Medical Policy: 02.01.15
Original Effective Date: February 2000
Reviewed: June 2021
Revised: June 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Surface electromyography (sEMG) technologies have been studied as a complement or potential alternative to needle electromyography (nEMG) and nerve condition studies (NCS) for the investigation of neuromuscular disorders and evaluate abnormal patterns of electrical activity in the paraspinal muscles in patients with back pain symptoms such as spasm, tenderness, limited range of motion, or postural disorders. The sEMG recording techniques vary significantly, but all involve analysis of myoelectrical signals using sensors positioned on the skin surface.
Surface electromyography (sEMG) is also referred to as surface scanning EMG, is a non-invasive, computer-based technique that records the electrical impulses using electrodies placed on the surface of the skin overlying the nerve at rest (i.e., static) and during activity (i.e., dynamic). The procedure studies the topography of the motor unit action potential (MUAP) and is assessed by computer analysis of the frequency spectrum, amplitude or root mean square of the electrical action potential. The sEMG differs from needle electromyography (nEMG) with respect to technical requirements and electrical properties. sEMG electrodes measure from a wide area of muscle, have a relatively narrow frequency band (range 20 to 500 Hz), have a low-signal resolution, and are highly susceptible to movement artifact. The proposed use for this type of EMG is to aid in the diagnosis of neuromuscular disorders and low back pain, and to aid in assessing the prognosis of disorders involving muscle lesions. The technology has also been used to monitor bruxism (i.e., grinding and clenching of teeth). The electrical activity of muscle may be recorded with surface EMG, although spontaneous electrical activity and voluntary motor units cannot be. The clinical utility of surface EMG has not been proven in the peer-reviewed medical literature.
High-density surface electromyography (HD-sEMG) is a non-invasive technique to measure electrical muscle activity with multiple (more than 2) closely spaced electrodes overlying a restricted area of the skin. Besides temporal activity, HD-sEMG also allows spatial EMG activity to be recorded, thus expanding the possibilities to detect new muscle characteristics. Muscle fiber conduction velocity (MFCV) measurements and the evaluation of single motor unit (MU) characteristics come into view. In principle, HD-sEMG allows pathological changes at the MU level to be detected, especially changes in neurogenic disorders and channelopathies. The clinical effectiveness of HD-sEMG has not been established; well- designed studies are needed to ascertain the clinical utility of HD-sEMG.
The difficulty in identifying the source of pathology for most low back pain disorders has led researchers to develop new technology to help in the diagnosis of low back pain. Assessment approaches based on paraspinal surface electromyography signal techniques have been proposed to overcome some of the problems identified in other technologies. The concept is to measure and identify the presence of abnormal muscle functioning in a manner that will suggest a form of treatment.
Paraspinal sEMG, also referred to as paraspinal EMG scanning, has been investigated as a method of assessing the paraspinal muscles of patients which provide support to the spinal column. Impairment of the paraspinal muscles may lead to abnormal motion and pain. The paraspinal sEMG is performed using a single electrode or an array of electrodes placed on the skin surface with recordings that are typically made at rest, in various positions or after physical activity.
Paraspinal surface EMG (sEMG) is an office- based procedure that may be most commonly used by physiatrists or chiropractors. The following clinical applications of the paraspinal sEMG have been proposed:
The diagnostic utility of paraspinal sEMG is not known, and its role in patient management has not been established.
There is insufficient evidence in the medical literature to support the use of any type of surface electromyography (sEMG) as the diagnostic utility is unknown and the role in patient management has not been established. Further well-designed clinical trials are needed to standardize sEMG approaches and diagnostic algorithms, increase diagnostic performance and to assess the role of sEMG in clinical practice. Therefore, this testing is considered investigational for all indications.
There have been a limited number of studies in the peer-reviewed medical literature addressing the use of surface electromyography (sEMG) devices for seizure monitoring. Currently, there are no society guidelines that have published recommendations on the use of sEMG for this indication.
Surface electromyography (sEMG) devices have been proposed as an adjunct in recording and storing data for characterization of seizure events in the home during periods of rest. The sEMG device is placed on the belly of the biceps muscle of an individual. An alarm alerts the caregivers when the device detects signal patterns associated with unilateral, appendicular, tonic extension that is potentially related to a generalized tonic-clonic seizures (GTCS).
In 2017, Halford et. al. published a prospective, multicenter, phase III trial that investigated an surface electromyography (sEMG) monitoring system for the detection of generalized tonic-clonic seizures (GTCS). In 11 epilepsy centers, 199 individuals were monitored for GTCS by the sEMG seizure monitoring system between August 2013 and December 2015; however, 50 (25%) individuals did not have proper placement of the sEMG device or had technical issues, such as sEMG data not being archived for reprocessing, but were still included in the trial. There were 29 (15%) individuals who withdrew from the trial early; however, the sEMG data recorded prior to withdrawal was included in the final data analysis. Three video EEG (vEGG) reviewers, who were not study site investigators, evaluated system detections and GTCS identified by clinical care providers. Using a majority rules approach, the data was independently adjudicated by the vEEG reviewers, who were blinded to system detections and sEMG recordings. Results showed that 37 (19%) of the individuals had at least one GTCS with a total of 46 GTCS identified with vEEG. The sEMG device detected 35 of the 46 GTCS (76%; 95% CI, 0.65-1.0) with a mean false alarm rate (FAR) of 2.5 per 24 hours. For data recorded while the device was appropriately positioned over the midline of the biceps muscle, the test system detected 29 of 29 GTCS (100%; 95% CI, 0.88-1.00) with a mean false alarm rate (FAR) of 1.44 per 24 hours. However, FAR for those properly wearing the device varied between 0 and 10 per 24 hours. The results of this small validation study are promising but challenged by a high false alarm rate for many of the users.
In 2018, Beniczky et. al. reported on the results of a prospective, multicenter study that evaluated the accuracy of surface electromyography (sEMG) device in the detection of generalized tonic-clonic seizures (GTCS) in 71 individuals at 3 centers between October 2014 and January 2017. Individuals underwent video EEG (vEEG) monitoring as a comparison for the sEMG device and results were reviewed by three clinical neurophysiologists and epileptologists who were blinded to all sEMG device data until the analysis of the vEEG recordings was completed. The data showed that 20 (28%) individuals had at least 1 GTCS with a total of 32 GTCS. The sensitivity of the sEMG device, defined as the percentage of GTCS detected, was 93.8% (30 out of 32 GTCS) (95% CI, 86%-100%). The specificity of the sEMG device, defined as the false alarm rate (FAR), was 0.67 per day. There was a total of 161 seizures other than GTCS that were identified in the vEEG recordings. Large field studies, with long-term, ambulatory use of the device, are necessary to evaluate its potential in reducing the number of seizure-related injuries and ultimately the number of sudden unexpected death in epilepsy (SUDEP).
Studies published to date are limited to studies performed in an inpatient setting. It is unclear if the test performance of surface electromyography (sEMG) monitoring of generalized tonic-clonic seizures (GTCS) in an ambulatory or home setting would be similar to the results obtained the inpatient settings. It is also unclear as to how using sEMG monitoring for GTCS would impact the management and treatment outcome (for example, seizure frequency, status epilepticus, aspiration, injury or death) of individuals with this disorder. Randomized, prospective comparative trials demonstrating the clinical utility of the device are needed. The evidence is insufficient to determine the effects of the technology on net health outcomes.
AANEM Evidenced Based Review: Use of Surface Electromyography in the Diagnosis and Study of Neuromuscular Disorders:
Further research is necessary to determine the clinical utility of sEMG in the diagnosis of neuromuscular diseases and in the differentiation of primary myopathic and neuropathic conditions.
In 2019 the American College of Occupational and Environmental Medicine (ACOEM), updated their practice guideline for diagnostic tests for low back disorders which states the following: Surface electromyography (sEMG) has been used to diagnose LBP and involves the recording of summated muscle electrical activity by skin electrodes (such as those used in an electrocardiogram or EKG). There are four moderate-quality studies incorporated into this analysis and no quality evidence of diagnostic efficacy, and thus, is not recommended to diagnose LBP. (Not Recommended, Insufficient Evidence (I), High Confidence).
SEMG devices approved by the U.S. Food and Drug Administration (FDA) include those that use a single electrode or a fixed array of multiple surface electrodes. Examples include the CMAP Pro (Medical Technologies) and Model 9200 EMG System (Myotronics-Noromed).
Several FDA approved devices combine SEMG along the spine with other types of monitors. For example, in 2007, the Insight Discovery (Fasstech) was cleared for marketing through the 510(k) process. The device contains 6 sensor types, one of which is for SEMG. The indications include measuring bilateral differences in SEMG along the spine and measuring SEMG along the spine during functional tasks.
sEMG devices have been proposed as an adjunct in recording and storing data for characterization of seizure events in the home or healthcare facilities during periods of rest. The sEMG device is placed on the belly of the biceps muscle of an individual. An alarm alert caregivers when the device detects signal patterns associated with unilateral, appendicular, tonic extension that is potentially related to a GTCS. While continuing to record sEMG data for future review, the alarms can be turned off by a physician order (U.S. Food and Drug Administration, 2019).
The U.S. Food and Drug Administration (FDA) cleared the SPEAC System (Brain Sentinel, Inc., San Antonio, TX), formerly known as the Brain Sentinel Monitoring and Alerting System (Predicate), through the 510(k) premarket approval process on May 11, 2019 as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The SPEAC System Traditional 510(k) Summary lists several warnings and limitations, including (FDA, 2019):
New features in the SPEAC System compared to the Brain Sentinel Monitoring and Alerting System include an increase in the surface area of the electrode patch and a feature for the physician to turn off alarms while still recording data. Currently, there are no other FDA cleared sEMG devices for seizure monitoring.
Surface electromyography (sEMG) including but not limited to the following, for the evaluation of neuromuscular disorders and to evaluate abnormal patterns of electrical activity in the paraspinal muscles for any indication is considered investigational.
There is insufficient evidence in the medical literature to support the use of any type of surface electromyography (sEMG) as the diagnostic utility is unknown and the role in patient management has not been established. Further well-designed clinical trials are needed to standardize sEMG approaches and diagnostic algorithms, increase diagnostic performance and to assess the role of sEMG in clinical practice. The evidence is insufficient to determine the effects of this technology on net health outcomes.
The use of surface electromyography (sEMG) devices for seizure monitoring and for all other indications is considered investigational, because the evidence is insufficient to determine the effects of the technology on net health outcomes.
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