EMS + Laser + RF/PEMF for Fat Loss

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores various methods for fat loss and body shaping. It tests a combination of treatments, including a special laser (1064 nm diode laser), electrical muscle stimulation (EMS), and radio frequency with pulsed electromagnetic fields (RF/PEMF). Researchers will divide participants into three groups to test the effects of these treatments in different combinations. Eligible participants have a body mass index (BMI) of 30 or less and agree not to start new abdominal workouts during the study. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for body shaping and fat loss.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in this trial, including the 1064 nm diode laser, electrical muscle stimulation (EMS), and radiofrequency/pulsed electromagnetic fields (RF/PEMF), have been safe in previous studies.

For the 1064 nm diode laser, studies have found it to be a safe and effective method for body shaping. Patients tolerated the treatment well, with no major side effects reported.

EMS treatments have also been positively received. Many studies found them safe for improving muscle tone, with only minor side effects like skin irritation, which were uncommon.

Similarly, RF/PEMF treatments have been used safely to reduce fat and improve skin condition. Research shows these treatments can enhance appearance without harming the skin.

Overall, past studies indicate that these treatments have been well-tolerated, providing reassurance about their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of EMS, laser, and RF/PEMF treatments for fat loss because they offer a multi-faceted approach that could enhance results beyond standard options like diet, exercise, or surgical procedures. The 1064 nm diode laser targets fat cells specifically, helping to break them down effectively. Meanwhile, EMS (Electrical Muscle Stimulation) and RF/PEMF (Radio Frequency/Pulsed Electromagnetic Fields) work together to stimulate muscle activity and improve skin elasticity. This combination not only aims to reduce fat but also to tone the body and tighten the skin, setting it apart from single-method treatments.

What evidence suggests that this trial's treatments could be effective for fat loss?

This trial will evaluate different combinations of treatments for fat loss. Research has shown that a 1064 nm diode laser, combined with EMS and RF/PEMF, can effectively reduce fat without surgery. Participants in Arm A of this trial will receive this combination, which safely destroys fat cells while protecting the surrounding skin. Patients have reported high satisfaction with this treatment.

Participants in Arm B will receive EMS and RF/PEMF, which studies suggest work well together to reduce fat and tighten skin. Arm C will focus on EMS alone, which can improve muscle tone and help shape the body, though its fat reduction effects are more noticeable when combined with other treatments. Overall, these treatments show promise for body shaping and reducing unwanted fat. ^{1 2 6 7 8}

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.

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 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?

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+

Published Research Related to This Trial

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]

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]

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/lsm.23654

Clinical evaluation of the safety and efficacy of a 1064 nm ... ... PEMF and RF energies for noninvasive fat reduction of the abdomen and flanks. ... and efficacy of a noninvasive 1,060-nm diode laser for fat ...

2. researchgate.net researchgate.net/publication/369657117_Clinical_evaluation_of_the_safety_and_efficacy_of_a_1064_nm_diode_laser_and_vacuum_assisted_pulsed_electromagnetic_fields_and_multipolar_radio_frequency_for_noninvasive_fat_reduction_of_the_abdomen_an

Clinical evaluation of the safety and efficacy of a 1064 nm ... 10 Previous clinical studies demonstrate the 1060/ 1064 nm diode laser as a safe and efficacious method for noninvasive fat reduction. [11][ ...

3. withpower.com withpower.com/trial/phase-fat-reduction-10-2021-36725

EMS + Laser + RF/PEMF for Fat Loss · Info for Participants ... 1064 nm diode laser, EMS and RF/PEMF will have tolerable side effects & efficacy for patients with Bell's Palsy, Fat Loss and Hypertonia. Learn more about the

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36994932/

Clinical evaluation of the safety and efficacy of a 1064 nm ... Treatment pain was low and tolerable, and subjects had high levels of satisfaction with the results. Keywords: PEMF; diode laser; fat reduction; ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11826928/

Histopathological Analysis of Abdominal Skin and Fat After ... These results demonstrate that the 1064 nm diode laser device can be safe and effective for noninvasive fat reduction, as it destroys adipocytes without harming ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7065637/

Efficacy and safety of long pulse 1064 and 2940 nm lasers ... In conclusion, the combined 1064 nm Nd:YAG and 2940 nm Er:YAG laser treatment for body shaping has proven to be a comfortable, safe and effective therapy for ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/14/NCT04012814/Prot_SAP_000.pdf

Clinical Evaluation of the Safety and Efficacy of a 1064 nm ... Laser in Surg Med. 2018 50: 96-110. Bass LS, Doherty ST. Safety and Efficacy of a noninvasive 1064nm Diode Laser for Fat Reduction of the.

8. academic.oup.com academic.oup.com/asjopenforum/article/doi/10.1093/asjof/ojae082/7769619

Impact of the Number and Duration of Treatments With a 1064 ... The 1064 nm diode laser noninvasively induces adipocyte apoptosis by elevating temperatures (42-47 °C) within the adipocyte and periadipocyte environments.