36 Participants Needed

EMS + Laser + RF/PEMF for Fat Loss

Recruiting at 2 trial locations
MG
AB
Overseen ByAndrea Biro, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Multi-center, three-arm, randomized, evaluator-blinded study of electrical muscle stimulation (EMS) and/or 1064 nm diode laser, pulsed electromagnetic field (PEMF) and vacuum assisted radio frequency (RF) using the Venus Bliss Max for fat reduction, body contouring and aesthetic improvement.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, such as antiplatelet medications (except for low-dose aspirin), anticoagulants, thrombolytics, and anti-inflammatory medications, at least 2 weeks before treatment. If you are using medications that cause sensitivity to light, you may also need to stop those. It's best to discuss your specific medications with the trial team.

Is EMS, including NMES and WB-EMS, safe for humans?

Research suggests that neuromuscular electrical stimulation (NMES) is generally safe for humans, even for those with certain heart devices, as long as individual risks are assessed beforehand. However, whole-body EMS (WB-EMS) has been associated with muscle damage in some cases, so it's important to be screened for risk factors and ensure proper supervision and training.12345

How does the EMS + Laser + RF/PEMF treatment for fat loss differ from other treatments?

This treatment is unique because it combines electrical muscle stimulation (EMS), a 1064 nm diode laser, and radiofrequency/pulsed electromagnetic fields (RF/PEMF) to target fat loss. EMS is known for enhancing muscle quality and strength, while the laser and RF/PEMF components may help in breaking down fat cells, offering a multi-faceted approach to fat reduction that is different from traditional methods like diet, exercise, or surgery.678910

What data supports the effectiveness of the treatment EMS + Laser + RF/PEMF for Fat Loss?

Research shows that neuromuscular electrical stimulation (NMES), a component of the treatment, can improve muscle strength and function, which may indirectly support fat loss by enhancing muscle activity and metabolism. However, there is no direct evidence from the provided studies specifically linking this combination of treatments to fat loss.68101112

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-65 with a BMI of ≤30 kg/m2 who are not currently changing their abdominal exercise routine. Participants must consent to the study's terms and cannot have had recent surgery or skin conditions in the treatment area, be pregnant or nursing, have immune deficiencies, bleeding disorders, certain chronic diseases, tattoos in the treatment area, or be on drugs that affect bleeding or cause light sensitivity.

Inclusion Criteria

You promise not to do any new exercises that focus on your abdomen during the study.
Your body mass index (BMI) is less than or equal to 30, which will be checked before the study starts.
You have read and signed a paper that explains the study and your involvement in it.
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Exclusion Criteria

You have significant skin problems in the area where the treatment would be given, like open wounds, sores, or infections.
Enrolled in a clinical study of any other investigational drug or device
Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months, including presence of post-partum diastasis
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatments based on their assigned arm: Arm A receives diode laser, EMS, and RF/PEMF; Arm B receives EMS and RF/PEMF; Arm C receives EMS only.

8 weeks
Multiple visits depending on arm assignment

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up assessments include photo reviews, live assessments, and various measurements.

20 weeks
2 follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • 1064 nm diode laser
  • EMS
  • RF/PEMF
Trial Overview The study tests electrical muscle stimulation (EMS), a 1064 nm diode laser, pulsed electromagnetic field (PEMF), and radio frequency (RF) treatments using Venus Bliss Max for non-invasive body contouring and fat reduction. It's a multi-center trial where participants are randomly assigned to one of three groups without knowing which group they're in.
How Is the Trial Designed?
3Treatment groups
Active Control
Group I: Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF)Active Control3 Interventions
Group II: Arm B: EMS/RF Arm (EMS + RF/PEMF)Active Control2 Interventions
Group III: Arm C: EMS Arm (EMS only)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Venus Concept

Lead Sponsor

Trials
35
Recruited
1,300+

Published Research Related to This Trial

A systematic review of literature on neuromuscular electrical stimulation (NMES) identified effective stimulation parameters for treating muscle impairments in conditions like stroke, ACL reconstruction, and knee osteoarthritis, based on a consensus among six Canadian PT experts.
The article serves as a comprehensive resource for physiotherapists, offering evidence-based recommendations and safety tips for the effective application of NMES in clinical practice.
Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice.Nussbaum, EL., Houghton, P., Anthony, J., et al.[2019]
Transcutaneous motor-level electrical stimulation has advanced significantly in the last 50 years, serving both as a research tool to study neuromuscular function and as a therapeutic method to enhance muscle strength and function in various populations.
Key improvements in understanding motor unit recruitment and the effects of stimulation parameters (like pulse duration and intensity) are crucial for optimizing both research outcomes and clinical applications of electrical stimulation.
Electrical stimulation for investigating and improving neuromuscular function in vivo: Historical perspective and major advances.Maffiuletti, NA., Dirks, ML., Stevens-Lapsley, J., et al.[2023]
A pilot safety study involving six patients with implantable cardioverter defibrillators (ICDs) showed that long-term neuromuscular electrical stimulation (NMES) of thigh muscles is safe, with no adverse events reported during the treatment.
All patients received a total of over 14 million electrical pulses without any abnormalities in ICD function, suggesting that NMES can be a viable option for improving muscle strength and endurance in patients with chronic heart failure who have ICDs, provided individual risks are assessed beforehand.
Long-term transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study.Crevenna, R., Wolzt, M., Fialka-Moser, V., et al.[2022]

Citations

Neuromuscular Electrical Stimulation Improves Energy Substrate Metabolism and Survival in Mice With Acute Endotoxic Shock. [2022]
Acute Effects of 3 Neuromuscular Electrical Stimulation Waveforms on Exercising and Recovery Microvascular Oxygenation Responses. [2022]
High-Frequency Neuromuscular Electrical Stimulation Increases Anabolic Signaling. [2019]
Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. [2019]
Electrical stimulation for investigating and improving neuromuscular function in vivo: Historical perspective and major advances. [2023]
Long-term transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. [2022]
Effects of whole-body neuromuscular electrical stimulation device on hemodynamics, arrhythmia, and sublingual microcirculation. [2021]
Side effects of and contraindications for whole-body electro-myo-stimulation: a viewpoint. [2020]
Position statement and updated international guideline for safe and effective whole-body electromyostimulation training-the need for common sense in WB-EMS application. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Comparison of maximum tolerated muscle torques produced by 2 pulse durations. [2014]
Once Weekly Whole-Body Electromyostimulation Enhances Muscle Quality in Men: Data of the Randomized Controlled Franconian Electromyostimulation and Golf Study. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Case report: endurance electrical stimulation training improves skeletal muscle oxidative capacity in chronic spinal cord injury. [2022]
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