BTL-899 Device for Musculoskeletal Health

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

36 Participants Needed

Trial Summary

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 data supports the effectiveness of the BTL-899 treatment for musculoskeletal health?

The research highlights the importance of integrated approaches for musculoskeletal health, such as combining therapies like exercise, acupuncture, and massage, which are similar to the components of the BTL-899 treatment. This suggests that BTL-899, which may incorporate similar principles, could be effective in improving musculoskeletal health. ^{1 2 3 4 5}

Is the BTL-899 device safe for human use?

There is no specific safety data available for the BTL-899 device in the provided research articles. ^{6 7 8 9 10}

How is the BTL-899 treatment different from other treatments for musculoskeletal health?

The BTL-899 device is unique because it is an on-body device designed to support and reduce the workload on muscles during lifting tasks, which can help prevent muscle fatigue and reduce the risk of injury. Unlike traditional treatments that may involve medication or physical therapy, this device provides mechanical assistance directly to the muscles, potentially offering immediate relief and support during physical activities. ^{11 12 13 14 15}

What is the purpose of this trial?

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. The main question it aims to answer is: Whether the BTL-899 device is able to change musculoskeletal system perception before and after treatment, based on the Subject Satisfaction questionnaire. Participants will complete four treatments, and two follow-up visits.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Integration of safety technologies into rheumatology and orthopedics practices: a randomized, controlled trial. [2008]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness evaluation of an integrated automatic thermomechanic massage system (SMATH® system) in non-specific sub-acute and chronic low back pain - a randomized double-blinded controlled trial, comparing SMATH therapy versus sham therapy: study protocol for a randomized controlled trial. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Usability Testing of a Digital Assessment Routing Tool for Musculoskeletal Disorders: Iterative, Convergent Mixed Methods Study. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Relationship between physical performance and self-reported function in healthy individuals across the lifespan. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

How to develop strategies for improving musculoskeletal health. [2007]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a Passive Back-Support Exoskeleton on Knee Joint Loading during Simulated Static Sorting and Dynamic Lifting Tasks. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Assessing the potential for "undesired" effects of passive back-support exoskeleton use during a simulated manual assembly task: Muscle activity, posture, balance, discomfort, and usability. [2021]

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

Side-effects and adverse events of a shoulder- and back-support exoskeleton in workers: A systematic review. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

[160 activities analyzed by the risk of biomechanical overload on the upper limbs in small industry, handicrafts, services and agriculture]. [2016]

10. England pubmed.ncbi.nlm.nih.gov

An ergonomic assessment tool for evaluating the effect of back exoskeletons on injury risk. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Soft pneumatic elbow exoskeleton reduces the muscle activity, metabolic cost and fatigue during holding and carrying of loads. [2021]

12. England pubmed.ncbi.nlm.nih.gov

The effect of on-body lift assistive device on the lumbar 3D dynamic moments and EMG during asymmetric freestyle lifting. [2008]

13. England pubmed.ncbi.nlm.nih.gov

An on-body personal lift augmentation device (PLAD) reduces EMG amplitude of erector spinae during lifting tasks. [2022]

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

Use of an In-Home Body Weight Support System by a Child With Spina Bifida. [2018]

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

Effects of Two Passive Back-Support Exoskeletons on Muscle Activity, Energy Expenditure, and Subjective Assessments During Repetitive Lifting. [2021]