A Noninvasive Mechanical Treatment to Reduce the Visible Appearance of Cellulite

Methods

This study was conducted in accordance with the guidelines set forth by the US Department of Health and Human Services’ Policy for Protection of Human Research Subjects and the World Medical Association’s Declaration of Helsinki. Participants were recruited through local area medical facilities in southeastern Michigan. Written informed consent was obtained from all participants prior to beginning the study.

Patients with grades II to IV cellulite, according to the Rossi and Vergnanini⁶ grading system, were allowed to participate. All participants in the study were asked not to make lifestyle changes (eg, exercise habits, diet) or use any other treatments for cellulite that might be available to them during the study period. Exclusion criteria included history of deep vein thrombosis, cancer diagnosed within the last year, pregnancy, hemophilia, severe lymphedema, presence of a pacemaker, epilepsy, seizure disorder, or current use of anticoagulants. History of partial or total joint replacements, acute hernia, nonunited fractures, advanced arthritis, or detached retina also excluded participation in the study.

Participants completed an 8-week, twice-weekly treatment protocol with a noninvasive mechanical device performed in clinic. The device consisted of a 10.16-cm belt with a layer of nonslip material wrapped around the belt. The belt was attached to a mechanical oscillator. We adjusted the stroke length to approximately 2 cm and moved the dermis at that length at approximately 1000 strokes per minute.

Each participant was treated for a total treatment time of 18 to 24 minutes. The total treatment area included the top of the iliac crest to just above the top of the popliteal space. The width of the belt (10.16 cm) was equal to 1 individual treatment area. Each individual treatment area was treated for 2 minutes. First the buttocks and bilateral thighs were treated, followed by the right lateral thigh and the left lateral thigh. The belt was moved progressively down the total treatment area until all individual treatment areas were addressed. The average participant had 3 to 4 bilateral thigh and buttocks treatment areas and 3 to 4 lateral treatment areas on both the left and right sides of the body.

Digital photographs were taken with standardized lighting for all participants. Photographs were taken before the first treatment on the lateral and posterior aspects of the participant and were taken again at the end of the treatment program immediately before the last treatment. Participants were asked to contract the gluteal musculature for all photographs.

Two board-certified plastic surgeons were asked to rate the before/after photographs in a blinded manner. They graded each photograph on a rating scale of 0 to 10 (0=no cellulite; 10=worst possible cellulite). These data were analyzed using a Wilcoxon signed rank test. These data were compared to the participants self-evaluation of the appearance of cellulite in the photographs from the initial and final treatments using a rating scale of 0 to 10 (0=no cellulite; 10=worst possible cellulite).

The circumference of the widest part of the gluteal area was measured before and after treatment (+/–0.5 cm). The data were analyzed using a paired t test.

Results

The study included 43 participants (age range, 21–67 years; mean age, 37.6 years; weight range, 51–97 kg; mean weight, 64.95 kg) who resided in the Midwestern United States, were interested in reducing their cellulite, and were willing to commit to treatment 2 times weekly for the duration of the 8-week study. Fourteen percent (6/43) of participants were smokers. Participant self-assessments were divided into 3 categories based on the Rossi and Vergnanini⁶ grading system: category II, n=7; category III, n=12; and category IV, n=24. Although all the categories in our analysis showed statistically significant improvements, we found that there was more improvement in category II participants versus category III, and then again more improvement in category III versus category IV. The data for each treatment were analyzed separately using a paired t test, as we were not interested in comparing categories, only the effect of the treatment. We were testing to see if the difference was greater than 0, and the paired t values were statistically significant in all cases (category II, P=.003; category III, P=.001; category IV, P=.002)(Figure 1).

Figure 1. Mean participant self-assessment of cellulite before and after treatment (0=no cellulite; 10=worst possible cellulite).

Using a correlation analysis, we found that age, body weight, or body mass index were not significantly correlated with the difference between the before and after physician rating. The difference between before and after treatment also was independent of whether or not the participant exercised or had an adverse reaction to the belt. Adverse reactions to the belt were characterized by redness and/or minor raising of the skin immediately following the treatment. These reactions all dissipated within 12 hours. It also appeared that the rating scales correlated well with the participants self-perception of their cellulite and the improvements seen in the photographs (Figures 2 and 3).

Figure 2. The right lateral thigh and buttocks of a 41-year-old woman (weight, 75.5 kg; body mass index, 25.7; cellulite category IV) before (A) and after treatment (B)(cellulite category III).

Figure 3. Bilateral thighs and buttocks of a 27-year-old woman (weight, 72.6 kg; body mass index, 23.3; cellulite category IV) before (A) and after treatment (B)(cellulite category III).

Of the 2 blinded board-certified plastic surgeons, one physician rated all participants in category III as significantly improved (P<.05) and rated the other categories as marginally insignificantly improved; the second physician rated all categories as marginally insignificantly improved.