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 Spinal Cord Stimulation for Painful Diabetic Neuropathy (NCT00487981), a na phase 4 study. The primary outcome is Pain Rating at 6 Months Post Activation Compared to Baseline.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00487981 |
| Phase | Phase 4 |
| Condition | Diabetic Neuropathy, Pain, Peripheral Neuropathy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boston Scientific Corporation |
| Results posted | Yes |
2. Clinical Question
The clinical question concerns pain ratings among people with painful diabetic peripheral neuropathy who selected spinal cord stimulation therapy. The registry describes an evaluation of spinal cord stimulation using the Advanced Bionics Precision system. It does not describe a randomized comparison with a control group, so the record cannot answer a comparative treatment question.
Population
People with painful diabetic peripheral neuropathy were the intended population. The registry also lists diabetic neuropathy, pain, and peripheral neuropathy as conditions. Eligibility criteria and details of the population actually analysed are not reported in the registry record.
Intervention
The intervention was Precision Spinal Cord Stimulation, described as a device. The brief summary says patients invited to participate would already have selected therapy with the Advanced Bionics Precision system independently of possible study inclusion. Details of treatment delivery and follow-up procedures are not reported in the registry record.
Comparator
No control group or alternative treatment comparator is described. The study is listed as single-group, with allocation recorded as NA. Its design therefore does not support a like-for-like comparison between treatment groups.
Primary question
The primary outcome is titled Pain Rating at 6 Months Post Activation Compared to Baseline. It is expressed as percent reduction and summarized as a mean with standard deviation. The actual outcome estimate and the scale used for the pain rating are not reported in the registry record.
3. Trial Design
The registry identifies NCT00487981 as a PHASE4 study titled Spinal Cord Stimulation for Painful Diabetic Neuropathy. The official title is Precision Spinal Cord Stimulation for Painful Diabetic Neuropathy. Boston Scientific Corporation is listed as the sponsor. The study is marked TERMINATED; its recorded start is 2007-02 and its primary completion is 2008-09.
The design is listed as SINGLE GROUP, with allocation recorded as NA and masking as NONE. These entries indicate that the record does not describe random assignment, masking, or a concurrent control group. A single-group study can describe outcomes among people receiving an intervention, but without a comparison group it cannot separate an intervention-associated change from other influences on outcomes over time.
The registry lists enrollment as 1. This is the enrollment figure recorded for the study, not evidence about how many participants contributed data to the primary outcome. The number analysed, the disposition of participants, and the reasons for termination are not reported in the registry record.
The intervention is listed as a device: Precision Spinal Cord Stimulation. The arm description names a Spinal Cord Stimulation treatment group. The brief summary says participants invited to take part would already have selected therapy independently of possible inclusion in the study. Thus, study participation was not described as the reason for choosing the therapy. Further information about recruitment, treatment administration, protocol deviations, or follow-up completion is not reported in the registry record.
The registry lists one outcome measure and zero analyses. The primary outcome is a pain-rating measure at 6 months after activation, compared with baseline. The posted record does not include a numerical result, an analysis population, or a statistical analysis plan.
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 | Spinal Cord Stimulation (SCS) Group |
|---|---|
| STARTED | 1 |
| COMPLETED | 0 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Spinal Cord Stimulation (SCS) Group |
|---|---|
| Hypothyroidism diagnosis | 1 |
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 | Spinal Cord Stimulation (SCS) Group |
|---|---|---|
| Participants analysed | 1 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age Continuous | years | 59 (SD 0) |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Pain Rating at 6 Months Post Activation Compared to Baseline, measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percent reduction |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled Pain Rating at 6 Months Post Activation Compared to Baseline. It is reported conceptually as percent reduction, with the parameter described as a mean and its dispersion described as a standard deviation. The endpoint therefore concerns a continuous measure of pain rating and the change framed relative to baseline. The registry does not identify the pain-rating instrument, its scoring range, the exact calculation used to express percent reduction, or the direction conventions for scores.
As a general statistical rationale, a continuous pain rating can retain information about the range of participants’ reported values rather than reducing each observation to a category. A mean describes the central value of such measurements, while a standard deviation describes their spread. A comparison with baseline can describe change over time in the group being followed. Those summaries do not, by themselves, establish that change was caused by the intervention; a single-group design has no concurrent control to account for other influences on change.
The 6-month timing defines the endpoint’s intended assessment point after activation. The exact visit window and the handling of measurements outside it are not reported in the registry record. Neither the endpoint estimate nor its standard deviation is reported, so the magnitude and precision of the pain-rating result cannot be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary outcome but does not report its numerical result. It also records zero analyses. As a result, there is no posted mean percent reduction, standard deviation, confidence interval, or p-value to interpret. The outcome title alone establishes what the study intended to assess, not what was observed.
The design matters when interpreting any change from baseline. This is a single-group study, with allocation recorded as NA and masking recorded as NONE. No concurrent control group is described. In general, a before-and-after change can reflect influences other than the intervention, including changes over time, expectations, or differences in who contributes measurements at follow-up. These are general interpretive concerns, not claims about what occurred among participants in this study.
The registry lists enrollment as 1, but the number contributing an endpoint value is not reported in the registry record. The enrollment entry cannot be used to establish that a primary outcome was measured or analysed. It also does not reveal whether the endpoint was available at the planned assessment time. The reasons for the study’s TERMINATED status are not reported in the registry record.
In general, a confidence interval communicates the range of values compatible with an estimate under the assumptions of the analysis. A narrow interval indicates greater statistical precision than a wide interval, while neither alone establishes whether a result is clinically important. No interval is reported for this endpoint, so its precision cannot be assessed. Similarly, no p-value or hypothesis-test result is reported; there is no basis to characterize the primary result as statistically significant or not statistically significant.
The registry also lists zero participants at risk for serious or other adverse events in the Spinal Cord Stimulation group and zero serious or other adverse events. With no participants listed as at risk, these counts cannot establish that no adverse events occurred in a larger treated population. The registry record does not provide further detail about adverse-event collection or reporting.
Overall, the record describes the study question and design, but not an analyzable treatment effect. It supports describing the intended endpoint and the design constraints. It does not support estimating the size, precision, or cause of any change in pain ratings.
9. Statistical Methods Explained
What does a mean describe?
The endpoint is a continuous measure summarized using a mean. In general, a mean combines the observed measurements into a central summary. It can be useful for describing the overall level of a continuous outcome, but it does not show the full distribution of individual values. A mean can also be influenced by unusually high or low observations. The registry does not report the outcome values, so the mean cannot be examined for this endpoint.
What does the standard deviation describe?
The registry identifies standard deviation as the measure of dispersion. In general, standard deviation describes how spread out observations are around their mean. It is a description of variability among measurements, not a measure of uncertainty in the mean itself. The standard deviation and the number of observations would both be relevant to assessing how precisely a group mean is estimated. The number of observations used in an analysis and the standard deviation for the primary endpoint are not reported in the registry record.
Why does the single-group design matter?
In general, a baseline assessment provides a reference for describing later measurements in the same study group. A change over time can be clinically informative as a description, but it does not alone establish what would have happened over the same period without the intervention. A control group can help estimate that counterfactual comparison when the design and analysis are appropriate. No control group is described in this record. Consequently, even if a before-and-after estimate were available, it would be a within-group change rather than a randomized treatment contrast.
The registry records no allocation and no masking. General methods reasoning recognizes that treatment selection and awareness of treatment can affect who enters a study and how subjective outcomes are reported or assessed. The brief summary specifically says participants invited to participate would already have selected therapy independently of possible study inclusion. The record does not report methods to address selection, expectations, or assessment-related influences.
What would a confidence interval add?
In general, a confidence interval expresses uncertainty around an estimated quantity under a statistical model and its assumptions. It gives readers more information than a point estimate alone about the estimate’s precision. Its interpretation depends on the design, the analysis, and the data available. No confidence interval is reported for the primary outcome, and the registry does not provide enough result information to interpret one.
What does a p-value answer?
In general, a p-value assesses how compatible observed data are with a specified null hypothesis, assuming the analysis model is appropriate. It does not measure the size or importance of an effect, and it does not establish causation. The registry lists zero analyses and does not report a p-value, a null hypothesis, or a statistical analysis plan. It would therefore be inappropriate to infer a test or its conclusion from the endpoint title.
How should planning illustrations be understood?
The planning assumptions described for the sample-size illustrations specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They also describe detecting a stated fraction of an observed effect. The record characterizes these as planning illustrations, not the trial’s own design. Its actual design is single-group, not an equal-allocation comparison between two arms. Any illustrative sample sizes are therefore hypothetical planning quantities, not observed power and not evidence about what this study detected. The registry does not report a numerical observed effect or the particular fractions used for the illustrations.
As a general concept, sample-size planning asks how much information a future study might need to detect an effect under chosen assumptions. The result depends on the target effect, variability, significance level, allocation, and analysis method. Planning calculations do not change the evidential limits of the study that generated an observed effect, and they cannot substitute for a reported outcome estimate. In this record, the numerical inputs and output values for the planning illustrations are not reported in the registry record.
Why can over-dispersion matter?
As a general concept, over-dispersion occurs when outcome variability is greater than assumed by a statistical model. A model that understates variability can produce confidence intervals that are too narrow and tests that appear more informative than the data warrant. This issue is most directly relevant to models for counts or other outcomes with a specified variance structure; the listed primary endpoint is continuous and summarized by a mean and standard deviation. The registry does not report a fitted model or diagnostic results, so no claim about over-dispersion in this study is possible.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and zero analyses. It identifies a primary endpoint, but does not report a statistical analysis plan, a list of planned hypotheses, or results for any analysis. The number of outcome measures alone does not establish how many statistical tests were planned or performed. The registry record does not report whether multiplicity adjustments were planned or used.
In general, multiplicity arises when several hypotheses or outcomes are tested. Testing many hypotheses can increase the chance of at least one apparently positive finding under a global null hypothesis. Statistical plans may address this through a prespecified hierarchy, adjustment, or other approach. Those are general methods; no such approach is reported for this study. With no analyses or numerical results recorded, there is no basis to evaluate multiplicity handling or to interpret a test result.
Missing-data methods are also not reported in the registry record. The record does not state how many participants had baseline or 6-month pain ratings, whether measurements were missed, why they might be missing, or how missing values were handled. These details matter because an estimate based only on observed follow-up measurements can represent a selected subset if availability is related to outcomes or participant characteristics. This is a general concern, not evidence that such a pattern occurred in this study.
The analysis population is not described. The enrollment entry does not establish which participants, if any, contributed to the primary endpoint analysis. There is no reported approach for including or excluding participants based on treatment receipt, follow-up, or other criteria. Without an analysis population and missing-data account, the intended target of any estimate cannot be determined from the registry record.
11. What the Result Does, and Does Not, Mean
The registry record establishes that a study of spinal cord stimulation for painful diabetic neuropathy was registered as a single-group study and marked TERMINATED. It identifies pain rating at 6 months post activation compared with baseline as the primary outcome, expressed as percent reduction and summarized by a mean and standard deviation. These details describe the question and intended outcome, not the result.
No numerical primary outcome estimate is reported, and the record lists zero analyses. Therefore, the record does not show the direction or magnitude of any change in pain rating, the variability of the observed measurements, or the precision of an estimated change. It also does not report a p-value or confidence interval. A treatment effect cannot be inferred from the outcome title or from the existence of a registered study.
The single-group design is important to what could be concluded even if a change were reported. A baseline-to-follow-up difference would describe change in the group over time; without a concurrent comparator it would not, by itself, establish that the intervention caused the change. The record’s statement that invited participants would already have selected therapy independently of possible study inclusion also distinguishes treatment choice from study participation. Further details on selection and outcomes are not reported in the registry record.
The adverse-event entries list zero at risk and zero events for the reported group. These entries do not establish safety or absence of adverse events among a broader population, particularly without a participant denominator and details of how events were collected. The enrollment figure, too, is not a substitute for an analysed sample size or outcome data.
Accordingly, the record is informative about registration, design, and the planned endpoint, but it does not permit conclusions about the observed pain-rating result, its statistical precision, its cause, or the balance of potential benefits and harms.
12. Why This Trial Matters Statistically
This study is statistically instructive because its registry entry separates a clearly named clinical outcome from the evidence needed to estimate it. The primary endpoint specifies a pain rating at 6 months after activation compared with baseline, and identifies a mean and standard deviation as the planned summary. Yet the record reports no analysis or numerical endpoint result. A defined outcome is not itself an observed finding.
The single-group design also illustrates the distinction between describing change and estimating a comparative effect. Repeated measurement can characterize what happened over time in a group, but a comparator is generally needed to assess how outcomes might have differed without the intervention. The registry record does not describe such a comparator or random allocation. This limits causal interpretation independently of the absence of a reported result.
The enrollment entry and the analysis population should likewise not be treated as interchangeable. The registry lists enrollment as 1, but does not state how many endpoint measurements were available or analysed. Transparent reporting of participant flow, outcome availability, analysis choices, and uncertainty is necessary for readers to judge what an estimate represents. Those details are not reported in the registry record.
The adverse-event entries offer another statistical lesson: counts need a meaningful denominator and clear collection methods. Zero events alongside zero participants at risk cannot establish that an intervention has no adverse events. A count without context does not provide a stable estimate of event frequency.
Finally, planning calculations should not be confused with trial evidence. The stated sample-size assumptions describe illustrative planning for a two-arm comparison, whereas the registered study is single-group. Such illustrations may help frame future design questions, but they do not supply an outcome estimate, remedy the lack of a control group, or establish observed power.
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 most direct limitation for interpreting this specific study is that the registry record does not report a numerical primary outcome or any analyses. The intended measure is identified, but there is no mean, standard deviation, confidence interval, or test result to assess. The record therefore does not support a quantitative description of the observed pain-rating change.
The single-group design and absence of a comparator limit causal interpretation. Allocation is recorded as NA and masking as NONE. The record does not describe randomization or a blinded outcome assessment. Because the primary outcome concerns pain rating, general concerns about expectations and assessment are relevant, but the registry does not report whether or how these were addressed.
Enrollment is recorded as 1, but participant flow, follow-up completion, and the endpoint analysis population are not reported in the registry record. It is not possible to determine whether a measurement was obtained at the planned 6-month time point or how any missing measurements were handled. The reasons for the TERMINATED status are also not reported.
The endpoint’s measurement details are incomplete. The pain-rating instrument, scoring range, exact definition of percent reduction, visit window, and analysis method are not reported in the registry record. These omissions prevent readers from independently interpreting the scale or reproducing the intended calculation.
The adverse-event record lists zero at risk and zero events in the Spinal Cord Stimulation group. With no participant denominator or additional account of event ascertainment, these entries cannot establish the frequency or absence of harms. More generally, the registry does not report a statistical analysis plan, prespecified handling of multiplicity, or missing-data methods. These limitations concern what the registry record allows readers to conclude; they do not establish that unreported procedures were or were not performed.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Spinal Cord Stimulation for Painful Diabetic Neuropathy — NCT00487981.
- Registry record last updated 2012-03-13; status last verified 2012-02.
- Results first posted 2012-03-13.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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17. Record Summary
NCT00487981 is listed as a PHASE4, SINGLE GROUP study sponsored by Boston Scientific Corporation and marked TERMINATED. Its recorded start is 2007-02 and primary completion is 2008-09. Enrollment is recorded as 1. Allocation is NA and masking is NONE.
The intervention is Precision Spinal Cord Stimulation, listed as a device, for painful diabetic peripheral neuropathy. The primary outcome is pain rating at 6 months post activation compared with baseline, expressed as percent reduction and summarized as a mean with standard deviation. The record lists one outcome measure and zero analyses.
No numerical primary result, analysis population, or statistical analysis plan is reported in the registry record. The reasons for termination and the outcome-measure details are also not reported.