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 Tailored Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain (NCT01518530), a non-randomized phase 2 study. The primary outcome is Occiflex Device Safety.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01518530 |
| Phase | Phase 2 |
| Condition | Neck Pain |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hillel Yaffe Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns patients with chronic neck pain. The registry describes eligible pain types as facet joint disorder, post-whiplash injury, and myofascial pain syndrome, using the International Association of the Study of Pain criteria. The recorded enrollment is 10. The adverse-effect results list 9 patients at risk, so the registry record does not establish that the safety figures cover everyone enrolled.
Intervention
The intervention is the Occiflex Robotic Intervention System, described as computerized mobilization of the cervical spine. The study summary says the approach uses tailored or personalized three-dimensional neck movement. The intervention is described as passive mobilization of the cervical spine.
Comparator
No comparator group is listed. The registry describes a single-group model and non-randomized allocation. Consequently, the posted safety counts describe the treated group; they do not estimate a difference between treatment and control or distinguish device-related effects from events that might also occur without the intervention.
Primary question
The primary endpoint is the number of adverse effects over a six-week timeframe. The registry describes documenting serious adverse effects and recording minor side effects, with attention to their possible relationship to treatment. It also describes counting minor and serious adverse effects out of 360 therapeutic sessions. The result can therefore be read as a safety description, not as a controlled test of efficacy. Efficacy measured using the Neck Disability Index is listed as a secondary outcome, but its results are not reported in the registry record.
3. Trial Design
This is a completed Phase 2 study registered as NCT01518530. The sponsor is Hillel Yaffe Medical Center. The registry lists the start as 2012-02 and primary completion as 2012-05. Enrollment is recorded as 10. The study concerns chronic neck pain and evaluates the Occiflex Robotic Intervention System, a device intervention described as computerized cervical-spine mobilization.
The design is single-group, with non-randomized allocation and no masking. The registry describes a group receiving passive mobilization of the cervical spine, rather than parallel treatment and control groups. Its summary presents the work as a continuation study examining tailored or personalized three-dimensional neck movement. These design features matter when reading the results: the adverse-effect counts are descriptive observations in the treated group, not a comparison against an untreated or alternative-treatment group.
The primary outcome is titled Occiflex Device Safety. It measures the number of adverse effects, with a six-week timeframe. The outcome description specifies documentation of serious adverse effects and recording of minor side effects, including attention to their possible relationship to treatment. It refers to adverse effects out of 360 therapeutic sessions, but the registry record does not establish that this number of sessions was completed or provide session-level results.
The Neck Disability Index is listed as a secondary efficacy outcome. Results for that outcome are not reported in the registry record. The record lists two outcome measures and no statistical analyses. Details such as eligibility beyond the stated pain types, treatment schedule, adherence, and analysis populations are not reported in the registry record. The available design information therefore supports a narrow reading: a completed, small, single-group device study with a registry-listed safety outcome, rather than a controlled efficacy comparison.
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: One recruited patient was dropped because of protocol violation.
Active Treatment Period
| Stage | Chronic Neck Pain Patients Treated With Occiflex |
|---|---|
| STARTED | 10 |
| COMPLETED | 9 |
| NOT COMPLETED | 1 |
Post-Treatment Follow-up
| Stage | Chronic Neck Pain Patients Treated With Occiflex |
|---|---|
| STARTED | 9 |
| COMPLETED | 9 |
| NOT COMPLETED | 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.
Population: One patient dropped out of the experiment due to lack of necessary documentation required for inclusion.
| Characteristic | Unit | Patients With Chronic Neck Pain Treated With Occiflex |
|---|---|---|
| Participants analysed | 9 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 9 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age Continuous | years | 47 (SD 11.21) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 2 |
| Region of Enrollment: Israel | participants | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Occiflex Device Safety, measured over 6 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Number of adverse effects |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of adverse effects associated with the Occiflex device, assessed over a six-week timeframe. The registry describes meticulous documentation of serious adverse effects and recording of minor side effects, with attention to their possible relationship to treatment. It also says that minor and serious adverse effects would be counted out of 360 therapeutic sessions. This is a count-based safety endpoint: its purpose is to describe the adverse effects recorded during the study, rather than to measure a change in neck pain or disability.
Counting adverse effects is useful because it can capture safety events of different types and seriousness. However, an event count alone does not show how many sessions were observed, how events were distributed across sessions or patients, or whether an event was caused by the device. Those details matter for interpreting frequency and attribution. The registry record lists the number of patients at risk for the reported safety figures, but it does not provide session-level exposure results or a breakdown of adverse-effect terms.
The registry lists the Neck Disability Index as a secondary efficacy outcome, but does not report its results. Thus, the primary endpoint addresses safety documentation, while the listed secondary measure would address neck-related disability. Neither the primary safety counts nor the available design support a controlled estimate of efficacy.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports safety figures for a single group of patients treated with Occiflex. In that group, 9 were listed as at risk for serious adverse effects and 0 as affected. For other adverse effects, 9 were listed as at risk and 7 as affected. These are descriptive counts. They should not be read as estimates of a treatment-versus-control difference, because the study is recorded as single-group and has no comparator.
The serious adverse-effect result means that the registry lists no serious adverse effects among those at risk in the reported group. It does not establish that serious harms are impossible, nor does it precisely characterize the frequency of uncommon events. In a small study, the absence of a recorded serious event can coexist with substantial uncertainty about events that might occur in a broader population or with different exposure. No confidence interval or other uncertainty estimate for these counts is reported in the registry record.
The record lists 7 affected for other adverse effects. The endpoint description distinguishes minor and serious effects, but the posted figures do not provide a term-by-term account or explain how the other-effect category maps to specific symptoms. The figures also do not show the number of individual events, their timing, duration, severity, or relationship assessment. Although the endpoint description refers to 360 therapeutic sessions, completed session exposure and session-level event counts are not reported in the registry record. The patient-based risk counts and the session-based endpoint description therefore should not be treated as interchangeable denominators.
Enrollment is recorded as 10, while the reported safety figures list 9 at risk. The registry record does not explain this difference. It should not be assumed that the unlisted enrollee had a particular outcome or reason for not appearing in the safety risk set. The population underlying the safety counts, including any exclusions or missing observations, is not reported in the registry record.
No statistical analyses are listed. The record does not report inferential testing, adjustment, or a statistical model for the primary endpoint. The Neck Disability Index is named as a secondary outcome, but its results are not reported in the registry record. Therefore, the posted data support a limited descriptive reading of the safety counts, not a conclusion about comparative safety or efficacy. Interpretation is further constrained by the absence of a control group, the lack of reported session-level exposure, and the absence of detail about the nature of the other adverse effects.
9. Statistical Methods Explained
The primary outcome is a count: the number of adverse effects recorded during a specified timeframe. Count outcomes differ from measurements such as a score, because one person or exposure period may contribute more than one event. A count can also depend on how long participants are observed and how much exposure they receive. For that reason, a count is easiest to interpret when the observation period, event definition, and exposure denominator are clear. The registry gives a six-week timeframe and refers to 360 therapeutic sessions, but completed exposure and session-level counts are not reported in the registry record.
What can a count tell us?
A count describes how many events were recorded according to the study’s definitions. It does not by itself say how severe the events were, whether multiple events came from the same person, when they occurred, or whether they were judged related to treatment. The outcome description says that serious effects would be documented and that minor effects would be recorded with attention to possible relationship to treatment. The posted adverse-effect figures do not include a detailed event list, timing, or attribution assessment. Those omissions limit interpretation of what the counts represent clinically.
Exposure is important for safety counts. A count across a fixed number of sessions can be interpreted differently from the same count across a different amount of exposure. A patient-based risk set and a session-based exposure denominator also answer different questions: the former concerns people at risk, while the latter concerns treatment sessions. The registry lists 9 at risk for each reported adverse-effect category and describes counting events out of 360 therapeutic sessions. It does not report whether the stated session exposure was achieved, how sessions were distributed, or which denominator was used to produce the posted figures. No event rate should be inferred without those details.
Why does over-dispersion matter?
In general, count data may be more variable than a simple statistical model expects. This can occur when events cluster within some people or exposure periods, or when risk differs across individuals. Such extra variation is called over-dispersion. If an analysis assumes less variation than is present, its uncertainty estimates can be too narrow. Evaluating over-dispersion requires suitable data and a specified model. The registry record lists no statistical analyses, so it does not report whether over-dispersion was assessed or how count variability was handled.
How should uncertainty be described?
In general, a confidence interval gives a range of values compatible with the data under a stated statistical procedure. It communicates precision as well as the observed estimate. A point count without an uncertainty interval can be difficult to generalize, especially when the number of people at risk is limited and the event is uncommon. No confidence intervals for the safety results are reported in the registry record. Nor are p-values or a fitted count model reported. The counts should therefore be read as recorded observations, not as precise estimates of a broader event frequency.
Because this is a single-group study, the analysis cannot use a between-group contrast to separate effects associated with the device from background events, other care, or characteristics of the participants. General statistical adjustment cannot replace a comparator when the intended question is a treatment-versus-control effect. The registry reports non-randomized allocation and no masking; details of any adjustment for participant characteristics are not reported in the registry record.
What does the design say about efficacy?
The Neck Disability Index is listed as a secondary efficacy outcome. In general, an efficacy analysis of a before-and-after measure would need to specify the measurement times, analysis population, handling of missing observations, and the statistical method. Those details, along with NDI results, are not reported in the registry record. A change observed within a single group would not by itself establish that the intervention caused the change, because changes over time can also reflect other influences. No efficacy result should be inferred from the safety counts.
The registry lists no statistical analyses. This does not establish what analyses may have been performed outside the record; it means that the record does not describe them. The statistical plan, model choices, handling of multiple outcomes, and methods for missing data are not reported in the registry record. Consequently, the posted information permits descriptive interpretation of the safety counts, but not reconstruction of an inferential analysis or assessment of its assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures: the primary safety measure and the Neck Disability Index as a secondary efficacy measure. It lists no statistical analyses. A multiplicity strategy—how to interpret statistical evidence when several outcomes or tests are considered—is not reported in the registry record. Since no inferential results are reported, there is no basis to assess whether any multiplicity adjustment was used or whether one was planned.
Missing-data methods are also not reported in the registry record. The enrollment is recorded as 10, whereas the safety figures list 9 at risk. The reason for this difference, and the status of the remaining enrollee for the safety analysis, are not reported. The registry does not describe withdrawals, incomplete follow-up, missing outcome assessments, or a method for handling them. These absences do not establish that data were missing; they mean the record does not explain the analysis population or the handling of incomplete records.
The record does not identify an intention-to-treat, per-protocol, or other analysis population. It also does not explain how the safety denominator was defined or how the 360 sessions mentioned in the endpoint description relate to the posted patient risk counts. These details are relevant because safety summaries depend on who was observed and on the amount of exposure captured. Without them, interpretation should remain at the level of the reported counts, without assuming that all enrolled patients or all intended sessions were included.
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 |
|---|---|---|---|
| Patients With Chronic Neck Pain Treated With Occiflex | 0 | 9 | 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 |
|---|---|
| Patients With Chronic Neck Pain Treated With Occiflex | 7 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Patients With Chronic Neck Pain Treated With Occiflex |
|---|---|---|
| Neck Pain | Musculoskeletal and connective tissue disorders | 5 of 9 |
| Headache | Nervous system disorders | 4 of 9 |
| Dizziness | Ear and labyrinth disorders | 4 of 9 |
The registry lists 0 serious adverse effects among 9 at risk in the treated group. For other adverse effects, it lists 7 affected among 9 at risk. These are the posted safety counts, not comparative estimates. The record does not provide event terms, severity details for the other category, timing, or an attribution breakdown. It also does not report confidence intervals or session-level event counts.
The endpoint description refers to adverse effects out of 360 therapeutic sessions, but the record does not establish that 360 sessions were completed or link the reported affected counts to that exposure. The risk figures use patients at risk, while a session count represents treatment exposure; the two should not be substituted for one another. Enrollment is recorded as 10, whereas the safety results list 9 at risk, and the reason is not reported in the registry record.
A zero serious-event count is an observation in this study, not proof that serious events cannot occur. The single-group design and limited reported safety detail mean the results cannot establish whether the device changes risk relative to another approach or no treatment. The counts are best understood as a limited descriptive record of reported safety outcomes.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this completed study examined the Occiflex device in a single group of patients with chronic neck pain. It reports a safety outcome with a six-week timeframe and lists 0 serious adverse effects and 7 affected for other adverse effects among 9 at risk in each category. These figures describe what was recorded in the registry for this group. They do not, on their own, quantify a comparative effect or establish the cause of an adverse effect.
The study does not provide a control group against which to compare safety or efficacy. It is recorded as non-randomized, unmasked, and single-group. Thus, there is no randomized treatment contrast to support attribution of differences to the device. The registry’s description of an intended count out of 360 therapeutic sessions does not establish that all those sessions occurred or provide the session-level data needed to interpret exposure-based event frequency.
The Neck Disability Index is listed as a secondary efficacy outcome, but its results are not reported in the registry record. No statistical analyses are listed, and uncertainty estimates for the safety counts are not reported. Enrollment is 10, while the safety results list 9 at risk; the record does not explain the difference. These limitations restrict how far the observations can be generalized.
Accordingly, the posted information supports a descriptive account of the recorded safety figures, not a conclusion that the intervention is effective, ineffective, safer, or less safe than an alternative. It also does not demonstrate that an adverse event was caused by treatment. The record leaves unresolved the distribution and nature of other effects, session-level exposure, completeness of follow-up, and the outcome of the listed disability measure. Those are important distinctions between reporting observations and establishing a treatment effect.
13. Why This Trial Matters Statistically
This trial is statistically informative chiefly because it illustrates the difference between describing events and estimating a treatment effect. The registry reports a single group, so the adverse-effect counts have no concurrent comparator. They can document events reported among treated patients, but cannot show how those counts compare with what would have happened under another treatment or without the device.
The endpoint description also highlights the importance of denominators. It refers to counting effects out of 360 therapeutic sessions, while the posted safety results list 9 patients at risk. People and sessions are distinct exposure units. Without confirmation of completed sessions and a clear link between the exposure denominator and event counts, an event frequency cannot be reconstructed reliably. The registry record does not provide that linkage.
The contrast between enrollment of 10 and 9 at risk in the safety results is another reason to examine analysis populations and follow-up information. The registry does not explain the difference, and it does not report missing-data methods. Statistical interpretation depends not only on an outcome count, but also on who was observed and how exposure was measured.
Finally, no statistical analyses are listed. The registry therefore offers no reported model, uncertainty interval, or inferential procedure for the counts. The Neck Disability Index is named as a secondary outcome, but its results are absent. These reporting limits do not erase the descriptive safety observations; they define what those observations can support. The study is a useful example of why outcome definitions, exposure denominators, comparator design, and transparent analysis reporting are necessary for moving from observed counts to broader statistical conclusions.
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 single-group design is the central limitation for comparative interpretation. There is no control group, and allocation is recorded as non-randomized. The posted safety counts cannot determine whether the observed events were more or less frequent than they would have been under another approach. No masking is listed, and the registry does not report procedures that might limit bias in event assessment.
The safety results list 9 at risk, while enrollment is recorded as 10. The reason for the difference and the safety analysis population are not reported in the registry record. Follow-up completeness, withdrawals, and missing-data handling are also not reported. These omissions leave uncertainty about which observations contribute to the outcome counts.
The endpoint description refers to 360 therapeutic sessions, but actual session exposure and session-level event counts are not reported. The posted counts do not include event terms, timing, duration, severity detail for other effects, or treatment-relatedness assessments. The record also does not explain how its patient-based risk counts correspond to the session-based endpoint description.
The registry lists the Neck Disability Index as a secondary efficacy outcome, but does not report results for it. No statistical analyses are listed; statistical methods, uncertainty estimates, multiplicity procedures, and analysis populations are not reported in the registry record. These limitations mean the available information is insufficient for a detailed evaluation of efficacy or for precise estimates of safety beyond the reported descriptive counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Tailored Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain — NCT01518530.
- Registry record last updated 2013-10-29; status last verified 2013-08.
- Results first posted 2013-10-29.
- 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
NCT01518530 is a completed Phase 2, single-group, non-randomized, unmasked study sponsored by Hillel Yaffe Medical Center. It evaluated the Occiflex Robotic Intervention System for chronic neck pain, with enrollment recorded as 10. The registry lists a six-week primary safety endpoint and the Neck Disability Index as a secondary efficacy outcome.
Safety results list 0 serious adverse effects among 9 at risk and 7 affected for other adverse effects among 9 at risk. The record lists no statistical analyses. NDI results, confidence intervals, detailed event descriptions, session-level exposure results, and explanations for the difference between enrollment and the safety risk count are not reported in the registry record. Because there is no comparator group, the counts are descriptive rather than estimates of a treatment contrast.