BTL-899 Device for Musculoskeletal Health

No longer recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BTL Industries Ltd.

Must not be taking: Anticoagulants

Disqualifiers: Cardiovascular diseases, Malignant tumor, Pregnancy, others

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

Compensation: Varies

Number of Visits: 7

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, BTL-899, to determine its impact on musculoskeletal health, which includes muscles, bones, and joints. Participants will receive four treatments with this device on either their arms or legs and complete a satisfaction questionnaire. The trial seeks volunteers without metal implants or serious health conditions. Ideal participants should not have recent muscle injuries and should be willing to maintain their current lifestyle during the study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially enhance musculoskeletal health.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be willing to abstain from any new treatments for musculoskeletal improvement during the study.

What prior data suggests that the BTL-899 device is safe for musculoskeletal health?

Research has shown that the BTL-899 device is safe for use. This non-invasive muscle stimulator operates without surgery and uses electromagnetic energy for treatment. While specific safety information for muscle and bone health is lacking, past studies have found it safe and effective for other applications, such as non-surgical fat reduction. This suggests that most people tolerate the device well. However, safety can vary based on usage and individual health. It is important to consult the trial team or a healthcare professional with any questions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BTL-899 device because it offers a new approach to improving musculoskeletal health. Unlike traditional treatments like physical therapy or medications, which often require ongoing sessions or prescriptions, BTL-899 delivers targeted electromagnetic therapy directly to the impaired area. This method can potentially enhance recovery by stimulating tissue repair and reducing inflammation more efficiently. The precision and non-invasive nature of this treatment make it a promising alternative for those seeking quicker and more effective relief from musculoskeletal issues.

What evidence suggests that the BTL-899 device is effective for musculoskeletal health?

Studies have shown that the BTL-899 device is effective and safe for non-invasive treatments. It has successfully reduced body fat and toned muscles, suggesting benefits for muscles and bones. The device uses high-intensity focused electromagnetic (HIFEM) technology to stimulate muscles and improve their function. This technology strengthens muscles and may enhance their feel and performance. While researchers continue to collect specific data on improvements to muscles and bones, the device's success in related areas is promising. Participants in this trial will receive four BTL-899 treatments applied to the impaired musculoskeletal area, either on the upper or lower extremity. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults who want to improve their musculoskeletal system. Specific eligibility criteria are not provided, but typically participants should not have conditions that the study excludes.

Inclusion Criteria

Women of child-bearing potential are required to use birth control measures during the whole duration of the study

Voluntarily signed an informed consent form

I am 22 years old or older.

Exclusion Criteria

Metal implants

Drug pumps

I have a cancerous tumor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline visit where subject's weight is recorded and the Western Ontario and McMaster Universities questionnaire is filled in

1 day

1 visit (in-person)

Treatment

Participants receive four BTL-899 treatments, each session lasting 30 minutes, delivered 5-10 days apart

4-6 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with satisfaction and physical function assessed at 1-month and 3-month follow-up visits

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BTL-899

Trial Overview

The BTL-899 device is being tested to see if it can enhance the musculoskeletal system in healthy volunteers. The study involves four treatments and two follow-up visits, with changes measured by a satisfaction questionnaire.

How Is the Trial Designed?

Group I: Treatment with BTL-899 Experimental Treatment 1 Intervention

Four (4) BTL-899 treatments will be applied to the impaired musculoskeletal area, either on the upper or lower extremity.

Who Is Running the Clinical Trial?

BTL Industries Ltd.

Lead Sponsor

Trials

59

Recruited

2,000+

Published Research Related to This Trial

The systematic review of 36 studies (4 in-field and 32 laboratory) on shoulder and back exoskeletons found that the most common side-effect reported was discomfort, affecting 30 participants, along with limited usability in 16 cases.

The review highlighted that many side-effects, such as changes in muscle activity and posture, were often due to incorrect fitting and reduced mobility of the exoskeletons, but overall evidence on adverse events is limited and primarily focused on short-term effects in young male workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side-effects and adverse events of a shoulder- and back-support exoskeleton in workers: A systematic review. Kranenborg, SE., Greve, C., Reneman, MF., et al.[2023]

The musculoskeletal Digital Assessment Routing Tool (DART) was successfully developed and tested with 22 adult participants, resolving all serious usability issues and achieving a high mean satisfaction score of 84.3, indicating it is user-friendly and effective for self-assessment in musculoskeletal disorders.

The study demonstrated that DART can provide immediate care recommendations without errors, paving the way for future randomized controlled trials to evaluate its safety and effectiveness compared to traditional care methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Testing of a Digital Assessment Routing Tool for Musculoskeletal Disorders: Iterative, Convergent Mixed Methods Study. Lowe, C., Browne, M., Marsh, W., et al.[2022]

Citations

1.

pubchem.ncbi.nlm.nih.gov

pubchem.ncbi.nlm.nih.gov/patent/US-12076576-B2

Methods and devices for aesthetic treatment of biological ...

... BTL 899 Powered Muscle Stimulator, dated Dec. 5, 2019, 11 pages. (APP,APP) ... Hirvonen, H.E., et al., “Effectiveness of Different Cryotherapies on Pain and ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04871503

Study Details | NCT04871503 | High-Intensity Focused ...

This study will evaluate the clinical efficacy and safety of the BTL-899 device for toning of buttocks. The study is a prospective multi-center open-label ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06677086

Study Details | NCT06677086 | HIFEM for Musculoskeletal ...

This study will evaluate the clinical efficacy and performance of the BTL-899 device for changes in the musculoskeletal system, specifically of the upper and ...

4.

withpower.com

withpower.com/trial/phase-musculoskeletal-diseases-4-2024-0543f

BTL-899 Device for Musculoskeletal Health

The goal of this clinical trial is to investigate the effect of the BTL-899 device on improving the Musculoskeletal System in healthy adult volunteers.

5.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf19/K192224.pdf

K192224 - David Chmel - accessdata.fda.gov

In conclusion, treatment with the BTL-899 device has shown to be both effective and safe for non-invasive lipolysis and circumference reduction ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf24/K240234.pdf

K240234 - David Chmel - accessdata.fda.gov

The BTL-899MS is a non-invasive, Class II powered muscle stimulator using electromagnetic energy for therapeutic purposes, with two applicators ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04643275?term=AREA%5BBasicSearch%5D(arm)&rank=8

Effect of BTL-899 Device for Non-invasive Lipolysis on ...

Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...