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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:Cellulite 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.Randomized-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.Intention-to-treat.a) 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.Six 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.12 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.This 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.

Project description:BackgroundExtracorporeal shock wave therapy (ESWT) has shown benefits in patients with nonunion or delayed bone healing, pseudarthrosis, and avascular necrosis of bone. Until now, these effects were explained by the release of growth factors, activation of cells, and microfractures occurring after ESWT. Microcirculation is an important factor in bone healing and may be compromised in fractured scaphoids because its blood supply comes from the distal end. Due to this perfusion pattern, the scaphoid bone is prone to nonunion after fracture. The ability of ESWT to enhance microcirculation parameters in soft tissue was of interest to determine if it improves microcirculation in the scaphoid.Questions/purposes(1) Does capillary blood flow increase after a single session of ESWT in the scaphoid? (2) Do oxygen saturation in the bone and postcapillary venous filling pressure increase after a single session of ESWT in the scaphoid?MethodsESWT (0.3 mJ/mm, 8Hz, 1000 impulses) was applied to the intact scaphoid of 20 volunteers who were without wrist pain and without any important metabolic disorders. Mean age was 43 ± 14 years, 12 men and eight women (40% of total). Volunteers were recruited from January 2017 to May 2017. No anesthetic was given before application of ESWT. An innovative probe designed for measurements in bone by compressing soft tissue and combining laser-Doppler flowmetry and spectrophotometry was used to noninvasively measure parameters of microcirculation in the scaphoid. Blood flow, oxygenation, and venous filling pressure were assessed before and at 1, 2, 3, 5, 10, 15, 20, 25, and 30 minutes after ESWT application. Room temperature, humidity, ambient light and measuring sequences were kept consistent. A paired t-test was performed to compare experimental data with baseline (p < 0.05 taken as significant).ResultsAt baseline, capillary blood flow of the bone was 108 ± 46 arbitrary units (AUs) (86 to 130). After treatment with ESWT, it was 129 ± 44 AUs (106 to 150; p = 0.011, percentage change of 19 %) at 1 minute, 138 ± 46 AUs (116 to 160; p = 0.002, percentage change of 28%) at 2 minutes, 146 ± 54 AUs (121 to 171; p = 0.002, percentage change of 35%) at 3 minutes and 150 ± 52 AUs (126 to 174; p < 0.001, percentage change of 39%) at 5 minutes. It remained elevated until the end of the measuring period at 30 minutes after treatment at 141 ± 42 AUs (121 to 161; p = 0.002) versus baseline). Oxygen saturation and postcapillary venous filling pressure in bone showed no change, with the numbers available.ConclusionsA single session of ESWT increased capillary blood flow in the scaphoid during measuring time of 30 minutes. Bone oxygenation and postcapillary venous filling pressure, however, did not change. Because increased oxygenation is needed for improved bone healing, it remains unclear if a sole increase in capillary blood flow can have clinical benefits. As the measuring period was limited to only 30 minutes, bone oxygenation and postcapillary filling pressure may subsequently show change only after the measuring-period ended.Clinical relevanceFurther studies need to evaluate if increased capillary blood flow can be sustained for longer periods and if bone oxygenation and postcapillary venous filling pressure remain unchanged even after prolonged or repetitive ESWT applications. Moreover, clinical studies must validate if increased microcirculation has a positive impact on bone healing and to determine if ESWT can be therapeutically useful on scaphoid fractures and nonunions.

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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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