Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief (NCT02204319), a na na study. The primary outcome is Percent Improvement Change in Visual Analogue Pain Scale (VAS) Calculated With Q-tip Palpation Over 6 Sites From Baseline Visit to Follow up at Two Week From Last Visit.

2. Clinical Question

3. Trial Design

This was a single-group pilot study of cold laser treatment, with an enrollment of 10. The registry lists the allocation as NA and masking as NONE. It therefore describes neither a randomized allocation process nor masking of participants or investigators. No control arm is listed, so the design does not support a like-for-like comparison between treatment groups.

The study record identifies Vulvar Vestibulitis and Vestibulodynia as conditions of interest. Its summary says the pilot objectives were to assess pain symptoms, oral medication use for pain, and effects on daily activities, relationships, and emotional well-being. Those aims describe the motivation for the study; they do not establish that changes in those areas were observed. The listed secondary outcome is change in the Patient Specific Functional Scale Questionnaire.

The listed intervention was a cold laser device used off the body over the vulvar involved area. The record describes the device as having three independent 7 milliWatt, 635 nanometer red light diodes. It does not report the treatment schedule or the number of treatment visits in the available record description.

The study started in 2014-03, had a primary completion date of 2015-07, and is marked TERMINATED. The reason for termination is not reported in the registry record. The phase is listed as NA. Numerical results for the primary endpoint are not reported, and the record lists zero analyses. These omissions mean that the design and intended outcome can be described, but the treatment-associated change in pain cannot be quantified from the registry record.

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

Reasons for not completing this period:

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: seven completed study and three withdrew

6. Primary Endpoint

The registry lists the primary outcome as Percent Improvement Change in Visual Analogue Pain Scale (VAS) Calculated With Q-tip Palpation Over 6 Sites From Baseline Visit to Follow up at Two Week From Last Visit, measured over Average of all sites Compared from baseline visit and at 8 week (from start) follow up.

The primary endpoint concerns pain elicited by Q-tip palpation. The record describes applying pressure at six vulvar sites in a specified order: 2:00, 10:00, 5:00, 7:00, 12:00, and 6:00. At each site, pain intensity was marked on a Visual Analogue Scale (VAS) from 0, described as no pain measured, to 100, described as maximum pain. The endpoint uses the average across sites and expresses change as percent improvement from baseline to follow-up.

A VAS gives a person a way to report pain intensity along a scale, while the site-specific ratings retain information about where pressure elicited pain. Averaging across the sites creates a single summary measure, which can be useful for describing overall pain in the examined areas. A change measure is intended to describe how that summary differs between assessments. The registry specifies a mean and standard deviation as the outcome summary.

The timing language is not uniform. The endpoint title refers to follow-up two weeks from the last visit, the timeframe refers to an eight-week follow-up from the start, and the description refers to reassessment two weeks following the last treatment. The intended assessment is described as after treatment, but the exact timing is not resolved by the registry record. No mean change, standard deviation, or other numerical primary outcome result is reported.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous primary outcome summarized by a mean and standard deviation. It does not report numerical results or an inferential analysis. The explanations below are general statistical context for understanding the stated endpoint and the limits of the record.

What does a mean change describe?

A mean is an average across participants. For a change outcome, it gives a group-level summary of the direction and size of participants’ measured changes, but it does not show how much individuals differed from one another. A mean may be influenced by unusually large or small changes. The standard deviation describes the spread of observed values around the mean; it is not the same as the uncertainty in the mean. The registry names both summaries for the primary outcome but reports neither value.

The endpoint is described as percent improvement from the first to the last treatment, while other wording frames the comparison as baseline to follow-up. Percent change can make a change relative to a starting value, but its interpretation depends on how the baseline value is defined and on the calculation used. The precise calculation details are not reported in the registry record. Consequently, the endpoint label alone is not enough to reproduce or verify a numerical result.

What does a confidence interval add?

General statistical explanation: a confidence interval gives a range of values compatible with an estimate under the assumptions of the analysis. It conveys precision as well as direction and size. A relatively narrow interval indicates greater precision than a wide interval, while an interval spanning values that would be interpreted differently can leave the conclusion uncertain. No confidence interval for the primary endpoint is reported in the registry record, so its precision cannot be assessed.

A p-value, when reported, describes how compatible data are with a specified statistical model and null hypothesis. It does not measure the size or clinical importance of a change, and it does not establish that a treatment caused the change. No p-value or statistical test is reported for the primary outcome. Neither a p-value nor a confidence interval can be inferred from the endpoint description alone.

What can a single-group comparison establish?

In general, a before-and-after analysis in one group describes within-participant change over time. Pairing measurements can account for the fact that each participant contributes measurements at more than one time, but it does not create a control group. Without a comparator, the analysis cannot isolate the intervention’s contribution from other influences on change. The registry identifies a single-group model, but it does not report the analysis method used to compare baseline with follow-up.

General statistical explanation: repeated measurements can also be affected by missing follow-up values. If some participants lack an endpoint measurement, the analyzed group may differ from the enrolled group. The methods used to handle missing measurements, and the number of participants contributing primary endpoint data, are not reported in the registry record. No assumptions about missingness or imputation can therefore be attributed to the study.

How should the planning illustration be read?

The planning assumptions describe a hypothetical two-arm calculation using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. They frame the effect to detect as a stated fraction of an observed effect. Such a calculation is a planning illustration, not observed power and not a description of this study’s single-group design. The posted record does not report the numerical primary effect needed to evaluate the illustration’s inputs. Sample-size planning values, where presented, should not be interpreted as participants actually analyzed or as evidence that the study had a particular probability of detecting an effect.

The record’s endpoint uses an average across six Q-tip sites. General statistical explanation: averaging multiple measurements can provide an overall summary, but it can conceal variation among sites. The record does not report site-specific results or a method for accounting for variation among the six measurements. It is therefore not possible to determine from the record whether the average reflects a consistent pattern across sites or differing patterns by site.

Finally, statistical significance and clinical meaning are distinct concepts. General statistical explanation: statistical significance concerns compatibility with a statistical model, while clinical meaning concerns whether a difference matters in the context of patients’ experiences and the measurement. Neither can be evaluated for this endpoint without a reported estimate and its uncertainty, and the registry record does not state a threshold for interpreting a meaningful change.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Cold Laser Treatment")
n   <- c(7)
m   <- c(76.52)
sp  <- c(24.36)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Cold Laser Treatment  7  76.520  24.360  53.991  99.049

11. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures and names the primary endpoint as percent improvement change in VAS pain. It lists change in the Patient Specific Functional Scale Questionnaire as a secondary outcome. The remaining outcome measure is not described in the record. No numerical results are reported for these outcomes.

When a study examines multiple outcomes or multiple statistical tests, the chance of obtaining at least one apparently unusual result can increase. General statistical explanation: a prespecified analysis plan may describe how to handle multiple comparisons, including whether any adjustment is intended or whether outcomes are interpreted separately. Such a multiplicity plan is not reported in the registry record. The record does not state whether there were additional comparisons, subgroup analyses, or repeated testing over time.

The registry lists zero analyses. It does not report an analysis population for the primary outcome, the number of participants with evaluable baseline and follow-up measurements, or how incomplete measurements were handled. No missing-data method, imputation procedure, or sensitivity analysis is reported in the registry record. Thus, it is not possible to establish whether the intended enrollment of 10 corresponds to the group included in a primary endpoint analysis.

The description of timing also varies across the endpoint title, timeframe, and outcome description. A prespecified rule for selecting an assessment time when descriptions differ is not reported. These gaps limit interpretation of which outcome and analysis were intended to be definitive; they do not establish that a particular analysis was or was not conducted outside the registry record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists one safety group, titled Cold Laser Light Therapy. For serious adverse events, 7 participants are listed as at risk, 0 as affected, and 0 deaths. For other adverse events, 7 are listed as at risk and 0 as affected. No serious adverse event terms are listed.

These figures describe the adverse-event entries in the registry record. They should not be read as proof that no adverse events occurred outside the recorded definitions, reporting period, or participants represented by the listed denominator. The record does not explain why the safety denominator is 7 when enrollment is listed as 10, nor does it report additional detail about collection or follow-up of adverse events. It is therefore not possible to determine from the record how the safety population relates to all enrolled participants.

A zero count is a reported count, not a guarantee that an event is impossible. In general, safety counts are most informative when their denominator, observation period, and event definitions are clear. Those details are not fully in the registry record. The figures should be interpreted narrowly as the recorded counts, without extrapolating them to a broader population.

13. What the Result Does, and Does Not, Mean

The registry record documents a pilot study of cold laser treatment in a single group and identifies a pain endpoint based on VAS ratings during Q-tip palpation. It also describes intended objectives concerning oral medication use and effects on daily activities, relationships, and emotional well-being. The record does not provide numerical findings for the primary endpoint or for these objectives, so it cannot show the size, direction, or precision of observed changes.

The study’s single-group design means that any baseline-to-follow-up change, if available elsewhere, would not by itself establish that the intervention caused it. General statistical explanation: a control group helps distinguish changes associated with an intervention from changes that may have occurred over time for other reasons. No comparator is listed in this record. This limitation is about what the design can support, not a claim about whether participants’ symptoms changed.

The safety entries report 0 serious adverse events among 7 at risk, 0 other adverse events among 7 at risk, and 0 deaths. These are registry counts with a denominator that differs from the listed enrollment. The record does not explain that difference or provide enough detail to generalize the counts beyond the recorded group.

Accordingly, the available record is informative about the intended clinical question, device, design, and measurement approach, but not about a numerical treatment effect. It does not establish that cold laser did or did not reduce pain, medication use, or functional impact. It also does not establish a comparative safety profile. Those conclusions would require results and analysis details not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically notable as a pilot with a single-group design and a patient-reported pain endpoint. The registry describes a concrete measurement process: Q-tip palpation across six named sites, with pain marked on a VAS and summarized as an average. That level of endpoint description helps readers understand what the intended outcome represents, even though the record does not provide its numerical results.

The design also illustrates a key distinction in clinical research: measuring change is not the same as estimating a comparative treatment effect. A single group can be followed from baseline to a later assessment, but without a comparator, change cannot be attributed uniquely to the intervention. This matters when interpreting any uncontrolled before-and-after result, and it remains relevant even when an outcome is measured systematically.

The record’s lack of numerical analyses highlights the importance of transparent outcome reporting. Without an estimate and a measure of uncertainty, readers cannot assess the size or precision of change. Without information about analysis populations and missing data, readers cannot determine how the enrolled group relates to those contributing endpoint measurements. The outcome timing descriptions also differ, making clarification of the intended assessment time important for reproducibility.

The safety counts are also limited by the unexplained difference between enrollment and the listed at-risk denominator. These details do not establish that the study’s methods were inappropriate; they identify what the registry record does and does not permit readers to evaluate. The statistical lesson is that a clearly defined measurement is only one part of an interpretable result. Design, analysis, denominators, timing, and uncertainty all contribute to the strength of conclusions that can be drawn.

15. 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.

Several trial-specific limitations affect interpretation of the registry record. The study is listed as single group, with allocation NA and masking NONE. No comparator is described, so any within-group change would not provide a controlled estimate of the intervention’s effect. The record does not report a numerical result for the primary outcome, its standard deviation, a confidence interval, or a test result. The reason for termination is not reported.

The primary endpoint’s timing is described in more than one way: the title refers to follow-up two weeks from the last visit, the timeframe refers to eight weeks from the start, and the detailed description refers to reassessment two weeks following the last treatment. The record does not resolve this difference. It also does not report the precise calculation used to derive percent improvement from the VAS measurements.

Although enrollment is listed as 10, the safety group lists 7 participants at risk. The record does not explain the difference. It does not report how many participants had primary endpoint measurements, whether any follow-up data were missing, or how missing data were handled. No statistical analysis method or multiplicity plan is reported, and the record lists zero analyses.

The registry lists three outcome measures but names only the primary VAS outcome and the secondary Patient Specific Functional Scale Questionnaire in the available outcome descriptions. Results for the secondary outcome are not reported. Participant characteristics beyond the listed conditions are not reported in the registry record, limiting assessment of the population represented. These are reporting limitations; they should not be replaced with assumptions about what occurred during the study.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief — NCT02204319.
• Registry record last updated 2017-07-02; status last verified 2017-04.
• Results first posted 2017-07-02.
• 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.

19. Record Summary

The registry record describes NCT02204319, a terminated single-group pilot study sponsored by ProHealth Care, Inc. It lists enrollment of 10 and conditions of Vulvar Vestibulitis and Vestibulodynia. The intervention was cold laser treatment using an Erchonia Corporation device described as having three independent 7 milliWatt, 635 nanometer red light diodes. The study started in 2014-03 and had a primary completion date of 2015-07.

The primary outcome was mean percent improvement change in VAS pain during Q-tip palpation over six sites. A secondary outcome listed was change in the Patient Specific Functional Scale Questionnaire. Numerical outcome results and statistical analyses are not reported in the registry record. The safety entries list 0 serious adverse events among 7 at risk, 0 other adverse events among 7 at risk, and 0 deaths. The reason for termination, the difference between enrollment and the safety denominator, and the precise follow-up timing are not explained in the record.