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 Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain (NCT02081456), a randomized na study. The primary outcome is Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02081456 |
| Phase | NA |
| Condition | Cervical Radiculopathy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 23 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Emilio J Puentedura, PT, DPT, PhD |
| Results posted | Yes |
2. Clinical Question
The trial asked whether soft tissue mobilization or therapeutic ultrasound was associated with different upper limb neurodynamic test range of motion in people with neck and arm pain who demonstrated neural mechanical sensitivity. The condition listed in the registry is cervical radiculopathy. The primary endpoint is expressed in degrees, with the timeframe recorded as up to 2-4 day follow up.
Population
Subjects with neck and arm pain and evidence of neural mechanical sensitivity. Cervical radiculopathy is the condition listed in the registry.
Intervention
Passive soft tissue mobilization to the neck and upper extremity.
Comparator
Therapeutic ultrasound applied to the most painful region of the neck and then the most painful region of the upper extremity. Each application is described as a 5 minute dose.
Primary question
What upper limb neurodynamic test range of motion, measured in degrees, was reported for each arm at the stated follow-up?
This framing is narrower than a general question about all symptoms or function. The registry names Neck Disability Index and Patient Specific Functional Scale as secondary outcomes, but their results are not included in the posted outcome values described for the primary endpoint. The question addressed by the reported figures is therefore about the named range-of-motion measure, not every possible consequence of either intervention.
3. Trial Design
The record describes a randomized, parallel-group clinical trial and lists quadruple masking. The trial is marked completed. It enrolled 23, with 11 assigned to therapeutic ultrasound and 12 to soft tissue mobilization in the posted primary-outcome results. The record does not explain who was masked or how masking was maintained, so the meaning of quadruple masking cannot be elaborated from the registry record.
The comparison involved two different interventions. Therapeutic ultrasound was described as being applied for 5 minutes to the most painful region of the neck, followed by a second 5 minute dose at the most painful region of the upper extremity. Soft tissue mobilization was described as passive mobilization to the neck and upper extremity. The posted descriptions do not state further treatment frequency, session count, provider training, or other delivery details; these are not reported in the registry record.
The study start is recorded as 2009-11 and primary completion as 2012-06. The phase is listed as NA. The sponsor is Emilio J Puentedura, PT, DPT, PhD. These record details describe the trial’s registration and conduct but do not establish how participants were recruited, how allocation was generated or concealed, or whether the analysis followed the original plan. Those methods are not reported in the registry record.
Random allocation is intended, in general, to support a fair comparison by balancing prognostic characteristics on average. With a modest enrolled group, balance in any particular trial is not assured. The registry record does not give baseline characteristics, participant flow, reasons for withdrawal, or outcome completion by arm, so the achieved balance and completeness cannot be assessed from these results alone.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Patients were excluded if they exhibited Red flags in the medical screening questionnaire such as tumor, fracture; had signs of CNS involvement such as hyper-reflexia, ataxia, nystagmus, etc. Cervical spine surgery within 3 months. Litigation, insufficient English language skills, inability to complete study schedule, or were pregnant.
Overall Study
| Stage | Therapeutic Ultrasound | Soft Tissue Mobilization |
|---|---|---|
| STARTED | 11 | 12 |
| COMPLETED | 11 | 12 |
| 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 | Therapeutic Ultrasound | Soft Tissue Mobilization | Total |
|---|---|---|---|---|
| Participants analysed | 11 | 12 | 23 | |
| Age, Continuous | years | 42.00 (SD 10.42) | 46.25 (SD 10.42) | 44.22 (SD 10.24) |
| Sex: Female, Male: Female | Participants | 10 | 11 | 21 |
| Sex: Female, Male: Male | Participants | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion, measured over up to 2-4 day follow up.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | degrees |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled “Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion” in the registry. The title appears with that spelling in the record. The measure is reported in degrees, and its timeframe is listed as up to 2-4 day follow up. The endpoint is a continuous measure, reported as a mean with a 95% confidence interval.
In general, a range-of-motion measure expresses the extent of movement on a scale such as degrees. A continuous endpoint can retain gradations in measurement rather than reducing observations to categories. For this trial, the outcome title connects the measurement to an upper limb neurodynamic test, while the study question concerns people with neural mechanical sensitivity. The registry does not give a detailed test protocol, assessor procedure, or definition of how the recorded range was derived, so the precise measurement procedure is not reported in the registry record.
The endpoint is relevant to the question because it is the primary measure named for the trial and provides a numerical outcome for comparison between the two intervention arms. It should not be treated as a direct measure of every aspect of pain, disability, or daily function. Neck Disability Index and Patient Specific Functional Scale are listed as secondary outcomes, but their posted results are not included in the primary values.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports a mean of 4.6 degrees for therapeutic ultrasound, with a 95% confidence interval from -0.6 to 9.8. For soft tissue mobilization, it reports a mean of 16.0 degrees, with a 95% confidence interval from 9.88 to 22.12. These are arm-specific summaries for the primary endpoint at the recorded follow-up timeframe, up to 2-4 day follow up.
A confidence interval describes uncertainty around an estimated mean under the statistical procedure used to construct it. In general, a wider interval indicates less precision than a narrower interval. The reported interval for therapeutic ultrasound includes values below zero, while the interval reported for soft tissue mobilization is entirely above zero. These intervals describe uncertainty for each arm’s mean; they are not a confidence interval for the difference between arms.
The registry record does not report an inferential two-arm comparison for this continuous endpoint. It also does not report a between-arm estimate, a confidence interval for that estimate, or a p-value. Therefore, the arm-specific means and intervals do not by themselves establish the magnitude or statistical uncertainty of a treatment contrast. A reader should not substitute visual comparison of two separate confidence intervals for a formal comparison.
The registry lists 23 as enrollment and shows 11 participants in the therapeutic ultrasound arm and 12 in the soft tissue mobilization arm for these results. These numbers describe the arm counts attached to the posted outcome summaries. The record does not explain whether the analysis included every randomized participant, only those with an observed endpoint, or a different analysis population. It also does not report missing endpoint counts or the handling of missing observations.
The outcome values are means, not individual observations. They do not show the spread of participant-level measurements, since no standard deviation or other dispersion measure is posted. The confidence intervals provide uncertainty about the estimated means, but do not reveal the full distribution of responses. The registry’s result entry also does not clarify whether the means represent endpoint values, change from baseline, or another form of summary. That distinction is not reported in the registry record.
In short, the posted results give arm-specific mean range-of-motion values and their confidence intervals, but the direct comparison needed to quantify the difference between interventions is absent. Interpretation should remain limited to those reported summaries and their precision, rather than making a claim about comparative effectiveness.
9. Statistical Methods Explained
The endpoint is a continuous measure, and the registry reports a mean and 95% confidence interval for each arm. The mean is a measure of central location: in general, it represents the average of the recorded values. The interval conveys uncertainty in the estimated mean under the method used to calculate it. It is not a range containing a fixed proportion of individual participants’ measurements, and it does not show the full distribution of those measurements.
The posted values are 4.6 degrees for therapeutic ultrasound, with a 95% confidence interval from -0.6 to 9.8, and 16.0 degrees for soft tissue mobilization, with a 95% confidence interval from 9.88 to 22.12. The record identifies the dispersion as a 95% confidence interval, but does not state the calculation method, assumptions, or whether any adjustment was made. Those details are not reported in the registry record.
For a randomized two-arm study, the central inferential question is generally about a contrast between arms. A contrast estimate would state the estimated difference under a specified direction, and an uncertainty interval for that contrast would describe its precision. A test of the contrast could also be reported. Here, the registry record does not provide a contrast estimate, its confidence interval, or a test result for the primary continuous outcome. The separate arm means are informative descriptive summaries, but cannot replace the missing direct comparison.
The registry indicates that values were missing or not estimable for a two-arm comparison of the continuous endpoint. It lists zero analyses. The record does not explain why the comparison was unavailable, whether an analysis was attempted, which method was considered, or whether the issue resulted from the data, the reporting process, or another reason. It would be speculation to attribute the missing comparison to a particular cause.
In general, a confidence interval is interpreted in the context of the data and the method used to construct it. Its width reflects precision, which can depend on the amount of information and the variability of measurements, among other factors. The registry does not report a standard deviation for this endpoint, so the participant-level variability cannot be directly assessed from the posted summary. Nor does the record state whether assumptions for a particular model were evaluated.
General statistical concepts can help explain what is absent. If measurements are unusually variable or clustered, a model that fails to account for that structure may estimate uncertainty poorly; over-dispersion is one example in settings where variability exceeds a model’s expectation. This is a general point, not a claim about this trial: the endpoint is continuous, and the record does not describe an over-dispersion assessment or a model to which that issue applies.
Randomization and masking describe design features, not the analysis itself. Random allocation can help reduce systematic differences between arms, while masking can reduce some risks of biased care, measurement, or assessment when implemented effectively. The registry gives the labels randomized and quadruple masked, but does not describe allocation concealment, the masked roles, or blinding procedures. Thus the labels alone do not establish the practical success of those protections.
For a continuous outcome, the analysis may depend on whether the target is the endpoint value, change from baseline, or an adjusted comparison. The registry does not identify which of these is represented by the posted means, and baseline values are not posted in the outcome summary. It also does not state whether covariates were included, how repeated measurements were handled, or what statistical test or model was planned. These items are not reported in the registry record.
Terms such as intention-to-treat and per-protocol refer, in general, to different analysis populations. An intention-to-treat approach aims to analyze participants according to their randomized assignment, while a per-protocol approach generally focuses on adherence to specified treatment conditions. The registry does not identify either population for the posted endpoint. Without participant flow and analysis-population definitions, it is not possible to determine how those choices affected the summaries.
Sample-size calculations are planning tools and are distinct from observed results. The registry record does not report the trial’s sample-size justification, target effect, or planning assumptions. Any planning illustration associated with the reported effect is not evidence of observed power and should not be read as the trial’s original design calculation. The record does not report interim analyses or a prespecified statistical analysis plan. No claim about those procedures can be made from the posted information.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures and names two secondary outcomes: Neck Disability Index and Patient Specific Functional Scale. The primary endpoint is upper limb neurodynamic test range of motion. The record does not report how many outcomes were prespecified in the protocol, whether the listed measures were assessed at multiple time points, or whether a hierarchy of outcomes was used.
Multiplicity arises in general when several outcomes, time points, or comparisons are examined. Repeated testing can increase the chance of a nominally unusual result, so studies may use a prespecified hierarchy or adjustment. The registry record does not describe a multiplicity strategy or adjustment. Because no two-arm analysis is posted for the primary continuous endpoint, there is no reported primary comparison to assess in relation to such a strategy.
The registry lists zero analyses and does not provide results for the two named secondary outcomes in the posted outcome information. It does not report whether those outcomes were collected, analyzed, or omitted from the record. Their results and any multiplicity handling are not reported in the registry record.
Missing-data details are also absent. There is no posted count of missing primary endpoint values, reason for missingness, imputation method, or sensitivity analysis. The arm counts attached to the outcome summaries do not establish whether all assigned participants contributed endpoint data. The analysis population and participant flow are not reported in the registry record, limiting assessment of attrition and potential bias.
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 |
|---|---|---|---|
| Therapeutic Ultrasound | 0 | 11 | 0.0% |
| Soft Tissue Mobilization | 0 | 12 | 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 |
|---|---|
| Therapeutic Ultrasound | 0 of 11 |
| Soft Tissue Mobilization | 0 of 12 |
For therapeutic ultrasound, the registry reports 0 serious adverse events among 11 at risk and 0 other adverse events among 11 at risk. For soft tissue mobilization, it reports 0 serious adverse events among 12 at risk and 0 other adverse events among 12 at risk. The record lists no serious adverse event terms.
These figures mean that the posted record contains zero events in the stated categories for the participants counted as at risk. They do not establish that no symptoms or unwanted experiences occurred, because the registry provides only these event categories and counts. The definitions, collection period, surveillance procedures, and event attribution rules are not reported in the registry record.
Deaths are recorded as null for both arms, rather than as a numerical count. Accordingly, a death count is not reported in the registry record. Zero recorded adverse events should not be interpreted as proof that either intervention is risk-free, particularly when the record does not describe how safety events were sought or classified.
12. What the Result Does, and Does Not, Mean
The result supports a limited descriptive statement: the registry reports a mean upper limb neurodynamic test range of motion of 4.6 degrees for therapeutic ultrasound and 16.0 degrees for soft tissue mobilization, with the respective 95% confidence intervals of -0.6 to 9.8 and 9.88 to 22.12. The endpoint is recorded at up to 2-4 day follow up. Those numbers describe the posted arm summaries, not a direct estimate of the difference between interventions.
The confidence intervals help communicate the uncertainty attached to each mean. They do not answer whether the arms differed under a formal statistical analysis. No between-arm estimate, confidence interval for a contrast, or p-value is reported for this endpoint. The absence of that analysis means that the registry results do not quantify the comparative effect with its uncertainty.
The result also does not establish whether values represent follow-up status, change from baseline, or another summary. Baseline outcome values and the analysis method are not reported. The listed secondary outcomes are Neck Disability Index and Patient Specific Functional Scale, but their results are not reported in the posted outcome information.
In general, statistical uncertainty and clinical importance are different questions. A result can be estimated imprecisely or precisely, and its practical relevance depends on the outcome’s meaning, measurement properties, patient context, and a suitable threshold for importance. The registry does not report such a threshold or enough detail to judge the measurement’s clinical interpretation. No conclusion about meaningful benefit or lack of benefit can be drawn from the arm summaries alone.
The trial is randomized, but a design label does not resolve limitations in outcome reporting. The absent direct comparison, unspecified analysis population, and unreported missing-data methods leave important parts of the evidence unclear. The posted values should therefore be read as descriptive findings from a small enrolled study, not as a complete statistical test of the trial’s comparative question.
13. Why This Trial Matters Statistically
This trial illustrates why an arm-by-arm summary and a comparative analysis answer different questions. A mean and confidence interval describe an estimated value within each arm. The clinical question, however, concerns the difference between interventions. A direct contrast with its uncertainty is needed to describe that comparison statistically; the registry does not report one for the primary endpoint.
The record also shows the importance of distinguishing an outcome’s label from its operational definition. The primary measure is named as upper limb neurodynamic test range of motion and expressed in degrees, but the registry does not provide the detailed measurement protocol or clarify whether the posted means are endpoint values or changes. Those details affect how readers interpret what the mean represents.
Randomization and masking are valuable design features in general, but they do not substitute for reporting participant flow, analysis populations, missing-data handling, or prespecified methods. The record gives the design labels while leaving those analytical details unreported. This limits assessment of how the recorded summaries relate to the originally randomized groups.
The trial also demonstrates why zero adverse-event counts need context. The registry records zero serious and zero other adverse events in both arms, yet does not describe event definitions or ascertainment. Counts are useful, but they cannot independently establish the completeness of safety monitoring.
For biostatisticians and clinical researchers, the central statistical lesson is to separate what is directly reported from what would require a formal analysis or further documentation. The arm summaries are interpretable as summaries; they should not be converted into a conclusion about comparative effect when the direct comparison and its methods are absent.
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 record leaves substantial uncertainty about the primary outcome analysis. Although means and 95% confidence intervals are reported for both arms, a direct two-arm comparison is not available, and the record identifies the comparison values as missing or not estimable. The reason is not reported in the registry record.
The endpoint’s measurement procedure is not described in detail. The registry does not clarify whether the means refer to follow-up values, change from baseline, or another summary. Baseline measurements, participant-level variability, and the endpoint’s completion by arm are not reported. These omissions restrict interpretation of the values and their precision.
The record does not state the analysis population, the handling of missing data, the statistical test or model, covariate adjustment, or whether an analysis plan was prespecified. It also does not explain who was masked under the quadruple-masking label or describe allocation concealment. These details are not reported in the registry record.
The enrollment was 23, with outcome summaries attached to arm counts of 11 and 12. The registry does not provide participant flow or explain whether those counts represent all randomized participants or all participants with observed outcomes. The two named secondary outcomes are not accompanied by posted results in the outcome information. Multiplicity procedures are not reported.
Safety interpretation is constrained by absent event definitions, collection methods, and follow-up details. Death counts are null, so they are not reported numerically. In combination, these reporting gaps mean that the posted summaries provide only a partial view of the trial’s outcome and safety evidence.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain — NCT02081456.
- Registry record last updated 2018-10-23; status last verified 2018-10.
- Results first posted 2018-10-23.
- 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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18. Record Summary
NCT02081456 is a completed randomized, parallel-group trial comparing soft tissue mobilization with therapeutic ultrasound for subjects with neck and arm pain and neural mechanical sensitivity. The registry lists cervical radiculopathy as the condition and quadruple masking as the masking design. Enrollment is recorded as 23.
The primary endpoint is upper limb neurodynamic test range of motion, in degrees, at up to 2-4 day follow up. The registry reports a mean of 4.6 with a 95% confidence interval from -0.6 to 9.8 for therapeutic ultrasound, and a mean of 16.0 with a 95% confidence interval from 9.88 to 22.12 for soft tissue mobilization. A direct two-arm analysis is not reported.
Neck Disability Index and Patient Specific Functional Scale are named as secondary outcomes, but their results are not reported in the posted outcome information. The registry records zero serious and zero other adverse events in each arm; death counts are not reported numerically. Analysis methods, missing-data handling, and analysis populations are not reported in the registry record.