Physics:High-Intensity Focused Electromagnetic Field

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High-Intensity Focused Electromagnetic Field (HIFEM) is a non-invasive medical technology brand that is used for strengthening[1][2] and re-education[3][4] of muscles via interaction of the magnetic field with the tissue of the patient. In aesthetic medicine it is also used for non-invasive reduction of abdominal fat.[1][2][5][6] HIFEM is the label of the technology that is used in aesthetic medicine, urology and gynecology. It uses focused electromagnetic field with intensity measured in Tesla[7] and is based on Faraday’s principle of electromagnetic induction. Electromagnetic field passes non-invasively through the body and interacts with motor neurons which subsequently trigger supramaximal muscle contractions due to the action potential.[1] The exposure of muscles to these contractions leads to muscle strengthening.

In aesthetic medicine, HIFEM is used as a non-invasive body contouring treatment for abdomen and buttocks.[1][8][9] The same technology is used in urology and gynecology to treat urinary incontinence through strengthening of the pelvic floor muscles.[4][10][11]

Mechanism of action

A pulse of electric current flowing through a wire coil generates a rapidly changing magnetic field. The changing magnetic field induces a secondary electric current in the nearby tissue.

When applied on peripheral level the secondary electrical current depolarizes neural membranes of underlying neurons. Motor neurons are predominantly depolarized due to their large diameter in comparison to other types of neurons. Other neurons or tissues are much less responsive to the electric current, and therefore stay unaffected. Induced action potential is transmitted to neural endings innervating the muscle. Consequently, the muscle contracts independently of the brain activity. When the stimulation induces action potentials at very high rates the muscle contraction becomes supramaximal as the muscle doesn't have time to relax between two consecutive stimuli.

Unlike electrical stimulation, HIFEM penetrates deep into the tissue, and thus affects deeper motor neurons. Electrical stimulation works on the basis of the flowing electric charge between the electrodes, and as such the current remains on the surface and innervates only superficial motor neurons.[12] Also intensity of electrical stimulation is limited due to pain and risk of burns.[13]

Use

Effect on muscles

Contrary to voluntary muscle contractions, the supramaximal contractions are independent of brain function. The HIFEM uses a specific range of frequencies that does not allow muscle relaxation between two consecutive stimuli. The muscle is forced to remain in contracted state for multiple seconds. When repeatedly exposed to these high load conditions the muscle tissue is stressed and is forced to adapt. Recent studies reported that on average 15% - 16%[1][2] increase in abdominal muscle thickness was observed in treated patients one to two months after HIFEM treatments. The same studies also reported on average 10% - 11%[1][2] reduction in abdominal separation. The increased volume of the treated muscles corresponds with previous research, concluding that intensive muscle contractions induce muscle hypertrophy[14][15][16][17] and hyperplasia.[18][19] This muscle strengthening effect is used in aesthetic medicine to non-invasively contour the abdomen and the gluteal region of a person, and in urology and gynecology to re-educate the pelvic floor muscles which affect urinary incontinence.

Effect on fat

Several recent studies using CT, MRI and ultrasound evaluations have reported approximately 19%[1][2][5] reduction in subcutaneous fat layer in patients treated by HIFEM based device on their abdomen. In a histology study, Weiss et al. reported a 92%[20] increase in the apoptotic index of adipocytes in the abdomen eight hours after applying HIFEM to pigs. The same study also reported increase in pro-apoptotic RNA markers measured by molecular biochemistry and increased concentrations of free fatty acids in post-application blood tests.

The principle of cell apoptosis induced by increased concentrations of free fatty acids has been previously observed and demonstrated in numerous research studies.[21][22] Yet the exact mechanism of the effects of HIFEM on fat tissue is not well understood and requires further research. Opposed to that, no change in adipose tissue has been reported after application of HIFEM on buttocks and the pelvic floor. It was suggested that this is primarily caused by different metabolic nature of adipocytes in different human body areas, however such claim requires further investigation.

Effect on pelvic floor

In urology and gynecology, the HIFEM technology is used to treat urinary incontinence through non-invasive strengthening of the pelvic floor muscles.[4][10][11][23] In treating incontinence HIFEM magnetic field is specifically designed to focus on strengthening the muscles of the pelvic floor, through specific designed magnetic pulse patterns. Many patients affected by urinary incontinence are unable to contract pelvic floor muscles selectively,[4] and application of HIFEM can help with muscle strengthening and re-education independent of the brain function. HIFEM induces deep pelvic floor muscle stimulation and restoration of the neuromuscular control.

To regain continence, regular pelvic floor muscles exercising is recommended. Normally, 300-500 contractions of the pelvic floor muscles should be performed to begin to develop a new motor pattern, whereas 3,000-5,000 contractions are required to erase and correct poor motor pattern. HIFEM technology can induce thousands of pelvic floor muscles contractions via interaction of its magnetic field with motor neurons.[23]

The effects of HIFEM on urinary incontinence have been reported by several recent studies.[4][10][11]

Regulatory approval

In the U.S., two HIFEM devices are FDA-cleared for use. The EMSELLA procedure is FDA-cleared for the treatment of urinary incontinence, and the EMSCULPT procedure is FDA-cleared for strengthening, firming, and toning of abdomen and buttocks.

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 Kent, David E.; Jacob, Carolyn. "COMPUTED TOMOGRAPHY (CT) BASED EVIDENCE OF SIMULTANEOUS CHANGES IN HUMAN ADIPOSE AND MUSCLE TISSUES FOLLOWING A HIGH INTENSITY FOCUSED ELECTRO-MAGNETIC (HIFEM) APPLICATION: A NEW METHOD FOR NON-INVASIVE BODY SCULPTING". Presented at 38th ASLMS annual conference on energy-based medicine & science. 
  2. 2.0 2.1 2.2 2.3 2.4 Kinney, Brian; Lozanova, Paula (April 2018). "HIGH INTENSITY FOCUSED ELECTRO-MAGNETIC THERAPY (HIFEM) EVALUATED BY MAGNETIC RESONANCE IMAGING (MRI): SAFETY AND EFFICACY STUDY OF A DUAL TISSUE EFFECT BASED NON-INVASIVE ABDOMINAL BODY SHAPING". Presented at 38th ASLMS annual conference on energy-based medicine & science. doi:10.1002/lsm.23024. 
  3. Ishikawa, N.; Suda, S.; Sasaki, T.; Yamanishi, T.; Hosaka, H.; Yasuda, K.; Ito, H. (1998-11). "Development of a non-invasive treatment system for urinary incontinence using a functional continuous magnetic stimulator (FCMS)" (in en). Medical & Biological Engineering & Computing 36 (6): 704–710. doi:10.1007/bf02518872. ISSN 0140-0118. https://link.springer.com/10.1007/BF02518872. 
  4. 4.0 4.1 4.2 4.3 4.4 Berenholz, J.; Sims, T.; Botros, G. (April 2018). "HIFEM™ TECHNOLOGY CAN IMPROVE QUALITY OF LIFE OF INCONTINENT PATIENTS". Presented at 38th ASLMS annual conference on energy-based medicine & science. https://www.avantemedicalcenter.com/images/documents/BTL_Emsella_LF_White-paper_ENUS100.pdf. 
  5. 5.0 5.1 Katz, Bruce; Bard, Robert; Goldfarb, Richard (April 2018). "CHANGES IN SUBCUTANEOUS ABDOMINAL FAT THICKNESS FOLLOWING HIGH-INTENSITY FOCUSED ELECTRO-MAGNETIC (HIFEM) FIELD TREATMENTS: A MULTI CENTER ULTRASOUND STUDY". Presented at 38th ASLMS annual conference on energy-based medicine & science. 
  6. Jacob, Carolyn I.; Paskova, Katya (2018-09-17). "Safety and efficacy of a novel high-intensity focused electromagnetic technology device for noninvasive abdominal body shaping" (in en). Journal of Cosmetic Dermatology. doi:10.1111/jocd.12779. ISSN 1473-2130. https://doi.org/10.1111/jocd.12779. 
  7. Barker, A.T.; Jalinous, R.; Freeston, I.L. (1985-05). "NON-INVASIVE MAGNETIC STIMULATION OF HUMAN MOTOR CORTEX". The Lancet 325 (8437): 1106–1107. doi:10.1016/s0140-6736(85)92413-4. ISSN 0140-6736. http://linkinghub.elsevier.com/retrieve/pii/S0140673685924134. 
  8. Busso, Mariano; Denkova, Radina (April 2018). "EFFICACY OF HIGH INTENSITY ELECTRO-MAGNETIC FIELD THERAPY WHEN USED FOR NON-INVASIVE BUTTOCK AUGMENTATION AND LIFTING: A CLINICAL STUDY". Presented at 38th ASLMS annual conference on energy-based medicine & science. 
  9. Carolyn, Jacob; Kinney, Brian; Busso, Mariano; Chilukuri, Suneel; McCoy, JD; Bailey, Chris; Denkova, Radina (April 2018). "High intensity focused electro-magnetic technology (HIFEM) for non-invasive buttocks lifting and toning of gluteal muscles: a multi-center efficacy and safety study". Presented at 38th ASLMS annual conference on energy-based medicine & science. 
  10. 10.0 10.1 10.2 Alinsod, Red M. (April 2018). "HIFEM TECHNOLOGY – A NEW PERSPECTIVE IN TREATMENT OF STRESS URINARY INCONTINENCE" (in en). https://www.aslms.org/annual-conference-2018/learn/program-at-a-glance/clinical-applications-gynecologic-women's-health-saturday. 
  11. 11.0 11.1 11.2 Samuels, J; Guerette, N. (April 2018). "HIFEM TECHNOLOGY – THE NON-INVASIVE TREATMENT OF URINARY INCONTINENCE". Presented at 38th ASLMS annual conference on energy-based medicine & science. 
  12. Doucet, Barbara M.; Lam, Amy; Griffin, Lisa (2012-6). "Neuromuscular electrical stimulation for skeletal muscle function". The Yale Journal of Biology and Medicine 85 (2): 201–215. ISSN 1551-4056. PMID 22737049. 
  13. "ELECTRICAL STIMULATION BURNS - Physical Therapy Malpractice Causes Electrical Stimulation Burns". http://pgmedicalmalpractice.com/physical-therapy-errors/electrical-stimulation-burns/. 
  14. Kraemer, William J. (1999-11-01). Strategies for Optimizing Strength, Power, and Muscle Hypertrophy in Women: Contribution of Upper Body Resistance Training. Fort Belvoir, VA. doi:10.21236/ada371349. https://dx.doi.org/10.21236/ada371349. 
  15. Charette, S. L.; McEvoy, L.; Pyka, G.; Snow-Harter, C.; Guido, D.; Wiswell, R. A.; Marcus, R. (1991-5). "Muscle hypertrophy response to resistance training in older women". Journal of Applied Physiology (Bethesda, Md.: 1985) 70 (5): 1912–1916. doi:10.1152/jappl.1991.70.5.1912. ISSN 8750-7587. PMID 1864770. 
  16. Schoenfeld, Brad J (2010-10). "The Mechanisms of Muscle Hypertrophy and Their Application to Resistance Training" (in en). Journal of Strength and Conditioning Research 24 (10): 2857–2872. doi:10.1519/jsc.0b013e3181e840f3. ISSN 1064-8011. https://insights.ovid.com/crossref?an=00124278-201010000-00040. 
  17. Seynnes, O. R.; de Boer, M.; Narici, M. V. (2007-1). "Early skeletal muscle hypertrophy and architectural changes in response to high-intensity resistance training". Journal of Applied Physiology (Bethesda, Md.: 1985) 102 (1): 368–373. doi:10.1152/japplphysiol.00789.2006. ISSN 8750-7587. PMID 17053104. 
  18. Alway, S. E.; Grumbt, W. H.; Gonyea, W. J.; Stray-Gundersen, J. (1989-7). "Contrasts in muscle and myofibers of elite male and female bodybuilders". Journal of Applied Physiology (Bethesda, Md.: 1985) 67 (1): 24–31. doi:10.1152/jappl.1989.67.1.24. ISSN 8750-7587. PMID 2759948. 
  19. Tesch, Per A. (1987), "Acute and Long-Term Metabolic Changes Consequent to Heavy-Resistance Exercise" (in english), Muscular Function in Exercise and Training, Medicine and Sport Science, 26, S. Karger AG, pp. 67–89, doi:10.1159/000414707, ISBN 9783805545983, https://www.karger.com/Article/Abstract/414707, retrieved 2018-07-17 
  20. Weiss, Robert; Bernardy, Jan (April 2018). "INDUCTION OF FAT APOPTOSIS BY A NON-THERMAL DEVICE: SAFETY AND MECHANISM OF ACTION OF NON-INVASIVE HIFEM TECHNOLOGY EVALUATED IN A HISTOLOGICAL PORCINE MODEL". Presented at 38th ASLMS annual conference on energy-based medicine & science. 
  21. Gunduz, Feyza; Aboulnasr, Fatma M; Chandra, Partha K; Hazari, Sidhartha; Poat, Bret; Baker, Darren P; Balart, Luis A; Dash, Srikanta (2012). "Free fatty acids induce ER stress and block antiviral activity of interferon alpha against hepatitis C virus in cell culture" (in En). Virology Journal 9 (1): 143. doi:10.1186/1743-422x-9-143. ISSN 1743-422X. PMID 22863531. PMC 3490746. http://virologyj.biomedcentral.com/articles/10.1186/1743-422X-9-143. 
  22. Zhang, Yong; Xue, Rongliang; Zhang, Zhenni; Yang, Xia; Shi, Hongyang (2012). "Palmitic and linoleic acids induce ER stress and apoptosis in hepatoma cells" (in En). Lipids in Health and Disease 11 (1): 1. doi:10.1186/1476-511x-11-1. ISSN 1476-511X. PMID 22221411. PMC 3306830. http://lipidworld.biomedcentral.com/articles/10.1186/1476-511X-11-1. 
  23. 23.0 23.1 Delgado, Cidranes E.; Estrada, Blanco (June 2018). "Safety And Preliminary Efficacy of Magnetic Stimulation of Pelvic Floor with Hifem Technology in Urinary Incontinence". Medical & Clinical Research 3. https://medclinres.org/pdfs/2018/safety-and-preliminary-efficacy-of-magnetic-stimulation-of-pelvic-floor-with-hifem-technology-in-urinary-incontinence-mcr-18.pdf.