HIFEM and Radiofrequency for Muscular System Function Improvement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-22

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HIFEM for Musculoskeletal System Improvement

NCT06677086

Muscle Disorder Musculoskeletal Diseases

COMPLETED NA

The Enhancement Effect of Low-Level Laser Therapy for Muscle Training with Combined NMES and BFR

NCT06739148

Blood Flow Restriction Therapy Neuromuscular Electrical Stimulation (NMES) Laser Therapy, Low-Level +1 more

RECRUITING NA

Evaluation of Thermal-Aided Muscle Stimulation

NCT01911312

Weakness Atrophy

UNKNOWN NA

High Tone Power Therapy on Lumbosacral Radiculopathy Patients

NCT07305792

Radiculopathy Lumbar

RECRUITING NA

High Frequency RF Current Effects on Muscle Pain and Function

NCT05345015

Transcutaneous Electric Nerve Stimulation Chronic Low-back Pain Hamstring Injury +3 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will evaluate the clinical efficacy and safety of the BTL-899M device for changes in muscular system function through muscle strength measurement by hand-held dynamometer. The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned to two groups - active and sham in a 3:1 ratio. All patients will be required to complete four (4) treatment visits receiving the treatment with the study device and two follow-up visits at 1 month and 3 months. The sham group will be treated with 5% of both energies only. 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. The device will induce visible muscle contractions along with heating by radiofrequency (RF). Each therapy session will last 30 minutes. At baseline, after the last treatment, and all follow-up visits, the strength measurement of the treated area will be performed by hand-held dynamometer in all subjects. At the last therapy visit, the patients will receive the Subject Satisfaction Questionnaire and Therapy Comfort Questionnaire to fill in. Subject satisfaction questionnaire will be given to the subjects at all follow-up visits. Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all follow-up visits. During the post-procedure visits (at 1-month and 3-month follow-up visits), all subjects will receive the Lifestyle Change Questionnaire to fill in.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Muscle Damage Muscle Strength Muscle Weakness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment with BTL-899M

Four (4) BTL-899M treatments will be applied to the lower extremities.

Group Type EXPERIMENTAL

Treatment with BTL-899M

Intervention Type DEVICE

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

Four (4) BTL-899M treatments will be applied to the lower extremities, with intensities below therapeutic threshold

Group Type PLACEBO_COMPARATOR

Treatment with BTL-899M with intensities below therapeutic threshold

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 the 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, and nursing
* Graves' disease

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes