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 CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial (NCT01267825), a randomized phase 4 study. The primary outcome is Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01267825 |
| Phase | Phase 4 |
| Condition | Disc Herniation, Lumbosacral Radiculopathy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Montefiore Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
The planned population was people with acute lumbar radiculopathy and a corresponding disc herniation. The registry describes disc herniation and lumbosacral radiculopathy as the conditions of interest. The primary outcome description says no patient data were collected, so the record does not provide information about the characteristics of people who might otherwise have entered the trial or how closely they matched the intended population.
Intervention
The intervention was a CT-guided perineural injection of a corticosteroid plus bupivacaine. The intervention arm was also described as receiving typical medical care. CT guidance identifies the imaging approach specified for delivering the injection; the registry record does not give further procedural details, medication doses, or the content of typical medical care.
Comparator
The comparator was standard medical care. The registry lists this as an intervention and names a standard-medical-care arm, but the arm description is blank. The specific treatments included in standard medical care, and whether they were standardized across participants, are not reported in the registry record.
Primary question
The planned primary question concerned change in functional impairment on the Roland Morris Disability Questionnaire (RMDQ), comparing the CT-guided intervention plus typical medical care with standard medical care. The measure was scheduled at baseline and one week after emergency department discharge. Because the study was terminated for low enrollment and no patient data were collected, the registry record does not answer whether the groups differed in RMDQ change.
In general, a randomized comparison is intended to estimate how outcomes differ between treatment strategies when assignment is made by chance. That goal depends on having outcome data from participants in the groups being compared. In this trial, the planned comparison and outcome are described, but there are no collected patient outcomes on which to estimate a difference. The clinical question therefore remains unresolved by this trial record.
3. Trial Design
The registry describes this as a randomized, parallel-group, single-masked Phase 4 trial. The planned groups were CT-guided perineural injection of corticosteroid plus bupivacaine with typical medical care, and standard medical care. The study title and official title identify the trial as a comparison in patients with acute lumbar radiculopathy and a corresponding disc herniation. The registry does not specify who was masked, so the meaning and implementation of single masking are not reported in the registry record.
The primary outcome was change in functional impairment measured with the RMDQ, at baseline and one week after emergency department discharge. Functional disability assessed with the Roland-Morris scale and adverse events are also listed among the secondary outcomes. The registry lists three outcome measures, but the available record does not provide patient-level results or group summaries for those measures. The trial was terminated due to low enrollment, and the primary-outcome population statement says that no patient data was collected.
The registry enrollment field records 1. The primary-outcome population statement, however, says no patient data was collected; the record does not explain what the enrollment entry represents or reconcile these statements. It would therefore be inappropriate to treat the enrollment value as evidence that a participant contributed outcome data. The actual number of participants with analyzable outcomes is not reported in the registry record, and the available outcome statement indicates none.
The record names Montefiore Medical Center as sponsor and gives the trial status as terminated. It does not report the details needed to reconstruct conduct, such as the randomization sequence, allocation concealment, masking procedures, treatment adherence, or the precise content of either care strategy. It also does not report a statistical analysis plan or completed analyses. These gaps limit assessment of how the planned design would have been implemented, independently of the more fundamental absence of patient outcome data.
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 | CT-guided Intervention | Standard Medical Care |
|---|---|---|
| STARTED | 1 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 1 | 0 |
Reasons for not completing this period:
| Reason | CT-guided Intervention | Standard Medical Care |
|---|---|---|
| study terminated. no data collected. | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Study terminated due to low enrollment. No patient data was collected.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: No data collected or analyzed because this study was terminated early due to low enrollment.
| Characteristic | Unit | CT-guided Intervention | Standard Medical Care | Total |
|---|---|---|---|---|
| Participants analysed | 0 | 0 | 0 | |
| Sex: Female, Male: Female | — | — | — | |
| Sex: Female, Male: Male | — | — | — | |
| Region of Enrollment: United States | participants | — | — | — |
6. Primary Endpoint
The registry lists the primary outcome as Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire, measured over Baseline and one week after emergency department discharge.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was change in functional impairment measured by the Roland Morris Disability Questionnaire. The RMDQ is described in the registry as a 24-item instrument about the impact of low back pain on daily life. Each item is answered yes or no, and the total score ranges from 0 to 24. Higher scores indicate greater impairment and, consequently, worse quality of life as described in the registry.
The measure was planned at baseline and one week after emergency department discharge. The registry defines change by subtracting the one-week score from the baseline score. Under that definition, a positive change corresponds to a lower score at follow-up than at baseline, while a negative change corresponds to a higher score at follow-up. This direction follows from the stated scoring and subtraction convention; it is not an observed result for this trial.
Functional impairment is relevant to the trial question because the study description concerns pain associated with herniated disc and its effect on daily function. A questionnaire score provides a structured way to record that impact. The registry notes that the RMDQ is most sensitive for people with mild to moderate disability due to acute, sub-acute, or chronic low back pain. The record does not report an observed baseline score, follow-up score, change estimate, confidence interval, or comparison between groups. No patient data was collected, so the endpoint cannot be evaluated in this trial.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that this terminated trial has no patient outcome data according to the primary-outcome population statement. The registry describes the intended randomized comparison and endpoint, but it does not report an estimated difference in RMDQ change between the groups. There is consequently no treatment-effect estimate to interpret, no confidence interval describing its precision, and no p-value for a group comparison in the registry record. This is not a finding of no difference: without outcome observations, the comparison was not estimated.
The record says that the trial was terminated due to low enrollment. It also records enrollment as 1, while the outcome statement says that no patient data was collected. The record does not explain this difference in reporting. The enrollment entry should not be read as proof that an RMDQ observation was available, because the trial's outcome statement explicitly says none was collected. The number of participants with evaluable outcomes is not reported in the registry record.
Because the outcome was not observed, statistical precision cannot be assessed. In general, a confidence interval describes a range of estimates compatible with the data and the assumptions used to calculate it. No such range is reported for this endpoint, and there are no collected outcomes from which to calculate one. Similarly, a p-value would address compatibility between observed data and a specified null hypothesis under an analysis model. In the absence of outcome data and a reported analysis, there is no trial p-value to interpret.
The registry lists adverse events as a secondary outcome and provides group entries with zero participants at risk and zero affected for serious and other events. These entries do not establish that the intervention or comparator had no adverse events among treated participants. The record says no patient data was collected, and the listed at-risk counts are zero. There is therefore no observed participant exposure and follow-up from which to infer event frequency or compare safety between groups. Death counts are not specified.
The record contains no reported outcome analyses and no reported statistical analysis plan. It does not state whether an interim analysis was planned or conducted, how missing outcomes would have been handled, which analysis population would have been used, or how adjustment for multiple outcomes would have been addressed. Those details cannot be reconstructed from the trial design or endpoint description. They remain unreported in the registry record.
The record's stated sample-size assumptions describe a planning illustration based on an observed effect, but no observed effect is available in this trial. No actual planning estimates are listed in the registry record for interpretation. In general, sample-size planning illustrations are conditional on assumptions about the target effect, variability, significance level, allocation, and analysis. They are not evidence of power achieved in a completed study. Here they cannot supply evidence about the trial's clinical question or compensate for absent outcomes.
In short, the registry documents an intended randomized evaluation that ended before patient outcomes were collected. It supports description of the planned design and measurement, not estimation of benefit, harm, or equivalence. Any conclusion about how the strategies compare would go beyond the posted results.
9. Statistical Methods Explained
The registry identifies the design as randomized and parallel-group. In general, random assignment uses chance to allocate participants to treatment strategies. Its purpose is to reduce systematic differences between groups at the point of assignment, so that a later outcome comparison can be interpreted as an estimate of the effect of assignment, subject to the study's conduct and analysis. A parallel-group design follows separate groups assigned to different strategies rather than having each participant receive every strategy. These are general properties of the named design; the registry does not report the randomization procedure or how allocation was concealed.
What would the primary comparison estimate?
The intended primary comparison concerned change in RMDQ score from baseline to one week after emergency department discharge, between the CT-guided injection strategy plus typical medical care and standard medical care. The registry defines each participant's change as baseline score minus the one-week score. A group comparison would ordinarily summarize the outcome in each arm and estimate a between-group contrast. The registry does not report the planned summary measure, the analysis model, any adjusted variables, or a completed estimate. Since no patient data was collected, no such contrast is available.
In general, a confidence interval communicates uncertainty around an estimated effect. Its width depends on the information in the data and the statistical assumptions used. It is not a guarantee that the true effect lies within the interval, and it cannot be interpreted without knowing what was estimated and how. Here there is no reported estimate or interval for RMDQ change. The endpoint description notes that mean and associated confidence interval values have been verified by staff statisticians, but the primary-outcome population statement says no patient data was collected and the registry reports no analyses. No numerical mean or interval is present in the trial details, so there is no interval to interpret for this comparison.
What does masking tell the reader?
The record labels the study single-masked. In general, masking can reduce the influence of knowledge about assignment on some aspects of trial conduct or outcome assessment. The particular person or group kept unaware of assignment matters for interpretation. The registry does not specify who was masked or how masking was maintained. The RMDQ is a questionnaire, but the record does not explain who completed it or whether assessment was masked. Those details cannot be inferred from the label alone.
How should the outcome scale be read?
The RMDQ contains 24 yes-or-no items and a score from 0 to 24, with higher scores indicating greater impairment. Change is defined as baseline minus the one-week score. For a general interpretation of this convention, a follow-up score lower than baseline produces a positive change; a follow-up score higher than baseline produces a negative change. This clarifies the sign of a possible estimate, but it does not imply that any change occurred in this study. No baseline or follow-up measurements were collected.
In general, statistical analysis of a continuous score may use a mean, a model-based adjusted comparison, or another summary. The appropriate choice depends on the protocol, data distribution, and analysis plan. The registry does not report which method was planned. It also does not report the variability of scores, distributional checks, covariate adjustment, or a method for handling repeated measurements. No analytical choice should be attributed to the investigators without a record of that choice.
Why do the listed analyses matter?
In general, an analysis plan specifies the primary comparison, the population to be analyzed, handling of missing observations, and methods for secondary outcomes and safety. Prespecification helps distinguish planned analyses from analyses selected after seeing results. The registry lists no analyses and does not report the statistical analysis plan. The record therefore does not establish whether an interim analysis was planned or performed, what analysis population was intended, or how any departures from the original plan would be handled.
Multiplicity arises when several outcomes, time points, or comparisons are tested. In general, considering many tests can increase the chance of at least one apparently unusual result under a collection of null hypotheses, so an analysis plan may specify which outcome is primary and how secondary questions will be handled. This record identifies an RMDQ primary outcome and lists functional disability and adverse events as secondary outcomes. It does not report a multiplicity procedure or a completed set of statistical tests. Because no outcome data were collected, there are no test results to interpret or adjust.
What can planning calculations establish?
In general, sample-size planning uses assumptions about a target effect and outcome variability to assess how many participants are needed for a chosen design and precision or power objective. A planning calculation is not an observed effect and is not observed power. The registry's stated assumptions describe illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. No observed effect is available for this trial, and no specific planning figures appear in the registry record. Accordingly, those generic assumptions do not yield a trial result or a credible estimate of achieved power. The registry does not report the trial's own sample-size justification.
Over-dispersion is a general concern when outcome variability exceeds what a statistical model assumes; if unaddressed, standard errors and inferential conclusions can be unreliable. This concept does not imply that over-dispersion was present in this trial. The primary outcome is a questionnaire score, and no outcome distribution or fitted model is reported. There is no basis to assess model fit or dispersion for the trial.
The methods distinction is important: a design describes what investigators intended to compare, while an analysis estimates a contrast from collected observations. This record describes the former but has no outcome data for the latter. Statistical concepts can clarify the planned comparison, but they cannot produce an estimate in the absence of observations.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies change in RMDQ score as the primary outcome and lists functional disability assessed using the Roland-Morris scale and adverse events as secondary outcomes. It does not report a multiplicity adjustment or a hierarchy for testing secondary outcomes. In general, multiplicity concerns arise when several outcomes or comparisons are analyzed, because interpreting each test separately can overstate the strength of evidence across the full set. No test results are available, so there are no reported p-values to adjust or interpret.
The record does not report a missing-data plan, an analysis population, or an approach to incomplete questionnaire measurements. Those issues are distinct from the fact that the outcome statement says no patient data was collected: there are no collected observations to classify as complete or incomplete for the primary endpoint. The registry enrollment field records 1, but the record does not explain this entry in relation to the statement that no patient data was collected. The number of participants with primary-outcome measurements is not reported in the registry record; the outcome statement indicates none were collected.
In general, a missing-data method addresses unavailable values among participants for whom data collection was intended or initiated. Such methods require information and assumptions about why observations are missing. They cannot recover an outcome comparison when no patient outcomes were collected. The registry record does not state whether an interim analysis was planned or conducted, and does not report an analysis population or a method for censoring, imputation, or sensitivity analysis. These details are not reported in the registry record, so no particular approach should be assumed.
11. What the Result Does, and Does Not, Mean
The trial record establishes that investigators planned a randomized comparison of CT-guided perineural corticosteroid plus bupivacaine with typical medical care against standard medical care. It also identifies the RMDQ measure and the planned timing of assessment. These details explain the question the study was designed to address; they are not evidence that one strategy produced a different outcome.
The trial was terminated due to low enrollment, and the primary-outcome statement says no patient data was collected. Consequently, the posted results provide no estimate of RMDQ change, no between-group comparison, and no precision measure. The absence of an estimate is not evidence that the strategies are equivalent, nor is it evidence that either strategy is better or worse. A randomized design can support a causal comparison only when relevant observations have been collected and analyzed; the design label by itself does not answer the clinical question.
The adverse-event entries likewise do not establish an absence of harm. The group records list zero participants at risk and zero affected for serious and other events, while the outcome statement says there were no patient data. Without participants contributing exposure and safety observations, these registry entries cannot be interpreted as an observed event rate or as a comparative safety result.
Some details about the intended outcome are informative independently of results: the RMDQ has 24 yes-or-no items, scores from 0 to 24, and higher scores represent greater impairment; the recorded change convention is baseline minus the score one week after discharge. These registry entries clarify how an outcome would have been measured and how a change's direction would be read. They do not describe actual participant experience in this trial.
The appropriate statistical reading is therefore limited but clear: this registry record documents a planned trial that did not produce patient outcome data. It cannot quantify an effect, characterize uncertainty about an effect, establish a null result, or support a conclusion about comparative adverse events. The clinical question remains unanswered by the posted results.
12. Why This Trial Matters Statistically
This trial is statistically instructive because a well-defined randomized question and a measured endpoint do not guarantee an estimable treatment effect. The registry identifies the intended population, two care strategies, a primary functional outcome, and an assessment interval. Yet the trial was terminated for low enrollment, and its primary-outcome statement says no patient data was collected. Without observations, the planned comparison cannot become an estimate.
That distinction matters when interpreting trial registries. A study can be listed as randomized and can specify a primary outcome without having results for that outcome. Readers should separate design information from evidence about outcomes. In this record, the planned RMDQ change is described precisely enough to explain what would have been measured, but there is no numerical result or uncertainty estimate to evaluate.
The record also illustrates why sample-size planning and observed results must not be conflated. General planning assumptions do not show what happened to participants, and a planning illustration based on an observed effect cannot be grounded in a study with no collected outcome data. A planned sample size or power calculation, even if reported, would not substitute for observed comparisons. The trial's own sample-size justification is not reported in the registry record.
Finally, the enrollment field and the no-data statement demonstrate the importance of reading registry entries together. The enrollment field records 1, whereas the outcome statement says no patient data was collected; the record does not explain the relationship between these entries. That ambiguity should be acknowledged rather than resolved by assumption. Overall, the record is useful for understanding the intended design and the limits of the evidence, but it offers no statistical estimate of the intervention's effects.
13. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for statistical interpretation is the absence of patient outcome data. The record says the trial was terminated due to low enrollment and that no patient data was collected. This prevents estimation of the primary RMDQ outcome and prevents comparison of the groups for secondary outcomes or adverse events. It is not possible to assess effect size, precision, variability, or statistical significance.
The registry enrollment field records 1, which is not explained alongside the statement that no patient data was collected. The record does not state whether this enrollment value refers to a person who was screened, enrolled, randomized, or otherwise counted, and it does not report an analyzable population. It should not be used to infer that outcome measurements exist.
Other design and analysis details are also absent. The registry does not specify who was masked, describe the randomization or allocation-concealment procedures, define the content of standard medical care, or give a statistical analysis plan. The standard-medical-care arm description is blank. Details about adherence, treatment delivery, outcome assessment, missing data, multiplicity, and interim analyses are not reported in the registry record. These omissions limit evaluation of how the proposed comparison would have been implemented, although they are secondary to the absence of outcomes.
The primary endpoint's assessment schedule and score are described, but the record contains no baseline or follow-up scores. No actual sample-size justification is reported. The record lists secondary outcomes and adverse-event categories, but there are no participant data to support an assessment of those outcomes. These limitations mean the trial record should be read as a description of an incomplete evaluation, not as a completed estimate of comparative effects.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial — NCT01267825.
- Registry record last updated 2018-08-31; status last verified 2018-08.
- Results first posted 2018-06-01.
- 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
NCT01267825 is a randomized, parallel-group, single-masked Phase 4 trial sponsored by Montefiore Medical Center. It was designed for acute lumbar radiculopathy with a corresponding disc herniation and compared CT-guided perineural corticosteroid plus bupivacaine with typical medical care against standard medical care. The primary outcome was change in RMDQ score from baseline to one week after emergency department discharge.
The registry status is terminated, with low enrollment given as the reason. The primary-outcome statement says no patient data was collected. Although the enrollment field records 1, the record does not explain this entry in relation to the no-data statement. No primary or secondary treatment-effect estimates, confidence intervals, or analysis results are reported. The record therefore documents the intended trial question and measurement strategy but does not provide an outcome comparison.