A randomised sham-controlled abdominal study found reduced subcutaneous fat thickness and increased rectus abdominis thickness after combined HIFEM and radiofrequency treatment, with individual results remaining variable.
How to interpret the measured result
Randomisation and the sham comparison help interpret the treatment effect. Keep muscle-thickness and fat-thickness results separate, with their own follow-up and participant counts.
Study at a glance
Design: Multicentre, single-blind, randomised sham-controlled trial.
Participants: 72 enrolled: 48 active, 24 sham; three months 40/16; six months 21/7.
Research protocol: Three weekly 30-minute abdominal sessions.
Follow-up: One, three and six months.
Evidence visual: Active treatment, comparison group, follow-up
The sections below explain each outcome separately. Group measurements are not individual forecasts.
Fat layer
Active, 3 months: -28.3 % thickness change.
Active n=40 at three months. Sham n=16: no significant comparable change; an exact zero has not been invented.
Rectus muscle
Active, 3 months: 24.2 % thickness change.
An ultrasound thickness endpoint, not a measured percentage improvement in strength.
Who returned?
Active, enrolled: 48 participants; Active, 3 months: 40 participants; Active, 6 months: 21 participants.
Sham group: 24 enrolled, 16 at three months, seven at six months. Do not use n=72 as the six-month denominator.
Source for the visual: [S01]. Active three-month results: fat thickness -28.3%, rectus thickness +24.2%. Observed outcomes, not a personal prediction.
Why this study is a useful starting point
EMSCULPT NEO has been investigated using several different methods, including ultrasound, magnetic resonance imaging and small tissue-biopsy studies. The sham-controlled abdominal trial is a useful place to start because it asked a direct question: did an active course produce different tissue measurements from a low-energy comparison procedure? [S01]
That is more informative than comparing photographs taken before and after an appointment. A comparison group helps separate the treatment signal from changes that might also occur without the active intervention. It does not answer every question about who should be treated, but it makes the central evidence question more concrete.
For someone considering treatment, the important distinction is between evidence that a device can alter measured tissue and a promise about what a particular person will see in the mirror. This study addresses the first question. A consultation is still needed for the second.
For treatment background, read What is EMSCULPT NEO?. This article focuses on the specific research question.
What the researchers did
Samuels and colleagues enrolled 72 adults and allocated 48 to active treatment and 24 to sham treatment. Participants received three weekly, 30-minute abdominal sessions. The active procedure combined high-intensity focused electromagnetic stimulation, or HIFEM, with synchronised radiofrequency, or RF. The sham used low settings. Ultrasound measured the subcutaneous fat layer and rectus abdominis muscle thickness. [S01]
The study was randomised and single-blind. It was not a comparison with resistance training, diet, liposuction or RF alone. Its results should therefore be described as evidence about the combined abdominal procedure under the study conditions, rather than proof that it is superior to every other option. [S01]
What changed at three months
At three months, the active group had an average 28.3% reduction in the measured fat-layer thickness and a 24.2% increase in measured rectus abdominis thickness. The corresponding average absolute changes were 7.6 mm and 2.3 mm. The sham group did not show significant comparable changes. Forty active participants and 16 sham participants contributed at that visit. [S01]
Those measurements are local. A percentage change in the thickness of a layer is not the same as a percentage change in body weight or total body-fat percentage. Similarly, a thicker muscle on ultrasound is not a direct measurement of how much weight someone can lift.
The accompanying evidence summary keeps these endpoints separate. It also shows the number of participants remaining at follow-up, rather than placing the original enrolment number next to every later result.
How to read the percentages without overinterpreting them
Imagine a hypothetical fat layer that measures 20 mm at baseline. A 25% thickness reduction would make that layer 15 mm at the same measurement point. That is an arithmetic illustration, not a patient result and not a prediction from this study.
It explains why a percentage alone is incomplete. The baseline thickness, the exact tissue being measured and the method of measurement all matter. Two people can have the same relative change but different absolute changes. Neither number, by itself, tells you how noticeable that change will be in clothing or photographs.
A useful discussion therefore asks: what outcome matters to you, how will it be assessed, and what would count as enough improvement to justify treatment? The most impressive percentage is not necessarily the most relevant answer.
What the six-month follow-up adds
The investigators reported maintained changes at six months, but only 21 active participants and seven sham participants attended that visit. The paper describes follow-up disruption during the COVID-19 period. The six-month observations are therefore based on a substantially smaller group than the original 72. [S01]
The appropriate interpretation is that persistence was observed among those assessed. It is not proof that every participant retained the same result, that the effect is permanent, or that a particular maintenance schedule is necessary.
Follow-up after a treatment course should remain an assessment, not an automatic sales event. It should establish what changed, whether that change matters to the patient and whether any further intervention has a sensible purpose.
How this evidence fits a ¹EM assessment
For ¹EM, the practical value of this paper is the move from a vague promise of “toning” to a discussion about specific tissues and measurable outcomes. It supports explaining the treatment as a local body-contouring intervention with published imaging findings, rather than a shortcut to whole-body weight loss. [S01, G01]
Before proceeding, ask the clinician to distinguish the concern being assessed: local fat, muscle contour, skin excess, a suspected hernia or another issue. These are not interchangeable treatment targets. A surface photograph or optical body scan also does not reproduce the internal ultrasound measurements used in this trial.
Agree on consistent documentation and a review point before starting. A change in posture, camera distance or measurement location should not be presented as a biological result. Where exercise capacity, pain or rehabilitation is the goal, those outcomes require their own assessment rather than being inferred from this abdominal imaging study.
Comfort, safety and study transparency
EMSCULPT NEO is non-surgical, but exposure to magnetic fields and RF is not risk-free. General risks of these technologies include muscular soreness or cramping and heat-related effects such as discomfort, redness or burns. Implanted devices, metal, pregnancy and relevant medical or surgical history require screening against the applicable device instructions. [G01]
The investigators disclosed medical-adviser relationships with BTL. That relationship belongs alongside the results, not hidden behind them. The study remains a useful controlled clinical report, but it should not be introduced as wholly independent research. [S01]
The balanced conclusion is encouraging and specific: active treatment produced measurable local tissue changes in this abdominal trial. It does not supply an individual guarantee.
Frequently asked questions
Does this trial prove EMSCULPT NEO works for everyone?
No. It supports measurable abdominal tissue changes under the study conditions. It does not establish that every person responds, that every body area behaves the same way or that the average result predicts an individual outcome. [S01]
Does 28.3% less fat mean losing 28.3% of my body fat?
No. The reported 28.3% was a relative reduction in the thickness of a measured local subcutaneous fat layer. It was not a change in total body-fat percentage or body weight. [S01]
Does 24.2% more muscle mean 24.2% more strength?
No. The endpoint was rectus abdominis thickness on ultrasound. Strength would need an appropriate functional test; it cannot be calculated directly from this imaging percentage. [S01]
How long did the researchers follow participants?
Visits extended to six months. The six-month sample was 21 active and seven sham participants, compared with 48 and 24 originally allocated. The smaller follow-up group matters when discussing durability. [S01]
Does this show that I need only three sessions?
The trial used three weekly abdominal sessions. That describes the research protocol, not a universal prescription. The appropriate area, settings, session plan and review schedule need an individual assessment.
Sources
[S01] Samuels JB, Katz B, Weiss RA. Radiofrequency Heating and High-Intensity Focused Electromagnetic Treatment Delivered Simultaneously: The First Sham-Controlled Randomized Trial. Plastic and Reconstructive Surgery. 149(5):893e–900e. 2022. DOI: 10.1097/PRS.0000000000009030. https://pmc.ncbi.nlm.nih.gov/articles/PMC9028295/
[G01] US Food and Drug Administration. Non-Invasive Body Contouring Technologies. Patient information. 2026. https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/non-invasive-body-contouring-technologies
Practical information
Start with an individual assessment
General information cannot determine whether treatment is right for you. Request a private assessment with the ¹EM team.
General educational information, not individual medical advice. Published research findings are not ¹EM patient-outcome data. Suitability, experience and results vary.