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 Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis (NCT05648565), a na na study. The primary outcome is Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05648565 |
| Phase | NA |
| Condition | Chronic Rhinitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | The University of Texas Health Science Center, Houston |
| Results posted | Yes |
2. Clinical Question
Population
People with chronic rhinitis. The registry record lists 17 participants enrolled. Further eligibility details and a description of the enrolled participants are not reported in the registry record.
Intervention
Radiofrequency ablation (RFA) of the posterior nasal nerve (PNN), listed as a device intervention. The record’s summary describes assessment before and after the procedure, but additional procedural details are not reported in the registry record.
Comparator
No separate comparison group is listed. This is a single-group study, so there is no concurrent control group for distinguishing changes after the procedure from changes that might occur for other reasons.
Primary question
The listed primary outcome is peak nasal inspiratory flow (PNIF), measured in liters per minute and described at baseline. The study summary also identifies patient-reported nasal symptoms and Type 2 cytokine levels as pre- and post-procedure assessment interests. Numerical results for these outcomes are not reported in the registry record.
The clinical question concerns whether nasal airflow and other rhinitis-related measures change around RFA of the PNN. The study description names reflective total nasal symptom score (rTNSS), nasal obstruction symptom evaluation (NOSE), PNIF, and Type 2 cytokines. These measures represent different kinds of information: reported symptom experience, measured airflow, and inflammatory markers. They should not be treated as interchangeable outcomes.
Because there is no separate comparator group, the study can describe measurements within the treated group but cannot directly compare them with outcomes under an alternative intervention or no intervention. The record does not report numerical before-and-after estimates or the analysis used to assess change. Consequently, the clinical question is identifiable, but the posted record does not establish the size or precision of any change.
3. Trial Design
The registry record describes a completed, single-group study of RFA in participants with chronic rhinitis. Allocation is listed as NA, masking as none, and the model as single group. Enrollment is 17. The sponsor is The University of Texas Health Science Center, Houston. The study started on 2023-01-10, reached primary completion on 2024-02-20, and has a completed status in the record.
With a single group, participants are assessed in relation to the intervention rather than assigned to a listed control arm. The registry summary says that patient-reported rTNSS and NOSE scores, PNIF, and Type 2 cytokine levels are considered before and after the procedure. However, the primary outcome entry specifies PNIF at baseline. The record does not specify a post-procedure primary-outcome time point or provide numerical measurements at either time.
The registry lists RFA as the intervention, without further arm-description details. It does not report randomization or masking, and the recorded masking status is none. These features matter when interpreting changes over time: without a concurrent control group, observed changes cannot be separated from time trends, measurement variability, or other influences on participants’ measurements.
The record lists 13 outcome measures and 0 analysis entries. This identifies a substantial set of outcome measures but does not supply analysis estimates. The listed secondary outcome titles include repeated entries for rTNSS and NOSE. Detailed outcome definitions, assessment schedules, analysis populations, and the statistical analysis plan are not reported in the registry record. The information available therefore describes the broad design and intended measurement domains, but not a complete account of how the study was conducted or analyzed.
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 | Radiofrequency Ablation (RFA) |
|---|---|
| STARTED | 17 |
| Received Intervention | 15 |
| COMPLETED | 13 |
| NOT COMPLETED | 4 |
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 | Radiofrequency Ablation (RFA) |
|---|---|---|
| Participants analysed | 17 | |
| Age, Continuous | years | 62.18 (SD 14.6) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 9 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 17 |
6. Primary Endpoint
The registry lists the primary outcome as Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF), measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | Liters Per Minute |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is nasal congestion assessed by peak nasal inspiratory flow (PNIF). The record describes PNIF as a measure of nasal airflow during maximal inspiration and gives its unit as liters per minute. It specifies a median with an inter-quartile range as the summary format and identifies the timeframe as baseline.
PNIF is an objective airflow measure: it records the peak flow achieved during an inspiratory maneuver rather than relying only on a participant’s rating of symptoms. That makes it conceptually distinct from rTNSS and NOSE, which are symptom-report measures. Objective and reported measures can each contribute useful information, but a change in one does not automatically imply a corresponding change in the other.
The record’s study summary describes pre- and post-procedure assessment, while the primary outcome entry identifies baseline as its timeframe. A post-procedure PNIF time point and numerical PNIF results are not reported in the registry record. Thus, the primary outcome definition indicates what was measured and how it was summarized, but the posted information does not permit an assessment of change, magnitude, or precision.
The median describes the center of a distribution, while the inter-quartile range describes the spread of its middle portion. These summaries can be useful when observations are skewed or when a typical value is more appropriately represented by a median than by a mean. The actual baseline median and inter-quartile range are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a completed study with 17 enrolled participants and a single-group design. It names PNIF as the primary outcome, with a baseline timeframe, and describes patient-reported symptom scores and Type 2 cytokines as additional assessment interests. It does not report numerical outcome results, estimates of change, confidence intervals, or outcome-specific analysis results. Therefore, the record does not show how PNIF or the other named measures changed.
The absence of a concurrent comparator is central to interpretation. In a single-group study, a difference between measurements taken at different times could reflect the intervention, but it could also reflect natural fluctuation, measurement conditions, participant expectations, or other changes over time. A before-and-after contrast, even if numerical results were available, would not by itself isolate the intervention’s effect in the way a suitable controlled comparison can.
The primary outcome entry’s baseline timeframe also limits what can be inferred from the record. A baseline description can characterize measurements before the procedure, but it cannot quantify a post-procedure change without a corresponding later measurement and a defined comparison. Although the summary describes pre- and post-procedure assessments, the record does not give the post-procedure timing, values, or analysis estimates.
The listed summary format is a median and inter-quartile range. These describe a distribution’s center and spread, not the precision of an estimated treatment effect. A confidence interval, when reported for an effect estimate, communicates a range of values compatible with the data and statistical model. No such interval is reported for the outcomes in this record. Nor are p-values, standard errors, or other inferential results reported.
The safety figures list 0 serious adverse events among 17 participants at risk and 3 participants with other adverse events among 17 at risk. The record does not provide event terms for those other events. These counts are descriptive; without more information about event definitions, timing, and follow-up, they do not characterize the full safety experience.
Overall, the record establishes that the study was completed and specifies intended measurement domains, but it does not provide the outcome data needed to judge the direction, size, or precision of changes. Any interpretation of intervention effects from the posted record would go beyond what its reported results support.
9. Statistical Methods Explained
The statistical information in the registry record is limited. It names the primary outcome’s summary format but contains 0 analysis entries. Outcome estimates, uncertainty intervals, hypothesis tests, and a detailed statistical analysis plan are not reported in the registry record. The concepts below explain how such information is generally interpreted; they do not describe analyses confirmed to have been used in this study.
What does a median and inter-quartile range describe?
For PNIF, the record specifies a median and inter-quartile range. The median is the central value when observations are ordered. The inter-quartile range describes the span of the middle half of the observations. Together, these summaries describe the distribution’s location and spread without requiring a symmetric distribution. They do not, on their own, estimate a before-and-after effect or convey how precisely an effect is estimated.
How would a change estimate be interpreted?
For a repeated-measures study, an analysis might estimate the difference between measurements taken before and after the procedure. The interpretation would depend on the time points, the measurement scale, the analysis population, and the statistical method. None of the numerical change estimates or the method used to obtain them is reported in the registry record. Because the study has one group, a within-group change would also need to be distinguished from a causal effect: changes over time can arise for reasons other than the intervention.
What does a confidence interval contribute?
In general, a confidence interval expresses uncertainty around an estimated quantity under a specified statistical model. A narrow interval indicates greater precision than a wide interval, while an interval spanning values consistent with different interpretations may leave substantial uncertainty. A confidence interval is not a guarantee that the true value lies within that particular interval, and it does not correct for limitations such as lack of a comparator or bias in measurement. No confidence interval for the study outcomes is reported in the registry record.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a model assumes. If a model does not account for extra variability, its standard errors may be too small and its uncertainty estimates too narrow. Different outcome types call for different modeling assumptions: a continuous airflow measure, a symptom score, and a cytokine measurement need not have the same distribution or analysis approach. The registry record does not report model choices, distributional checks, or whether over-dispersion was assessed.
What does a planning calculation mean?
The registry record’s planning description states that its illustrations use a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation, with the effect to detect expressed as a fraction of an observed effect. For non-time-to-event outcomes, the described planning quantity is participants per arm; for time-to-event outcomes, it is the total number of events. These are planning illustrations, not observed study results or observed power. They do not change the actual design: this study is listed as a single-group study, and its enrollment is 17. The observed effect used for the illustrations and the resulting planning values are not reported in the registry record.
Sample-size planning is conditional on assumptions about the target effect, variability, allocation, and analysis. If those assumptions differ from the eventual study conditions, the planning result may not describe the precision achieved. A planning illustration does not demonstrate that a study had adequate power, nor does it supply evidence of an intervention effect. In particular, observed power is not a substitute for a reported effect estimate and its uncertainty.
What can be inferred from the listed analysis count?
The registry record lists 0 analysis entries. This means that the record does not present outcome-specific analysis results in those entries. It does not establish whether analyses were conducted outside the registry or what their findings were. Numerical estimates, uncertainty intervals, p-values, model specifications, and adjustments for the number of outcomes are not reported in the registry record, so none can be used to assess statistical evidence or precision.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 13 outcome measures, including repeated titles for rTNSS and NOSE, but lists 0 analysis entries. It does not report a multiplicity strategy, such as designating a hierarchy of outcomes, adjusting significance thresholds, or controlling an error rate across analyses. It is therefore not possible to determine how the number of outcomes was handled in statistical inference. The record also does not report outcome-specific p-values or confidence intervals.
Missing-data information is not reported in the registry record. The number of participants with available measurements for each outcome, reasons for missing measurements, and methods for handling missing data are not specified. The enrollment figure alone does not show how many participants contributed to any particular outcome analysis.
Analysis populations are not described in the registry record. It does not identify whether analyses included all enrolled participants, only participants with completed measurements, or another defined group. It also does not state how participants who did not complete follow-up, if any, were handled.
These omissions matter because outcome availability and analysis choices affect how results should be interpreted. When multiple outcomes are assessed, chance findings can become more likely if each is tested separately without an appropriate plan. When measurements are missing, an analysis based only on observed values may not represent all enrolled participants if the missingness is related to outcomes or participant characteristics. These are general methodological concerns; the record does not establish that any particular issue occurred in this study.
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 |
|---|---|---|---|
| Radiofrequency Ablation (RFA) | 0 | 17 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Radiofrequency Ablation (RFA) | 0 of 17 |
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 |
|---|---|
| Radiofrequency Ablation (RFA) | 3 of 17 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Radiofrequency Ablation (RFA) |
|---|---|---|
| Headaches | General disorders | 3 of 17 |
| dental infection | Infections and infestations | 1 of 17 |
The registry record lists a Radiofrequency Ablation (RFA) group with 17 participants at risk for serious adverse events and 0 serious adverse events. It also lists 17 participants at risk for other adverse events and 3 affected by other adverse events. Deaths are listed as 0. No serious adverse event terms are listed.
These are descriptive counts in the registry record. The entry for other adverse events does not identify the event types, severity, timing, duration, or whether events were considered related to the intervention. The record also does not describe the approach used to collect or classify adverse-event information. Consequently, the figures do not provide a detailed account of the nature of the reported events.
A count of 0 serious adverse events in a study of this size does not establish that serious events cannot occur or that risk is absent. A small study can provide limited information about uncommon events, and the registry figures do not include an estimate of uncertainty around the event rate. The counts should be read as the adverse-event information recorded for this group, not as a complete safety profile or a comparison against another treatment.
12. What the Result Does, and Does Not, Mean
The registry record supports a narrow description of the study: it was completed, enrolled 17 participants with chronic rhinitis, and evaluated RFA of the PNN in a single group. Its summary names patient-reported symptoms, PNIF, and Type 2 cytokines as assessment interests. The primary outcome entry describes PNIF in liters per minute, summarized by median and inter-quartile range at baseline.
The record does not report numerical outcome results. It therefore does not establish whether measurements changed, the direction or magnitude of any change, or the precision of an estimate. The summary’s reference to pre- and post-procedure assessments does not substitute for posted values or a defined analysis. The listed baseline timeframe for the primary outcome does not provide a post-procedure comparison.
The design also limits what a change could mean. Without a concurrent control group, an observed within-group change would not by itself show that RFA caused the change. Other influences, including variation over time or in measurement, could contribute. This is a general limitation of interpreting change in an uncontrolled design, not a claim about what occurred in these participants.
The record does not report a statistical analysis plan, outcome-specific analysis results, or details about missing measurements and analysis populations. Those gaps prevent evaluation of how consistently outcomes were assessed, how uncertainty was quantified, and how the listed outcomes were handled in inference.
The safety counts provide a limited descriptive record: 0 serious adverse events, 3 participants with other adverse events, and 0 deaths, with 17 participants listed at risk for each adverse-event category. Event descriptions and further safety context are not reported in the registry record.
Accordingly, the posted information can be used to understand the study’s broad question and design, but not to determine the size or reliability of an outcome effect or to make a controlled comparison. It also does not support a conclusion about the completeness of safety reporting beyond the recorded counts.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between a clearly named clinical question and a reportable estimate of effect. The registry identifies an intervention, a population, and several outcome domains. Yet without numerical outcome results, it is not possible to assess the direction, size, or precision of changes in airflow, symptoms, or cytokine levels.
The single-group design makes the comparison structure especially important. Repeated measurements can describe how participants’ measurements differ over time, but a control group is generally needed to help separate intervention-associated change from other temporal influences. The record lists no separate comparator, so any potential change would need cautious interpretation even if estimates were available.
The endpoint information also illustrates why timing and measurement definitions matter. PNIF is described as a baseline measure, while the study summary refers to pre- and post-procedure assessment. Without a reported post-procedure time point and corresponding results, readers cannot determine how the primary outcome was used to quantify change. Symptom scores and inflammatory markers measure different aspects of the study question and should be interpreted separately.
Finally, outcome availability, missing-data handling, multiplicity, and analysis populations shape the strength of statistical conclusions. These details are not reported in the registry record. The study’s listing of multiple outcomes without analysis results leaves readers unable to examine those choices. The record therefore highlights a general principle: design and outcome definitions are useful, but transparent estimates and uncertainty are needed to evaluate what a study’s data show.
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 principal limitation for interpretation is that the registry record does not report numerical outcome results, despite listing 13 outcome measures and describing several pre- and post-procedure assessment interests. No estimated changes, confidence intervals, p-values, or outcome-specific analysis results are available in the record.
The study is listed as single group, with allocation NA and no masking. There is no concurrent control group listed. This design does not allow a direct comparison against an alternative intervention or an untreated group, and it limits the extent to which changes over time could be attributed to RFA.
The primary outcome entry identifies PNIF at baseline, while the summary describes measurements before and after the procedure. The registry does not specify a post-procedure primary endpoint time point or provide the measurements needed to assess change. Detailed eligibility criteria, participant characteristics, procedural details, and arm-description information are also not reported in the registry record.
The record does not describe analysis populations, missing-data handling, the statistical analysis plan, or a strategy for addressing multiple outcomes. It lists 0 analysis entries, which leaves the statistical methods and results unavailable in the registry record. The enrollment figure does not establish how many participants contributed data to each outcome.
Safety information is limited to counts: no serious adverse events are listed, 3 participants are listed with other adverse events, and no deaths are listed. The event types and additional context are not reported. These limitations mean the record offers an outline of the study but insufficient detail to evaluate outcome effects, statistical precision, or the full safety experience.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis — NCT05648565.
- Registry record last updated 2025-04-03; status last verified 2025-03.
- Results first posted 2025-04-03.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed, single-group study of RFA of the PNN in participants with chronic rhinitis. Enrollment was 17. The study started on 2023-01-10 and reached primary completion on 2024-02-20. The sponsor is The University of Texas Health Science Center, Houston.
The primary outcome is nasal congestion assessed by PNIF, reported in liters per minute, with a median and inter-quartile range specified at baseline. The summary names rTNSS, NOSE, PNIF, and Type 2 cytokines as assessment interests. The record lists 13 outcome measures and 0 analysis entries, but numerical outcome results are not reported in the registry record.
The design has no separate comparator group and no masking is listed. Safety entries list 0 serious adverse events, 3 participants with other adverse events, and 0 deaths, with 17 participants at risk in the adverse-event groups. Further details about outcomes, analyses, missing data, and adverse-event types are not reported in the registry record.