Functional Change With MMS: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Functional Change With MMS (NCT04506502), a na na study. The primary outcome is Change in Body Satisfaction Questionnaire From Baseline to 1-month Post-Treatment Follow-up Visit.

2. Clinical Question

In plain terms, the study was intended to assess whether participants’ questionnaire scores differed at follow-up from their baseline scores after MMS treatment. Because the design had a single group, any recorded before-and-after change would describe change over time among treated participants. It would not, by itself, estimate how those participants’ outcomes compared with what would have happened without treatment or with a different treatment. The record describes the study as completed, but completion status does not supply the missing outcome estimate or establish a treatment effect.

3. Trial Design

The registry describes Functional Change With MMS as a completed, single-group study of the ZELTIQ System for magnetic muscle stimulation of abdominal muscle. The condition listed is muscle weakness. The record gives an enrollment of 16 and identifies Zeltiq Aesthetics as the sponsor. The recorded study start date is 2020-03-04, and the primary completion date is 2021-05-18. The phase is listed as NA.

There was no randomized allocation described: allocation is listed as NA, and the study model is single group. Masking is listed as none. Thus, the design information does not describe a concurrent control group, random assignment, or blinded assessment. In a single-group before-and-after design, the observed change may be described within the treated group, but it cannot separate treatment-associated change from other explanations for change over time. General examples include natural variation, participants’ expectations, measurement conditions, and events occurring during follow-up; whether any of these affected this study is not reported in the registry record.

The arm description says treatments were designed to evaluate muscle toning, firming and strengthening in the abdomen. The primary outcome description specifies a baseline assessment and a 1-month post-treatment follow-up visit. The per-protocol population is described as treated subjects who received 8 MMS treatments and had a weight change of no more than 5% of total body weight at the time of the 1-month assessment. The registry also says two subjects were excluded from that population because of incomplete treatments and withdrawal of consent. The exact number included in the per-protocol analysis and the details of any other analysis populations are not reported in the registry record.

The record lists two outcome measures and zero analyses. It does not give a statistical analysis plan, an outcome estimate, a confidence interval, or a p-value. The registry status is completed, but the result information available in the record is insufficient to quantify the primary outcome change or assess its precision.

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: Per protocol, subjects received magnetic muscle stimulation (MMS) treatments in the abdominal area in 8 sessions over a 1-month period. Office follow-up visits were required at 4 days, 1 month, 2 months and 3 months after the final treatment. During all visits, subjects were assessed for pain and adverse events and required study activities were performed per protocol.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Two subjects were excluded from per protocol population due to incomplete treatments and withdrawal of consent. The Per Protocol population consisted of all treated subjects that received 8 MMS treatments and with a weight change of no more than 5% of total body weight at the time the 1-month assessments were performed compared to the weight obtained at the first treatment visit.

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: Data presented here as planned and collected (all enrolled).

6. Primary Endpoint

The registry lists the primary outcome as Change in Body Satisfaction Questionnaire From Baseline to 1-month Post-Treatment Follow-up Visit, measured over Baseline, 1-month post-treatment follow-up visit.

The primary endpoint is the change in the mean Body Satisfaction Questionnaire (BSQ) score from baseline to the 1-month post-treatment follow-up visit. The BSQ is described as a set of dichotomous items about body shape and appearance, with a total score ranging from 10 to 50 units on a scale. The endpoint is expressed as a numerical change between the mean baseline score and the score recorded at follow-up.

The registry description defines a positive change as an increase in the total score and interprets that direction as perceived improvement in appearance in the treated region, the abdomen. That direction is important when reading an estimate: an increase is not the same as a decrease for this outcome, according to the record’s stated interpretation. The measure captures participants’ reported body satisfaction, not a direct measurement of muscle strength or an independent assessment of abdominal appearance.

In general, a baseline-to-follow-up change score gives a way to describe how an outcome differs over time within a group. Reporting the mean change can convey the average direction and magnitude of those changes, while a measure of spread can show how much participant-level changes vary. The registry identifies mean and standard deviation as the outcome parameter and dispersion, respectively, but it does not report the numerical mean change or standard deviation. The result’s precision and the range of individual experiences therefore cannot be assessed from the registry record.

The endpoint is relevant to the stated aim of evaluating perceived appearance, but interpretation should stay specific to that questionnaire and follow-up visit. A change in BSQ score should not be treated as a direct measure of every aspect of muscle function, toning, or safety.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: it is a numerical score, and the registry specifies the mean as the parameter of interest and the standard deviation as the measure of dispersion. In general, a mean describes the average value in a group, while a standard deviation describes variation of individual values around that average. They answer different questions. A mean change can describe the group’s average direction of change; the standard deviation can indicate whether individual changes were relatively similar or widely spread. Neither statistic is reported numerically for this endpoint in the registry record.

The change is defined by comparing the baseline mean with the score at the 1-month post-treatment follow-up. The record says results were tabulated as the numerical change between those mean scores and that a positive change reflects an increase in the BSQ total score. This is the record’s stated direction of interpretation. General statistical practice distinguishes a group-level mean change from each participant’s own change: an average can conceal variation, including participants changing in different directions. The registry does not give participant-level results or a distribution of change scores.

A standard deviation is not the same as the standard error or a confidence interval. In general, the standard deviation describes variation among observed measurements, while the standard error describes uncertainty in an estimated mean under a statistical model. A confidence interval uses an estimate and an uncertainty calculation to indicate a range of values compatible with the data and assumptions. These measures are not interchangeable. Since the primary numerical results and confidence interval are not reported in the registry record, the estimate’s precision cannot be evaluated.

For a continuous outcome, distributional assumptions can matter when a method relies on a particular model. General methods may assume that observations, or model errors, behave in a specified way; strong departures can make estimates of uncertainty less reliable. Choosing an appropriate method depends on the data structure, sample size, and distribution. The statistical method used for the primary endpoint is not reported in the registry record. It would therefore be inappropriate to claim that a particular test, model, adjustment, or assumption was used.

The single-group structure also shapes the estimand: the quantity the analysis is intended to describe. The stated endpoint is a within-group mean change over time. That is different from a between-group treatment contrast, which compares outcomes under distinct treatment conditions. In general, a within-group change does not isolate the effect of treatment because there is no concurrent control condition to indicate how the outcome might have changed otherwise. This is a design limitation, not a defect that can be removed merely by reporting a smaller p-value or a more precise interval.

The outcome description refers to a per-protocol population. It says that this population consisted of treated subjects who received 8 MMS treatments and whose weight change was no more than 5% of total body weight at the time of the 1-month assessment. It also says two subjects were excluded because of incomplete treatments and withdrawal of consent. These details describe criteria and exclusions, but the exact number analyzed is not reported in the registry record. The record does not explain how missing questionnaire assessments were handled, whether all enrolled participants contributed baseline data, or whether an analysis population other than the per-protocol population was used for the primary outcome.

In general, restricting an analysis to participants who complete specified treatment or follow-up criteria can change the population represented by the estimate. Excluded participants may differ from those retained, and their outcomes may be unavailable for reasons related to treatment experience or other factors. This does not establish that bias occurred in this study; it means the interpretation depends on knowing the analysis population and how missing observations were addressed. Those details are not reported in the registry record beyond the stated per-protocol criteria and exclusions.

Multiplicity refers, in general, to the increased chance of finding an apparently notable result when several outcomes, time points, subgroups, or statistical tests are examined. The record lists two outcome measures, but does not report a multiplicity strategy or describe the relationship between those outcomes. It would be inappropriate to assume that an adjustment was or was not applied. The registry lists zero analyses, so no test statistics or adjusted findings are recorded.

The record includes assumptions for a planning illustration based on an observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also says the effect to detect is a stated fraction of the observed effect. These are described as planning assumptions, not as the trial’s own design. The study itself is single group, and no observed primary effect is reported in the registry record. Thus, the planning assumptions do not establish that the study used a two-arm design, nor do they supply evidence of observed power or the precision of the primary result. Any sample-size illustration is a planning exercise rather than an observed trial outcome.

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("Magnetic Muscle Stimulation (MMS) Treatment Group")
n   <- c(14)
m   <- c(8.6)
sp  <- c(5.4)
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  Magnetic Muscle Stimulation (MMS) Treatment Group  14  8.600  5.400  5.482  11.718

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures, but does not report a multiplicity procedure or explain how the outcomes were ranked or interpreted together. In general, multiplicity becomes relevant when investigators examine several outcomes, time points, subgroups, or tests: repeated opportunities to identify a result can affect how evidence is interpreted. No adjustment should be assumed from the record, and no conclusion about the consequences of multiplicity can be made without the analysis plan and results.

The primary outcome description identifies a per-protocol population and states that two subjects were excluded because of incomplete treatments and withdrawal of consent. The criteria for that population include receiving 8 MMS treatments and having a weight change of no more than 5% of total body weight at the time of the 1-month assessment. The exact number included in the analysis is not reported in the registry record. The record also does not describe an intention-to-treat analysis or any other analysis population.

Missing-data handling is not reported in the registry record. It is not stated whether follow-up BSQ scores were missing, what approach was used if they were, or whether any sensitivity analyses assessed how missing observations might affect the result. In general, missingness can influence an estimate when participants with unobserved outcomes differ in relevant ways from those with observed outcomes. The available description does not establish whether that occurred.

The registry lists zero analyses, and no primary estimate, uncertainty interval, or test result is recorded. As a result, readers cannot assess how exclusions, missing data, or multiple outcomes affected the statistical findings. The completion status and the stated per-protocol criteria do not answer those questions.

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.

Most frequent non-serious adverse event terms

The registry reports 0 serious adverse events among 16 at risk in the Magnetic Muscle Stimulation (MMS) Treatment Group. It separately reports 6 other adverse events among 16 at risk. These are the posted counts; the record does not identify the terms or nature of the other events, and it lists no top serious-event terms.

These categories should be read separately. A count of 0 serious adverse events in the recorded group means that the registry entry reports no serious events for that category. It does not establish that serious harms are impossible, nor does it show that no adverse events of any kind occurred. The separate count of 6 other adverse events indicates that the record contains events in that category, but their clinical details, severity, timing, and relationship to treatment are not reported in the registry record.

In general, adverse-event counts describe what was recorded under the registry’s reporting categories. They do not by themselves establish causation: an event occurring during a study is not necessarily caused by the intervention. Interpretation also depends on definitions, follow-up, completeness of reporting, and the population observed. The registry record does not provide enough detail to assess these features or compare safety with a control group, which is not described.

These safety figures are distinct from the BSQ primary outcome and do not establish a benefit or an overall balance of benefits and harms. They should be interpreted as the reported counts for this single-group study, not as a controlled estimate of comparative risk.

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

The registry record establishes what the study set out to assess: change in mean BSQ score from baseline to the 1-month post-treatment follow-up after abdominal MMS. It defines an increase in score as a positive change reflecting perceived improvement in appearance in the treated region. It also records a single-group design, enrollment of 16, and the per-protocol criteria and exclusions. Those details describe the question and the design, but they do not provide the primary outcome result.

The record does not report the numerical mean change, standard deviation, confidence interval, or p-value. It therefore does not show whether the mean score increased or decreased, how large any change was, or how precisely it was estimated. A completed study is not the same as a reported result. Neither the objective nor the scoring direction can substitute for an observed estimate.

Even if a within-group change were reported, the design would limit what it could establish. With no control group described, the change could not be interpreted as a direct comparison between MMS and no treatment or another treatment. In general, a before-and-after difference can reflect multiple influences over time, and the single-group record does not isolate those influences. The design therefore supports a descriptive question about change in the observed group, not a controlled estimate of comparative treatment effect.

The endpoint is a participant-reported body-satisfaction score. It addresses perceived body shape and appearance as measured by the BSQ; it is not, by itself, a direct measurement of muscle strength, physical function, or every aspect of safety. The registry’s stated interpretation should remain tied to that measure and the specified follow-up visit. A clinically meaningful threshold for score change is not reported in the registry record.

The safety entry reports 0 serious adverse events and 6 other adverse events in the treatment group, with 16 at risk in each category. The details of the other events are not reported. These counts are descriptive and do not provide a controlled comparison or establish whether events were caused by treatment. Overall, the record describes the study question and some design and safety information, but leaves the primary efficacy result and its statistical precision unavailable.

14. Why This Trial Matters Statistically

This trial is statistically notable because the principal question is framed as a change from baseline in a continuous, participant-reported outcome, while the design is single group. That combination makes clear the distinction between describing change over time and estimating a treatment effect relative to a comparator. The registry record supports the former as the stated endpoint, but does not describe a control condition that would support the latter.

The endpoint’s direction is defined: an increase in BSQ score is described as a positive change and as perceived improvement in appearance in the treated abdominal region. Clear direction matters because the sign of a change score is meaningful only in relation to how the instrument is scored. Yet direction alone is not a result. Because the registry does not report the mean change or its uncertainty, readers cannot determine whether the observed data followed that direction or how precisely any average was estimated.

The population description also illustrates why analysis-population details matter. The record gives per-protocol criteria and notes exclusions for incomplete treatment and withdrawal of consent, but does not report the exact number analyzed or how missing outcome data were handled. In general, the participants included in an analysis determine whom its estimate represents. A transparent account of exclusions and missingness helps readers judge how well that population aligns with the study question.

Finally, the distinction between outcome reporting and safety reporting is important. The record gives adverse-event counts but not the primary BSQ result. One type of information cannot stand in for the other: event counts do not reveal the direction or precision of the questionnaire change. These features make the record useful for understanding the planned measure and design limitations, while leaving the central numerical outcome unresolved.

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.

The primary limitation for interpreting the study is that the registry record does not report the numerical primary outcome result. Although it specifies the BSQ, its scoring direction, the mean and standard deviation as the planned summary measures, and the 1-month post-treatment follow-up, it does not give the observed change or its uncertainty. The magnitude, direction, and precision of the primary outcome therefore cannot be assessed.

The single-group design is a further limitation. No control group or randomized comparison is described, so a change from baseline would not show how outcomes differed from a concurrent alternative. General influences over time cannot be separated from an intervention-associated change using a within-group comparison alone. Masking is listed as none, and the outcome concerns participants’ perceptions; the record does not describe blinded assessment or other steps that might address measurement or expectation effects.

The per-protocol description creates additional interpretive questions. It identifies treatment completion and a weight-change criterion, and notes two exclusions for incomplete treatments and withdrawal of consent. However, the exact analysis-population size is not reported in the registry record. The handling of missing questionnaire data, the availability of follow-up scores, and the use of any other analysis population are also not reported.

The registry lists two outcome measures but provides no analysis results or multiplicity strategy. It does not report a statistical method, confidence interval, p-value, or a threshold for meaningful BSQ change. The safety entry gives counts but not details of the other adverse events, and no controlled safety comparison is described. Taken together, these omissions prevent assessment of the primary result’s precision, robustness, clinical meaning, and comparative interpretation.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Functional Change With MMS — NCT04506502.
• Registry record last updated 2025-05-16; status last verified 2025-04.
• Results first posted 2025-05-16.
• 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

Functional Change With MMS is recorded as a completed, single-group study of the ZELTIQ System for magnetic muscle stimulation of abdominal muscle. Enrollment was 16; the condition listed was muscle weakness. The registry lists Zeltiq Aesthetics as sponsor, gives a start date of 2020-03-04 and a primary completion date of 2021-05-18, and lists phase as NA. Allocation is listed as NA and masking as none.

The primary outcome was mean BSQ change from baseline to the 1-month post-treatment follow-up. An increase in score was defined as a positive change reflecting perceived improvement in appearance in the treated abdominal region. The registry describes a per-protocol population and two exclusions, but does not report the exact analyzed number or the numerical primary result. It lists zero analyses.

The safety record reports 0 serious adverse events and 6 other adverse events, with 16 at risk in each category. Details of the other events are not reported. The registry record therefore describes the study design, intended endpoint, and some event counts, but does not provide the primary outcome estimate or its statistical precision.