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 Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain (NCT02132910), a randomized na study. The primary outcome is Pain Scores.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02132910 |
| Phase | NA |
| Condition | Lower Back Pain |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 68 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Defense and Veterans Center for Integrative Pain Management |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with chronic or recurrent low back pain. The registry record identifies lower back pain as the condition, but does not report further eligibility details such as age, symptom duration, or required pain severity. The enrollment listed in the record is 68.
Intervention
RESTORE is described as gentle stretching and strengthening exercises incorporating breath-work and mindfulness. The study aimed to assess pain, physical function, and behavioral health. The intervention description mentions an initial assessment and a first four-week period, but the available record does not give enough detail to characterize the full intervention schedule.
Comparator
The comparator is named Control Group 2. Its description mentions an initial assessment and says participants would be contacted once; details beyond that are not reported in the registry record. The control condition therefore cannot be characterized more specifically from the record.
Primary question
The primary outcome is pain score, assessed at baseline, midtreatment, posttreatment, 3 month follow-up, and 6 month follow-up. The research question is whether pain scores across the study’s assessment schedule differ between participants assigned to RESTORE and those assigned to the control group. The registry record does not report a numerical comparison answering that question.
The trial also sought to examine physical function and behavioral health, and disability is listed as a secondary outcome. The record does not report results for these outcomes. It also does not specify a single time point as the sole primary comparison, so the pain question spans repeated assessments rather than one stated endpoint contrast.
3. Trial Design
RESTORE is a randomized, parallel-group trial with no masking listed in the registry record. Participants were assigned to the RESTORE Intervention or Control Group 2. The record lists enrollment as 68 and identifies the study as completed. Its start is recorded as 2013-12, with primary completion on 2015-08-07.
The intervention is described as a series of gentle stretching and strengthening exercises incorporating breath-work and mindfulness. Both arm descriptions mention an initial assessment involving pain, physical function, behavioral health, questionnaires, and physical assessments. The description for RESTORE refers to the first four weeks, while the control description says participants would be contacted once. These brief descriptions do not establish the full content, intensity, or duration of either arm; details not stated are not reported in the registry record.
The primary outcome is pain score, measured repeatedly from baseline through 6 month follow-up. Disability is listed as a secondary outcome. The record lists four outcome measures, but it does not identify a single primary time-point comparison or report a statistical analysis for the outcome. The trial’s phase is listed as NA. A detailed statistical analysis plan, including the intended model and adjustment variables, is not reported in the registry record.
Random allocation can help balance measured and unmeasured participant characteristics across groups on average, although it does not guarantee balance in any particular trial. Because masking is listed as none, participants and study personnel were not masked according to the record. Whether outcome assessors or analysts were masked is not reported in the registry record. The record does not give enough detail to assess adherence, treatment exposure, or departures from assigned treatment.
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 | RESTORE Intervention | Control Group 2 |
|---|---|---|
| STARTED | 34 | 34 |
| COMPLETED | 34 | 34 |
| NOT COMPLETED | 0 | 0 |
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 | RESTORE Intervention | Control Group 2 | Total |
|---|---|---|---|---|
| Participants analysed | 34 | 34 | 68 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 32 | 33 | 65 |
| Age, Categorical: >=65 years | Participants | 2 | 1 | 3 |
| Sex: Female, Male: Female | Participants | 19 | 24 | 43 |
| Sex: Female, Male: Male | Participants | 15 | 10 | 25 |
| Region of Enrollment: United States | Participants | 34 | 34 | 68 |
6. Primary Endpoint
The registry lists the primary outcome as Pain Scores, measured over Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome is pain score in units on a scale, summarized as a mean with standard deviation. Participants were asked to rate the severity of their current pain using the Defense and Veteran's Pain Rating Scale 2.0. The scale runs from 0, described as no pain, to 10, described as pain as bad as it could be, with descriptions between those endpoints linking pain severity to distraction and interference with activities. Higher values represent worse outcomes.
Pain is relevant to the study because the registry describes chronic or recurrent low back pain as the condition under study and identifies pain levels as one of the intended areas of impact. Repeated assessment at baseline, midtreatment, posttreatment, 3 month follow-up, and 6 month follow-up can describe pain over the course of the study and after treatment. These observations could address both change over time and differences between assigned groups, depending on the analysis plan.
The registry record does not report the observed means, standard deviations, or a between-group result for any assessment time. It also does not state which time point or contrast was designated as the primary statistical comparison. The measure therefore establishes what pain was intended to capture, but the posted record does not provide numerical evidence about the outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies pain scores as the primary outcome and describes repeated assessment from baseline through 6 month follow-up. It does not report numerical pain results, a treatment-group contrast, an estimate of uncertainty, or an inferential test. As a result, the record does not support a conclusion about the size, direction, or precision of any difference between RESTORE and Control Group 2.
The record also notes that the primary outcome has several categories or time points and has not been reduced to one comparison. That matters for interpretation: a set of measurements across time is not itself a single treatment effect. An analysis might compare groups at one selected follow-up, assess change from baseline, or model the repeated measurements together. Which approach was used, and which contrast should be treated as primary, are not reported in the registry record.
The absence of a numerical result should not be read as evidence that the groups had identical outcomes, nor as evidence that the intervention changed pain. It means the registry record does not provide the outcome information needed to evaluate either possibility. The same caution applies to physical function, behavioral health, and disability: they are described as study interests or outcomes, but numerical findings are not reported in the registry record.
Even if group means were available, their interpretation would depend on the comparison and its uncertainty. A mean describes the average score in a group, while a standard deviation describes the spread of individual scores around that average. Neither alone indicates whether a between-group difference is clinically meaningful or statistically distinguishable from random variation. A confidence interval, when reported, communicates a range of values compatible with the data under the analysis assumptions; it does not guarantee that the true effect lies in that range.
The study is randomized and parallel, which identifies the broad comparison structure, but the record does not report the analysis population, missing-data approach, or adjustment for repeated measures. Those details can affect the estimate and its uncertainty. Therefore, the appropriate reading is limited: the registry describes a randomized study and a repeated pain measure, but does not report a quantitative primary outcome result from which to judge the observed group comparison.
9. Statistical Methods Explained
What does a randomized parallel-group design mean?
The record classifies the study as randomized and parallel. In a randomized design, assignment to groups is determined by a chance-based process rather than being chosen solely by the participant or researcher. This helps reduce systematic differences between groups at the start of the study, on average. It does not ensure that every characteristic is balanced in the realized groups, and it does not eliminate issues such as missing outcomes or differences in adherence.
A parallel-group design means the assigned groups are compared over the same general study period rather than participants crossing from one intervention to another. Here, the named groups are RESTORE Intervention and Control Group 2. The registry lists no masking. The exact randomization method, concealment procedures, and any masking of outcome assessors or analysts are not reported in the registry record.
How should the pain summary be understood?
The primary outcome is a continuous score, summarized using a mean and standard deviation. In general, a mean is the arithmetic average of recorded scores and gives a concise description of the group’s central level. A standard deviation describes how dispersed individual scores are around the mean. A larger standard deviation indicates greater spread, not necessarily a worse average outcome.
The scale asks about current pain and anchors its values with verbal descriptions. The record states that higher values represent worse outcomes. A difference between group means would therefore need to be read with its direction in mind, as well as its uncertainty and practical meaning. No group means, standard deviations, or between-group estimates are reported in the registry record, so no such interpretation can be made for RESTORE from the posted outcome information.
Why do repeated measurements require care?
Pain was scheduled for assessment at baseline, midtreatment, posttreatment, 3 month follow-up, and 6 month follow-up. Repeated measurements from the same participant are related: a participant’s scores over time are not generally independent observations. As a general statistical principle, an analysis of repeated measurements should account for this dependence rather than treating every score as unrelated.
There are several possible ways to summarize repeated outcomes. An analysis could compare groups at a specified follow-up, compare change from baseline, or estimate group patterns over time. These choices answer related but not identical questions. The record does not report which repeated-measures model or contrast was used, whether baseline values were incorporated in an adjusted analysis, or how the primary comparison was selected. It explicitly notes that the primary outcome has several time points and is not reduced to one comparison.
What do significance tests and confidence intervals contribute?
In general, a significance test evaluates how compatible the observed data are with a specified null hypothesis under stated assumptions. A p-value is not the probability that the null hypothesis is true, and it does not describe the magnitude or practical importance of an effect. A confidence interval conveys uncertainty around an estimate and helps show which effect sizes are compatible with the data and analysis assumptions.
Neither a p-value nor a confidence interval is reported for the primary outcome in the registry record. The record also does not report a prespecified hypothesis, test, model, or statistical analysis plan. Consequently, there is no basis in the posted information for interpreting statistical significance or precision for the pain comparison.
What do the planning assumptions mean?
The record describes a sample-size planning illustration based on a fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. In general, a planning calculation asks how many participants per arm might be needed to detect a specified effect under chosen assumptions. Such a calculation is not an observed result and is not observed power. It should not be confused with the trial’s actual enrollment or with evidence that an effect was detected.
The record says the illustration is based on an observed effect, but a primary outcome comparison and its observed effect are not reported in the registry record. The assumptions for the illustration are not the same as a documented rationale for the original trial design. The trial’s own sample-size justification and statistical plan are not reported in the registry record. No planning estimate should be interpreted as a finding about treatment effect.
Why can over-dispersion matter?
As a general concept, over-dispersion occurs when outcome variability is greater than a statistical model assumes. When that happens, a model may understate uncertainty if it does not accommodate the extra variability. The stated primary outcome is continuous and summarized by a mean and standard deviation; the registry does not report a fitted model, a dispersion assessment, or any evidence of over-dispersion. This concept is therefore relevant only as general statistical context, not as a reported feature of this trial’s analysis.
10. Multiplicity, Missing Data and Analysis Populations
The primary pain outcome was scheduled at baseline, midtreatment, posttreatment, 3 month follow-up, and 6 month follow-up. The record also lists disability as a secondary outcome and describes intended study interests in physical function and behavioral health. Multiple outcomes and assessment times can create multiple opportunities to examine group differences. As a general statistical issue, testing many contrasts can increase the chance of finding an apparently notable result by chance unless the analysis plan addresses multiplicity.
The registry record does not report a primary time-point contrast, a hierarchy among outcomes, or a multiplicity adjustment. It also does not state whether any outcome or time point was designated for confirmatory interpretation. These omissions prevent assessment of how the investigators intended to control or interpret multiple comparisons. They do not establish that no such plan existed outside the registry record.
Missing-data methods are not reported in the registry record. The record does not give the amount or pattern of missing pain assessments, the assumptions used to address missing outcomes, or whether sensitivity analyses were conducted. These details matter because participants with incomplete follow-up may differ from those with complete measurements, and different assumptions can lead to different estimates.
The analysis populations are also not reported. The registry record does not state whether results were intended to follow randomized assignment regardless of treatment received, to include only participants meeting a particular adherence definition, or to use another population. No analysis counts or outcome analyses are listed. Without those details, the relationship between random assignment, participation, missing assessments, and any estimated effect cannot be evaluated.
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 |
|---|---|---|---|
| RESTORE Intervention | 0 | 34 | 0.0% |
| Control Group 2 | 0 | 34 | 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 |
|---|---|
| RESTORE Intervention | 0 of 34 |
| Control Group 2 | 0 of 34 |
The registry lists 0 serious adverse events for RESTORE Intervention and 0 for Control Group 2. For each group, 34 participants are listed as at risk for serious events. It also lists 0 other adverse events for each group, with 34 at risk in each. These are the recorded counts; they are not a complete description of event types, timing, severity, or causal assessment.
The death counts are not reported in the registry record. The record lists no top serious adverse-event terms, but this does not provide details about how events were solicited, monitored, or classified. A zero count in a registry entry means no events were recorded in that category in the reported data; it does not establish that the intervention has no risk or that no unrecorded events occurred.
These safety figures should be interpreted separately from the pain outcome. They do not show whether pain scores differed, and they do not replace a detailed account of adverse events or exposure. Because the record does not provide event narratives or additional safety analyses, comparisons between groups should remain limited to the counts and at-risk figures stated in the registry.
12. What the Result Does, and Does Not, Mean
The record establishes that RESTORE was studied in a randomized, parallel-group trial for chronic or recurrent low back pain, with pain scores identified as the primary outcome. It describes a gentle stretching and strengthening intervention incorporating breath-work and mindfulness, and names a control group. It also states that pain was to be assessed repeatedly through 6 month follow-up.
It does not establish whether RESTORE reduced pain, increased pain, or produced outcomes similar to the control group. The registry record does not report the numerical pain scores, a between-group estimate, or uncertainty around an estimate. Without those results, the direction and size of any observed difference cannot be described. The absence of reported results is not evidence that there was no effect.
The record also does not support conclusions about physical function, behavioral health, or disability. These are among the study’s intended areas or listed outcomes, but their numerical findings are not reported in the registry record. Nor does the record provide enough detail to determine whether the recorded adverse-event counts capture every relevant event or how the intervention was delivered in practice.
Even when a trial is randomized, conclusions depend on the quality and completeness of outcome data, the analysis choices, and the precision of the estimates. Details about missing assessments, analysis populations, and the statistical plan are not reported. The result should therefore be read as a description of the registered study and its intended measurements, rather than as evidence for or against a treatment effect.
General statistical interpretation also distinguishes an estimated effect from its uncertainty and from its practical importance. A point estimate alone would not answer all three questions; a confidence interval and clinical context would also be relevant. Since these numerical results are absent from the registry record, no claim about precision or practical importance can be made.
13. Why This Trial Matters Statistically
This study is statistically notable for combining random assignment with repeated measurement of a subjective symptom. Randomization defines a comparative framework, while the pain scale provides a structured way to record participants’ current pain. The assessments from baseline through 6 month follow-up could, in principle, describe both short-term patterns and whether group differences persist over time.
The repeated schedule also makes the choice of statistical question important. A group contrast at one follow-up is not interchangeable with a comparison of change from baseline or an overall pattern across assessments. The registry record does not identify one primary time-point contrast, and notes that the primary outcome has several time points without reducing it to one comparison. That limits the ability to interpret what a single headline effect would represent, even if an estimate were available.
The record’s lack of numerical results is a central statistical limitation. Without outcome estimates and uncertainty, readers cannot assess effect direction, magnitude, or precision. Without the analysis plan, it is also not possible to determine how repeated observations, multiple outcomes, missing data, or analysis populations were handled.
These limits illustrate why a trial’s design description and its outcome evidence are different kinds of information. A randomized design can support a clear comparison in principle, but evaluating the comparison requires reported data and methods. The record documents the intended question and broad design, while leaving the primary statistical result and the details needed to assess it unreported.
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 registry description is incomplete for evaluating the intervention and comparator. RESTORE is characterized broadly as gentle stretching and strengthening with breath-work and mindfulness, but the arm description does not provide a complete delivery schedule or enough detail to characterize treatment exposure. The control description says participants would be contacted once; further details are not reported in the registry record. It is therefore not possible to describe the full contrast between the arms.
The population is also only broadly specified as people with chronic or recurrent low back pain. Eligibility criteria, participant characteristics, and the setting are not reported in the registry record. Those details would help readers assess how closely the enrolled population corresponds to the people or circumstances of interest.
Several limitations concern outcome interpretation. Pain is self-reported as current pain on a scale whose higher values represent worse outcomes. The registry record does not report the numerical results, missing follow-up information, or any assessment of how well the outcome data represent participants’ experiences over time. It does not state which time point or contrast was primary, how multiplicity was addressed, or how repeated measurements were analyzed.
The record also does not report the statistical analysis plan, analysis populations, adherence, or the handling of missing data. Although the trial is listed as randomized and unmasked, the randomization procedures and any masking of outcome assessors or analysts are not reported. Finally, the safety entry gives event counts and at-risk figures but no event descriptions, and deaths are not reported in the registry record. These gaps restrict conclusions to the registry entries explicitly recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain — NCT02132910.
- Registry record last updated 2019-11-25; status last verified 2019-11.
- Results first posted 2019-11-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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.
18. Record Summary
NCT02132910 is the RESTORE trial, titled Restorative Exercise for Strength Training and Operational Resilience for Chronic or Recurrent Low Back Pain. The record lists a randomized, parallel-group design with no masking and a completed status. Enrollment is listed as 68; the study start is recorded as 2013-12, and primary completion as 2015-08-07.
The intervention is described as gentle stretching and strengthening exercises incorporating breath-work and mindfulness. The primary outcome is pain score on the Defense and Veteran's Pain Rating Scale 2.0, summarized as a mean with standard deviation and assessed from baseline through 6 month follow-up. Disability is listed as a secondary outcome.
The registry record does not report numerical primary outcome results, a single primary time-point comparison, or statistical analyses. It lists 0 serious adverse events and 0 other adverse events in each group, with 34 at risk in each; death counts are not reported in the registry record. The broad design and outcome schedule are documented, but the missing results and analysis details prevent evaluation of the treatment-group comparison.