EMS + Laser + RF/PEMF for Fat Loss

Recruiting at 2 trial locations

Overseen By Andrea Biro, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Venus Concept

Must not be taking: Antiplatelets, Anticoagulants, Anti-inflammatories, others

Disqualifiers: Pregnancy, Liposuction, Immunosuppression, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

36 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 11 12}

Eligibility Criteria

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF) Active Control 3 Interventions

Arm A: Three (3) diode laser treatments treatments at days 0, 28 and 56 (±2 days). Subjects will also receive bi-weekly electrical muscle stimulation and pulsed electromagnetic fields/vacuum assisted radio frequency treatments at days 0, 14, 28, 42 and 56 (±2 days).

Group II: Arm B: EMS/RF Arm (EMS + RF/PEMF) Active Control 2 Interventions

Arm B: Subjects will receive bi-weekly electrical muscle stimulation and pulsed electromagnetic fields/vacuum assisted radio frequency treatments at days 0, 14, 28, 42 and 56 (±2 days).

Group III: Arm C: EMS Arm (EMS only) Active Control 1 Intervention

Arm C: Subjects will receive weekly electrical muscle stimulation treatments at days 0, 7, 14, 21, 28 and 35 (±2 days).

Who Is Running the Clinical Trial?

Venus Concept

Lead Sponsor

Trials

35

Recruited

1,300+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Whole-body electro-myo-stimulation (WB-EMS) can lead to elevated creatine-kinase (CK) levels and has been associated with cases of rhabdomyolysis, although it is unclear if WB-EMS was the sole cause in these instances.

Current research lacks comprehensive data on the safety and contraindications of WB-EMS, particularly regarding muscle damage and risk factors for rhabdomyolysis, highlighting the need for better regulation and physician screening before use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of and contraindications for whole-body electro-myo-stimulation: a viewpoint. Stöllberger, C., Finsterer, J.[2020]

Whole-Body Electromyostimulation (WB-EMS) is a time-efficient and joint-friendly training method that stimulates all major muscle groups simultaneously, making it suitable for individuals who may struggle with traditional exercise.

To enhance the safety and effectiveness of WB-EMS, updated guidelines emphasize the importance of qualified trainers, thorough participant assessments, and close supervision during sessions, addressing previous concerns about adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position statement and updated international guideline for safe and effective whole-body electromyostimulation training-the need for common sense in WB-EMS application. Kemmler, W., Fröhlich, M., Ludwig, O., et al.[2023]

In a study involving 10 adults, neuromuscular electrical stimulation (NMES) with a 200-microsecond pulse duration allowed participants to tolerate significantly greater muscle torques compared to a 50-microsecond pulse duration, indicating enhanced efficacy for muscle strengthening.

The findings suggest that medium pulse durations may be more effective for maximizing muscle torque responses, despite the common belief that shorter pulses are preferable due to lower pain thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. Scott, WB., Causey, JB., Marshall, TL.[2014]

References

1. United States pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation Improves Energy Substrate Metabolism and Survival in Mice With Acute Endotoxic Shock. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Acute Effects of 3 Neuromuscular Electrical Stimulation Waveforms on Exercising and Recovery Microvascular Oxygenation Responses. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

High-Frequency Neuromuscular Electrical Stimulation Increases Anabolic Signaling. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Electrical stimulation for investigating and improving neuromuscular function in vivo: Historical perspective and major advances. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

Effects of whole-body neuromuscular electrical stimulation device on hemodynamics, arrhythmia, and sublingual microcirculation. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Side effects of and contraindications for whole-body electro-myo-stimulation: a viewpoint. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. [2014]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Once Weekly Whole-Body Electromyostimulation Enhances Muscle Quality in Men: Data of the Randomized Controlled Franconian Electromyostimulation and Golf Study. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Case report: endurance electrical stimulation training improves skeletal muscle oxidative capacity in chronic spinal cord injury. [2022]