IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia (NCT01200069), a randomized phase 4 study. The primary outcome is Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1.

2. Clinical Question

The clinical question is whether the reported pattern of post-ECT myalgia ratings differs between the ibuprofen and placebo groups. The registry’s rationale describes myalgia as a concern after ECT and frames ibuprofen as a possible approach to treating or preventing it. That rationale explains why the question was studied, but it is not evidence of an observed benefit. The available outcome summaries are ratings, not a direct measure of prevention, recovery, or daily functioning. The record also lists headache outcomes as secondary outcomes, but does not include their results in the registry entries.

3. Trial Design

The registry identifies this as a Phase 4, randomized, double-masked, parallel-group trial. Random assignment means that the intended design allocated participants to one of the two infusion groups by chance. Double masking indicates that the registry classified the trial as masked at two levels, but the record does not specify which people were masked or how masking was maintained. A parallel-group design means the treatment groups were separate rather than a crossover in which each participant received both study infusions.

The listed arms were sugar water and intravenous ibuprofen. Both infusion regimens were described as being administered before ECT treatments 1, 2 and 3. The primary outcome, however, concerns self-reported myalgia after Treatment 1, with ratings recorded at 1 hour, 6 hours, 24 hours and 48 hours. The outcome population description specifically refers to subjects reporting at one hour, while the outcome timeframe lists the later assessments as well. The record does not clarify this difference in wording.

Enrollment is listed as 14. The outcome summaries report 8 in the sugar-water arm and 6 in the ibuprofen arm at each stated time. The record lists the trial status as terminated, with a start of 2010-07 and primary completion of 2014-09. It does not report the reason for termination, whether the planned recruitment target was reached, or whether all planned assessments were completed. A reason for termination or a fuller account of trial conduct is not reported in the registry record.

The registry lists six outcome measures and three secondary outcomes, but the registry entries available for the primary endpoint are arm-level medians and full ranges. No analysis is reported. The record does not describe the randomization procedure, allocation concealment, masking implementation, protocol deviations, or a statistical analysis plan. Those details should not be inferred from the trial’s design labels.

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:

Analysis population for the primary outcome, as defined in the registry: subjects report at one hour following treatment

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.

6. Primary Endpoint

The registry lists the primary outcome as Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1, measured over Treatment day 1 at 1hour, 6 hour, 24 hours, 48 hours.

The primary endpoint is described as the subject’s numerical rating of the incidence and severity of post-ECT myalgia after Treatment 1. The scale defines 0 as no pain; ratings from 1-3 as mild pain or annoyance with little interference with activities of daily living; ratings from 4-6 as moderate pain that interferes significantly with activities of daily living; and ratings from 7-10 as severe pain that prevents activities of daily living. This gives the reader a qualitative guide to how the rating scale was intended to be interpreted.

The registry reports the median and full range for each arm at 1 hour, 6 hours, 24 hours and 48 hours. The median indicates the central rating in the reported group, while the range gives the lowest and highest ratings. These summaries retain information about the scale’s ordered levels without assuming that the distance between adjacent ratings has a specific quantitative meaning. They are useful for describing the reported distribution, particularly when a group is small or ratings may be unevenly distributed.

The endpoint is relevant to the stated clinical question because it records participants’ own assessments of pain after ECT. It is not, by itself, a measure of the frequency of myalgia separate from its severity, functional recovery, or longer-term outcomes. Nor does an arm-level median establish whether a difference between groups is statistically reliable or important to participants. The registry does not report a prespecified threshold for a meaningful change, a treatment-effect estimate, or an uncertainty interval for this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a median describe?

General statistical explanation: the median is the middle value when observations are ordered. It describes a typical point in the observed group without requiring that extreme values have the same influence they would have on an arithmetic average. For an ordered pain scale, a median can be a useful summary because the scale ranks responses from no pain through increasing levels of severity. The registry identifies the reported parameter as a median and the dispersion as a full range.

Here, the medians are reported separately for each arm and assessment time. They are not individual participant trajectories. A sequence of arm medians across time cannot show whether the same people improved, worsened, or stayed unchanged, because the summaries do not preserve the linkage between each person’s ratings. Nor can the medians alone reveal how ratings were distributed around the center. Several different distributions can have the same median.

What does the full range add?

General statistical explanation: a range reports the minimum and maximum observed values. It indicates the span of the recorded observations, but not how common the endpoints or intermediate values were. A range is particularly dependent on the observations at its extremes. With small groups, one rating can determine an endpoint, so the range should not be read as a stable description of the full population’s variability.

For the posted outcome, ranges are shown alongside medians at each time. Where both endpoints are the same, the reported group observations share that value in the summary. Where the endpoints differ, the range demonstrates that at least some recorded values were not at the median, but it does not give the count at any particular rating. The registry does not provide a standard deviation, interquartile range, or participant-level values for this outcome.

How should an ordered pain scale be understood?

General statistical explanation: an ordinal scale ranks responses, but it does not necessarily establish equal distances between adjacent response categories. The registry’s anchors give practical meanings to rating bands: no pain, mild pain, moderate pain, and severe pain. They help readers understand the intended interpretation, but do not specify that a change of one point has the same importance at every position on the scale. The posted results do not state a threshold for a clinically meaningful difference.

The scale is described as a numerical rating scale from 0 to 10, with 0 meaning no pain and the bands defined in the endpoint description. A group median falling within a band can be described using that band’s wording, but it does not classify every participant in the group. A median also does not provide the incidence of any pain unless the underlying individual values or an appropriate count are reported.

What can a treatment comparison establish?

General statistical explanation: randomized assignment is intended to make treatment groups comparable on average, but a reliable estimate of a treatment contrast still requires an analysis that accounts for sampling variation. A descriptive difference between two group summaries is not itself a hypothesis test or uncertainty interval. Confidence intervals, when reported, express a range of values compatible with the data and the stated method; they are not a guarantee that the true effect lies within that range. A p-value, when reported, describes how surprising data at least as incompatible with a specified null hypothesis would be under the test’s assumptions. Neither measure alone establishes clinical importance.

The registry record does not report a formal comparison for the primary endpoint. It lists zero analyses and the posted information contains no p-value, confidence interval, or adjusted treatment-effect estimate. Consequently, no inferential result can be attributed to the trial from these summaries. A recalculated comparison is not reported in the registry record, so none should be substituted for a sponsor analysis.

How do repeated assessment times matter?

General statistical explanation: multiple measurements from the same participant are related rather than independent. An analysis of repeated ratings may need to account for that within-person relationship. Looking at each time separately can also raise a multiplicity issue: if many tests are conducted, the chance of at least one apparently unusual result can increase. A prespecified primary time point, a repeated-measures model, or an adjustment strategy can address different aspects of this problem, but the appropriate approach depends on the trial’s planned question and design.

The registry gives primary-outcome summaries at 1 hour, 6 hours, 24 hours and 48 hours. It does not report whether one of these times was designated as the sole confirmatory assessment, how repeated observations were analyzed, or whether any adjustment for multiple comparisons was planned. No analysis method should be inferred from the presence of multiple time points.

What do planning calculations mean?

General statistical explanation: sample-size planning uses assumptions about a target effect, variability, significance level, allocation, and analysis method to illustrate how much information a future study might need. It is not a measure of the probability that this completed trial found a true effect. The registry describes planning illustrations based on a fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. These are planning assumptions, not a reported justification for the trial’s design or evidence of observed power. The registry does not report the trial’s own sample-size justification.

10. Multiplicity, Missing Data and Analysis Populations

The primary endpoint is summarized at 1 hour, 6 hours, 24 hours and 48 hours after Treatment 1. Multiple assessment times raise questions about which comparison was intended to be primary for inference and how dependence between repeated reports from the same participant would be handled. The registry record does not report a multiplicity strategy, a prespecified testing hierarchy, or a repeated-measures analysis plan. It therefore does not establish whether the time-specific summaries were intended as separate tests, descriptive follow-up, or components of one overall analysis.

The record lists three secondary outcomes concerning headache after ECT. It does not report results for those outcomes in the registry record for the posted results. If multiple outcomes or time points were tested, multiplicity can increase the chance of a seemingly notable result arising by chance. General statistical approaches can control or otherwise address that issue, but no particular approach is reported for this trial and none should be assumed.

Outcome group sizes are reported as 8 for sugar water and 6 for ibuprofen at each primary assessment. The reason these numbers are reported, how missing observations were handled, and whether the analysis included all randomized participants are not reported in the registry record. The record does not define an intention-to-treat, per-protocol, or safety analysis population. It also does not describe imputation, exclusion rules, or sensitivity analyses. The difference between enrollment and outcome-arm reporting should not be used to infer why any observations may be absent.

The registry reports no analyses. It does not give a statistical analysis plan or clarify whether any analyses were performed but not posted. Accordingly, the posted record cannot establish how missing data, repeated measurements, or multiple outcomes were addressed.

11. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 3% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse events for each arm as counts of affected participants and participants at risk. In the sugar-water group, 0 of 8 were reported as having a serious adverse event; in the ibuprofen group, 0 of 6 were reported as having one. The serious-adverse-event terms list is empty. These figures describe what is posted in the record; they do not establish that no serious events occurred outside the recorded reporting period or population.

For other, non-serious adverse events, the registry reports 2 of 8 in the sugar-water group and 1 of 6 in the ibuprofen group. These are counts, not estimates of comparative risk. The record does not provide event types, severity details, timing, or an analysis comparing the groups. A simple comparison of these small counts would not account for uncertainty and should not be treated as a causal conclusion.

Deaths are listed as null for both groups. That is not the same as a reported count of zero; death information is not reported in the registry record. Adverse-event reporting also does not, by itself, establish whether an event was caused by an infusion, ECT, or another factor. The posted safety figures should therefore be read as limited descriptive reporting, not a comprehensive estimate of safety.

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

The posted results show arm-level self-reported myalgia ratings after the first ECT treatment, summarized by medians and full ranges at four assessment times. At some assessments, the reported medians and ranges differ between arms; at 48 hours, the posted median and range are 0.0 in both groups. This describes the registry’s recorded summaries and does not amount to a formal estimate of a treatment effect.

The record does not report a p-value, confidence interval, adjusted comparison, or other inferential analysis for the primary outcome. It therefore does not show the precision of a between-group effect or whether a difference is compatible with chance variation. The absence of a reported analysis is not evidence that the groups are equivalent, and a difference between medians is not, on its own, evidence that one infusion caused a change in pain ratings.

The clinical scale gives context for ratings but does not resolve the interpretive limits. A group median in a severity band does not mean all participants had pain at that level. The range does not reveal how many participants had any particular value. The summaries also do not show participant-level change, the number experiencing any myalgia, or whether pain affected daily activity for each participant.

The record’s terminated status, small outcome-group counts, lack of a reported analysis plan, and absence of documented missing-data methods further limit interpretation. The reason for termination and the completeness of outcome collection are not reported in the registry record. The registry entries do not establish whether the planned sample size was reached or whether all planned analyses were completed.

Thus, the result supports a narrow descriptive statement about the ratings recorded and reported for these groups. It does not establish a statistically reliable or clinically meaningful difference, nor does it support a general conclusion about outcomes in other populations or settings. The registry’s rationale and treatment descriptions explain the question and the assigned infusions, but they do not change what can be concluded from the posted outcome summaries.

13. Why This Trial Matters Statistically

This trial illustrates the distinction between a clinical question and the evidence needed to answer it statistically. Randomized assignment and masking are design features intended to support a fair comparison. But the registry’s posted primary results are descriptive summaries, and the record does not report a treatment-effect analysis. Readers should distinguish the presence of a randomized design from the availability of an inferential result.

The outcome also illustrates why the choice of summary matters. A median and full range can communicate the center and span of an ordered pain rating, while leaving out the distribution of individual values. With small reported arm sizes, each observation can substantially shape these summaries. The data presentation therefore invites careful attention to the scale, the group counts, and the uncertainty that is not quantified in the record.

Multiple assessment times create an additional statistical question. Repeated ratings from the same participant are related, and examining several time points can complicate interpretation if the analysis plan is unknown. Without a reported prespecification or multiplicity approach, readers cannot tell which time-specific result, if any, was intended to carry confirmatory weight.

Finally, status and reporting completeness are part of statistical interpretation. The trial is listed as terminated, but the reason and the handling of missing observations are not reported. These omissions limit assessment of how the posted results relate to the intended design. The example underscores that transparent reporting of analysis methods, participant flow, uncertainty, and outcome handling is needed to move from descriptive numbers to a well-supported comparison.

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.

Several limitations are specific to the registry information for this trial. The record lists enrollment of 14, while the primary outcome summaries show group sizes of 8 and 6. It does not explain the relationship between enrollment and the outcome counts, whether any ratings were unavailable, or how any missing values were handled. No participant-level data or accounting of outcome completion is reported.

The trial is marked terminated, but the reason for termination is not reported in the registry record. The start and primary completion dates are listed, but they do not explain whether recruitment, follow-up, or data collection proceeded as planned. The record does not give a protocol, a sample-size justification, or a detailed statistical analysis plan.

The endpoint description combines incidence and severity in its title, while the posted summaries are medians and ranges of a numerical rating. The record does not provide a separate count of participants with any myalgia. It also describes the population for the primary outcome as reporting at one hour, while listing multiple assessment times in the timeframe. This wording is not clarified in the posted record.

The reported primary results do not include uncertainty intervals or a formal comparison. The record does not explain how repeated measurements were handled, whether assessment times were prespecified for inference, or whether multiple comparisons were addressed. Secondary headache outcomes are listed, but their results are not reported in the registry record. The adverse-event information is similarly limited: event terms and details are absent, and death counts are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia — NCT01200069.
• Registry record last updated 2017-03-29; status last verified 2015-03.
• Results first posted 2016-11-18.
• 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.

18. Record Summary

This registry record describes a Phase 4 randomized, double-masked, parallel-group trial of intravenous ibuprofen versus a sugar-water infusion before ECT. Enrollment is listed as 14; the trial status is terminated. The primary outcome is a subject-reported numerical rating of myalgia after Treatment 1, with median and full-range summaries reported at 1 hour, 6 hours, 24 hours and 48 hours.

The posted primary results are descriptive and do not include a formal between-group analysis, p-value, or confidence interval. The record lists three secondary headache outcomes but does not report their results in the registry entries. It reports no serious adverse events in either group, reports other adverse events in both groups, and does not report death counts. The reason for termination, missing-data methods, analysis populations, and statistical plan are not reported in the registry record.