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Predictability of the individual clinical outcome of extracorporeal shock wave therapy for cellulite.

ABSTRACT: BACKGROUND:Extracorporeal shock wave therapy has been successfully introduced for the treatment of cellulite in recent years. However, it is still unknown whether the individual clinical outcome of cellulite treatment with extracorporeal shock wave therapy can be predicted by the patient's individual cellulite grade at baseline, individual patient age, body mass index (BMI), weight, and/or height. METHODS:Fourteen Caucasian females with cellulite were enrolled in a prospective, single-center, randomized, open-label Phase II study. The mean (± standard error of the mean) cellulite grade at baseline was 2.5±0.09 and mean BMI was 22.8±1.17. All patients were treated with radial extracorporeal shock waves using the Swiss DolorClast(®) device (Electro Medical Systems, S.A., Nyon, Switzerland). Patients were treated unilaterally with 2 weekly treatments for 4 weeks on a randomly selected side (left or right), totaling eight treatments on the selected side. Treatment was performed at 3.5-4.0 bar, with 15,000 impulses per session applied at 15 Hz. Impulses were homogeneously distributed over the posterior thigh and buttock area (resulting in 7,500 impulses per area). Treatment success was evaluated after the last treatment and 4 weeks later by clinical examination, photographic documentation, contact thermography, and patient satisfaction questionnaires. RESULTS:The mean cellulite grade improved from 2.5±0.09 at baseline to 1.57±0.18 after the last treatment (ie, mean ?-1 was 0.93 cellulite grades) and 1.68±0.16 at follow-up (ie, mean ?-2 was 0.82 cellulite grades). Compared with baseline, no patient's condition worsened, the treatment was well tolerated, and no unwanted side effects were observed. No statistically significant (ie, P<0.05) correlation was found between individual values for ?-1 and ?-2 and cellulite grade at baseline, BMI, weight, height, or age. CONCLUSION:Radial shock wave therapy is a safe and effective treatment option for cellulite. The individual clinical outcome cannot be predicted by the patient's individual cellulite grade at baseline, BMI, weight, height, or age.

SUBMITTER: Schlaudraff KU

PROVIDER: S-EPMC4043818 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Predictability of the individual clinical outcome of extracorporeal shock wave therapy for cellulite.

Schlaudraff Kai-Uwe KU Kiessling Maren C MC Császár Nikolaus Bm NB Schmitz Christoph C

Clinical, cosmetic and investigational dermatology 20140523

<h4>Background</h4>Extracorporeal shock wave therapy has been successfully introduced for the treatment of cellulite in recent years. However, it is still unknown whether the individual clinical outcome of cellulite treatment with extracorporeal shock wave therapy can be predicted by the patient's individual cellulite grade at baseline, individual patient age, body mass index (BMI), weight, and/or height.<h4>Methods</h4>Fourteen Caucasian females with cellulite were enrolled in a prospective, si ...[more]

PMID: 24920933

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Project description:BACKGROUND:Extracorporeal shock wave therapy (ESWT) has been used as a safe alternative treatment for refractory musculoskeletal diseases, such as plantar fasciitis, Achilles tendinopathy and gluteal tendinopathy, and various forms of fibromatosis including palmar or penile fibromatosis. However, there is limited published data for clinical and sonographic features of plantar fibromatosis after ESWT. The purpose of this study was to evaluate the long-term clinical outcome of ESWT in ultrasonography-confirmed plantar fibromatosis and ultrasonographic changes of plantar fibroma after ESWT. METHODS:Medical charts of 26 patients (30 feet) with plantar fibromatosis confirmed by ultrasonography were reviewed. Finally, a total of 10 feet who underwent ESWT for "Poor" or "Fair" grade of Roles-Maudsley Score (RMS) and symptoms persisted for >6 months were included in this study. Short-term follow-up was conducted one week after ESWT and long-term follow-up time averaged 34.0 months. The Numerical Rating Scale (NRS) and RMS were collected for the evaluation of clinical features. Follow-up ultrasonography was conducted at long-term follow-up and changes of plantar fibroma was assessed. A greater than 50% reduction in the NRS and achievement of a "good" or "excellent" grade in the RMS were regarded as treatment success. Additionally, medical charts of 144 patients (168 feet) with plantar fasciitis confirmed by ultrasonography were reviewed and subsequently, 42 feet who underwent ESWT with the same protocol were included for the comparison of clinical features. RESULTS:In plantar fibromatosis, baseline NRS (6.2 ± 1.3) and RMS (3.5 ± 0.5) were significantly improved at short-term follow-up (NRS, 1.8 ± 1.0; RMS, 2.0 ± 0.8, P < .001, respectively) and long-term follow-up (NRS, 0.6 ± 1.1; RMS, 1.4 ± 0.8, P < .001, respectively). Treatment success was recorded in seven feet (70.0%) at short-term follow-up and 8 feet (80%) at long-term follow-up, which is comparable to that of the plantar fasciitis group (28 feet, 66.7%; 35 feet, 83.3%, respectively). In long-term follow-up ultrasonography, mean fibroma thickness was reduced from 4.4±1.0 to 2.6±0.8 mm (P = .003); however, length and width were not significantly changed. There were no serious adverse effects. CONCLUSION:While these are preliminary findings, and must be confirmed in a randomized placebo control study, ESWT can have a beneficial long-term effect on pain relief and functional outcomes in painful plantar fibromatosis. However, ESWT is unlikely to affect the ultrasonographic morphology of plantar fibroma, with the exception of reducing the thickness. LEVEL OF EVIDENCE:Level III, retrospective cohort study.

Project description:BackgroundCellulite is a widespread problem involving females' buttocks and thighs based on the female specific anatomy. Given the higher number of fat cells stored in female fatty tissue in contrast to males, and the aging process of connective tissue leads to an imbalance between lipogenesis and lipolysis with subsequent large fat cells bulging the skin. In addition, microcirculatory changes have been suggested, however remain largely unknown in a controlled clinical setting. We hypothesize that the combination of extracorporeal shockwave and a daily gluteal muscle strength program is superior to the gluteal muscle strength program alone in cellulite.Methods/designStudy designRandomized-controlled trial. IRB approval was granted at Hannover Medical School, Germany on May 22, 2009. For allocation of participants, a 1:1 ratio randomization was performed using opaque envelopes for the concealment of allocation. Reporting: according to CONSORT 2010. Eligible patients were females aged 18 or over and 65 or younger with cellulite with documented cellulite 1°-4° according to the Nürnberger score. Exclusion criteria were suspected or evident pregnancy, no cellulite, no informed consent or age under 18 years or above 65 years. Patients were recruited by advertisements in local regional newspapers and via the Internet.AnalysisIntention-to-treat.Outcome parametersa) Photonumeric severity scale, b) Nürnberger Score, c) circumference measurements, d) capillary blood flow, e) tissue oxygen saturation, f) postcapillary venous blood flow. Intervention group: Six sessions of extracorporeal focused shock wave for six sessions (2000 impulses, 0,25 mJ/m2 every 1-2 weeks) at both gluteal and thigh regions plus a specific gluteal strength exercise training.Control groupSix sessions of sham extracorporeal focused shock wave for six sessions (2000 impulses, 0,01 mJ/m2 every 1-2 weeks) at both gluteal and thigh regions plus a specific gluteal strength exercise training.Follow-up12 weeks. Blinding was achieved for all participants enrolled in the trial, the photograph taking the digital images for the primary outcome measure, the two assessors of the outcome measures, all additional health care providers and for the analyst from the biometrical department. Only one researcher (BJ) was aware of the group assignment performing the randomisation and the extracorporeal shock wave therapy.DiscussionThis randomised-controlled trial will provide much needed evidence on the clinical effectiveness of focused extracorporal shock wave therapy as an adjunct to gluteal strength training in females suffering cellulite.

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Predictability of the individual clinical outcome of extracorporeal shock wave therapy for cellulite.

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Predictability of the individual clinical outcome of extracorporeal shock wave therapy for cellulite.

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