Pulsed electromagnetic field therapy | |
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Other names | Pulsed 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]
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]
This article or section appears to contradict itself on the evidence supporting PEMF therapy.(January 2023) |
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] PEMFs is generally not among the guidelines to treat bone and osteochondral defects. Notwithstanding, there is strong evidence for ELF-PEMF treatment. [5] Pulsed Electromagnetic Fields promote the synthesis of skeletal extracellular matrix. The physiologic process of the response of skeletal cells to PEMF is the synthesis of extracellular matrix structural and signaling molecules in the wound. The result of the signaling processes is to instruct skeletal cells to synthesize structural extracellular matrix and signaling molecules and enhance the ability of skeletal tissues to respond to changing physicochemical environments and biomechanical demands, and facilitate healing. [6] A reduction in time to union and an increase in the percentage of fracture healing in PEMF-stimulated patients compared with controls was reported in fresh tibial fractures, [7] and in femoral neck fractures. [8]
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, [9] 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. [9]
Veterinarians were the first health professionals to use PEMF therapy, usually to attempt to heal broken legs in racehorses. [10] 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. [10] On 8/9 September 2020 the FDA recommended to shift PEMF medical devices from the Class 3 category to a Class 2 status. [11] PEMF devices that have been FDA cleared are able to make health claims that require a doctor's prescription for use.[ citation needed ] [12] [ 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. [13] [14] [15] [16] The use of electrical stimulation in the lumbosacral region was first attempted by Alan Dwyer of Australia. [17] [18]
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. [12] 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. [12]
A 2013 review found that evidence was of very low quality, there might be a benefit for improved function, and there was no evidence for benefit for pain. [19]
In 2017 the wearable ActiPatch PEMF Device was FDA 510k Cleared, Application #K152432, for "Adjunctive treatment of musculoskeletal pain related to: (1) plantar fasciitis of the heel; and (2) osteoarthritis of the knee". This clearance was for over the counter use. [20]
Use of pulsed electromagnetic field therapy has been studied for depression. Researchers speculated that "the [postulated] antidepressant effect of PEMF may be specifically attributable to its effects on local brain activity and connectivity." [21]
In 2019 a wearable RecoveryRx PEMF Device was FDA Cleared, Application K190251, for "Adjunctive treatment of postoperative pain". [22]
In January 2020 the wearable ActiPatch was granted FDA 510k Clearance, Application # K192234, for over the counter marketing relating to "Adjunctive treatment of musculoskeletal pain". [23] The manufacturer of ActiPatch, Bioelectronics Corp, submitted 3 clinical studies to support the efficacy of ActiPatch relating to musculoskeletal pain. [23]
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.
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.
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.
Transcutaneous electrical nerve stimulation is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes. TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to reduce pain. The unit is usually connected to the skin using two or more electrodes which are typically conductive gel pads. A typical battery-operated TENS unit is able to modulate pulse width, frequency, and intensity. Generally, TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction or low frequency (<10 Hz) with an intensity that produces motor contraction. More recently, many TENS units use a mixed frequency mode which alleviates tolerance to repeated use. Intensity of stimulation should be strong but comfortable with greater intensities, regardless of frequency, producing the greatest analgesia. While the use of TENS has proved effective in clinical studies, there is controversy over which conditions the device should be used to treat.
Degenerative disc disease (DDD) is a medical condition typically brought on by the normal aging process in which there are anatomic changes and possibly a loss of function of one or more intervertebral discs of the spine. DDD can take place with or without symptoms, but is typically identified once symptoms arise. The root cause is thought to be loss of soluble proteins within the fluid contained in the disc with resultant reduction of the oncotic pressure, which in turn causes loss of fluid volume. Normal downward forces cause the affected disc to lose height, and the distance between vertebrae is reduced. The anulus fibrosus, the tough outer layers of a disc, also weakens. This loss of height causes laxity of the longitudinal ligaments, which may allow anterior, posterior, or lateral shifting of the vertebral bodies, causing facet joint malalignment and arthritis; scoliosis; cervical hyperlordosis; thoracic hyperkyphosis; lumbar hyperlordosis; narrowing of the space available for the spinal tract within the vertebra ; or narrowing of the space through which a spinal nerve exits with resultant inflammation and impingement of a spinal nerve, causing a radiculopathy.
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 wound healing. Additionally, the term "electrotherapy" or "electromagnetic therapy" has also been applied to a range of alternative medical devices and treatments.
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.
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.
Low-intensity pulsed ultrasound (LIPUS) is a technology that can be used for therapeutic purposes. It exploits low intensity and pulsed mechanical waves in order to induce regenerative and anti-inflammatory effects on biological tissues, such as bone, cartilage, and tendon. Even if the real mechanism underlying its effectiveness has not been understood yet, it is plausible that the treatment relies on non-thermal phenomena, such as microbubbles and microjets induced by cavitation, acoustic streaming, and mechanical stimulation.
Energy medicine is a branch of alternative medicine based on a pseudo-scientific belief that healers can channel "healing energy" into a patient and effect positive results. The field is defined by shared beliefs and practices relating to mysticism and esotericism in the wider alternative medicine sphere rather than any sort of unified terminology, leading to terms such as energy healing or vibrational medicine being used as synonymous or alternative names. In most cases there is no empirically measurable energy involved: the term refers instead to so-called subtle energy. Practitioners may classify the practice as hands-on, hands-off, and distant where the patient and healer are in different locations. Many schools of energy healing exist using many names: for example, biofield energy healing, spiritual healing, contact healing, distant healing, therapeutic touch, Reiki or Qigong.
Extracorporeal shockwave therapy (ESWT) is a non-invasive, out-patient alternative to surgery for those with many joint and tendon disorders. ESWT sends acoustic shock waves into bone or soft tissue, in effect reinjuring the area on a cellular level and breaking up the scarring that has penetrated tendons and ligaments. The controlled reinjuring of tissue allows the body to regenerate blood vessels and bone cells. The resulting revascularization leads to faster healing and often a return to pre-injury activity levels. ESWT is mostly used for kidney stones removal, in physical therapy and orthopedics.
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.
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.
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.
Neuronetics is a Malvern, PA based, publicly traded company incorporated in Delaware in April 2003, that develops non-invasive treatments for psychiatric disorders that have shown resistance or lack of improvement using traditional medicine. The treatments are based upon neuromodulation technology.
Electromagnetic therapy or electromagnetic field therapy refers to therapy involving the use of magnets or electromagnets.
Chandler's disease, also known as idiopathic avascular osteonecrosis of the femoral head, is a rare condition in which the bone cells in the head of the femur (FH) die due to lack of blood. This disease is caused when blood flow is reduced to the part of a bone near a joint. It is specifically unique because the femoral head is for some reason the only affected part of the body and rarely travels down to the main part of the femur. In 1948, F. A. Chandler did a multi-case review and first released his interpretations as Coronary Disease of the Hip. This term is now considered incorrect as it improperly describes the actual disease.
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.
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.
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.
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