Clinical efficacy of Acoustic Wave Therapy and its effects on skin elasticity and cellulite

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1 Clinical Report Clinical efficacy of Acoustic Wave Therapy and its effects on skin elasticity and cellulite Background: The cellulite is a topographic skin change that occurs predominantly in female skin structure. The modification of skin topography is evident by skin dimpling and appears mainly on the pelvic region and lower limbs. The female skin is thinner, the orientation of collagen fibers is different to the male one and hormonal changes play an important role. Objective: The objective of this study was to evaluate the efficacy of BTL Acoustic Wave Therapy (BTL-6000 SWT) for the treatment of cellulite. Methods: The study was conducted on the group of 18 patients aged between 19 and 60. The recommended therapeutic protocol for cellulite treatment was performed by BTL Acoustic Wave Therapy (BTL-6000 SWT). The photographs of treated areas (the buttocks and the back thighs) together with the measurements of skin parameters were taken at each treatment, immediately after the last treatment and three months following the end of the entire protocol. The measurements of weight and BMI were taken at the same intervals and the changes in structure of connective tissue were documented using the DermaLab Elasticity system with embedded DermaLab Elasticity module. The improvement in cellulite appearance was rated by patients between 1 and 10 score (1 = no changes, 10 = the changes are visible to the naked eye) as a part of self-assessment questionnaires and was objectively evaluated by professionals through the blinded review procedure of standardized before and after photographs. Results: The group of patients demonstrated the substantial improvement in cellulite appearance. The results were confirmed by both patient survey including the self-assessments and the professionals evaluation comprising of the before and after photographs judgments based on blinded review procedure. The average skin evaluation score increased from 5.6 resp. 4.8 before the initial treatment to 8.6 resp. 7.1 at the follow-up appointment three months after the last treatment. The skin elasticity was increased by 73.6 % (3.9 MPa) from 5.3 MPa before the first treatment to 9.2 MPa in three months after the last treatment. The above numbers were supported by 89 % patients who would recommend this treatment to the others. Conclusion: The BTL Acoustic Wave Therapy (BTL SWT) significantly improves the cellulite appearance and represents an effective non-invasive method for the treatment of cellulite. The skin elasticity evaluation confirmed the improvement of monitored parameters and supported the blinded review judgments of taken before and after photographs. No side effects were reported over the course of treatments and the patient survey with its high satisfaction rate validated the success of this modern efficacious cellulite treatment. 1

Introduction The Appearance of Cellulite All skin tissue contains collagen and elastin fibers. The collagen is a fibrous protein that gives skin its specific structure and strength.

However, further to several hormonal processes occurring after puberty (increasing level of the estrogen hormones), if those compartments become over-full and rigid, the septae cannot keep the excess

2 Introduction The Appearance of Cellulite All skin tissue contains collagen and elastin fibers. The collagen is a fibrous protein that gives skin its specific structure and strength. That same collagen forms a series of fatstoring compartments (septae) within the skin which, when functioning normally, provide structural support and insulation [1, 2]. However, further to several hormonal processes occurring after puberty (increasing level of the estrogen hormones), if those compartments become over-full and rigid, the septae cannot keep the excess fat anymore. The septae bend or break and the fat bulges out towards the surface of the skin, developing non- esthetic lumps on the skin. Rapid weight loss and gain, poor hydration are also contributing factors while genetics are probably the most significant factor of all. The reason why cellulite occurs mostly in women (in men very rarely, approximately 3%) consist particularly in different volume and arrangement of the fat layer. The women s fat cells are larger and they are approximately twice more in comparison with men. They are located perpendicularly (Figure 1.) to the skin surface. Women have less firm connective tissue than men and their collagenous/elastic fibres are arranged collaterally (Figure 2.). When increasing their volume they can grow only upwards, which results in the occurrence of the mentioned unsightly dimples. In addition, women s sexual hormones oestrogen, progesterone and folliculin, cause physiological thinning and loosening of subcutaneous connective tissue. However natural weakening of connective tissue can cause the orange skin phenomenon [2, 3, 4]. Figure 1: Female skin structure Figure 2: Male skin structure Stage of Cellulite In this study the measurements of cellulite stage were taken using the Nürnberger- Müller scale (Figure 3.). The more detailed description of stages I, II and III is mentioned below, includes the main symptoms and is supplemented by the stage IV. This stage is no more a cosmetic but a health problem and therefore no patients with this stage of cellulite were included in the study [5]. Stage I. is perceptible only at the pinch test. There occur changes of the water management, sometimes also skin congestion. The symptoms are similar to those of the premenstrual syndrome, but without acne or feeling of tension in the chests and lower abdomen. Stage II. is characterized by the stagnation of blood in the venous system results in increased permeability of the inner lining (endothelium) of capillaries and consequent permeation of the plasma into the interstitial 2

3 tissue. The effect is uneven swelling of skin and lipedema (fat swelling). The orange skin is visible in harsh artificial light, at contraction of the muscle in the region in question, while sitting and standing. In lying position the relief smoothens and the unevenness disappears. The therapy in this stage is based especially on the recovery of microcirculation and prevention from further stagnation of blood and lymph in the vascular system. Stage III. is the next stage of the recurring or long-lasting untreated stage II, i.e. swelling. There occurs propagation of ligamentous fibres which surround and encapsulate the hypertrophied fat cells. The flow of lymph is significantly reduced, and shows drainage insufficiency. Unevenness dimples are visible both in the lying and standing positions. The skin is colder, sensitive or even painful to palpation. In this stage there may already occur damage of the connective tissue and it is necessary to prevent further (usually irreversible) damages. Stage IV. is the logical consequence of the untreated third stage. There occurs irreversible degeneration of fat cells and connective tissue. The skin is cold, hypertrophied, stretched and tough, in most affected areas it is painful even without a touch, hard lumps of a diameter up to 10 mm can be felt. Marked unevenness is visible to the naked eye under all conditions. This stage is accompanied with a higher risk of health complications, e.g. chronic skin inflammation [1, 6]. The previous scientific research has proven that acoustic waves stimulate microcirculation in the tissue. An accelerated blood flow and high vasomotor activity stimulate lipolysis, whereas a slower blood flow causes fat storage [7, 8, 9, 10]. Judging by recent findings, it is assumed that there must be some correlation between blood and lymph circulation on the one hand and the formation of fat tissue on the other hand. Slow circulation causes lipogenesis, whereas fast circulation stimulates lipolysis, i.e. fat breakdown. Methods and Study Design Acoustic Wave Therapy The acoustic waves are the shock waves that are characterized by a jump change in pressure, a high amplitude and nonperiodicity. They are capable of temporarily transmitting energy from the point of generation to remote regions to cause window panes to shatter, for instance [11]. In aesthetic medicine, the acoustic radial soft wave was successfully modified to the clinical needs of cellulite therapy. a lower energy level is used to avoid tissue damage. The waves are penetrating the tissue affecting a large treatment area penetrating the tissue affecting a large treatment area [12, 13]. Patient Group A total number of 18 female patients between the ages of with the body index (BMI) in range of kg/m 2, cellulite grade I III according to the Nürnberger- Müller scale were enrolled in this prospective single-centre study. Figure 3: Nürnberger-Müller scale of cellulite All patients gave informed consent with the treatment and the weight and BMI information. Every single patient received six treatments under recommended protocols at the intervals of 2 5 days and completed in three months. Four patients who failed to comply with the prescribed number of treatments were excluded from the study. 3

Figure 4: Graphic representation of the difference between waveforms of radial SWT and acoustic waves induced by BTL Acoustic Wave Therapy (BTL-6000 SWT) All included patients were treated on the

4 Figure 4: Graphic representation of the difference between waveforms of radial SWT and acoustic waves induced by BTL Acoustic Wave Therapy (BTL-6000 SWT) All included patients were treated on the buttocks [n= 14] and the back side of thighs [n=14]. The following exclusion criteria were respected: coagulation disorders, thrombosis, cardiovascular diseases, pacemaker, metal implants in the treated area, pregnancy / nursing, febrile conditions, tumour diseases, polyneuropathy, acute inflammations, local corticosteroid therapy and any sensation lost or irregularity in the treated area. Treatment The prescribed protocols were carried out by means of BTL Acoustic Wave Therapy (BTL SWT) using the compact technology for targeted and localised introduction of therapeutically effective energy into the body. The novel non-invasive technique is designed to avoid the damage to the patient s body surface. The kinetic energy of the projectile, created by compressed air, is transferred to the transmitter at the end of the applicator. The treatment session lasted on average fifteen minutes and consisted of two parts: Active and Support Phase. The number of acoustic shocks per patient and treated zone (approximate size of 400 cm 2 ) reached 6,000 pulses. All treatments were performed with the BTL focused massage transmitter on the regions of buttocks (see Figure 6, treatment zone 1, 2) and the back side of thighs (see Figure 7, treatment zone 3, 4). The preset parameters had started at an acoustic pressure of 3.5 Bar. Due to the very positive patients feedback the average pressure increased on 3.7 Bar. The value of patient tolerance varied according to the area of application. The application on the certain body zones such as head, myocardium, spinal cord, gonads, kidney, liver and above air-filled tissue (lungs), close to large nerve bundles or blood vessels was strictly forbidden. Figure 5: BTL Acoustic Wave (BTL-6000 SWT) applicator Figure 6: Treatment zones 4

5 Evaluation and Results The study involved 14 female patients who completed the entire treatment protocol and 4 other patients who had not finished the entire treatment protocol and were excluded from the study. The average age was 37 years (range 19-60). All patients included in the study finished six treatments over a period of three weeks and all of them closed the prescribed protocols within three months. The follow-up visits with the measurements and the data and photographs collection were done three months after the last treatment. During the entire therapy protocol the patients maintained their current lifestyle and did not change the nutrition and caloric intake or physical activity routines. Neither average weight loss nor the change of BMI average value was significant during the entire protocol. Skin Quality The standardized photographs were taken before and after the initial treatment, immediately after the last treatment and at the follow up appointment three months after the last treatment. All photographs were taken from both lateral and posterior view under the prescribed protocol including the preset values of the lighting, camera setting and its distance and the dark background. The medical professionals were given the before and after photographs to arbitrate the possible changes of skin elasticity, cellulite appearance and overall impression (1 = no changes, 10 = the changes are visible to the naked eye). The evaluation was performed according to the blinded review protocol in order to ensure the highest level of the objective results. The patients were asked to self-evaluate the skin quality (including the cellulite appearance) on this scale as a part of the patient questionnaire before the initial treatment, after completing all treatments and at follow-up appointment after three months. Before the initial treatment patients evaluated their skin quality at higher score 5.6 in comparison to the medical professionals (4.8). This trend was confirmed after the last treatment when the difference in evaluation between both groups increased by 1.2 to 7.5 (patients) and 6.3 (medical professionals). Three months after the course of treatment, the average self-evaluation score by patients improved to 8.6 and the medical professionals objectively assessed the average score improvement at 7.1. The difference in improvement evaluations was more significant in patient s self-assessments and increased by 53.6 %. Skin Elasticity Skin elasticity parameters were measured by means of the DermaLab Elasticity system. The measurements of treated skin were taken before the first treatment, after the last treatment and three months after the end of treatments. The DermaLab Elasticity probe creates distortion of the skin via suction. The probe and its negative pressure is used to lift the skin and the differential negative pressure needed to lift the skin creates the input to calculate the skin elasticity parameters. The average elasticity increased by 73.6 % from 5.3 MPa before the initial treatment to 9.2 MPa at the follow-up appointment in three months after the end of entire treatment. The substantial improvement in skin elasticity parameters were observed between the first measurement (5.3 MPa) and the measurement following immediately after the last treatment (8.1 MPa). This upward trend continued during the follow-up period and reached 9.2 MPa at the final appointment after three months. Overall Impression Regardless the age most patients stated that they were very pleased with the therapy (82 %) and highly appreciated the maximum level of comfort (85 %) and safety (94 %). More than 89 % of all patients would recommend this therapy to the others. Side effects No adverse effects were observed during the therapy. After two treatments the increased microcirculation was demonstrated through mild erythema in the area of application. This condition disappeared within 5 minutes after the end of treatment. 5

6 Conclusion The results and data evaluation indicate the benefits of the Acoustic Wave Therapy on cellulite and skin elasticity. BTL Acoustic Wave Therapy (BTL-6000 SWT) does stimulate regenerative processes in the dermal layers and initiate the significant changes in the skin structure that result in positive skin elasticity effects and improvement in cellulite. These effects occurred as a result of the therapy and were confirmed by both patients and medical professionals. Furthermore, all observed parameters affirmed the positive influence of the acoustic waves and its effects. BTL Acoustic Wave Therapy (BTL SWT) is therefore a safe and efficient non-invasive cellulite treatment with the high satisfaction rate. Nevertheless, the monitored parameters should be researched and analyzed in further studies with more participating subjects in order to confirm the positive results of this pilot study. References/Bibliography [1] Goldman P. M., Bacci A. P., Leibaschoff G., Hexsel D., Angelini F. Cellulite Pathophysiology and Treatment, New York, USA: Taylor&Francis, [2] Silbernagl S., Despopoulos A. Taschen der Physiologie, Stuttgart, Germany: Georg Thieme Verlag, [3] Voss W, Siebrecht S. Gesunde Haut, 1 st ed., Stuttgart, Germany: Trias Verlag, [4] Dini G., Ghersetich I., Grappone C., Lotti T. Proteoglycans in so-called cellulite. Int. J Dermatol, 1990, s [5] Nürnberger F., Müller G. So-called cellulite: an invented disease. J. Dermatol Surg Oncol, 1978, s [6] Gartner P. L., Hiatt L. J. Color Atlas of Histology. Lippincott Williams & Wilkins, [7] Christ C., Brenke R., Sattler G., Siems W., Novak P., and Daser A. Improvement in Skin Elasticity in the Treatment of Cellulite and Connective Tissue Weakness by Means of Extracorporeal Pulse Activation Therapy Aesthetic Surgery, Volume 28, [8] Siems W, Grune T, Voss P, Brenke R. Antifibrosclerotic effects of shock wave therapy in lipedema and cellulite. Biofactors [9] Johnson J. B., Use of Acoustic Wave Therapy (AWT) in the treatment of Cellulite. BioFactors, [10] Gabriel G., Christ C., Brenke R., Sattler G., Siems W. and Daser A. Boosting skin elasticity and revitalising the dermis in cellulite and connective tissue weakness by means of extracorporeal Acoustic Wave Therapy (AWT). Aesthetic Surgery, Volume 28, 2008, s [11] Wess O., Überle F., Durhben, r. n. Consensus reporting high energy shock waves in medicine. In: Chaussy, C., Eisenberger, F., Jocham, D., Gilbert, D.: High energy shock waves in medicine. Thieme, Stuttgart [12] Gilbert, D. M. a comparative review of extracorporal shock wave generation. BJU 6

7 International, 2002, s [13] Folberth W, Köhler G., Rohwedder, A., Matura, E.: Pressure distribution and energy flow in the focal region of two different electromagnetic shock wave sources. J. Stone Disease, 1992, s

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CELLACTOR SC1»ultra«AWT ACOUSTIC WAVE THERAPY

CELLACTOR SC1»ultra«AWT ACOUSTIC WAVE THERAPY Contents 02 l 03 Aesthetics with a fine medical tradition STORZ MEDICAL AG is a Swiss member company of the KARL STORZ Group, established in 1945. Our products