HIFEM for Musculoskeletal System Improvement

BTL

Status: Completed

Conditions: Muscle Disorder; Musculoskeletal Diseases

Treatments: Device: Treatment with BTL-899

Study type: Interventional

Funder types: Industry

Identifiers

NCT06677086

BTL-899_CTUS900

Details and patient eligibility

About

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.

Full description

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 lower extremities. The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the study device.

At the baseline visit, the subject's weight will be recorded and subjects will fill in the Western Ontario and McMaster Universities questionnaire.

The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the designated area. Each therapy session will last 30 minutes.

At the last therapy visit, the subject's weight will be recorded. In addition, subjects will receive Therapy Comfort, Subject Satisfaction Questionnaire and Western Ontario and McMaster Universities questionnaire to fill in.

Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all of the follow-up visits.

During the post-procedure visits (at 1-month and 3-month follow-up visits), the subject's satisfaction, Western Ontario and McMaster Universities questionnaire, and weight will be recorded. In addition, subjects will receive a Lifestyle Change Questionnaire to fill in.

Enrollment: 36 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 22 years and older
• Voluntarily signed an informed consent form
• BMI ≤ 35 kg/m2
• Women of child-bearing potential* are required to use birth control measures during the whole duration of the study
• Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime and the study procedure for improvement of the musculoskeletal system
• Subjects willing and able to maintain their regular (pre-procedure) diet, exercise and therapy regimen without affecting significant change in either direction during study participation

Exclusion criteria

• Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
• Metal implants
• Drug pumps
• Malignant tumor
• Pulmonary insufficiency
• Application over muscles in acute phase of injury
• Cardiovascular diseases
• Disturbance of temperature or pain perception
• Hemorrhagic conditions, blood coagulation disorders or anticoagulation therapy.
• Septic conditions and empyema
• Acute inflammations
• Systemic or local infection such as osteomyelitis and tuberculosis
• Contagious skin disease
• Elevated body temperature
• Pregnancy, postpartum period, nursing, and menstruation
• A metal-containing intrauterine device (IUD)
• Graves' disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Treatment with BTL-899

Experimental group

Description:

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

Treatment:

Device: Treatment with BTL-899