John Hubacher, MA,1 Richard C. Niemtzow, MD, PhD, MPH,2,* Michael D. Corradino, DAOM, MTOM, LAc,3 James C.Y. Dunn, MD, PhD,4 and Duong Huy Ha, LAc5
1Pantheon Research Inc., Culver City, CA.
2U.S. Air Force Acupuncture and Integrative Medicine Center, Joint Base Andrews, MD.
3DMC-Acupuncture-Neuropuncture, San Diego, CA.
4Department of Bioengineering and Surgery, University of California–Los Angeles School of Medicine, Los Angeles, CA.
5Santa Monica Acupuncture Center, Venice, CA.
*The opinions and assertions contained herein are the private views of the author and are not to be construed as official or as reflecting the views of the United States Air Force Medical Corps, the Air Force at large, or the Department of Defense. The author indicates that he does not have any conflicts of interest.
CME available online at www.medicalacupuncture.org/cme Questions on page 254.
Address correspondence to:
John Hubacher, MA
Pantheon Research Inc.
11282 West Washington Boulevard #204
Culver City, CA 90230
E-mail: pantheonr@aol.com
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ABSTRACT
Reporting of electronic and other key experimental parameters in published experiments using electroacupuncture (EA) may be insufficient to enable reliable clinical and research replication. A proposal for more-vigorous electronic-stimulation parameters is described in this article. These parameters can enable more-accurate reporting on electric stimulation for accurate reproduction of EA procedures. This may influence reporting favorably with respect to accurate clinical electrical dosages, leading to more-effective patient therapeutic protocols and reproducible results.
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Introduction
The current reporting of electronic parameters in published experiments on electroacupuncture (EA) is consistently insufficient to enable reliable replication. Hundreds of studies have been published on EA.1 White2 reported that a metadata analysis of EA showed a small number of studies showing that EA was effective. This deficiency could be the result, in part, of inadequate electronic-parameter reporting and duplication. This problem should be eliminated as a confounding factor, as it is most readily controllable.
A clinical EA case report may delineate stimulation frequency, treatment duration, or voltage/amperage. Another study may report only frequency and duration. In addition, usually, those factors being reported are in themselves insufficient for complete replication of the electrical stimulus. For instance, Omura
3 recommended at least 10 relevant electronic parameters.
What is more, the accuracy of the parameters being reported may be questioned, as many reports have described the inherent inaccuracy of manufacturer's specifications and the devices' real-world performance.
4,5 Most researchers do not report whether or not their parameter information was taken from a manufacturer's specifications or from direct measurements. For instance, a frequency as stated on the manufacturer's equipment might be 5Hz, but the real-world measurement could indicate a deviation of up to 50%. At higher frequencies, inaccuracies may develop into a safety issue. Precise replication of EA studies must be performed without experimental ambiguity.
The need to report electrical power dosage adequately is as important as reporting a pharmacologic dosage. The anatomical specificity reporting with respect to needle placement and depth also influences the quality of the electrical stimulation significantly.
With the inherent variation that exists in manufactured equipment,
4,5 real-world measurements should be made to verify electronic and experimental factors. Reporting the test instrumentation methods and equipment used to measure key electronic parameters—such as waveform, current, voltage, and frequencies—will enable an optimum level of clinical and research reproduction.
Many published EA studies are available in biomedical journals. The accuracy of the parameters reported might be questionable, as the methodology is not commonly described. Even the manufacturer's stated specifications of EA stimulators may be unreliable. It is possible that the lack of agreement involving EA could, in part, be attributed to an inability to reproduce any given study, as sufficient details of methodology are not reported to enable replication of the study.
The current authors propose that more-comprehensive reporting of relevant electrical parameters is needed for rigorous research, as each possible parameter can affect physiologic response and could be a key indicator for optimized clinical treatments.
The
Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) was created in 2001.6 That reporting guideline was created in an attempt to facilitate completeness of reporting on randomized controlled trials undertaken on acupuncture interventions. STRICTA was updated in 2010.7 Under Item 2e (of the updated guideline), it was noted that needle stimulation should be identified as manual or electrical. As an explanation, the sentence that describes the proposed EA reporting parameters reads: “For electrical stimulation, the current, amplitude and frequency settings should be recorded.” In addition, according to the current authors' new enhanced recommendations for EA reporting, clinicians and researchers could measure the actual frequency, provide an actual picture of the waveform, and measure the actual voltage and current levels. It is possible that a lack of agreement among EA studies on efficacy, could, in part, be attributed to an inability to reproduce any given study, as sufficient electronic details of methodology are not reported to allow for replication among clinicians and researchers.
It is not intended for these recommendations to serve as excessive reporting requirements or to require elaborate electronic measuring equipment to perform EA. However, each of these electronic parameters—and probably others not yet identified—influence patient outcomes.
title
Navigate ArticleTop of pageAuthor informationABSTRACTIntroductionElectronic Parameters <
Electronic Parameters
There are seven electronic parameters to consider as described in the following sections.
(1) Frequency, Pulse Repetition Rate
The pulse repetition rate describes the number of electrical impulses occurring each second. This information will partially determine total power levels being introduced into tissues, as increasing or decreasing frequency correspondingly changes the total electrical power provided over a time period or duration of treatment.
8–10
(2) Waveform (with Pictures)
Waveform includes rise and fall time of the pulse. Oscilloscope pictures of waveforms will show actual waveform shapes clearly.
3 Different waveform patterns may contribute to a variation of physiologic responses of the acupuncture point.
(3) Pulse Width
The pulse width describes the elapsed time between the rise and fall time of any electrical impulse of any given polarity. Pulse width can determine power levels delivered to tissue through an electrode needle. Specific tissues or cell anatomy can also be affected differentially by pulse width.
11 Both the outer and the inner cell membranes can be affected by the pulse width, causing untoward electroporation and damaging voltages across the bilayer membranes, leading to possible cellular death in some instances, if the experimental pulse width is not within standard U.S. Food and Drug Administration safety parameters.
(4) Voltage or Pulse Amplitude Applied to Patients
Typically, a patient will report when an EA stimulus is beginning to be painful, and the voltage level is then reduced slightly to a level of tolerance by the clinician. This can be highly variable for each patient or condition being treated or studied.
12 Therefore, actual measurement of the applied voltage is needed and the method of measurement should be described. It is also useful to characterize the voltage output of the machine before it is hooked up to the acupuncture needles and during the hookup to the needles, which will be different.
(5) Current Applied to Patients
Current is also a measure of the total power given during specific treatment. Current can measure the total amount of electrons and, hence, the total electrical force applied. The average current applied in a stimulus, and the peak current of an electrical pulse, needs to be characterized.
13 Given that the EA stimulus will be an alternating current (AC) waveform (normally), the current would be measured in AC root mean square (RMS), the standard AC measure.
(6) Positioning of Clips
Reportage should include the location or position of anode (+) and cathode (–), respectively, the red and black clip leads corresponding to the acupuncture points.
(7) Environmental Electromagnetic Noise
Environmental electromagnetic (EM) noise or interference is a difficult issue. We exist in very electromagnetically noisy environments. Power lines contribute to stray EM fields of varying strength, computer equipment and electronic equipment add to this, and even compact fluorescent light bulbs have high-frequency noise, etc. This all can be conducted in the long, 6 foot alligator-clip wires that are used to deliver pulses from an EA stimulator to a patient. Such noise is then introduced into that patient, unbeknownst to the researcher. It constitutes a very real, unmeasured and uncontrolled EM stimulus that will vary among patients and also will vary among offices and laboratories. It is complex, hard to characterize, may be spurious and random, and small amounts could affect a physiologic response. For example, a patient may be receiving a stimulus of 15 Volts from the EA machine of 2
Hz. Unknown—and simultaneously—the patient could be receiving 2–5 volts of overlaying 60Hz AC noise from local power lines, 0.5 volt of 15KHz of AC noise from a local compact fluorescent light bulb, and 0.1 volt of MHz noise from a local computer. The patient wires and alligator clips assemblies are efficient antennae for local EM noise.14
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Equipment Needed to Measure the Output of the Electrical Stimulator
Accurate measurement of the recommended electronic parameters can be accomplished using a standard digital oscilloscope (Fig. 1). A simple version is best, and is all that is needed. However, a bench-top multimeter can also be a useful tool for the current measurements. An oscilloscope is a versatile device that is easy to obtain and can be used with minimal training.
FIG
figure1
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FIG. 1. A digital oscilloscope delineating a series of square waves on the top row that could be from a monophasic electrostimulator, and the bottom row displays a sawtooth waveform, showing a useful dual-input channel ability of the oscilloscope.
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As with any research apparatus, a piece of equipment will have a manufacturer's specification for range of accuracy. However, the highest measurement integrity will be obtained by sending an intended research device to a recognized calibration laboratory to ensure equipment-measurement integrity.
Oscilloscope waveform pictures can be taken, using any camera (digital or other), smartphone, or directly from the scope using a Universal Serial Bus storage-and-capture device that plugs into the scope. Waveform pictures can display frequency, pulse width, voltage, and waveform information (
Fig. 2). The screen will display the measurement settings, and the observed waveform tracing can be analyzed by referring to this information on the screen.
FIG
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FIG. 2. An oscilloscope screen displaying an electrostimulator waveform. The frequency of the signal originating from the electrostimulator is 100.782Hz. The displayed pattern is frozen to visualize the electrostimulator output waveform.
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Frequency is indicated by referring to the setting on the “X” axis or horizontal scale. Each section of the scale will indicate a time period, which can be used to calculate frequency information. Pulse width is also indicated in this manner, as this is the time period during which the electrical pulse duration occurs. These parameters can be seen directly on the horizontal scale settings. Most digital scopes now also indicate a pulse frequency directly, as a direct readout from the screen, as a menu-selected item.
Likewise, the voltage measurement is a function of the “Y” scale settings, the vertical scale component. The voltage can be read by looking at how high or low the waveform travels on the vertical scale.
A waveform of the EA stimulus is obtained by using the oscilloscope probe, and connecting the red alligator clip lead to the scope probe tip and the black lead to the scope probe ground contact. While the EA machine is stimulating a patient, a picture may be obtained. It might be advisable to consult or receive training from a qualified electronic technician to ensure that measurements are made reliably.
Current measurements may also be obtained using a digital oscilloscope. This procedure will require a technician who can interface the scope with a computer to determine the AC values or the RMS. The RMS is the amount of AC power that produces the same heating effect as an equivalent DC power. AC current values may also be taken from a calibrated digital multimeter (
Fig. 3). In this case, the meter is placed “in series” or “in line” with the EA stimulator. This procedure also requires that the measurement be taken during patient treatments.
FIG
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FIG. 3. A precision desktop style multimeter with the ability to measure voltage, current, and other useful electronic parameters of the electrostimulator.
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The electronic parameters of each needle pair are likely to be different and unique. This illustrates how complex EA truly can be. Ideally, a complete measurement checklist would be made on each needle pair.
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Discussion
Reported electronics variable parameters are usually taken from manufacturers' specifications. Studies have shown that manufacturers' specifications are inaccurate.4,5 Reported frequencies can have error rates as high as 50%. Therefore, reliance on the equipment indicator dials, or manufacturer's descriptions of performances, is scientifically unreliable and contributes to potentially inaccurate reporting of dosages and experimental conditions. Each parameter should, ideally, be actually physically measured during experimentation to ensure accurate reporting. This, ideally, would be described, along with the method of measurement, to enable replication. Thus, like most physics or engineering studies, actual measurement of physical variable conditions imposed by therapeutic equipment need to be characterized by actual measurement and documentation through a standard procedure that is described and thus capable of replication. Until such a time that equipment integrity can be documented or taken at face value through verification studies, researchers should consider the need to assume nothing about EA devices that are commercially supplied.
Frequency sweeping is available as a feature on some EA devices. This allows the stimulation frequency to sweep between two set points, a low frequency and a high frequency, inside a time frame. In such a parameter, the low frequency and the high frequency could be measured to ensure accuracy as well as verifying the actual sweep time.
Researchers with the engineering resources for specialized studies could use automated data-acquisition electronics and software analysis programs that are commonly used for instrumentation. This could provide some advantages, for example, the instantaneous current of each pulse could be determined; this would be a more-exact measure of current. An interesting parameter might be the exact electrical dosage applied to each needle—information that is obtained easily from a data-analysis program.
Actual measurement of standardized electronic parameters used in EA studies is therefore proposed to facilitate accurate reporting. It is not meant to overburden doctors or researchers with difficult or expensive procedures that are of questionable value. These procedures can usually be performed with relative ease, and the value of the contribution to our genuine understanding of the physiologic effects of EA could be considerable and of profound clinical importance.
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Conclusions
It is recommended that standardized electronic parameter reporting be established in EA research protocols. This would become an accepted component of the STRICTA guidelines for acupuncture research. Such reporting can contribute to improved clinical outcomes for patients, as researchers would be more capable of determining optimal treatment parameters for various specific conditions. In addition, basic science research using EA can improve as comprehensive variables are adequately controlled and accounted for in study designs. Improvements in parameter reporting will likely result in greater cross-experimental replication and agreement on optimal clinical protocols.
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Author Disclosure Statement
The lead author John Hubacher, MA, is president of Pantheon Research Inc., in Culver City, CA, a company that manufactures EA devices and equipment. For all of the other authors, no competing financial interests exist.
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