dermatological shock wave therapy – new ways...

STORZ MEDICAL DERMASELECT

Dermatological shock waves October 2005

1

– Dermatological shock wave therapy –

New ways to healthy skin

STORZ MEDICAL AG Unterseestrasse 47 · 8280 Kreuzlingen · Switzerland Tel. +41 (0)71 677 45 23 Fax +41 (0)71 677 45 04 E-mail [email protected]



2

Principle ___________________________________________________________________________ Shock waves are acoustic waves that are characterised by high pressure amplitudes. They are capable of temporarily transmitting energy from the point of generation to remote regions to cause window panes to shatter, for instance. At the end of the 1960s, the idea emerged to generate shock waves extracorporeally and to introduce them into the body for the contactless disintegration of kidney stones, for example. Today, medicine has at its disposal a compact technology designed for the targeted and localised introduction of therapeutically effective energy into the body by using a non-invasive technique to avoid damage to the patient's body surface.

Fig. 1) Time/pressure profile of a shock wave. The pressure increase time to peak pressure is only a few nanoseconds (ns). The peak pressures are about 10 - 150 megapascals (MPa). The pulse duration is about 500 ns. Medically used shock waves are generated extracorporeally and introduced into the body without causing skin lesions. In order to minimise reflection losses as the shock waves enter the body, shock waves must not be generated in air but in a medium whose acoustic properties are similar to those of the human tissue.



3

For this purpose, the DERMASELECT applicator is equipped with a coupling membrane which is applied to the skin of the female patient. In addition to this, ultrasound gel is applied to the applicator and skin to avoid energy loss through air inclusions.

Fig. 2) DERMASELECT applicator

Fig. 3) Application on thighs

Fig. 4) Application on upper arms



4

Shock waves versus ultrasound waves ___________________________________________________________________________ Despite their similarity to ultrasound waves, shock waves basically differ from ultrasound waves in terms of their pressure amplitudes. Ultrasound waves are stable periodic oscillations with constant bandwidth. Shock waves, on the other hand, are characterised by a single, mostly positive pressure pulse.

Fig. 5) Unlike shock waves, ultrasound waves are periodic oscillations of limited duration. Different properties produce different effects: Shock waves and ultrasound waves have different characteristic properties: Ultrasound waves penetrate the tissue with high-frequency alternating stress in the range of several megahertz, which may cause heat and tissue damage in case of high amplitudes. Shock waves transmit the pulse energy in homogeneous tissues, e.g. water, at a speed of 1500 m/s without causing tissue damage. If the tissue properties change, e.g. at boundary layers with muscles, bones or connective tissue, energy is released which can be increased to levels required for the disintegration of kidney stones. The different effects thus produced in the tissue may lead to a reversible deformation of cell membranes as a result of the mechanical force of the shock waves, for example, or stimulate healing processes thanks to the intensification of metabolic processes such as those observed primarily in orthopaedic applications.



5

Female fat tissue: the ideal "medium" for shock waves ___________________________________________________________________________ Fat tissue is composed of large, bubble-shaped, fat- filled cells that are surrounded by fine reticular fibres and organised into larger groups of cells called lobules by collagen and elastic fibres. Fat is either taken up from the blood by micropinocytosis or developed in the cell from carbohydrates. Initially, it consists of several drops which then flow together to form a single large fat cell.

Fig. 6) 1 = fat cell, 2 = blood capillary, 3 = fat cell nucleus The propagation speed of a shock wave in human fat tissue is almost the same as in water (1450 m/s = fat; 1500 m/s = water). The energy generated outside the body can be transported through the tissue without any significant loss and fully develop at the boundary layers.

Fig. 7) Propagation of shock wave by displacement of parts from their rest position



6

Aspects of microcirculation in tissue: the lymphatic system __________________________________________________________________________________ The human body has 600 to 700 lymph nodes. Most of them are found in the abdominal viscera region. However, many lymph nodes are also located in the head and neck region. Lymph nodes must be considered independent "organs", as pumping and cleaning stations for metabolic decomposition products, foreign particles and pathogenic agents. The lymph itself develops in the lymph capillaries of the tissue from interstitial fluid (tissue fluid from the interstitial tissue). The main task of the lymph vessels in the tissue is to return substances that make up the lymphatic load from the interstice into the venous system. These substances, which can only be removed through the lymphatic system, include proteins, fat and cells, for example. Water only acts as transport medium. These large molecules are transported by the lymph collectors, which are also referred to as "lymphatic hearts" because, similarly to the cardiac system, they pulsate at a frequency of 10 beats per minute via a proximal and distal valve.

Fig. 8) ©: Urban & Fischer Verlag, Földi, Stroessenreuther, Grundlagen der manuellen Lymphdrainage [Basics of manual lymph drainage] This lymphangion movement is driven by the pumping muscle action. Little muscle movement and large fat cells cause an increasing insufficiency of the lymphatic vascular system. In other words, the lymphatic load exceeds the transport capacity of the lymphangions. 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.



7

Cellulite – the visible fat deposits ___________________________________________________________________________ The combination of high-calorie diets, lack of exercise and hormonal effects causes most women to suffer from some kind of cellulite. In genetic terms, females have 21 to 22 billion fat cells, whereas males only have around 17 to 18 billion. This is due to the fact that the fat cells in females act as energy reserve during pregnancies. In addition to this, there is a sex-specific fat distribution within the organism: in females, the balance between lipogenesis and lipolysis is very much altered in favour of the former. Fat accumulates relentlessly on the thighs, buttocks, hips, abdomen and knees. One reason for this phenomenon is the density of lipolysis- inhibiting receptors in fat cells. The density of these receptors in the female subcutaneous fat tissue is much higher that the density of lipolysis-stimulating receptors. The well-known "orange peel" appearance of female skin is caused by the specific structure of the collagen fibre bundles: the fat cell chambers with the surrounding fibre bundles project straight upwards into the corium. If one pinches the skin between the thumb and index finger, these fat chambers curve upwards, thus forming bumps. The male subcutis, on the other hand, is held together by lattice-shaped tangential fibre bundles. The pinch test would merely reveal epidermal wrinkles and grooves.

a) b)

©STORZ MEDICAL AG, 2004 Fig. 9)

a) normal skin and subcutis: epidermis, epidermal ridges, epidermal papillae, superficial derma layer, arterial and venous loops of the subpapillary dermal plexus, lower corium layer, fat cells.

b) stage IV cellulite: epidermal indentations caused by the retraction of sclerotic connective tissue bundles of the derma; fat cells have formed macronodules which can be palpated as conglomerates.



8

Hypotheses on the efficacy of dermatological shock wave therapy ___________________________________________________________________________ Biological reactions at boundary layers Years of cellulite cause extreme insufficiency of the fat metabolism in the gluteal and thigh regions and lead to a high lymphatic load in the tissue. Intrinsic muscle contraction alone is no longer sufficient to guarantee an optimum blood/lymph exchange. The lymphatic vascular system is no longer able to take up sufficient protein molecules from the interstitial space and return them into the venous blood system. The high concentration of plasma proteins in the interstice causes fibrosing and hardening and thus alters the tissue properties. Fibrosing changes the acoustic impedance of the tissue, thus causing the boundary layer effect to release shock wave energy. Shock waves break up cell structures. The tissue becomes softer and more active. Stimulation of microcirculation: Shock wave research has proved for decades that shock waves stimulate microcirculation in tissue. Intrinsic movements of the smallest terminal vessels in the microvascular system are an elementary characteristic of microangiodynamics and allow the blood flow through the vascular bed to be regulated. An accelerated blood flow and high vasomotor activity stimulate lipolysis, whereas a slower blood flow causes fat storage. 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. Membrane permeability Shock waves produce a transient increase in the membrane permeability of cells without causing cell death. Fat tissue, in particular, consists of capillaries characterised by a higher permeability than plasma proteins and by low hydrostatic pressure. The capillary filtration coefficient is double the value of the resting skeletal muscle. Thanks to these conditions, fat can be broken down very rapidly and removed via the bloodstream. Application of shock waves renders the cell permeable not only to small molecules, but also to very large molecules with a molecular weight of several million daltons. The plasma protein exchange is thus improved, and the fat-splitting phospholipases on the fat cell membrane are activated.



9

Results of the pilot studies ___________________________________________________________________________ Study objectives:

- Increasing the firmness of the connective tissue in the gluteal- femoral region - Optical improvement of the skin texture in cellulite patients - Volume reduction - Tolerability of the new therapy method without side effects

Participating study centres / research institutes

1) Clinics ? LICCA Clinic, Augsburg, Germany Director: Dr. Popp ? Bodensee-Laserklinik,

Überlingen on Lake Constance, Germany Director: Dr. Braun ? Plastische Chirurgie am Utoquai, Zurich, Switzerland Director: Dr. Christ, Dr. Steiger ? Schlossparkklinik, Specialist Clinic for Aesthetic

Plastic Surgery, Ludwigsburg, Germany Director: Dr. Grübmeyer ? Hufeland Clinic, Specialist Clinic for Naturopathy,

Bad Ems, Germany Director: Dr. Brenke ? Eggbergklinik, Specialist Clinic for Lymphology,

Bad Säckingen, Germany Director: Dr. Hakuba 2) University research institutes ? Research Institute for Environmental Medicine

Heinrich Heine University Düsseldorf, Germany Molecular gerontology Düsseldorf, Germany Director: Dr. Grune

? University Clinic Essen

Centre for Internal Medicine Director: Dr. A. Gutersohn 3) Medical experts ? Priv. Doz. Dr. Dr. med. Werner Siems,

medical specialist in biochemistry Bad Harzburg, Germany ? Prof. C. Crifo, University of Rome La Sapienza Rome, Italy ? Prof. Dr. P. Eckl, University of Salzburg Salzburg, Austria ? Dr. med. Gerrit Schlippe, Dermatest Institut GmbH Münster, Germany



10

Patients ___________________________________________________________________________ So far, a total of 99 females aged between 20 and 66 have been treated. Exclusion criteria for study participation:

- serious renal or hepatic insufficiency - pregnancy / breast- feeding - phlebitis or deep venous thrombosis in leg - venous surgery on legs / sclerotherapy

General contraindications to shock wave therapy:

- serious cardiovascular disorders - pain regions tha t cannot be precisely localised - untreated bleeding diathesis or use of Marcumar - implanted cardiac pacemakers that are not approved for shock wave therapy - diabetes mellitus - arterial hypertension - pregnancy



11

Study design ___________________________________________________________________________ Treatment cycle: 3 weeks, 2 therapy sessions per week, i.e. 6 shock wave therapy sessions in total Observation period: December 2002 - July 2005 Applied shock waves: 1600 per leg Energy: maximum tolerated energy level Therapy region: lateral and medial thigh region

Fig. 10) Therapy regions: front and back 1st follow-up: 2 weeks after last shock wave therapy session 2nd follow-up: 3 months after last shock wave therapy session



12

Results ___________________________________________________________________________ 1. Epidermal improvement: Measuring method: 20 MHz sonography of cutaneous and subcutaneous dermis Scanning rate: 100.0 MHz

(Licca Clinic, Feb. 2003) Fig. 11) Sonography: prior to shock wave therapy

(Licca Clinic, March 2003) Fig. 12) Sonography: 3 weeks after 6th shock wave therapy session Explanation: The subcutaneous fat tissues appear as low-echo or echo-free zones on the sonographic image. The reflexogenic structures diagonal to the corium are connective tissue septa. The increased compactness of the structures after shock wave therapy shows the strengthened epidermal connective tissue.



13

Skin elasticity ___________________________________________________________________________ Therapy period: 3 weeks, 6 therapy sessions Observation period: 3 months Measuring method: DermaLab® (Cortex Technology) with elasticity module

0

2

4

6

8

10

12

14

16

Hau

tela

stiz

ität

in M

Pa

vorher nachher follow up Fig. 13) Utoquai Clinic results 2004; assessment by O. Kraut, STORZ MEDICAL AG, 2005 Skin elasticity improvements over the observation period: a) Therapy effect: before/after comparison (dermatological shock wave therapy) = 46.5 % b) Long-term effect of "before" and "follow-up" (after 3 months) conditions = 71.6 % In general, improvements in skin elasticity resulting from the use of chemical skin products (skin lotions, gels) range between 12 % and 25 % and may even reach just over 30 % in individual cases. The effects produced by an innovative gel (Pure Moisture nano-emulsion) developed by Sangui BioTech GmbH were also measured with the DermaLab® and revealed an improvement in skin elasticity by 40 % up to 50 % (5 female subjects). According to Dr. Voss (medical specialist in dermatology), Director of Dermatest GmbH, an improvement of over 40 % is to be considered a phenomenal result [see Sangui web site].



14

Lymph volume reduction ___________________________________________________________________________

Absolute volume reduction (ml)

6000.00

6500.00

7000.00

7500.00

8000.00

8500.00

9000.00

1 2 3 4 5 6 7

Oberservation weeksReduction: - 10.24%

Wo

lum

en (m

l)

Volumen-Mittelwerte Fig. 14)

The therapy success in terms of the lymph volume was much better during the summer than during the winter months. In fact, during the summer the total volume of the treated leg had decreased by 10.25 % after the three weeks' therapy, whereas during the winter the relative volume reduction in the treated leg was only 4 %. One of the reasons for the effectiveness of shock wave therapy is that the favourable ambient temperature of 34°C assists in reducing the lymph volume. In this temperature range, arteriolar muscles increasingly tend to contract, which means that the manual effect produced by the shock waves on the lymphangions stimulates a faster blood/lymph exchange. Influence on the biochemical processes in the tissue Leg circumference reduction:

Circumference reduction in cm

54

54.5

55

55.5

56

56.5

57

57.5

1 2 3

treatment weeks

cm

behandeltes Bein

Placebo Bein

Fig. 15) Circumference



15

Influence on the biochemical processes in the tissue ________________________________________________________________

1) Products of fat metabolism: lipid mobilisation The analysis of the blood serum of the female patients before and after the shock wave therapy and the comparison of the values with those of a healthy control group not subjected to shock wave treatment were key criteria for assessing the efficacy of dermatological shock wave therapy. In any cellulite therapy, lipid mobilisation, i.e. the question as to whether shock wave therapy is able to stimulate the breakdown of fat reserves, is of crucial importance. If fat reduction takes place in the tissue, this process involves the breakdown of fat into its constituents, i.e. free fatty acids (FFA), glycerol (GLY) and triglycerides. Blood samples were drawn both from the cubital vein and from a side-branch vein of the treated thigh (subcutaneous veins of the thigh drain almost exclusively subcutaneous tissue) immediately before and after the shock wave therapy. The measured lipids included the free fatty acids (mmol/l) and the glycerol (mg/dl). Result: fat mobilisation and lipolysis are significantly enhanced by shock wave therapy. FFA increase in lipedema patients: 0.15 mmol/l (before shock wave therapy)

0.41 mmol/l (after shock wave therapy) Glycerol increase: 1.16 mg/dl (before shock wave therapy)

1.80 mg/dl (after shock wave therapy)



16

Influence on the biochemical processes in the tissue

1) Reduction of oxidative stress: Years of cellulite along with severely adipose structures cause massive oxidative stress in

the tissue. This results in an increased formation of reactive oxygen species (ROS

formation) and in a high content of metabolic products of an accelerated lipid peroxidation

(LPO).

Acute effect:

In female lipedema patients, the acute effect produced by dermatological shock wave

therapy was a fast mobilisation of LPO products. This was revealed by the rapid increase

in the serum levels of malonic dialdehyde (MDA) and protein carbonyls. Shock wave

therapy removes a certain percentage of these radical metabolic products from the

lipedematous tissue. Medical experts refer to this phenomenon as antioxidative defence of

the edematous tissue.

0.000

0.200

0.400

0.600

0.800

1.000

1.200

1.400

1.600

Before After 1SWT After 6SWT Control

MD

A (

nm

ol/m

l p

lasm

a)

Fig. 16)



17

Serial effect:

A serial application of shock wave therapy leads to a reduction in the pathologically

increased MDA and protein carbonyl serum concentrations after an average therapy

period of only two weeks. This positive effect definitely reflects an improved tissue status.

Initial protein carbonyl values

0

10

20

30

40

50

60

pmol

/mg

Fig. 17)

For the first time ever, the increased plasma concentrations of protein carbonyls in

lipedema / cellulite were measured as part of the study.

Tissue status:

The significant reduction of the malonic dialdehyde content in the tissue (15 % reduction

of the initial value after 15 therapy days) also produced an improvement in the mechanical

skin properties, in particular in skin elasticity, of the cutis and subcutis.



18

Cosmetic results ___________________________________________________________________________ Fig. 18) Female patient aged 38, 67 kg extremely weak connective tissue – six therapy sessions –

before after Fig. 19) Female patient aged 36 weak connective tissue – six therapy sessions –

before after Fig. 20) Female patient aged 25, 81 kg. Uneven fat distribution with epidermal indentations – six therapy sessions –

before after



19

Indications __________________________________________________________________________________ Medical indications Study results so far suggest that dermatological shock wave therapy is effective in the following indications: ? Pathological alterations of the subcutaneous fat tissue in cellulite / lipedema

? Fibrotic tissue changes ? Lymphostatic indurations ? Prevention of vascular diseases ? Improved wound healing after liposuction ? accelerate wound healing e.g. Ulcus curis ? treatment of scars ? polyneuropathies (PNP) Cosmetic applications ? Cellulite ? Weak connective tissue ? Vascular training ? Cosmetic lymph drainage EPAT Indications: - activation of muscle- -and connective tissue - massage applications



20

Treatment recommendations ________________________________________________________________ After exclusion of contraindications, the following therapy approaches can be used in the treatment of the extremities: Basic conditions! 1) There should always be a one day break between the individual therapy sessions. This is crucial to ensure complete breakdown of the metabolic products in the treated tissue. 2) The energy level must be selected according to the patient's sensation of pain. The therapy should not cause any pain, but patients should still clearly feel the effects of shock wave application. Participants show a significant increase in sensitivity to shock wave application 2 to 3 days before their period. During these days, the shock wave energy level should be reduced. 3) A coupling gel (ultrasound gel) should always be used to couple the applicator to the body surface. The gel must be applied both to the applicator head and to the patient's skin to ensure optimum energy transmission. Therapy regions:

Fig. 21)



21

Treatment recommendations ________________________________________________________________ Standard treatment: for normal-weight to overweight subjects (BMI 25 - 28) Number of therapy sessions: 6 Therapy duration: 2 weeks Therapy sessions per week: 3 Applied shock waves: 800 per therapy region The therapy should be repeated after about 5 months. Connective tissue active programme: for subjects with age-related weak connective tissue (BMI 20 - 27) Number of therapy sessions: 3 Therapy duration: 1 week Applied shock waves: 500 - 600 per therapy region The improvement in skin elasticity lasts for about 6 months. Regeneration / cure programme: for normal-weight to overweight subjects (BMI 25 - 30) Number of therapy sessions: 8 Therapy duration: 2 x 2 weeks Therapy sessions during first 2 weeks: 4 Two weeks' interval Therapy sessions during last 2 weeks: 4 Applied shock waves: 800 per therapy region The regeneration programme therapy should be performed twice a year.



22

Side effects __________________________________________________________________________________ None of the patients suffered any clinically relevant side effects. Observations:

1) Slight skin reddening may appear in the therapy region during and shortly after the treatment. Reason: strong stimulation of the blood circulation as a result of shock wave application.

2) Most subjects reported that the first shock wave application had seemed more intense than the

following sessions. Reason: the tissue gets used to the intensity of the stimulus. 3) Cramps after shock wave application. Reason: the released metabolic products may influence

the biochemical potential of the muscles. 4) Nausea after shock wave application. Reason: overstimulation of sympathetic nervous fibres

by shock wave application.



23

Patient satisfaction __________________________________________________________________________________ The female patients were asked to complete a questionnaire to specify their subjective satisfaction with the shock wave therapy: Have you perceived any changes in your legs after completion of shock wave therapy?

0 5 10 15 20

Hautoberfläche glatter

Hautfarbe verändert

Bein straffer geworden

Abnahme d. Umfang ( z.B. in derHose)

Nein

Ja

Fig. 23) Results of the pilot study conducted in Überlingen Results of the pilot study conducted in Überlingen Would you recommend this therapy method to others?

0

5

10

15

20

25

Ja Nein Vielleicht

Ja

Nein

Vielleicht

Fig. 24) Results of the pilot study conducted in Überlingen



24

Literature __________________________________________________________________________________

(1) Thoma H. : Lymphologica, Jahresband 1996, Stroessenreuther, Roman: Physikalische Massnahmen bei Venenerkrankungen.

- (2) R.H:K. Stroessenreuther:“Lipödem und Cellulitis sowie andere Erkrankungen des Fettgewebes“, Viavital Verlag 2001.

- (3) Paukstadt W.: Orangenhaut sorgt für ein Milliardengeschäft“, MMW-Fortsch.Med.4 (2001) 4-6.

- (4) Curri S.B., Gernandez G.:“Venous stasis and panniculopathy: a semilogic study study”. Angiologia 42 (1990), 127-132.

- (5) Horst Weissleder und Christian Schuchhardt: “Erkrankungen des Lymphgefässystems”, Viavital Verlag, 2000.

- (6) M.Földi/F.Tischendorf: “Lipödem und Zellulitis“ ein Symposium, Medizinischer Verlag Erdmann-Brenger, München, 1988.

- (7) M.Földi/ R. Stroessenreuther: „Grundlagen der manuellen Lymphdrainage“, 3.Auflage, Urban&Fischer 2003

- (8) Dini G.,Ghersetich, I., Grappone C. Lotti T.: Proteoglycans in so-called cellulite. International Journal Dermatology 20 (1990), 272-274

- (9) O. Wess, STORZ MEDICAL AG, Kreuzlingen, in J Mineral- Stoffwechs. 2004,;11(4): 7-8.

- (10) Stiftung Warentest „Es bleibt nur der Traum“, Cellulitemittel und Gerät, Test April 2003.

- (11) Beauty & Aesthetic, 3/2004; Ebner Verlag Ulm, Seite 40 u. 41.; Methoden der Apparativen Kosmetik im Überblick.

- (12) Gambihler S., Delius M, Ellwart JW. Transient increase in membrane permeability of L1210 cells upon exposure to lithotripter shock waves in vitro. Naturwissenschaften 79: 328-29, 1992.

- (13) Gambihler S. Delius M, Ellwart JW. Permeabilization of the plasma membrane of L1210 mouse leukaemia cells using lithotripter shock waves. J. Membr. Biol. 141:267:275, 1994.

- (14) H. Lohse-Busch, M. Kraemer, U. Reime, “Pilotuntersuchung zur Wirkung von niedrigenergetischen, extrakorporalen Stosswellen auf Muskelfunktionsstörungen bei spastischen Bewegungsstörungen von Kindern, Springer-Verlag 1997, Der Schmerz,2,: S.108-112.

- (15) C.E. Bachmann; „ESWT und Sonographie der Stütz- und Bewegungsorgane“, Steinkopf Verlag Darmstadt, 1999, Seite 4

- (16) Loew M, Jurgowski W., Thomsen M. “Die Wirkung extrakorporaler Stosswellen auf die Tendinosis calcarea der Schulter“, Der Urologe (A), 1995; S.34-49.

- (17) Dahmen GP, Haupt G, Haist J, Loew M, Rompe JD, Schleberger, „Die Stosswelle -Forschung und Klinik“ Attempo Verlag, Tübingen 1995.

- (18) Forssman B, Hepp W., „Stosswellen in der Medizin“, Medizin in unserer Zeit 1980.

- (19) Thoma H. Lymphologica, Jahresband 1996; Stroessenreuther, R.H.K. Physikalische Massnahmen bei Venenerkrankungen, Lymphologica, Jahresband 1996).

- (20) W. Voss, S. Siebrecht, R.Jermann; „Gesunde Haut“, Trias Verlag Stuttgart, 2005

- (21) Ästhetische Dermatologie, MDM Verlag, Heft 4/2005, „Effekte der Stosswellentherapie bei pathologischen Veränderungen des subkutanen Fettgewebes. Eine Pilotstudie“.

dermatological shock wave therapy – new ways...

Documents