Pilot Study to Assess the Efficacy and Safety of a Novel, Bioelectric Muscle Activation Device for Muscle Toning and Fat Reduction

October 2021 | Volume 20 | Issue 10 | Original Article | 1096 | Copyright © October 2021


Published online September 30, 2021

William LoVerme MDa, Glen Calderhead MSc PhDb

aNewton Wellesley Hospital, Wellesley, MA
bL’ACADEMIE Seoul, Korea

Abstract
Background and Aims: Stimulation of muscles for improved strength and tone has historically been achieved using electro-muscular stimulation. Discomfort often limited the amount of current applied thereby limiting efficacy. Lutronic’s Bioelectric Muscle Activation (BMA) system, (Accufit)TM, employs unique waveforms and proprietary electrodes to enable various muscle contractions while minimizing discomfort.
Subjects and Methods: Twenty-nine subjects were treated in an IRB-approved study to assess improvement in abdominal muscle strength, tone, and appearance following a regimen of four 30-minute treatments. Clinical photography, weight, abdominal circumference, and ultrasound images were recorded at baseline and 30 days post-final treatment.
Results: Twenty-nine subjects completed a subjective questionnaire. Of these subjects, 14 were very satisfied, 13 were satisfied, 1 was neutral, and 1 was dissatisfied. In addition, ninety-seven percent (97%) would recommend the treatment. A tingling sensation and pressure were commonly reported during treatment with minimal discomfort. Independent randomized expert photography grading correctly identified the treated versus the baseline images with a concordance rating of >90%. Ultrasound imaging showed an increase in abdominal muscle thickness with a decrease in the abdominal fat layer for most patients.
Conclusions: The data showed that the bioelectric muscle activation device produced an observable reduction in abdominal contour, which is consistent with ultrasound measurements and blinded expert grading. Based on the results of this pilot study, further studies with larger populations are warranted.

J Drugs Dermatol. 2021;20(10):1096-1104. doi:10.36849/JDD.0100

INTRODUCTION

When looking at the history of using electricity to stimulate muscles (ie, electric muscle stimulation [EMS] or electrostimulation), as with many other new medical and scientific concepts, we can infer there is nothing new under the sun. Ancient Egyptians had been treating pain by using fish that emitted electrical impulses over 2000 years ago. Documentation shows that fish (such as the electric torpedo ray) were used in the same way in Ancient Greece and Rome.1 Jumping forward to the 18th century, the Italian physician and scientist Luigi Galvani experimented on ‘bioelectricity’ in the use of electrical current applied to the spine to evoke muscle contractions in frogs’ legs.2 This then gave rise to the concept of galvanism (one fictitious product of which in the 19th century was Frankenstein’s monster [Frankenstein, Mary Shelley, 1818].) A technique developed in the early part of that century using electrostimulation therapy called Faradization successfully restored movement and function in patients with paralysis.3 Towards the latter part of the 19th century and into the 20th century, gradual acceptance of ‘electrostimulation therapy’ led to the development of specific devices very similar to our current concept of EMS (Figure 1). However, while these early EMS systems were effective, discomfort for the patient was reportedly very high. To bring us more up to date, following the success exhibited by Russian scientists in the use of direct EMS in muscle groups for their cosmonauts to counteract the weightless conditions encountered in orbit, Dr. Yakov Kots caught the attention of the sports medicine world by the success of the Russian athletes in the 1976 Montreal Olympics.