2. Authors: Dr. med. Hans-Ulrich May Facharzt für Neurologie und Psychiatrie Neurologist & Psychiatrist Albert-Einstein-Straße 1 D - 75015 Bretten Dr. med. Eckhard Rhades Facharzt für OrthopädieOrthopedist Königstraße 3-7 D - 32545 Bad Oeynhausen Prof. Dr. Berthold Schneider Institut für BiometrieInstitute for Biometry Medizinische Hochschule HannoverMedical University Carl-Neuberg-Straße 1Hannover D - 30625 Hannover

3. 0. Summary 0.1.Background In this presentation I will begin with the explanation of the reasons for the decision for the development of a new sophisticated method within the physical therapy, described as “electrical high tone frequency alternating field therapy”, abbreviated in German “Hochtontherapie”, in English “high tone therapy”, in Polish “terapia energotonowa”, that means “energy tone therapy”. The new method has been realised in Germany by gbo. The result is the equipment HiToP ® (High Tone Power Therapy). The study of RHADES & SCHNEIDER were carried out to examine the efficacy of HiToP ® in patients with painful conditions of the musculo-skeletal system.

4. 0.2. Material and methods of the clinical study In 48 patients 94 “organs” or parts of the body respectively had been treated, 9 vertebral columns in general, 18 patients with low back pain, 12 shoulder- joints, 22 hip- joints and 33 knee-joints. All patients received local and whole-body treatments simultaneously. All patients received10 treatments. The duration of one treatment was one hour. Parameters for the judgement were the scaled estimation of pain, range of motion, measurements of circumferences and results of joint-specific tests. Measurements and judgements were carried out by the doctor and/or the patients and statistically evaluated.

5. 0.3 Results and valuation The evidence for the efficacy of HiToP-treatments can be exposed as in many cases statistically high significant.

6. 1. Introduction and Questions High tone therapy is a purposeful new development in the field of electrotherapy. It appears with the pretension to realise all effects known and expected from the traditional low and middle frequency therapy with higher efficacy. Including ranges of frequencies never used until now and introducing the simultaneous modulation of frequency and amplitude a completely novel method of electrotherapy has been created. Important aspects of this innovative creation were to optimise the therapeutically width and to take more into account the very interesting non-stimulatory effects. Several clinical investigations published recently (2002, 2003 and 2004) in Poland confirm the expectations concerning the efficiency of high tone therapy in various injuries and/or diseases.

7. To understand correctly and completely the position of the high tone therapy within the electrotherapy it is required to be well acquainted with some terms of the fields of physiology, related disciplines and physical therapy. However, neither all medical doctors nor all physical therapists have been sufficiently educated during their specific education's in both disciplines, or may be they have forgotten some details. Therefore I will try to repeat, to explain and to comment some of the most important terms and facts.

8. 1.1. Terms: 1.1.1. The term “High tone therapy” This term, abbreviated from “electrical high tone frequency alternating field therapy” was proposed by medical doctors just after the introduction of the first generation of high tone therapy units

9. 1.1.2. High tone therapy High tone therapy is a purposeful new development in the field of electrotherapy, basing on the principles of the electric differential therapy (HANSJÜRGENS & MAY, 1990). By means of simultaneous modulation of frequency and amplitude (SimulFAM ® ), either a) along the threshold graph after it’s individual determination (SimulFAMi) or b) with crossing of this threshold graph with adjustable crossing angles (SimulFAMx) it is possible to generate alternatively either a) selectively non-stimulatory effects or b) non-stimulatory effects in combination with stimulatory effects.

10. The modulation of frequency happens between two corner frequencies, 2 12 Hz and 2 15 Hz. The duration of one period of the “slow” threshold-adapted modulation of frequency and amplitude, SimulFAMi, is 144 s (2 min 24 s). Frequency and amplitude will be changed all the time stepwise periodically in the same direction, either both upstairs or both downstairs. The frequency of the “fast” simultaneous modulation of frequency and amplitude (SimulFAMx) can be varied between 0,1 Hz and 200 Hz. In this case frequency and amplitude can be changed periodically quickly either in the opposite direction or in the same direction (upstairs or downstairs). Opposite changes lead to more or less brusque stimulation, corresponding changes lead to softer stimulation (paradoxical stimulation).

11. 1.1.2.1. The aim of the development of the high tone therapy The aim of this development was, to intensify and to combine already known effects of the especially well tolerable currents, the so called middle frequency currents. Moreover, the equipment should indicate not only the current intensity (amperage) in mA as a singular quantitative parameter of the applied electricity: Now additionally will be indicated the voltage in V, the power in mW, the impedance in  and the sum of the applied electrical energy in mWh. Until now no other electrotherapy equipment offers such completeness of indication of important electric parameters.

12. The most important fundamental facts for the purposeful development of the high tone therapy equipment are originated from the publications of the physiologists Martin GILDEMEISTER (Straßburg, Leipzig), Friedrich SCHWARZ (Leipzig, Posen, Jena), Oscar A. M. WYSS (Zürich), and of a pioneer of physical medicine, Siegfried KOEPPEN (Halle, Wolfsburg), furthermore from the electrotoxicological investigations of GEDDES and co-workers (1969). KOEPPEN already 1935 introduced the term “Tonfrequenzströme”, English “tone frequency currents”, GILDEMEISTER 1944 the term “Mittelfrequenzströme”, English “middle frequency currents, defined as alternating currents with frequencies between ca. 1000 Hz and 100 kHz.

13. Monographs of WYSS (1975) and of his pupil SENN (1980) contain comprehensive descriptions of the history and the peculiarities of the middle frequency currents. However, the descriptions of the pain relieving effects of unmodulated and modulated middle frequency currents are incomplete. The possibilities to use either the blocking or pseudo-blocking effects of unmodulated middle frequency currents or the counter-irritation principle (GAMMON & STARR 1941), caused by the low frequency effects of modulated middle frequency currents have not been mentioned. On the other hand, just the pain relieving effect by means of unmodulated middle frequency currents can be easily explained by the results of neurophysiological investigations of WYSS and his pupils, for instance the “reversible reactive partial depolarisation”, with other words the “plateau effect” (KUMAZAWA & WYSS 1966). These results, gained by means of intracellular recordings, could be confirmed later by extracellular recordings (BOWMAN 1981).

14. The cited publications reveal 1.) that the local and systemic tolerability of alternating currents above 50 Hz is increasing with increasing frequencies and accordingly the possibility of incoupling of electric power into the body is increasing too with increasing frequencies – without any local discomfort and without any risks for the heart, 2.) that these currents, named “(high) tone frequency currents” or “middle frequency currents” have particular advantageous qualities in comparison to the traditional low frequency currents and direct current.

15. The frequency-correlated increase of the threshold of afferent fibres of the sensory nervous system is also valid for the motor fibres innervating the striated muscles (DALZIEL, 1941-1973), and we can assume for the sympathetic fibres responsible for the smooth muscles of the vasculature as well. Originally, interferential therapy was introduced by Hans NEMEC (1947/1950-1960) with the aim to make the stimulating (stimulatory) effects of traditional electrotherapy more comfortable: two unmodulated middle frequency currents with slightly different frequencies should be superimposed within the tissue to generate interferential beats, a special kind of amplitude modulation. The low frequency of beat generation or amplitude modulation respectively determines the frequency of the neuronal responses, that means the frequency of action potentials. Therefore, the differences between the two middle frequencies have to be within the low frequency range, that means mostly between > 0 Hz and 100 Hz.

16. In comparison to the interferential therapy and later introduced other modifications of middle frequency therapy for the development of high tone therapy (MAY, 2002) higher frequencies and greater frequency ranges are included: Interferential therapy mostly is using middle frequencies around 4000 Hz, in some equipment moderately higher frequencies but below 10000 Hz. However, the newest version of high tone therapy equipment, more exactly “high tone power therapy” equipment, HiToP ®, are able to generate frequencies up to 2 15 Hz (32768 Hz), and between 2 12 Hz (4096 Hz) and 2 15 Hz 73 different frequencies are available. In comparison to NEMEC’s interferential therapy the highest frequency in HiToP ® equipment is more than eight times higher, and the range of frequency modulation is more than 286 times higher: 28672 Hz in comparison to 100 Hz.

17. For therapeutic purposes mostly the mentioned 73 frequencies in logarithmic steps between 2 12 Hz and 2 15 Hz are used. The factor is 2 -24 corresponding a little bit less than 1,03. Because of the great distance between the lower and the upper corner frequency linear steps were not suitable. The “distances” between the neighbouring frequencies of tones in our music are defined too as logarithmic steps. The factor for the elevation in half tone steps is 2 -12.

18. The decision for the term “high tone frequency therapy”, abbreviated “high tone therapy”, derived from relations to tones or music respectively, resulted from the following considerations: 1.) The term “high tone frequency” is more concrete than “middle frequency”. The high tone frequency range (~ 1000 - 20 000 Hz) covers the low middle frequency range. 2.) The frequencies of the first generation of equipment varied in the high tone frequency range only. The new generation, HiToP ®, includes even frequencies of the ultrasound range. Nevertheless, the introduced term has not been changed besides in Poland; there the term “energy tone therapy” is preferred. Both terms are ingenious: “high” characterises the means, namely the high tone frequencies as the agens for the possibility for an easier application of more energy, “energy” this purpose itself. 3.) The distances between the frequency steps correspond to distances of quarter tone steps in music.

19. 4.) By means of frequency scanning the probability of resonance phenomena within structures of the treated tissue should be increased. Resonance plays an im- portant part in music too. 5.) The new term should emphasise the great difference to traditional middle frequency units. 6.) It is possible and useful to explain the modes of action of HiToP ® by an loud-speaker. It facilitates the understanding of the physical realisation of the various “programs”, SimulFAMi and the variations of SimulFAMx using modulation frequencies between 0.1 and 200 Hz. The demonstration of hearing emphasises the relation to tones and the absence of similarity to a “current” as a great river.”

20. 1.1.2.2. Main differences between traditional electrotherapy and high tone power therapy (HiToP ® ) 1. Main differences in comparison to direct current (DC) and low frequency currents with DC-components: HiToP is without any risks of DC as chemical burning caused by electrolysis. Vasodilatation and acceleration of reabsorption of topically applied substances in the treatment area, known as DC- iontophoresis, can be achieved by HiToP too, but by other mechanisms: vasodilatation via fatiguing stimulatory effects upon sympathetic fibres, and the acceleration of resorption via an electrochemical shaking effect resulting in facilitation of diffusion.

21. 2. Main differences in comparison to low frequency currents: HiToP has important advantages: Great superiority concerning local and systemic tolerance, very much greater spectrum of effects by additional sophisticated utilisation of non-stimulatory effects. 3. Main differences in comparison to traditional middle frequency equipment: The most important difference or advantage respectively is basing on the ability of HiToP to generate very much (up to circa 50 times) more power without any discomfort or systemic risks for the patient in comparison to traditional middle frequency equipment. HiToP offers 5000 mW as maximum output per channel; this limit of the output is prescribed by law.

22. Additional advantageous differences: The greater frequency range increases the probability of resonance. SimulFAMx, used for stimulation of nerves including motor and sympathetic fibres, can be adjusted as more brusque (“combined” or “parallel” stimulation) or more soft (“paradoxical” stimulation) according the slope of the graph representing the simultaneous modulation of frequency and amplitude. SimulFAMi can be used to minimise or avoid stimulatory effects

23. Threshold graph of the current sensation Threshold curve Threshold current mA (eff) Frequency in Hz

24. Threshold Curve Sensation threshould beim Menschen in Abhängigkeit der frequency Horizontal stimulation. Vertical stimulation. Threshold curve as a function of frequency Threshold Frequency Intensity

25. Threshold Curve SimulFAM ® i

36. Frequency SimulFAMi Intensity f min f max

37. Threshold Curve SimulFAM ® i Frequency SimulFAMi Intensity f min f max 3 octaves in 72 steps of 1/4 tones 1 second each

38. SimulFAM ® X Frequenz SimulFAM X I n t e n s i t ä t f min f max

39. SimulFAM ® X

53. Advantages of SimulFAM ® X

56. Balanced relation between the phases above threshold and below threshold

57. Advantages of SimulFAM ® X Sensitive patient

58. Advantages of SimulFAM ® X

59. Now I fmax can be adjusted via the modification knob as x% of I fmin. I fmax

60. Advantages of SimulFAM ® X Now I fmax can be adjusted via the modification knob as x% of I fmin.

61. “Paradoxical” Stimulation via SimulFAM ® X Now I fmax can be adjusted via the modification knob as x% of I fmin.

62. “Paradoxical” Stimulation via SimulFAM ® X Now I fmax can be adjusted via the modification knob as x% of I fmin until the patient has the maximum comfort

63. The recommended whole body treatment carried out besides the topic application has not only general effects upon the mood and the general condition of the patient; moreover, the superposition of the alternating electric fields of the general treatment and the topical treatment causes periodical changes of the directions of the vectors of the local electric fields responsible for the electrochemical shaking effect. This kind of interference is used for the support of non-stimulatory effects and not for the generation of stimulatory effects, realised in traditional interferential current units, invented by NEMEC. HiToP allows the use of more than two electrodes per channel. The purpose is to compensate the different sensitivities of different body regions or to concentrate the effects in particular areas respectively. Moreover, it is possible to treat two different body regions in the same time using only one channel

64. 1.1.3. Electric differential therapy Electric differential therapy (MAY & HANSJÜRGENS, 1988; HANSJÜRGENS & MAY, 1990) can be considered as a principle to classify currents used in electrotherapy and as a principle to select the most suitable kind of current for the pathological condition or symptom just to be treated. For the selection of the best suitable current is decisive – like in pharmacology – the best relation between efficacy and tolerability, in other words: the therapeutic width.

65. 1.1.4. Tolerance We have to distinguish between local and systemic tolerance for currents. 1.1.4.1. Local tolerance The local tolerance is correlated with or described by respectively a) the value of the (“direct”) pain threshold, b) the risk of chemical burning, c) the risk of burning by heat, d) the value of the (“indirect”) pain threshold caused by intensive muscle contraction, measured as functions of frequency and intensity, for b and c additionally as functions of time.

66. 1.1.4.2. Systemic tolerance The systemic tolerance can be defined mainly by means of the a) the value of the threshold for ventricular fibrillation or b) the value of the threshold for cardiac arrest. In cases of current applications including head and brain thresholds for undesired sensations and/or generalised epileptic seizures are important. In cases of treatments of the trunk with high current intensities above the motor threshold the thresholds of the muscles responsible for respiration are important.

67. 1.1.5. Effects The electric differential therapy distinguishes between stimulatory and non-stimulatory effects. 1.1.5.1. Stimulatory effects Stimulatory effects are caused by generation of action potentials in excitable structures (nerves, muscles, receptors). The frequency of the triggered action potentials ranges between > 0 and – for very short periods – 1000 Hz, defined in physiology and physical medicine as the “low frequency range. The application of stimulatory effects can be realised either according the functional imitation principle or according the functional fatiguing principle, depending on the values of the frequencies of stimulation in relation to the fatiguing frequency of the just stimulated excitable structure.

68. 1.1.5.1.1. Important frequencies for therapeutically desired special effects, basing on well known physiological investigations regarding the discharge behaviour of excitable structures - usable as border line frequencies between the functional imitation principle and the functional fatiguing principle Efferent nerve fibres Sympathetic nerve fibres Lipolysis 3 Hz This frequency of 3 Hz is not a border line frequency between imitation and fatiguing frequencies. The lipolytic effect of a stimulation of sympathetic nerve fibres innervating fatty tissue is decreased in case of using higher frequencies than 3 Hz because of the simultaneously increasing vasoconstriction (ROSELL, 1966). Vasoconstriction 10 Hz Motor nerve fibres 20 Hz Afferent nerve fibres100 Hz, however, not valid for all groups of afferent fibres

69. 1.1.5.1.1.1. instructions regarding the meaning of the principles of functional imitation and functional fatiguing related to the stimulation of the mentioned groups of nerve fibres The principle of imitation can be used therapeutically for all of the mentioned groups, the principle of fatiguing mainly for sympathetic fibres, in few cases for motor nerves as well. To avoid undesired fatiguing effects during the initial phase of a treatment in cases of applications of various (low) modulation frequencies, please start every time with the lowest frequency!

70. Stimulation of sympathetic nerve fibres: Frequencies up to 3 Hz: activation of the lipolysis within the innervated area Frequencies up to 10 Hz: mainly vasoconstriction increasing with frequency reduced lipolysis caused by vasoconstriction and product inhibition Frequencies > 10 Hz, for example 100 Hz: vasodilatation after initial vasoconstriction

71. Stimulation of motor nerve fibres : Frequencies up to 20 Hz: muscle exercise, re-education, strengthening with individually designed and adjusted periods consisting in phases of stimulation interrupted by pauses. Physiological tetanising frequency, i. e. maximum discharge frequency in the efferent neurones of the motor units during voluntarily initiated maximum isometric contraction (HENNEMAN 1957; HENNEMAN et al. 1965; SOMJEN et al 1965; MILNER-BROWN et al. 1973; FREUND, BÜDINGEN & DIETZ 1975; BÜDINGEN & FREUND 1976) Frequencies > 20 Hz: muscle relaxation caused by fatiguing stimulation

72. Stimulation of afferent (somato-sensory) nerve fibres: This group of nerve fibres is not homogeneous. Therefore a frequency limit valid for all fibres does not exist. Furthermore, there is no indication for purposeful fatiguing stimulation of this group of fibres. Nevertheless, 100 Hz can be accepted as the most useful frequency to cause central pain relief according the imitation principle by means of counter-irritation.

73. 1.1.5.2. Non-stimulatory effects These effects are defined as effects caused independently from the generation of action potentials. 1.1.5.2.1. Non-stimulatory effects at the physical and chemical levels of efficacy Such effects are for instance movements of freely movable charged particles, ions as carriers of the electrical currents, of water molecules (dipoles) and of charges fixed in molecules as constituents of the tissue. Results of these primary effects are facilitation and acceleration of diffusion, that means equilibration of concentration differences, and the enhancement of the ability of water to act as an solvent.

74. 1.1.5.2.2. Non-stimulatory effects at the biochemical level of efficacy 1.1.5.2.2.1. Increase of the probability of “meetings” and contacts between enzymes and substrates Enzymes are biocatalysts. The mediated biochemical reactions are in all cases electrical events too, facilitated by means of alternating electrical fields.

75. 1.1.5.2.2.2. Conformation changes of signal molecules as a a reason for the activation of the adenylatcyclase In several papers changes of the intracellular formation of cAMP (cyclic Adenosinemonophosphate, one of the most important second messengers) caused by middle frequency currents have been published (KORENSTEIN 1984; BRIGHTON & TOWNSEND 1986; NOSZVAY-NAGY 1988- 1994). Beneficial influences upon the trophism of the tissues, anti- asthmatic, generally activating and antidepressive effects - within the therapeutic level of efficacy – could be explained by this electro-biochemical effect.

76. 1.1.5.2.3. Non-stimulatory effects at the neurophysiological level of efficacy Intensities of unmodulated middle frequency currents distinctly above the threshold cause in nerves and muscles partial depolarisation, in nerves correlated with a block, in muscles additionally with a physiological contracture. Below of these relatively high intensities a range of intensities exists which is characterised by some particularities:

77. 1. The principle of apolar “stimulation” is valid: Using two electrodes (of the same size) under both electrodes are generated the same effects at the same time. Anodic or cathodic effects do not exist. 2. The law of “Alles oder nichts” (everything or nothing) is not valid.. With repetitions of tests of the thresholds the values increase. 3. There are no relations between the single phases of the middle frequency current and the begin of the triggered action potentials. 4. Around the threshold single action potentials are triggered irregularly, but this kind of ongoing activity disappears after a while 5. Intensities above the threshold trigger a “transient excitatory activity”, abbreviated “tea”: immediately after the start of the establishment of the alternating electrical field the firing rate has it’s highest values, followed by decreasing discharge frequencies. “Tea” is correlated at the psychophysical level of efficacy with a fading tingling sensation. “Tea” leads to fatigue of the involved excitable structures.

78. 1.1.5.2.4. Non-stimulatory effects at the therapeutic level of efficacy 1.) Pain relief a) symptomatic, immediate, transient via distribution and thinning of mediators of pain and inflammation via blocking of afferent fibres involved in coding of pain information b) causal, longer lasting by facilitation and/or activation of metabolic processes, acceleration and abbreviation of healing processes c) indirect by anti-oedematous effects via reversible physiological contractures of the smooth muscles of the vessels including lymphatic vessels

79. 3.) Acceleration and abbreviation of healing processes, which are not accompanied by pain (s. 1 b) 4.) Local anti-oedematous effects (explained under 1 c) and diuretic effects

80. Results of the study of RHADES and SCHNEIDER concerning low back pain 18 patients had been treated. The range of motion could be improved by 5.3° (  4.7°), statistically significant. The distance of the fingers to the ground could be diminished by 3.7 cm (  4.0) cm, (significant). Pain relief after the end of the treatment series in 8 patients (44%), later additionally in 3 patients (16.6%), together circa 60%. Degree of pain relief: Statistically high significant improvement from 6.25 (  1.73) to 3.44 (  1.82) (NAS-Score).

81. Fig.1 Judgement of the efficiency

82. Fig. 2 Effects upon bowing and range of motion

87. To understand correctly and completely the position of the high tone therapy within the electrotherapy it is required to be well acquainted with some terms of the fields of physiology, related disciplines and physical therapy. However, neither all medical doctors nor all physical therapists have been sufficiently educated during their specific education in both disciplines, or may-be they have forgotten some details. Therefore I will try to repeat, to explain and to comment some of the most important terms and facts.