A 12‐Week, Prospective, Non‐Comparative, Non‐Randomized Study of Magnetic Muscle Stimulation for Improvement of Body Satisfaction With the Abdomen and Buttocks

• Published in: Lasers in surgery and medicine 2021-01, Vol.53 (1), p.79-88
• Main Authors: Fabi, Sabrina, Dover, Jeffrey S., Tanzi, Elizabeth, Bowes, Leyda E., Tsai Fu, Felicia, Odusan, Abi
• Format: Article
• Language: English
• Subjects: Abdomen; Adverse events; Body mass; Body mass index; Body size; Clinical Report; Clinical Reports; Contouring; Gluteal muscle toning; Lasers; Magnetic muscle stimulation; Magnetic studies; MMS, Abdominal muscle toning; Muscles; Non‐invasive body contouring; Questionnaires; Skeletal muscle; Stimulation; Surgery; Toning
• ISSN: 0196-8092; 1096-9101
• DOI: 10.1002/lsm.23348

Background and Objective Magnetic muscle stimulation (MMS) is a relatively new energy‐based technology that provides a non‐invasive option for body contouring through stimulation and toning of underlying skeletal muscles. This study was conducted to examine the safety, efficacy, and body satisfaction scores of MMS using a CoolToneTM prototype for the aesthetic improvement of abdominal and buttock contour. Study Design/Materials and Methods This was a prospective, non‐comparative, non‐randomized, 12‐week, multicenter study. Male and female participants aged 22‐65 years received 4 MMS treatment sessions to the abdomen and/or buttocks. Body Satisfaction Questionnaire (BSQ) scores for abdomen and/or buttocks were assessed at baseline, immediately post final treatment, at 4 weeks (primary endpoint), and 12 weeks post final treatment. Subject‐rated Global Aesthetic Improvement Scale (SGAIS) was assessed at 4 weeks post final treatment (secondary endpoint), and 12 weeks post final treatment. Additional efficacy assessment included abdominal circumference obtained by 3D imaging at baseline, immediately post final treatment, and at 4 and 12 weeks post final treatment. A Subject Experience Questionnaire (SEQ) was used to assess treatment satisfaction and perspectives at 4 weeks and 12 weeks post final treatment. Adverse events (AEs) were monitored throughout the study. Results A total of 110 participants were recruited, who were 75% female, 80% Caucasian (mostly non‐Hispanic), average age of 39.5 years (range 22–59) with an average body mass index (BMI) of 23.3 kg/m2 (range 18–29.9). At the 4‐week post final treatment visit, the average BSQ score for participants receiving abdominal treatment (n = 93) was significantly improved with a 5.1 average increase in total score from baseline (possible score range 10–50) and by a 5.5 average increase from baseline for participants receiving buttocks treatment (n = 32) (p “Improved” was 68.1% for participants receiving treatment of the abdomen (n = 94), and 81.8% for those receiving buttocks treatment (n = 33). The mean total decrease from baseline in waist circumference was significant at all time points. At the 12‐week post final treatment visit, SEQ data revealed that a majority of participants were “Satisfied” or “Very Satisfied” with overall treatment results and “Agreed” or “Strongly Agreed” that they were motivated to maintain r