Clinical trial NCT06677086: HIFEM for Musculoskeletal System Improvement
Official title: Effect of HIFEM Application on Musculoskeletal System: Evaluation of Musculoskeletal System Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Disorder
Musculoskeletal Diseases
Keywords: muscle
musculoskeletal system
extremities
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-06
Enrollment: 36
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Musculoskeletal System Perception
timeFrame: 15 months
Secondary outcomes:
measure: Incidence of Treatment-related Adverse Events
timeFrame: 15 months
measure: Comfort Assessed by Therapy Comfort Questionnaire
timeFrame: 15 months
measure: Physical Function Assessed by the Western Ontario and McMaster Universities questionnaire.
timeFrame: 15 months
Other outcomes:
Locations:
city: Closter
country: United States
facility: Trokhan Orthopaedics LLC
state: New Jersey
city: Brooklyn
country: United States
facility: New York Orthopedic Hand Surgery
state: New York
city: Houston
country: United States
facility: Southeast Texas Orthopedic Group
state: Texas
Study officials:
References: