The Analysis Of Parameters Of Electroacupuncture Device (EAD) And Relevant Factors

Market is filled with many electroacpuncture device (EAD) without CE compliance of EU which are sold in low prices, but it is threatening to both the users and patients,because this EAD cannot provide safety assurance and adjustable effective parameter. The parameter input of these EAD are mostly knobbing button which are not able to subtle parameter calibrations.This study is comprised of four parts, including literature review, experimental trial, questionnaires to the physicians and clinical testing, which help to understand the definition of EAD stimulation parameters and to improve the efficacy and modernization of acupuncture therapy. 1 Literature review1.1 The apply of electro-acupuncture electrode on the acupoints with different frequency can safe a lot of manpower. Nowadays, the apply of EAD is very common in the world. In recent years, the research and development of electro-acupuncture device are with continuous improvement, and so the success rate and long-term effects are.1.2 In the neural mechanisms, acupuncture can inhibit the harfaml by the interaction between the spinal cord and brain stem level. The PAG, RVM and NA brainstem of descending inhibitory system in nerve nuclei release the opioid peptides 5-HT, P substance and NA. Through regulating pain modulation of the diencephalon, limbic system and basal ganglia, it results analgesia effect. Neurochemical mechanisms in acupuncture analgesia is related to the various central neurotransmitter.1.3. Electrical stimulation of different parameters have different effects on the body, clinical practice shows that manipulative acupuncture technique is to determine the efficacy of acupuncture as an important factor, often in acupuncture analgesia by altering various parameters of electro-acupuncture in order to simulate different traditional manipulative acupuncture technique. Therefore, the effect of electrical stimulation parameters to the analgesic effect is an important research issue. EAD parameters, including waveform, amplitude, pulse width, frequency, rhythm and duration, of which amplitude and frequency of EAD stimulation output are considered as the most important parameters.1.4 Cholecystokinin CCK-8 is the most potent known endogenous anti-opioid peptides, the release of which is relating to tolerance phenomenon of the prolonged acupuncture treatment.1.5 In reviewing the literature of 1994 to 2009 in recent 15 years if the electro-acupuncture treatment of knee-pain syndrome, it can be found that the acupoints of Xi Yan, Xue Hai and Liang Qiu are most commonly used acupuncture points for the treatment of knee pain. It is often with TDP radiation, continuous waveform and 30 minutes treatment duration.On the other hand, most of the studies did not specify in detail the model used of EAD, or just mention G6805 or other names similar of it without detailed manufacturing specifications, therefore users are always confused and result to the lack of comparability and repetitive basis of the literature.2 Experimental study2.1 The purpose of the experiment By measuring the output parameters of electro-acupuncture device, such as waveform, frequency, intensity, pulse width, the performance of different types of electro-acupuncture device can be more easily understood and so do the proper use of electro-acupuncture device. In this experiment, National Instruments USB-6009 is used to record the output parameters of the DEA, by which we can understand the pulse power characteristics and the morphological features of the output current2.2 Experimental procedureAll 16 different brands, a total of 29 electro-acupuncture device are measured the output parameters. The parameters of EAD are recorded by National InstrumentsTM USB-6009. Two sets of software based on LabVIEWTM 7. lversion from National InstrumentsTM had been designed to record and display the data.2.3 Results(1) By comparing the electric parameters of difference brand/model of EAD, such as wave form, frequency, intensity and wave duty width, we can learn more about the performance of the EAD and can utlilise them more efficiently. The result are as follows:(2) 4 brands included five sophisticated EADs using digital display have linear regression relation (R2=1, y=x+b) between display value and actual pulse frequency. Other 7 sets show exponential equation relation and finally 4 sets show nearly linear.(3) Pulse output voltage:output zero reset function found in 6 sets. It protects sudden electric shock applied on patient due to last forgetting reset to zero output.(4) There were non symmetric of positive and negative waves found in 22 sets. The difference found as high as±198%. It seems to be cause electrolysis and make early adaptation. Only ITO adopted Symmetric bi-phase rectangular pulse design in production of its ES-160. It makes the red/black polarity plug to be meaningless.(5) Only华陀SDZ-Ⅱ,华陀-V and ITO ES-160 are comply with the electric safety standard of European Union CE. Using the electric device without electric security label is dangerous and easily cause electric shock.(6) More than 400 sets of data have been tested from 16 brands EAD (totally 29 sets) being collected.1. Pulse frequency:4 brands included five sophisticated EADs using digital display have linear regression relation (R2=1, y=x+b) between display value and actual pulse frequency. Other 7 sets show exponential equation relation and finally 4 sets show nearly linear.2. Pulse output voltage:output zero reset function found in 5 sets. It protects sudden electric shock applied on patient due to last forgetting reset to zero output.3. There were non symmetric of positive and negative waves found in 18 sets. The difference found as high as±198%. It seems to be cause electrolysis and make early adaptation. Only ITO adopted Symmetric bi-phase rectangular pulse design in production of its ES-160. It makes the red/black polarity plug to be meaningless.4. Electric security label only found in two models i. e. sdz-II and ITO ES-160. Others operated in AC would cause danger and easy to make accidents. It is strongly recommended that new generation LCD EAD with electric security approved should be used by Chinese medicine practitioner.3 The questionnaire of the electro-acupuncture device usage to the physicians3.1 Through this survey, in addition to physicians can learn to use knowledge of acupuncture instrument can also be aware of the use daily are physicians what EA instrument deficiencies, this will help select the appropriate machine and upgrade the electric needle acupuncture device specifications.3.2 The questionnaire result shows that electro-acupuncture devices are commonly used in daily acupuncture treatment amongst the physicians, but most of the physicians have misunderstanding of the electro-acupuncture device and this lead to they cannot fully utilise the advantages of it.3.3 The result also shows that "adaptation phenomenon" and "electric shock" are very common during the electro-acupuncture treatment, but only a little somewhat aware of this with the polarization of the electrodes and the depreciation of CVR, the carbon electric resistor.3.4 By studying 50 pieces of questionnaire filled by the EAD users,88.4% believe that appropriate output parameters of EAD can incrase the curative effect, but they do not show any knowledge about the relationship between the early adaption and NSBP.4 Clinical trials4.1 The purpose of the test in recent years, many of the acupuncture stimulation parameters of the instrument to study the subject of most of them are wave frequency, wave, wave type and intensity, few pulse width on the efficacy of acupuncture analgesia to the main I believe the only reason is because the market can provide an acupuncture instrument features adjustable pulse width, it is time for clinical trials is to narrow to understand wave (50μs) and wide wave (400μs) in the analgesic effect of the differences.4.4 The results of the research showed that the paients with knee pain syndrome all felt the soothingness after either 2Hz 400μs or 2Hz 50μs consective electroacupuncture pluse simulation. The VAS values of the former were decreased significantly (p<0.01). This demonstrated that the clinical effectiveness of 2Hz 400μs is much greater than 2Hz 50μs.ConclusionThe performance of ITO ES-160 is the best and most safe, and it shows a linear relationship between frequency and voltage with what it shown on the device.The user can be easy to control the output frequency and voltage, and this result to the less opportunity of patient discomfort and fear, but also facilitate the research data collection.In addition, the zero output reset function of ITO ES-160 can prevent the electrical shock due to the lack of manual zero reset in previous use.ITO ES-160 is also with CE and UL electrical safety test assurance and with the limitation of the output voltage not more than 40 volts, which can reduce the electric shock situation.In effect, because the output of ITO ES-160 is the symmetric pulse (SBP), "adaptation phenomenon" during treatment can be avoided.From the result of questionnaire, we know that "electric shock" is not uncommon in the treatment. And most of the user think this is inevitable. However, this dangerous and terrible situation can be avoided if the following points are cautioned.(1) Push button input of EAD (2) the linear relationship of the voltage output (3) zero reset safety function (4) Electrical safety compliance (5) Maximum output voltage (6) Be caution of using stepFrom the result of questionnaire, most of the users have been "electric shock" during the treatment but the little know this phenomenon is relating to its non-symmetric bi-phase rectangular pulse (NSBP) output. The study shows that the output of华陀SDZ-II,华陀SDZ-V,达佳6805AII and Ito ES-160 are symmetric bi-phase rectangular pulse (NSBP), therefore most users of other EADs cannot avoid the "adaptation phenomenon. "Different pulse width of EAD output can result different treatment effect, as we know from the results of the VAS value test, which shows the VAS value of 2Hz 400μs EAD treatment group drops more significantly than 2Hz 50μs group. It implies that wide pulse width is with better analgesic effect.Due to limited resources in the study, only 16 different brands, a total of 29 electrocacupuncture device (EAD) can be put into this study. Objective views of purchase and usage of EAD can be projected to the users, according to this study, as well as the acceptance and safety can be increased.In long term, government agencies and research institutes should develop a standard of EAD production, such as the ISO certification, therefore the function and safety of EAD can be assured, and this also is for the sake of developers, physicians and patients.