HIFEM and Radiofrequency for Muscular System Function Improvement

NCT06703749 | Active Not Recruiting FDA Device

• 1 other identifier: BTL-899_CTUS1100
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Muscle Damage; Muscle Strength; Muscle Weakness

Keywords

muscle; muscle impairment; lower extremities; muscle weakness

Outcome Measures

Primary Outcomes (1)

• % change from baseline in the muscle strength for the active group vs. sham group at 3 months.

  The evaluation of the percentual (%) change in muscle strength in the active group by evaluation of dynamometer score 3 months posttreatment compared to the sham group

  baseline and 3 months

Secondary Outcomes (3)

• Subject satisfaction as assessed by Subject Satisfaction Questionnaire at 3 months

  from the first therapy to the 3 months after the last treatment session

• Comfort as assessed by Therapy Comfort Questionnaire after the final treatment

  from the first to the last treatment session, assessed up to 40 days

• Incidence of Treatment-related Adverse Events

  from the first therapy to the end of subject's participation, assessed up to 5 months

Study Arms (2)

Treatment with BTL-899M

EXPERIMENTAL

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

Device: Treatment with BTL-899M

Treatment with BTL-899M with intensities below therapeutic threshold

PLACEBO COMPARATOR

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

Device: Treatment with BTL-899M with intensities below therapeutic threshold

Interventions

Treatment with BTL-899M 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

Treatment with BTL-899M with intensities below therapeutic threshold 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.

Treatment with BTL-899M with intensities below therapeutic threshold

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 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (3)

Royal Spine Surgery

Scottsdale, Arizona, 85260, United States

Location

The Longevity Lab

Greenwood Village, Colorado, 80111, United States

Location

Saville Spine Institute

Palm Beach Gardens, Florida, 33410, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 25, 2024
• Study Start: April 22, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

US (3)