Pulsed electromagnetic field therapy

Last updated
Pulsed electromagnetic field therapy
Rhumart MBI 3000 RESC Controller.JPG
Drolet's 1990 Rhumart system, a PEMF device.
Other namesPulsed magnetic therapy, pulse magnetotherapy (PEMF)

Pulsed electromagnetic field therapy (PEMFT, or PEMF therapy), also known as low field magnetic stimulation (LFMS) is the use of electromagnetic fields in an attempt to heal non-union fractures and depression. [1] By 2007 the FDA had cleared several such stimulation devices. [2]

Contents

In 2013 the U.S. Food and Drug Administration (FDA) warned a manufacturer for promoting the device for unapproved uses such as cerebral palsy and spinal cord injury. [3]

Efficacy

An old fracture with nonunion of the fracture fragments. Nonunion2010.JPG
An old fracture with nonunion of the fracture fragments.

While PEMF therapy is claimed to offer some benefits in the treatment of fractures, the evidence is inconclusive and is insufficient to inform current clinical practice. [4]

History

Prior to 2000, in parallel with the PEMF research being done in Western Europe, the United States, and Japan, a great deal of scientific work was being done in scientific isolation behind the Iron Curtain, as summarized in a detailed technical report, [5] showing scientific evidence for promising benefits from the use of PEMF for a very wide range of applications including peripheral vascular disease, lung disease, gastrointestinal disease, neurological disease, rheumatic disease, pediatrics, dermatology, surgery, gynecology, oral medicine, otorhinolaryngology, ophthalmology, immunity, inflammation, reproduction, and tumors, based on over 200 referenced scientific papers involving both human and animal studies. [5]

Veterinarians were the first health professionals to use PEMF therapy, usually to attempt to heal broken legs in racehorses. [6] In 2004, a pulsed electromagnetic field system was approved by the FDA as an adjunct to cervical fusion surgery in patients at high risk for non-fusion. [6] On 8/9 September 2020 the FDA recommended to shift PEMF medical devices from the Class 3 category to a Class 2 status. [7] PEMF devices that have been FDA cleared are able to make health claims that require a doctor's prescription for use.[ citation needed ] [8] [ failed verification ]

Although claims that electricity might aid bone healing were reported as early as 1841, it was not until the mid-1950s that scientists seriously studied the subject. During the 1970s, Bassett and his team introduced a new approach which attempted to treat delayed fractures; a technique that employed a very specific biphasic low frequency signal to be applied for non-union/delayed fractures. [9] [10] [11] [12] The use of electrical stimulation in the lumbosacral region was first attempted by Alan Dwyer of Australia. [13] [14]

Wellness devices

The original PEMF devices consisted of a Helmholtz coil which generated a magnetic field. The patient's body was placed inside the magnetic field to deliver treatment. Today, the majority of PEMF wellness devices resemble a typical yoga mat in dimensions but are slightly thicker to house several flat spiral coils to produce an even electromagnetic field. A frequency generator is then used to energize the coils to create a pulsed electromagnetic field. A wide variety of professional and consumer PEMF devices are sold and marketed as FDA registered wellness devices. [8] The majority are manufactured in Germany, Austria and Switzerland and are imported into North America as electric massagers or full body electric yoga mats. They are either placed on a massage table for clinical use or directly on the floor in the home to practice simple yoga postures. The companies that sell and manufacture them as "general wellness products" are not permitted to make medical claims of effectiveness in treating disease. [8]

See also

Related Research Articles

Magnetic therapy is a pseudoscientific alternative medicine practice involving the weak static magnetic field produced by a permanent magnet which is placed on the body. It is similar to the alternative medicine practice of electromagnetic therapy, which uses a magnetic field generated by an electrically powered device. Magnet therapy products may include wristbands, jewelry, blankets, and wraps that have magnets incorporated into them.

<span class="mw-page-title-main">Transcranial magnetic stimulation</span> Brain stimulation using magnetic fields

Transcranial magnetic stimulation (TMS) is a noninvasive form of brain stimulation in which a changing magnetic field is used to induce an electric current at a specific area of the brain through electromagnetic induction. An electric pulse generator, or stimulator, is connected to a magnetic coil connected to the scalp. The stimulator generates a changing electric current within the coil which creates a varying magnetic field, inducing a current within a region in the brain itself.

<span class="mw-page-title-main">Cranial electrotherapy stimulation</span> Form of neurostimulation

Cranial electrotherapy stimulation (CES) is a form of neurostimulation that delivers a small, pulsed, alternating current via electrodes on the head. CES is used with the intention of treating a variety of conditions such as anxiety, depression and insomnia. CES has been suggested as a possible treatment for headaches, fibromyalgia, smoking cessation, and opiate withdrawal, but there is little evidence of effectiveness for many of these conditions and the evidence for use in acute depression is not sufficient to justify it.

<span class="mw-page-title-main">Electrotherapy</span> Use of electricity for medical purposes, and to stimulate Muscle for more strength.

Electrotherapy is the use of electrical energy as a medical treatment. In medicine, the term electrotherapy can apply to a variety of treatments, including the use of electrical devices such as deep brain stimulators for neurological disease. The term has also been applied specifically to the use of electric current to speed up wound healing. The use of EMS is also very wide for dealing with muscular pain. Additionally, the term "electrotherapy" or "electromagnetic therapy" has also been applied to a range of alternative medical devices and treatments. Evidence supporting the effectiveness of electrotherapy is limited.

<span class="mw-page-title-main">Implant (medicine)</span> Device surgically placed within the body for medical purposes

An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. For example, an implant may be a rod, used to strengthen weak bones. Medical implants are human-made devices, in contrast to a transplant, which is a transplanted biomedical tissue. The surface of implants that contact the body might be made of a biomedical material such as titanium, silicone, or apatite depending on what is the most functional. In 2018, for example, American Elements developed a nickel alloy powder for 3D printing robust, long-lasting, and biocompatible medical implants. In some cases implants contain electronics, e.g. artificial pacemaker and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents.

<span class="mw-page-title-main">Vagus nerve stimulation</span> Medical treatment that involves delivering electrical impulses to the vagus nerve

Vagus nerve stimulation (VNS) is a medical treatment that involves delivering electrical impulses to the vagus nerve. It is used as an add-on treatment for certain types of intractable epilepsy, cluster headaches, treatment-resistant depression and stroke rehabilitation.

<span class="mw-page-title-main">Nonunion</span> Failure of a bone to heal after breakage

Nonunion is permanent failure of healing following a broken bone unless intervention is performed. A fracture with nonunion generally forms a structural resemblance to a fibrous joint, and is therefore often called a "false joint" or pseudoarthrosis. The diagnosis is generally made when there is no healing between two sets of medical imaging, such as X-ray or CT scan. This is generally after 6–8 months.

<span class="mw-page-title-main">Spinal fusion</span> Immobilization or ankylosis of two or more vertebrae by fusion of the vertebral bodies

Spinal fusion, also called spondylodesis or spondylosyndesis, is a surgery performed by orthopaedic surgeons or neurosurgeons that joins two or more vertebrae. This procedure can be performed at any level in the spine and prevents any movement between the fused vertebrae. There are many types of spinal fusion and each technique involves using bone grafting—either from the patient (autograft), donor (allograft), or artificial bone substitutes—to help the bones heal together. Additional hardware is often used to hold the bones in place while the graft fuses the two vertebrae together. The placement of hardware can be guided by fluoroscopy, navigation systems, or robotics.

Bioelectromagnetics, also known as bioelectromagnetism, is the study of the interaction between electromagnetic fields and biological entities. Areas of study include electromagnetic fields produced by living cells, tissues or organisms, the effects of man-made sources of electromagnetic fields like mobile phones, and the application of electromagnetic radiation toward therapies for the treatment of various conditions.

<span class="mw-page-title-main">Anterior cervical discectomy and fusion</span> Surgical procedure

Anterior cervical discectomy and fusion (ACDF) is a surgical procedure to treat nerve root or spinal cord compression by decompressing the spinal cord and nerve roots of the cervical spine with a discectomy, followed by inter-vertebral fusion to stabilize the corresponding vertebrae. This procedure is used when other non-surgical treatments have failed.

<span class="mw-page-title-main">Radionics</span> Form of alternative medicine

Radionics—also called electromagnetic therapy (EMT) and the Abrams method—is a form of alternative medicine that claims that disease can be diagnosed and treated by applying electromagnetic radiation (EMR), such as radio waves, to the body from an electrically powered device. It is similar to magnet therapy, which also applies EMR to the body but uses a magnet that generates a static electromagnetic field.

Total disc replacement (TDR), or artificial disc replacement (ADR), is a type of arthroplasty in which degenerated intervertebral discs in the vertebral column are replaced with artificial disc implants in the lumbar (lower) or cervical (upper) spine. The procedure is used to treat chronic, severe low back pain and cervical pain resulting from degenerative disc disease. Disc replacement is also an alternative intervention for symptomatic disc herniation with associated arm and hand, or leg symptoms.

Pulsed radiofrequency is the technique whereby radio frequency (RF) oscillations are gated at a rate of pulses (cycles) per second (one cycle per second is known as a hertz (Hz)). Radio frequency energies occupy 1.0×104 Hz to 3.0×1011 Hz of the electromagnetic spectrum. Radio frequency electromagnetic energy is routinely produced by RF electrical circuits connected to a transducer, usually an antenna.

Electromagnetic therapy or electromagnetic field therapy refers to therapy involving the use of magnets or electromagnets.

Neurostimulation is the purposeful modulation of the nervous system's activity using invasive or non-invasive means. Neurostimulation usually refers to the electromagnetic approaches to neuromodulation.

<span class="mw-page-title-main">Spinal stenosis</span> Disease of the bony spine that results in narrowing of the spinal canal

Spinal stenosis is an abnormal narrowing of the spinal canal or neural foramen that results in pressure on the spinal cord or nerve roots. Symptoms may include pain, numbness, or weakness in the arms or legs. Symptoms are typically gradual in onset and improve with leaning forward. Severe symptoms may include loss of bladder control, loss of bowel control, or sexual dysfunction.

Cardiac contractility modulation is a therapy which is intended for the treatment of patients with moderate to severe heart failure with symptoms despite optimal medical therapy who can benefit from an improvement in cardiac output. The short- and long-term use of this therapy enhances the strength of ventricular contraction and therefore the heart's pumping capacity by modulating (adjusting) the myocardial contractility. This is provided by a pacemaker-like device that applies non-excitatory electrical signals adjusted to and synchronized with the electrical action in the cardiac cycle.

Neuromodulation is "the alteration of nerve activity through targeted delivery of a stimulus, such as electrical stimulation or chemical agents, to specific neurological sites in the body". It is carried out to normalize – or modulate – nervous tissue function. Neuromodulation is an evolving therapy that can involve a range of electromagnetic stimuli such as a magnetic field (rTMS), an electric current, or a drug instilled directly in the subdural space. Emerging applications involve targeted introduction of genes or gene regulators and light (optogenetics), and by 2014, these had been at minimum demonstrated in mammalian models, or first-in-human data had been acquired. The most clinical experience has been with electrical stimulation.

Non-invasive cerebellar stimulation is the application of non-invasive neurostimulation techniques on the cerebellum to modify its electrical activity. Techniques such as transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) can be used. The cerebellum is a high potential target for neuromodulation of neurological and psychiatric disorders due to the high density of neurons in its superficial layer, its electrical properties, and its participation in numerous closed-loop circuits involved in motor, cognitive, and emotional functions.

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, which are used in health informatics.

References

  1. Martiny, K; Lunde, M; Bech, P (15 July 2010). "Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression". Biological Psychiatry. 68 (2): 163–169. doi:10.1016/j.biopsych.2010.02.017. PMID   20385376. S2CID   799448.
  2. Markov, Marko S (2007). "Expanding Use of Pulsed Electromagnetic Field Therapies". Electromagnetic Biology & Medicine. 26 (3): 257–274. doi:10.1080/15368370701580806. PMID   17886012. S2CID   10871893.
  3. "Warning Letters – Curatronic Ltd. 1/9/13". www.fda.gov. Archived from the original on 26 July 2018. Retrieved 7 January 2018.
  4. Griffin, XL; Costa, ML; Parsons, N; Smith, N (13 April 2011). "Electromagnetic field stimulation for treating delayed union or non-union of long bone fractures in adults". The Cochrane Database of Systematic Reviews (4): CD008471. doi:10.1002/14651858.CD008471.pub2. PMID   21491410.
  5. 1 2 Jerabeck, J; Pawluk, W (1998). Magnetic therapy in eastern Europe : a review of 30 years of research. W. Pawluk. ISBN   0966422708.[ page needed ]
  6. 1 2 "Electrical stimulation of the spine as an adjunct to spinal fusion procedures". Blue Cross & Blue Shield of Mississippi. Archived from the original on 2015-04-02. Pulsed electromagnetic field systems with FDA PMA include the EBI Bone Healing System from Electrobiology, Inc., which was first approved in 1979 and indicated for nonunions, failed fusions, and congenital pseudarthroses; and the Cervical-Stim from Orthofix, which was approved in 2004 as an adjunct to cervical fusion surgery in patients at high risk for non-fusion.
  7. "Reclassification of Non-Invasive Bone Growth Stimulators" . Retrieved 12 July 2024.
  8. 1 2 3 "General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff" (PDF). U.S. Food and Drug Administration. 29 July 2016. Retrieved 16 February 2016.
  9. Bassett CA, Pawluk RJ, Pilla AA; Pawluk; Pilla (1974). "Acceleration of fracture repair by electromagnetic fields. A surgically noninvasive method". Ann N Y Acad Sci. 238 (1): 242–262. Bibcode:1974NYASA.238..242B. doi:10.1111/j.1749-6632.1974.tb26794.x. PMID   4548330. S2CID   40853657.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  10. Bassett CA, Pawluk RJ, Pilla AA; Pawluk; Pilla (1974). "Augmentation of Bone Repair by Inductively Coupled Electromagnetic Fields". Science. 184 (4136): 575–577. Bibcode:1974Sci...184..575B. doi:10.1126/science.184.4136.575. PMID   4821958. S2CID   21947271.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  11. Bassett CA, Pilla AA, Pawluk RJ; Pilla; Pawluk (1977). "A non-operative salvage of surgically-resistant pseudarthroses and non-unions by pulsing electromagnetic fields. A preliminary report". Clin Orthop. 124 (124): 128–143. doi:10.1097/00003086-197705000-00017. PMID   598067.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  12. Bassett CA, Mitchell SN, Norton L, Pilla A; Mitchell; Norton; Pilla (1978). "Repair of non-unions by pulsing electromagnetic fields". Acta Orthop Belg. 44 (5): 706–724. PMID   380258.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  13. Mackenzie, Donald, Francis D Veninga; Veninga (2004). "Reversal of delayed union of anterior cervical fusion treated with pulsed electromagnetic field stimulation: case report". Southern Medical Journal. 97 (5): 519–524. doi:10.1097/00007611-200405000-00021. PMID   15180031.{{cite journal}}: CS1 maint: multiple names: authors list (link)[ unreliable medical source? ]
  14. Bose, B (2001). "Outcomes after posterolateral lumbar fusion with instrumentation in patients treated with adjunctive pulsed electromagnetic field stimulation". Advances in Therapy. 18 (1): 12–20. doi:10.1007/BF02850247. PMID   11512529. S2CID   35946552.