User:Biofeedback 2019/sandbox

= Bioelectromagnetic medicine = It 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
Bioelectromagnetics refers to the ability to live cells, tissues, and organisms that produce electromagnetic fields. Bioelectromagnetism is mostly studied via electrophysiological techniques [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 [6 ]. Evoked potentials are merely acquired when the applied excitation is more than the excitation threshold of the biological entity [7 ]. 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 [8 ]. In some cases, stimulation module of ESCP, SEP, and SSEP techniques is similar to pulsed electromagnetic field (PEMF) generators [9, 10 and 11 ].

PEMF therapy
Development of pulsed electromagnetic field (PEMF) therapy has always been a rough patch due to controversial findings of scientifically-derived, evidence-based knowledge of the mechanism of action. For example, PEMF therapy found to be successful in the management of postsurgical pain and edema [12, 13 ], which then criticized of not having a strong body of evidence for improving physical function and pain relief [14 ].

Of certain PEMF therapies that are approved to have considerable therapeutic impact, we can name the following methods: treatment of fractures non-unions [15 ], decreased back pain [16 ], improved range of motion [17 ], decreased pelvic pain [18 ], accelerated nerve repair [19 ], diminished depression [20 ], reduced stress following leg injury [21 ], and enhanced sport performance [22 ].

Pulsed radio-frequency fields (PRF) are a subsection of PEMF s, which then divide to thermal and non-thermal (athermal), based on the energy that delivers to the biological object [23 ]. 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 [24 ].

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” [25 ]. Tuning electrical activity of the body via biofeedbacks then assigns to tunning the physiology of the body, which has diagnostic and therapeutic applications [26 ]. 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. 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 [27, 28].

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 [29 ]. 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 [30 ]. 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 [31 ], but only PHYSIO-STIM I & II MODEL 6000 & 7000 are FDA approved [32, 33 ] that are used for the treatment of long-bone non-unions fracture [34 ], [35 ]. 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 [36 ], because they are substantially equivalent to the FDA approved device like NeuroMove (NM900 device, Dan Med, Inc).

Allowed specific absorption rate (SAR)
According to the FDA’s criteria for significant risk investigations of magnetic resonance, the amount of 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 [37 ]. 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) [16]. Such PEMF devices must not be confused with EMT devices, which are accused of Class I recall [39 ].

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, et al. "Bioelectromagnetic medicine: The role of resonance signaling." Electromagnetic biology and medicine 32.4 (2013): 484-499.

[2] Malmivuo, Plonsey, Jaakko Malmivuo, and Robert Plonsey. Bioelectromagnetism: principles and applications of bioelectric and biomagnetic fields. Oxford University Press, USA, 1995.

[3] Niedermeyer E.; da Silva F.L. (2004). Electroencephalography: Basic Principles, Clinical Applications, and Related Fields. Lippincott Williams & Wilkins. ISBN 978-0-7817-5126-1.

[4] Lilly, Leonard S, ed. (2016). Pathophysiology of Heart Disease: A Collaborative Project of Medical Students and Faculty (sixth ed.). Lippincott Williams & Wilkins. p. 74. ISBN 978-1451192759.

[5] Burden, Adrian, and Roger Bartlett. "Normalisation of EMG amplitude: an evaluation and comparison of old and new methods." Medical engineering & physics 21.4 (1999): 247-257.

[6] Malmivuo, Plonsey, Jaakko Malmivuo, and Robert Plonsey. Bioelectromagnetism: principles and applications of bioelectric and biomagnetic fields. Oxford University Press, USA, 1995.

[7] Hodgkin, Alan L., and Andrew F. Huxley. "A quantitative description of membrane current and its application to conduction and excitation in nerve." The Journal of physiology 117.4 (1952): 500-544.

[8] https://us.nihonkohden.com/media/1066/meb-2300-brochure_nmlb-027-c-co-0162.pdf

[9] https://www.ncbi.nlm.nih.gov/pubmed/23083041/

[10] Omar AS, Awadalla MA, El-Latif MA. Evaluation of pulsed electromagnetic field therapy in the management of patients with discogenic lumbar radiculopathy. Int J Rheum Dis. 2012;15(5):e101-108.

[11] https://www.practicalpainmanagement.com/treatments/interventional/stimulators/pulsed-electromagnetic-field-therapy-innovative-treatment

[12] Strauch, Berish, et al. "Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery." Aesthetic Surgery Journal 29.2 (2009): 135-143.

[13] Sisken, B. F., et al. "Stimulation of rat sciatic nerve regeneration with pulsed electromagnetic fields." Brain research 485.2 (1989): 309-316.

[14] Negm, A., A. Lorbergs, and N. J. Macintyre. "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 (2013): 1281-1289.

[15] Bhavsar, Mit Balvantray, et al. "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 (2019): 1-20.

[16] Lisi, Anthony J., et al. "A Pulsed Electromagnetic Field Therapy Device for Non-Specific Low Back Pain: A Pilot Randomized Controlled Trial." Pain and therapy (2019): 1-8.

[17] Massari, Leo, et al. "Biophysical stimulation of bone and cartilage: state of the art and future perspectives." International orthopaedics 43.3 (2019): 539-551.

[18] Rowe, E., et al. "A prospective, randomized, placebo controlled, double-blind study of pelvic electromagnetic therapy for the treatment of chronic pelvic pain syndrome with 1 year of followup." The Journal of urology 173.6 (2005): 2044-2047.

[19] Weintraub, Michael I., et al. "Pulsed electromagnetic fields to reduce diabetic neuropathic pain and stimulate neuronal repair: a randomized controlled trial." Archives of physical medicine and rehabilitation 90.7 (2009): 1102-1109.

[20] Malling, Anne Sofie Bøgh, et al. "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 of neuroengineering and rehabilitation 16.1 (2019): 19.

[21] Winters, Marinus, et al. "Treatment of medial tibial stress syndrome: a systematic review." Sports Medicine 43.12 (2013): 1315-1333.

[22] Kim, Soo-Byeong, et al. "Effects of PEMFs (Pulsed Electromagnetic Fields) stimulation on acupoint in quadriceps fatigue recovery." International Journal of Precision Engineering and Manufacturing 13.9 (2012): 1697-1703.

[23] Foster, Kenneth R. "Thermal and nonthermal mechanisms of interaction of radio-frequency energy with biological systems." IEEE Transactions on Plasma Science 28.1 (2000): 15-23.

[24]  Smith, Crosbie. The science of energy: A cultural history of energy physics in Victorian Britain. University of Chicago Press, 1998.

[25] Schwartz, Mark S., and Frank Andrasik, eds. Biofeedback: A practitioner's guide. Guilford Publications, 2017.

[26] Mohl, Norman D., et al. "Devices for the diagnosis and treatment of temporomandibular disorders. Part III: Thermography, ultrasound, electrical stimulation, and electromyographic biofeedback." The Journal of prosthetic dentistry 63.4 (1990): 472-477.

[27] https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript

[28] https://en.wikipedia.org/wiki/Code_of_Federal_Regulations

[29] https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

[30] https://www.fda.gov/media/74034/download

[31] http://web.orthofix.com/Products/Pages/Physio-Stim.aspx

[32] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?start_search=1&sortcolumn=do_desc&PAGENUM=500&pmanumber=P850007

[33] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P850007

[34] https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

[35] Huegel, Julianne, et al. "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 (2018): 553-560.

[36] https://www.accessdata.fda.gov/cdrh_docs/pdf4/K042650.pdf

[37] https://www.fda.gov/media/71385/download

[38] Lisi, Anthony J., et al. "A Pulsed Electromagnetic Field Therapy Device for Non-Specific Low Back Pain: A Pilot Randomized Controlled Trial." Pain and therapy (2019): 1-8.

[39] "Class 1 Device Recall VIBE". www.accessdata.fda.gov. Retrieved 2018-05-18.