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→‎Pulsed electromagnetic field (PEMF) therapy: rm biomedical claim based on primary source
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Development of pulsed electromagnetic field (PEMF) therapy has ben problematical because of the lack of scientifically-derived, evidence-based knowledge of the mechanism of action. For example, PEMF therapy used by plastic surgeons the management of postsurgical pain and edema,<ref>{{cite journal |last1=Strauch |first1=Berish |title=Evidence-Based Use of Pulsed Electromagnetic Field Therapy in Clinical Plastic Surgery |journal=Aesthetic Surgery Journal |date=2009 |volume=29 |issue=2 |page=135–143 |doi=10.1016/j.asj.2009.02.001 |url=https://academic.oup.com/asj/article-abstract/29/2/135/270272}}</ref> has been criticized for not having a body of evidence for improving physical function and pain relief.<ref>{{cite journal |last1=A. |first1=Negm |title=Efficacy of low frequency pulsed subsensory threshold electrical stimulation vs placebo on pain and physical function in people with knee osteoarthritis: systematic review with meta-analysis |journal=Osteoarthritis and Cartilage |date=2013 |volume=21 |issue=9 |page=1281-1289 |doi=10.1016/j.joca.2013.06.015 |url=https://www.sciencedirect.com/science/article/pii/S1063458413008510}}</ref>
Development of pulsed electromagnetic field (PEMF) therapy has ben problematical because of the lack of scientifically-derived, evidence-based knowledge of the mechanism of action. For example, PEMF therapy used by plastic surgeons the management of postsurgical pain and edema,<ref>{{cite journal |last1=Strauch |first1=Berish |title=Evidence-Based Use of Pulsed Electromagnetic Field Therapy in Clinical Plastic Surgery |journal=Aesthetic Surgery Journal |date=2009 |volume=29 |issue=2 |page=135–143 |doi=10.1016/j.asj.2009.02.001 |url=https://academic.oup.com/asj/article-abstract/29/2/135/270272}}</ref> has been criticized for not having a body of evidence for improving physical function and pain relief.<ref>{{cite journal |last1=A. |first1=Negm |title=Efficacy of low frequency pulsed subsensory threshold electrical stimulation vs placebo on pain and physical function in people with knee osteoarthritis: systematic review with meta-analysis |journal=Osteoarthritis and Cartilage |date=2013 |volume=21 |issue=9 |page=1281-1289 |doi=10.1016/j.joca.2013.06.015 |url=https://www.sciencedirect.com/science/article/pii/S1063458413008510}}</ref>


Of certain PEMF therapies that are approved to have considerable therapeutic impact, we can name the following methods: treatment of fractures non-unions,<ref>{{cite journal |last1=Mit Balvantray |first1=Bhavsar |title=Electrical stimulation-based bone fracture treatment, if it works so well why do not more surgeons use it? |journal=European Journal of Trauma and Emergency Surgery |date=2019 |page=1-20 |url=https://link.springer.com/article/10.1007/s00068-019-01127-z}}</ref> diminished depression <ref>{{cite journal |last1=Anne Sofie |first1=Bøgh Malling |title=The effect of 8 weeks of treatment with transcranial pulsed electromagnetic fields on hand tremor and inter-hand coherence in persons with Parkinson’s disease |journal=Journal of NeuroEngineering and Rehabilitation |page=16-19 |doi=10.1186/s12984-019-0491-2 |url=https://jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-019-0491-2}}</ref>, reduced stress following leg injury <ref>{{cite journal |last1=Marinus |first1=Winters |title=Treatment of medial tibial stress syndrome: a systematic review |journal=Sports Medicine |date=2013 |volume=43 |issue=12 |page=1315-1333 |doi=10.1007/s40279-013-0087-0 |url=https://link.springer.com/article/10.1007/s40279-013-0087-0}}</ref>''','''and enhanced sport performance <ref>{{cite journal |last1=Soo-Byeong |first1=Kim |title=Effects of PEMFs (Pulsed Electromagnetic Fields) stimulation on acupoint in quadriceps fatigue recovery |journal=International Journal of Precision Engineering and Manufacturing |date=2012 |volume=13 |issue=9 |page=1697-1703 |doi=10.1007/s12541-012-0222-0 |url=https://link.springer.com/article/10.1007/s12541-012-0222-0}}</ref>.
Of certain PEMF therapies that are approved to have considerable therapeutic impact, we can name the following methods: treatment of fractures non-unions,<ref>{{cite journal |last1=Mit Balvantray |first1=Bhavsar |title=Electrical stimulation-based bone fracture treatment, if it works so well why do not more surgeons use it? |journal=European Journal of Trauma and Emergency Surgery |date=2019 |page=1-20 |url=https://link.springer.com/article/10.1007/s00068-019-01127-z}}</ref> reduced stress following leg injury <ref>{{cite journal |last1=Marinus |first1=Winters |title=Treatment of medial tibial stress syndrome: a systematic review |journal=Sports Medicine |date=2013 |volume=43 |issue=12 |page=1315-1333 |doi=10.1007/s40279-013-0087-0 |url=https://link.springer.com/article/10.1007/s40279-013-0087-0}}</ref>''','''and enhanced sport performance <ref>{{cite journal |last1=Soo-Byeong |first1=Kim |title=Effects of PEMFs (Pulsed Electromagnetic Fields) stimulation on acupoint in quadriceps fatigue recovery |journal=International Journal of Precision Engineering and Manufacturing |date=2012 |volume=13 |issue=9 |page=1697-1703 |doi=10.1007/s12541-012-0222-0 |url=https://link.springer.com/article/10.1007/s12541-012-0222-0}}</ref>.


[[Pulsed radiofrequency|Pulsed radio-frequency]] fields (PRF) are a subsection of [[Pulsed electromagnetic field therapy|PEMF]]<nowiki/>s, which then divide to thermal and non-thermal (athermal), based on the energy that delivers to the biological object <ref>{{cite journal |last1=Kenneth R. |first1=Foster |title=Thermal and nonthermal mechanisms of interaction of radio-frequency energy with biological systems |journal=IEEE Transactions on Plasma Science |date=2000 |volume=28 |issue=1 |page=15-23 |doi=10.1109/27.842819 |url=https://ieeexplore.ieee.org/abstract/document/842819}}</ref>. PRF should not be confused with [[Radionics|electromagnetic therapy (EMT)]], which is also known as [[radionics]]. EMT is a form of [[alternative medicine]], which is inspired by [[holistic medicine]] logic. Producers of EMT devices claim that they can cure people by "balancing" their discordant energies, according to alternative and holistic medicine references <ref>{{cite book |last1=Crosbie |first1=Smith |title=). The Science of Energy – a Cultural History of Energy Physics in Victorian Britain |date=1998 |publisher=The University of Chicago Press |isbn=978-0-226-76420-7 |url=https://www.press.uchicago.edu/ucp/books/book/chicago/S/bo3628434.html}}</ref>.
[[Pulsed radiofrequency|Pulsed radio-frequency]] fields (PRF) are a subsection of [[Pulsed electromagnetic field therapy|PEMF]]<nowiki/>s, which then divide to thermal and non-thermal (athermal), based on the energy that delivers to the biological object <ref>{{cite journal |last1=Kenneth R. |first1=Foster |title=Thermal and nonthermal mechanisms of interaction of radio-frequency energy with biological systems |journal=IEEE Transactions on Plasma Science |date=2000 |volume=28 |issue=1 |page=15-23 |doi=10.1109/27.842819 |url=https://ieeexplore.ieee.org/abstract/document/842819}}</ref>. PRF should not be confused with [[Radionics|electromagnetic therapy (EMT)]], which is also known as [[radionics]]. EMT is a form of [[alternative medicine]], which is inspired by [[holistic medicine]] logic. Producers of EMT devices claim that they can cure people by "balancing" their discordant energies, according to alternative and holistic medicine references <ref>{{cite book |last1=Crosbie |first1=Smith |title=). The Science of Energy – a Cultural History of Energy Physics in Victorian Britain |date=1998 |publisher=The University of Chicago Press |isbn=978-0-226-76420-7 |url=https://www.press.uchicago.edu/ucp/books/book/chicago/S/bo3628434.html}}</ref>.

Revision as of 17:16, 19 June 2019

Bioelectromagnetic medicine deals with the phenomenon of resonance signaling and discusses how specific frequencies modulate cellular function to restore or maintain health. Such electromagnetic (EM) signals are then called “medical information” that is used in health informatics.[1].

Bioelectromagnetics

Main article: Bioelectromagnetics

Bioelectromagnetics refers to the ability to live cells, tissues, and organisms that produce electromagnetic fields. Bioelectromagnetism is mostly studied via electrophysiologicaltechniques [2].

Some of the electrophysiological monitoring methods such as electroencephalography (EEG) and electrocardiography (ECG or EKG) measure the electrical activity of the brain and heart via the installation of electrodes placed on the skin. Recorded evoked potential (EP) amplitudes tend to be low, ranging from tens of microvolts for EEG, millivolts for electromyography (EMG), and about 20 millivolts for ECG [3], [4] and [5].

Other electrophysiological monitoring techniques such as evoked spinal cord potential (ESCP), somatosensory evoked potential (SEP) and SSEP (short-latency SEP) could be coupled with ECG, which then present excitatory ECG-triggered SSEP technique. The amplitude of the EP or evoked response is usually interpreted as the severity of the biological entities’ response toward the applied electromagnetic field [2]. Evoked potentials are merely acquired when the applied excitation is more than the excitation threshold of the biological entity [6]. In such cases, excitatory input voltages are applied in different modes, by a stimulation rate of 0.1 to 100 Hz, current stimulation amplitudes of 0 to 200 mA and load resistance of 1 kΩ, which gives 0-200 mV amplitude (in case of constant resistance) and 40 mW electrical power [7]. In some cases, stimulation module of ESCP, SEP, and SSEP techniques is similar to pulsed electromagnetic field (PEMF) generators [8], [9].

Pulsed electromagnetic field (PEMF) therapy

Main article: Pulsed electromagnetic field therapy

Development of pulsed electromagnetic field (PEMF) therapy has ben problematical because of the lack of scientifically-derived, evidence-based knowledge of the mechanism of action. For example, PEMF therapy used by plastic surgeons the management of postsurgical pain and edema,[10] has been criticized for not having a body of evidence for improving physical function and pain relief.[11]

Of certain PEMF therapies that are approved to have considerable therapeutic impact, we can name the following methods: treatment of fractures non-unions,[12] reduced stress following leg injury [13],and enhanced sport performance [14].

Pulsed radio-frequency fields (PRF) are a subsection of PEMFs, which then divide to thermal and non-thermal (athermal), based on the energy that delivers to the biological object [15]. PRF should not be confused with electromagnetic therapy (EMT), which is also known as radionics. EMT is a form of alternative medicine, which is inspired by holistic medicine logic. Producers of EMT devices claim that they can cure people by "balancing" their discordant energies, according to alternative and holistic medicine references [16].

Biofeedback

Main article: Biofeedback

If we consider the human body as a complex electrical circuit, tuning its electrical activity needs a trigger and response system via fast sweeping. This approach of receiving information (feedback) from the body (bio) is named “biofeedback” [17]. Tuning electrical activity of the body via biofeedbacks then assigns to tunning the physiology of the body, which has diagnostic and therapeutic applications [18]. So, biofeedback instrumentation somehow is similar to electromagnetic therapy (EMT), but its mechanism is explained by modern electrophysiology instead of alternative medicine.

As explained in previous paragraphs, combining diagnostic electrophysiological techniques (e.g., EEG, ECG, and EMG) with stimulatory modules, facilitate the manufacture of devices that are working like PEMF therapy devices. Synchronized application of sensory electrodes along with stimulatory modules, can then provides instrumentation of biofeedback setups. Therefore, most of the methods mentioned above are similar to a matter of instrumentation. However, the mechanism that explains their performance could be completely different. In the following paragraphs, we describe food and drug administration (FDA) regulations that are taken in action to differentiate effective bioelectromagnetic medical devices from gadget quacks.

FDA approved vs. FDA registered PEMF devices

FDA provides two different services when it comes to PEMF devices. When a PEMF device is FDA registered, it means that the FDA is aware of the fact that this device is imported into the USA. On the other hand, FDA approval confirms that a PEMF device has health benefits to treat a specific health condition.[citation needed] Since PEMF devices need to be condition-specific, either of PEMF devices that are inspired by holistic medicine or alternative medicine ideas, which treat a wide range of health conditions, will not be completely approved by the FDA.

FDA labels

The FDA decides which label to grant to a medical device. There are three main classes of medical devices according to the potential risk that they might have on human health.

Class 1 – Very low-risk devices and drugs. For example, dental floss and bedpans.

Class 2 – Devices with a higher risk than Class 1. For example, condoms and pregnancy tests.

Class 3 – Devices with a very high risk to human health. For example, pacemakers and heart valves [19].

If the device labeling makes new or remote use of the currently marketed similar devices, the FDA places it into Class 3, which will need premarket approval (PMA) before marketing. Class two medical devices only need to be cleared by the FDA [20]. This means that the FDA will not test them itself. In those instances where a device is substantially equivalent to an existing device, a firm should attempt to obtain 510(k) clearance rather than go for premarket approval [21]. For example, orthofix produces different PEMF devices that decrease markers of inflammation, which has been utilized in clinical studies to treat osteoarthritis, epicondylitis, and rotator cuff tears [22], but only PHYSIO-STIM I & II MODEL 6000 & 7000 are FDA approved [23][24] that are used for the treatment of long-bone non-unions fracture [25]. The same story applies to other devices that are produced by Biomove. By this regard, only certain models that are provided by Biomove company, such as Biomove 3000, 5000, are FDA cleared [26], because they are substantially equivalent to the FDA approved device like NeuroMove (NM900 device, Dan Med, Inc).

Allowed specific absorption rate

According to the FDA’s criteria for significant risk investigations of magnetic resonance, the specific absorption rate (SAR) that a medical device is licensed to deliver to the body is limited to certain electrical power during a limited time. The SAR for whole body and head is less than 4 and 3.2 Watt per kilogram, which should not exceed 15 and 10 minutes, respectively. In case that body is exposed to a static magnetic field, the amplitude of the magnetic field should not exceed 4 and 8 Tesla for infants and adults, respectively [27]. By this regard, some of the PEMF devices such as MDcure®, Aerotel Ltd., (Holon, Israel) and Aerotel Inc. (USA, New York, NY, USA) are categorized as FDA Class-1 therapeutic device since they deliver extremely low-intensity electromagnetic field with nanoTesla amplitude (nT; 10-9) at a set of low frequencies (1–100 Hz) [14]. Such PEMF devices must not be confused with EMT devices, which are accused of Class I recall [28]

In conclusion, having a device that has either licensed SAR or standard instrumentation does not approve its marketing. FDA only gives PMA certificates or clearance to the medical devices that have a decisive mechanism of action beside a significant diagnostic/therapeutic efficiency.  

References

  1. ^ Foletti, Alberto (2013). "Bioelectromagnetic medicine: The role of resonance signaling". Electromagnetic biology and medicine. 32 (4): 484-499.
  2. ^ Malmivuo, Jaakko (1995). Bioelectromagnetism: principles and applications of bioelectric and biomagnetic fields (PDF). USA: Oxford University Press.
  3. ^ Niedermeyer, Ernst. Electroencephalography : basic principles, clinical applications, and related fields (5th ed.). Lippincott Williams & Wilkins. ISBN 978-0-7817-5126-1.
  4. ^ Leonard S, Lilly (2012). Pathophysiology of heart disease: a collaborative project of medical students and faculty. Lippincott Williams & Wilkins.
  5. ^ Burden, Adrian (1999). "Normalisation of EMG amplitude: an evaluation and comparison of old and new methods". Medical engineering & physics. 21 (4): 247-257. doi:10.1016/S1350-4533(99)00054-5.
  6. ^ Alan L, Hodgkin (1952). "A quantitative description of membrane current and its application to conduction and excitation in nerve". Journal of physiology. 117 (4): 500–544. PMID 12991237.
  7. ^ "Neuropack X1, EP/EMG/NCV Measuring System MEB-2300 Desktop System" (PDF). {{cite web}}: External link in |ref= (help)
  8. ^ Aziza Sayed, Omar (2012). "Evaluation of pulsed electromagnetic field therapy in the management of patients with discogenic lumbar radiculopathy". International journal of rheumatic diseases. 15 (5): e101-e108. doi:10.1111/j.1756-185X.2012.01745.x.
  9. ^ Shealy, Norman. "Pulsed Electromagnetic Field Therapy: Innovative Treatment for Diabetic Neuropathy".
  10. ^ Strauch, Berish (2009). "Evidence-Based Use of Pulsed Electromagnetic Field Therapy in Clinical Plastic Surgery". Aesthetic Surgery Journal. 29 (2): 135–143. doi:10.1016/j.asj.2009.02.001.
  11. ^ A., Negm (2013). "Efficacy of low frequency pulsed subsensory threshold electrical stimulation vs placebo on pain and physical function in people with knee osteoarthritis: systematic review with meta-analysis". Osteoarthritis and Cartilage. 21 (9): 1281-1289. doi:10.1016/j.joca.2013.06.015.
  12. ^ Mit Balvantray, Bhavsar (2019). "Electrical stimulation-based bone fracture treatment, if it works so well why do not more surgeons use it?". European Journal of Trauma and Emergency Surgery: 1-20.
  13. ^ Marinus, Winters (2013). "Treatment of medial tibial stress syndrome: a systematic review". Sports Medicine. 43 (12): 1315-1333. doi:10.1007/s40279-013-0087-0.
  14. ^ Soo-Byeong, Kim (2012). "Effects of PEMFs (Pulsed Electromagnetic Fields) stimulation on acupoint in quadriceps fatigue recovery". International Journal of Precision Engineering and Manufacturing. 13 (9): 1697-1703. doi:10.1007/s12541-012-0222-0.
  15. ^ Kenneth R., Foster (2000). "Thermal and nonthermal mechanisms of interaction of radio-frequency energy with biological systems". IEEE Transactions on Plasma Science. 28 (1): 15-23. doi:10.1109/27.842819.
  16. ^ Crosbie, Smith (1998). ). The Science of Energy – a Cultural History of Energy Physics in Victorian Britain. The University of Chicago Press. ISBN 978-0-226-76420-7.
  17. ^ Mark S., Schwartz (2017). Biofeedback. Guilford Publications. ISBN 9781462531943.
  18. ^ Mark S., Schwartz (2017). Biofeedback: A Practitioner's Guide (4th ed.). Guilford Publications. ISBN 9781462531943.
  19. ^ Bill, Sutton. "Overview of Regulatory Requirements: Medical Devices - Transcript".
  20. ^ "Overview of Device Regulation".
  21. ^ "Labeling Regulatory Requirements for Medical Devices". U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES.
  22. ^ "The PhysioStim Device". orthofix.
  23. ^ "PMA of PHYSIO-STIM(TM) I & II MODEL 6000 & 7000".
  24. ^ "Premarket Approval (PMA) of PHYSIO-STIM devices".
  25. ^ Julianne, Huegel (2018). "Effects of pulsed electromagnetic field therapy at different frequencies and durations on rotator cuff tendon-to-bone healing in a rat model". Journal of Shoulder and Elbow Surgery. 27 (3): 553-560. doi:10.1016/j.jse.2017.09.024.
  26. ^ "Biomove 3000 System 510(k) Number K042650" (PDF). Curatronic Ltd.
  27. ^ "Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices, Guidance for Industry and Food and Drug Administration Staff".
  28. ^ "Class 1 Device Recall VIBE".
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