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HIFEM and Radiofrequency for Muscular System Function Improvement
Sponsor: BTL Industries Ltd.
Summary
The goal of this clinical trial is to investigate the effect of the BTL-899M device on muscular system function in adult subjects seeking treatment for improving their muscular system function in the lower extremities. The main question it aims to answer is: Whether the BTL-899M device is effective for muscular system function improvement 3 months posttreatment compared to the sham group, based on the dynamometer measurement. Researchers will compare a sham group to see if the device is effective. Participants will complete four treatment visits and two follow-up visits. Their strength will be recorded via a dynamometer.
Official title: Simultaneous Application of HIFEM Procedure and Radiofrequency for Improvement of Muscular System Function
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2024-04-22
Completion Date
2025-06
Last Updated
2024-11-25
Healthy Volunteers
Yes
Interventions
Treatment with BTL-899M
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899M will be applied over the designated area. Each therapy session will last 30 minutes. The starting intensity of the radiofrequency energy will be set to 100%. The intensities of both energies will be adjusted according to the patient's feedback.
Treatment with BTL-899M with intensities below therapeutic threshold
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899M will be applied over the designated area. Each therapy session will last 30 minutes. The intensities of both energies will be set below the therapeutic threshold.
Locations (3)
Royal Spine Surgery
Scottsdale, Arizona, United States
The Longevity Lab
Greenwood Village, Colorado, United States
Saville Spine Institute
Palm Beach Gardens, Florida, United States