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.