Cellulite and focused extracorporeal shockwave therapy for non-invasive body contouring: a randomized trial

Abstract

Introduction: Focused extracorporeal shockwave therapy (ESWT) has been demonstrated to improve wound healing and skin regeneration such as in burn wounds and scars. We hypothesized that the combination of focused ESWT and a daily gluteal muscle strength program is superior to SHAM-ESWT and gluteal muscle strength training in moderate to severe cellulite.

Methods: This was a single-center, double-blinded, randomized-controlled trial. For allocation of participants, a 1:1 ratio randomization was performed using opaque envelopes for the concealment of allocation. Eligible patients were females aged 18-65 years with cellulite. The primary outcome parameter was the photo-numeric Cellulite Severity Scale (CSS) determined by two blinded, independent assessors. The intervention group (group A) received six sessions of focused ESWT (2,000 impulses, 0.35 mJ/mm(2), every 1-2 weeks) at both gluteal and thigh regions plus specific gluteal strength exercise training. The control group (group B) received six sessions of SHAM-ESWT plus specific gluteal strength exercise training.

Results: The CSS in group A was 10.9 ± 3.8 (mean ± SE) before intervention and 8.3 ± 4.1 after 12 weeks (P = 0.001, 2.53 improvement, 95% confidence interval (CI) 1.43-3.62). The CSS in group B was 10.0 ± 3.8 before intervention and 10.1 ± 3.8 after 12 weeks (P = 0.876, 95% CI 1.1-0.97). The change of the CSS in group A versus group B was significantly different (P = 0.001, -24.3 effect size, 95% CI -36.5 to -12.1).

Conclusion: The combination of non-invasive, focused ESWT (0.35 mJ/mm(2), 2,000 impulses, 6 sessions) in combination with gluteal strength training was superior to gluteal strength training and SHAM-ESWT in moderate to severe cellulite in terms of the CSS in a 3-month perspective. Long-term results have to be evaluated in terms of the sustainability of these effects.

Figures

Fig. 1

CONSORT patient flow chart. Modified with permission from Knobloch et al. [14]

Fig. 2

Placement of the shockwave probe from distal to proximal on both thighs

Fig. 3

First exercise (15 repetitions per leg twice a day over 12 weeks)

Fig. 4

Second exercise (15 repetitions per leg twice a day over 12 weeks)

Fig. 5

Improvement of the Cellulite Severity Score from 15 to 7 in a female patient suffering from cellulite before and 3 months after six sessions of focused extracorporeal shockwave therapy (0.35 mJ/mm2)

Fig. 6

Improvement of the Cellulite Severity Score from 12 to 2 in a female patient suffering from cellulite before and 3 months after six sessions of focused extracorporeal shockwave therapy (0.35 mJ/mm2)

Fig. 7

Improvement of the Cellulite Severity Score from 10 to 6 in a female patient suffering from cellulite before and 3 months after six sessions of focused extracorporeal shockwave therapy (0.35 mJ/mm2)

Fig. 8

No significant improvement of the Cellulite Severity Score from 13 to 11 in a female patient suffering from cellulite before and 3 months after six sessions of sham extracorporeal shockwave therapy (0.01 mJ/mm2, control group)

Fig. 9

No improvement of the Cellulite Severity Score from 4 to 5 in a female patient suffering from cellulite before and 3 months after six sessions of sham extracorporeal shockwave therapy (0.01 mJ/mm2, control group)

Fig. 10

Change of the Cellulite Severity Score before and 3 months after six sessions of either focused extracorporeal shockwave therapy (ESWT) (0.35 mJ/mm2, intervention group) or SHAM-ESWT (0.01 mJ/mm2, control group)