HIFEM for Musculoskeletal System Improvement

NCT06677086 | Completed FDA Device

• 1 other identifier: BTL-899_CTUS900
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Muscle Disorder; Musculoskeletal Diseases

Keywords

muscle; musculoskeletal system; extremities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of Treatment-related Adverse Events

  15 months

• Comfort Assessed by Therapy Comfort Questionnaire

  15 months

• Physical Function Assessed by the Western Ontario and McMaster Universities questionnaire.

  15 months

Study Arms (1)

Treatment with BTL-899

EXPERIMENTAL

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

Interventions

Treatment with BTL-899 DEVICE

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.

Treatment with BTL-899

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (3)

Trokhan Orthopaedics LLC

Closter, New Jersey, 07624, United States

Location

New York Orthopedic Hand Surgery

Brooklyn, New York, 11215, United States

Location

Southeast Texas Orthopedic Group

Houston, Texas, 77024, United States

Location

MeSH Terms

Conditions

Muscular Diseases; Musculoskeletal Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 6, 2024
• Study Start: May 8, 2024
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: June 8, 2025

Record last verified: 2024-12

Locations

US (3)