NCT06677086

HIFEM for Musculoskeletal System Improvement

Effect of HIFEM Application on Musculoskeletal System: Evaluation of Musculoskeletal System Improvement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Muscle Disorder
• Musculoskeletal Diseases

Interventions

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

Timeline

• Start date: 2024-05-08
• Primary completion: 2025-01-22
• Completion: 2025-01-22
• First posted: 2024-11-06
• Last updated: 2025-06-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study