HIFEM for Musculoskeletal System Improvement

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

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Diseases; Muscle Disorder
• Intervention / Treatment: Device: Treatment with BTL-899

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Closter, New Jersey, United States, 07624
      • Trokhan Orthopaedics LLC
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Orthopedic Hand Surgery
  • Texas
    • Houston, Texas, United States, 77024
      • Southeast Texas Orthopedic Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with BTL-899; Four (4) BTL-899 treatments will be applied to the impaired musculoskeletal area, either on the upper or lower extremity.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Musculoskeletal System Perception	The evaluation of changes in musculoskeletal system perception before and after treatment will be based on the 5-point Likert Scale Subject Satisfaction questionnaire. Responses to questions about the treated musculoskeletal area will range from "strongly agree" (1 point) to "strongly disagree" (5 points). A higher score for each statement indicate better outcomes. The Subject Satisfaction Questionnaire will be administered after the final treatment, as well as at the 1-month and 3-month follow-up visits.	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-related Adverse Events	To evaluate the safety of the device and determine side effects and adverse events (AE) associated with the BTL-899 treatment of the musculoskeletal system through monitoring of adverse reactions and side effects.	15 months
Comfort Assessed by Therapy Comfort Questionnaire	Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. Therapy Comfort questionnaire consists of the question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree") and the 10-point Numeric Pain Rating Scale (0 = no pain, 10 = worst possible pain"). A higher score for the statement "I found the treatment comfortable", and lower score on the Numeric Pain Rating Scale indicate higher therapy comfort. The Therapy Comfort questionnaire will be given to subjects after the last treatment.	15 months
Physical Function Assessed by the Western Ontario and McMaster Universities questionnaire.	Changes in physical function post-treatment will be assessed using the Western Ontario and McMaster Universities (WOMAC) questionnaire. This 24-item questionnaire measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Improvement is considered a decrease in the obtained score. The questionnaire will be administered at the baseline visit, after the final treatment, and during both follow-up visits at 1 month and 3 months post-treatment.	15 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Actual): January 22, 2025
• Study Completion (Actual): January 22, 2025

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: muscle; extremities; musculoskeletal system
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Muscular Diseases; Musculoskeletal Diseases
• Other Study ID Numbers: BTL-899_CTUS900

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No