Open-label, baseline-controlled, multi-center study evaluating an electrical muscle stimulation system for circumferential reduction and muscle toning. The study will enroll up to 100 subjects desiring circumferential reduction and muscle toning. Each subject will receive up to 12 bi-weekly treatments over a 6-week period. Follow Up Visits planned for 2, 30- and 90-days post treatment. Measurement outcomes will be compared to baseline.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Magnet-based and Direct muscle stimulation devices are commonly used to generate current flow through the muscles in order to activate the muscle. The Accufit Electrical Muscle Stimulation device is an FDA cleared device having a two-channel stimulator that provides up to 8 electrodes with waveforms of interferential and biphasic for muscle stimulation. The Accufit system is indicated for relaxation of muscles, muscle re-education, reduction of pain and increased local blood circulation. Muscle stimulation technology has been around for many decades and has been shown to be safe and effective for a variety of clinical applications. The foundational basis for the technology revolves around electrical current flowing through the muscle can be used to activate the muscle.
Lutronic US Headquarters
Billerica, Massachusetts, United States
Union Square Dermatology
New York, New York, United States
Photographic Evaluation
Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at follow up visits (48 hours, 30 days, 90 days).Results will be reported as a % of the correctly identified post treatment photographs chosen per Blinded Reviewer. An average of the % of the correctly identified post treatment photographs chosen by Blinded Reviewer will be calculated and used to determine efficacy.
Time frame: Baseline, 48-hours post treatment, 30-day FU, 90-day FU
Circumferential Reduction
Reduction in circumference as measured by Seca Circumferential System at follow up visits compared to baseline measurement. Measurements were taken of the right and left arm in both a relaxed and engaged position.
Time frame: Baseline, 30-day FU, 90-day FU
Subject Satisfaction
Assess subject satisfaction using Satisfaction survey at each follow up visit. Scores available in the scale include the following: 1. \- Very Satisfied 2. \- Satisfied 3. \- Neutral 4. \- Dissatisfied
Time frame: 30-day FU, 90-day FU
Global Aesthetic Improvement Scale
A scale to assess the overall improvement in a subject's condition in an unblinded fashion. Choices on the scale include the following: 1. \- Very Much Improved 2. \- very Improved 3. \- Improved 4. \- No Change 5. \- Worsened
Time frame: 30-day FU, 90-day FU
Muscle Strength
Improvement in muscle strength of the treated extremity as measured by a dynamometer at follow up visits compared to baseline measurements. Subjects are asked to hold onto a handheld device which will then be used to measure the strength of the bicep and tricep muscles.
Time frame: Baseline, 30-day FU, 90-day FU
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