not possible to evaluate the observed change, its precision, or whether any result was compatible with a meaningful difference.

How should planning illustrations be read?

Sample-size calculations are planning tools, not observed trial outcomes. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect set as a stated fraction of the observed effect. The assumptions describe a planning illustration and do not describe this trial’s single-group design. The registry record does not report the trial’s own sample-size justification or design assumptions. Any planning illustration based on an observed effect must also be distinguished from a result of this study, and it is not observed power.

More generally, a planning calculation depends on choices about the target effect, variability, significance level, allocation, and statistical model. Different choices can yield different planning estimates. A planning illustration cannot show how likely a result from the completed study was to be statistically significant, and it cannot substitute for an observed estimate with an uncertainty interval. No outcome estimate from this trial is reported in the registry record.

What can a p-value establish?

In general, a p-value measures how compatible observed data are with a specified null model, given the analysis assumptions. It is not the probability that the null hypothesis is true, nor does it state the size or practical importance of an effect. A p-value also does not remedy limitations of a single-group design. No p-value is reported for the primary or secondary outcomes in the registry record, so no significance-based interpretation is available.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies the ODI as the primary outcome and the Numeric Pain Rating Scale as a secondary outcome. It reports 2 outcome measures and 0 analyses. No results are reported for either measure, and the registry record does not describe a multiplicity strategy, such as how interpretation would account for evaluating more than one outcome. Whether any adjustment or hierarchy was planned is not reported in the registry record.

Multiplicity is a general concern when several outcomes or analyses are examined. The more opportunities there are to identify an apparently unusual result, the more important it becomes to understand which outcomes were prespecified and how the analyses were handled. Naming one primary endpoint can help distinguish the main study question from secondary questions, but it does not reveal whether a formal multiplicity procedure was used. The record does not describe further outcome analyses or an analysis plan.

Missing-data handling is also not reported in the registry record. The record gives enrollment of 22 but does not state how many participants contributed ODI measurements at baseline or follow-up, whether any observations were missing, or how missing observations were treated. It does not report imputation, complete-case analysis, or another strategy. No assumption about the extent or handling of missing data can therefore be made.

The analysis population is not reported in the registry record. It is not stated whether analyses were intended to include all enrolled participants, only participants with follow-up measurements, or another defined group. The registry’s count of 0 analyses means there is no reported analytic sample to assess. These omissions limit interpretation independently of the study’s small enrollment and single-group design: even a descriptive change requires knowing which observations were included and how incomplete records were addressed.

11. 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 lists a Home Exercise Program group with 22 participants at risk for serious adverse events and 0 affected. It also lists 22 at risk for other adverse events and 0 affected. These are the event counts recorded in the registry; they should be read as reported counts, not as a demonstration that no safety concerns are possible.

The deaths value is not reported in the registry record. The record does not provide descriptions of adverse events, collection procedures, observation duration, or detail on how events were assessed. It is therefore not possible to evaluate the completeness of event monitoring or to understand the context of the reported counts.

Zero affected participants in the listed categories means that the registry reports no events in those categories for the stated at-risk group. It does not establish that an event could not occur, and it does not provide a comparison of event experience against another group. The single-group design has no concurrent comparator for safety contrasts. These figures should be interpreted narrowly as registry-reported counts for this study, without broader conclusions about the intervention.

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

The record establishes that a study was registered to assess a Thera-Band® based home exercise program for low back pain secondary prevention. It enrolled 22 participants, used a single-group design, listed ODI as the primary outcome, and identified NPRS as a secondary outcome. It also records the study status as terminated. These details describe the study’s intended question and recorded status, not its outcome.

The record does not report ODI or NPRS results, an estimate of change, an uncertainty interval, or a statistical analysis. As a result, it does not show whether disability or pain changed, how large a change might have been, or how precisely such a change was estimated. It cannot establish that the program was effective, ineffective, or equivalent to another approach. No comparator group is registered, so the design would not provide a randomized between-group treatment effect even if within-group outcomes were available.

In general, statistical significance and clinical importance are different considerations. A statistical test addresses compatibility with a specified model, while clinical importance concerns whether an observed difference matters in context. Both require interpretable outcome data and an appropriate analysis. Neither can be assessed from an endpoint description and study purpose alone.

The sample-size assumptions describe planning illustrations based on an observed effect, with two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. They are not the study’s own design, do not turn the single-group study into a two-arm comparison, and are not observed power. The registry record does not report the effect estimates needed to interpret any such illustration in relation to trial results.

The appropriate reading is therefore restrained: the study record describes a planned evaluation and reports limited design and safety counts, but contains no efficacy analysis results. The absence of reported results is not evidence that the outcome did or did not change. It leaves the clinical question unanswered in the registry record.

13. Why This Trial Matters Statistically

This trial matters statistically because its design makes the distinction between describing change and estimating a treatment effect especially important. The registry identifies a single-group study, not a randomized comparison. A baseline-to-follow-up description could characterize the enrolled group, but it would not isolate the contribution of the home exercise program from other explanations for change. The design label is central to interpreting what any possible outcome estimate could mean.

The record also illustrates the difference between specifying an outcome and reporting a result. The ODI is described in detail, including its scoring direction and measurement times, and NPRS is listed as a secondary outcome. Yet the registry reports 0 analyses. A clear endpoint definition helps readers understand what was intended to be measured; it does not reveal the observed values, the size of change, or the uncertainty around it.

Enrollment was 22, but enrollment alone does not tell readers how many participants contributed outcome data at each time point. The analysis population and missing-data approach are not reported in the registry record. Those details matter for judging whether an estimate represents the enrolled group and how much confidence to place in it.

Finally, the record’s terminated status and absence of analysis results underscore the limits of interpreting a registry entry as a completed evidence report. The reason for termination is not reported, so no explanation should be inferred. A transparent record of outcome data and analysis would be necessary for evaluating the study’s statistical findings. In its absence, the most useful statistical lesson is to keep design, measurement, analysis, and inference distinct.

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.

Several trial-specific limitations follow directly from the registry record. The study is single group and is not a randomized comparison, so it has no registered concurrent control group for separating intervention-associated change from other changes over time. Enrollment was 22, and the record does not report how many participants contributed outcome data at baseline or follow-up.

The study is recorded as terminated, but the reason for termination and its relationship to planned recruitment, follow-up, or analysis are not reported in the registry record. The record lists 0 analyses and contains no ODI or NPRS results, estimates, confidence intervals, or p-values. This prevents assessment of outcome direction, magnitude, variability, and precision.

The intervention is named as a Thera-Band® based home exercise program, but its exercise content, schedule, duration, progression, and adherence information are not reported. Eligibility criteria, participant characteristics, and details of treatment received before discharge are also not reported in the registry record. These omissions restrict understanding of who was studied and what intervention was evaluated.

The primary outcome description identifies baseline and 4 weeks later, while the study purpose refers to assessment 4 weeks post treatment discharge. Further detail connecting those time points is not reported. Longer-term outcomes, missing-data procedures, analysis populations, multiplicity handling, and the reason for selecting the reported design are not reported in the registry record. These limitations prevent a detailed appraisal of the intended analysis and the generalizability of any potential results.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Thera-Band® HEP for LBP Secondary Prevention — NCT02355275.
• Registry record last updated 2016-02-09; status last verified 2016-01.
• Results first posted 2016-02-09.
• 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.

18. Record Summary

The registry record describes Thera-Band® HEP for LBP Secondary Prevention, a single-group study sponsored by Sport and Spine Rehab Clinical Research Foundation. Enrollment was 22; allocation is listed as NA, masking as NONE, and status as TERMINATED. The study start is recorded as 2015-01 and primary completion as 2016-01.

The stated purpose was to assess a Thera-Band® based home exercise program on low back pain and disability 4 weeks post treatment discharge. The primary outcome was the Oswestry Disability Index, described at baseline and 4 weeks later. Numeric Pain Rating Scale was listed as a secondary outcome. The record lists 2 outcome measures and 0 analyses.

The record reports 0 participants affected by serious adverse events and 0 affected by other adverse events among 22 at risk for each category. Deaths are not reported in the registry record. No outcome estimates, analysis methods, missing-data procedures, or reason for termination are reported. The registry therefore documents the study question and selected design details, but not analyzed results with which to evaluate change or treatment effect.