Medical Policies - Medicine


Surface Electrical Stimulation

Number:MED201.026

Effective Date:10-01-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Surface electrical stimulation is considered experimental, investigational and/or unproven for any indication* including, but not limited to, ANY of the following:

H-Wave electrical stimulation for all indications including, but not limited to:

o Treatment of pain,

o Wound healing,

o Post-operative treatment to improve function and/or range of motion; or

Threshold electrical stimulation for all indications including, but not limited to:

o Treatment of motor disorders, or

o Treatment of cerebral palsy; or

Microcurrent stimulation; or

Galvanic stimulation; or

Electroceutical therapy, which is identified by other names including, but not limited to, non-invasive neuron blockade, electroceutical neuron blockade, bioelectric treatment systems; or

Cranial electrotherapy stimulation (CES) for all indications including, but not limited to, treatment of anxiety disorders, depression, substance abuse or any other mental health purposes (e.g. Alpha-Stim®); or

Treatment of dysphagia (e.g., VitalStim™); or

Treatment of scoliosis (e.g., ScoliTron™); or

Treatment of muscle weakness in adults with advanced disease (e.g. advanced chronic respiratory disease, chronic heart failure, cancer, or HIV/AIDS).

*NOTE: This policy does not apply to any electrical stimulation modality that is addressed in a separate medical policy. Electrical stimulation modalities that are specifically addressed in a separate medical policy include:

Auricular electrostimulation, see SUR702.005.

Transcutaneous electrical stimulation (TENS), including transcutaneous electrical modulation pain reprocessing (TEMPR), and conductive garments, see MED201.040.

Interferential (IF) current stimulation, see MED201.041.

Electrical stimulation for the treatment of arthritis, see MED201.042.

Sympathetic therapy, see MED201.043.

Functional Neuromuscular Electrical Stimulation (FNMES), see MED201.033

Description:

Surface neuromuscular electrical stimulation uses devices that transmit electrical impulses by way of electrodes placed on the skin. Although the various types of stimulation may differ in waveform or method of delivering current, electrical stimulation is postulated to generally have any of the following physiological effects:

Re-education of muscle;

Development and increase of muscle tone and strength;

Maintenance or increase of range of motion;

Improvement of local blood circulation;

Prevention of muscle atrophy;

Relaxation of muscular spasms;

Create a state of generalized relaxation for relief of anxiety, depression, and/or insomnia.

The following are descriptions and uses of some different types of surface electrical stimulation.

H-Wave Electrical Stimulation

H-wave stimulation is a distinct form of electrical stimulation, and an H-wave device is U.S. Food and Drug Administration (FDA)-approved for medical purposes that involve repeated muscle contractions. H-wave electrical stimulation has been evaluated primarily as a pain treatment, but it has also been studied for other indications such as wound healing and improving post-surgical range of motion. Both office-based and home models of the H-wave device are available.

H-wave stimulation differs from other forms of electrical stimulation, such as transcutaneous electrical nerve stimulation (TENS), in terms of its wave form. While H-wave stimulation may be performed by physicians, physiatrists, chiropractors, or podiatrists, H-wave devices are also available for home use. H-wave stimulation has been used for the treatment of pain related to a variety of etiologies, such as diabetic neuropathy, muscle sprains, temporomandibular joint dysfunctions, or reflex sympathetic dystrophy. H-wave stimulation has also been used to accelerate healing of wounds such as diabetic ulcers and to improve range of motion and function after orthopedic surgery.

H-wave electrical stimulation must be distinguished from the H-waves that are a component of electromyography.

In 1992, the H-Wave® muscle stimulator (Electronic Waveform Lab, Huntington Beach, CA) was cleared for marketing by the FDA through the 510(k) process. The FDA classified H-wave stimulation devices as “powered muscle stimulators.” As a class, the FDA describes these devices as being “intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.” According to the FDA, manufacturers may make the following claims regarding the effect of the device: “1) relaxation of muscle spasms; 2) prevention or retardation of disuse atrophy; 3) increasing local blood circulation; 4) muscle re-education; 5) immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and, 6) maintaining or increasing range of motion.” (1)

Uses of the device not cleared by the FDA include, but are not limited to, treatment of diabetic neuropathy and wound healing.

Threshold Electrical Stimulation

Threshold electrical stimulation is provided by a small electrical generator, lead wires, and surface electrodes that are placed over the targeted muscles. The intensity of the stimulation is set at the sensory threshold and does not cause a muscle contraction.

Threshold electrical stimulation is described as the delivery of low-intensity electrical stimulation to target spastic muscles during sleep at home. The stimulation is not intended to cause muscle contraction. Although the mechanism of action is not understood, it is thought that low-intensity stimulation may increase muscle strength and joint mobility, leading to improved voluntary motor function. The technique has been used most extensively in children with spastic diplegia related to cerebral palsy but also in those with other motor disorders, such as spina bifida.

Devices used for threshold electrical stimulation are classified as “powered muscle stimulators.” As a class, these devices are described by the FDA as “an electronically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.”

Microcurrent Stimulation

Microcurrent stimulation is similar to TENS, except that it uses current in the microampere range, which is 1000 times less than that of TENS and below sensation threshold. While TENS is used for pain, the sub-sensory microcurrent stimulation acts on the body’s naturally occurring electrical impulses to decrease pain and facilitate healing. The device is used to manage acute and chronic pain, reduce edema and inflammation, promote wound healing, and treat anxiety disorders. Examples include Health Pax™, VST Myo Dynamic Device™, and Electro-Acuscope™, among others.

Galvanic Stimulation

A high-voltage pulsed galvanic stimulator generates small twin pulses of electrical current at an adjustable rate from two pairs (two pulses) per second to 100 pairs per second. Each pulse is much shorter in duration and has higher voltage than a conventional stimulator. The positive electrode behaves like ice, causing reduced circulation to the area under the pad and reduction in swelling. The negative electrode behaves like heat, causing increased circulation, reportedly speeding healing. Galvanic stimulation is used to treat pain and reduce edema.

Electroceutical Therapy

Electroceutical therapy is also identified by several other names, including non-invasive neuron-blockade, bioelectric nerve block, bioelectric treatment, electroceutical neuron-blockade. This therapy is non-invasive, electrical-based treatment that is given for acute and chronic pain, e.g., fibromyalgia, back pain, neuropathy, joint pain, headache, or reflex sympathetic dystrophy. Electroceutical devices are similar to TENS in that they deliver stimulation through electrodes, or suction cups, attached to the skin; but they differ in that they use an electrical frequency many times higher than TENS. The proposed advantages of electroceutical therapy include relief of pain and reduction or elimination of pain medication. Examples of electroceutical devices may include CellGen HealthStation™ and PRO GeneSys System Electroceutical Treatment.

Cranial Electrotherapy Stimulation (CES)

Cranial electrotherapy stimulation (CES) is a category of FDA approved devices. A CES device applies electrical current to a patient's head to treat insomnia, depression, or anxiety. One example of a CES device is Alpha-Stim®, which uses microcurrent.

Treatment of Dysphagia, i.e., VitalStim™

VitalStim™ is a relatively new treatment for dysphasia (difficulty in swallowing), and is claimed to restore enough swallowing function to reduce or eliminate the need for tube feedings. With VitalStim™ therapy, electrical neuromuscular stimulation is delivered through electrodes attached to the skin of the throat, over the pharyngeal muscles; stimulation activates key swallowing muscles, which helps patients create or re-learn muscle function necessary for swallowing.

Electrical Stimulation as Treatment of Scoliosis

Scoliosis is a progressive lateral curvature of the spine, occurring in the thoracic region and/or lumbar spine. Neuromuscular electrical stimulation has been used as a treatment of idiopathic scoliosis to halt or reverse spinal curvature. This may be accomplished by either surface electrical stimulation of the lateral spinal musculature, or implanted deep muscle electrical stimulation to the paraspinal musculature. There are various stimulators that can be used to treat scoliosis; ScoliTron™ is one example.

Regulatory Status

Many electrical stimulation devices have received marketing clearance through the U.S. Food and Drug Administration (FDA) 510(k) process. Marketing clearance via the 510(k) process does not require data regarding clinical efficacy; these devices are considered substantially equivalent to predicate devices marketed in interstate commerce prior to May 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified and do not require approval of a premarket approval application (PMA).

Rationale:

This policy was originally developed in 2005 and has been updated with searches of peer reviewed literature through April 2018. The following is a summary of key literature to date.

H-Wave Electrical Stimulation

Pain treatment

In 2008, Blum and colleagues published a meta-analysis of studies evaluating the H-Wave device for treatment of chronic soft tissue inflammation and neuropathic pain. (2) Five studies, 2 randomized controlled trials (RCTs) and 3 observational studies, met inclusion criteria. Four of the studies used a measure of pain reduction. In a pooled analysis of data from these 4 studies (treatment groups only), the mean weighted effect size was 0.59. Two studies reported the effect of the H-Wave device on pain mediation use; the mean weighted effect size was 0.56. (An effect size of 0.5 is considered a moderate effect and of 0.80 is considered a large effect.) A limitation of this analysis was that the authors did not use data from patients in the control or comparison groups; thus, the incremental effect of the H-Wave device beyond that of a comparison intervention cannot be determined.

The five studies identified by the systematic review for the meta-analysis were published by two research groups; Kumar and colleagues published three studies and the other two were published by Blum and colleagues. Blum and several co-investigators are consultants to the device manufacturer. Descriptions of the individual published studies are included below.

In 1997, Kumar and Marshall published an RCT comparing active H-wave electrical stimulation with sham stimulation for treatment of diabetic peripheral neuropathy. (3) The authors selected 31 patients with type 2 diabetes and painful peripheral neuropathy in both lower extremities lasting at least 2 months. Patients were excluded if they had vascular insufficiency of the legs or feet or specified cardiac conditions. Patients were randomly assigned to the active group (n=18) or the sham group (n=13). Both groups were instructed to use their devices 30 minutes daily for 4 weeks. The device used in the sham group had inactive electrodes. Outcomes were assessed using a pain-grading scale (ranging from 0 to 5). Both groups experienced significant declines in pain, and the post-treatment mean grade for the active group was significantly lower than the mean grade for the sham group. This study did not state whether patients and/or investigators were blinded and did not state whether any patients withdrew from the study.

Another randomized study published by Kumar and colleagues in 1998 compared active H-wave electrical stimulation with sham stimulation among patients treated initially with a tricyclic antidepressant. (4) The authors enrolled 26 patients with type 2 diabetes and painful peripheral neuropathy persisting for 2 months or more. Exclusion criteria were similar to those used in the earlier study. Amitriptyline was administered for 4 weeks initially, and those who had a partial response or no response were later randomly assigned to the 2 groups. After excluding 3 amitriptyline responders, the active stimulation group included 14 patients, and the sham stimulation included 9 patients. Sham devices had inactive output terminals. Stimulation therapy lasted 12 weeks, and final outcome assessment was conducted by an investigator blinded to group assignment 4 weeks after the end of treatment. As in the earlier study, mean pain grade in both groups improved significantly, but the difference between groups after treatment significantly favored active H-wave stimulation. Results on an analogue scale were similar. It is unclear whether patients were blinded to the type of device, and the report does not note whether withdrawals from the study occurred. A later report from this research group (5) described a case series of 34 patients who continued H-Wave electrical stimulation for more than 1 year and achieved a 44% reduction in symptoms.

Two observational studies on the H-Wave device were published by Blum and colleagues and consisted of patients’ responses to 3 of 10 questions on a manufacturer’s customer service questionnaire (i.e., warranty registration card). (6, 7) In the larger of the two reports, 80% of 8,498 patients with chronic soft tissue injury and neuropathic pain who were given the H-Wave device completed the questionnaire. (7) The answers were compared with an expected placebo response of 37% improvement. Following an average 87 days of use, 65% of respondents reported a decrease in the amount of medication needed, 79% reported an increase in function and activity, and 78% of respondents reported an improvement in pain of 25% or greater.

Wound healing

The only published study identified in literature searches was a case report from 2010 describing outcomes in 3 patients with chronic diabetic leg ulcers who used the H-Wave device. (8)

Post-operative rehabilitation

In 2009, Blum and colleagues published a small double-blind placebo-controlled randomized trial evaluating home use of the H-Wave device for improving range of motion and muscle strength after rotator cuff reconstruction surgery. (9) Electrode placement for the H-Wave device was done during the surgical procedure. After surgery, patients were provided with an active H-wave device (n=12) or sham device (n=10) and were instructed to use the device for 1 hour twice daily for 90 days. Individuals in the sham group were told not to expect any sensation from the device. Both groups also received standard physical therapy. At follow-up, range of motion of the involved extremity was compared to that of the uninvolved extremity. At the 90-day postoperative examination, patients in the H-wave group had significantly less loss of external rotation of the involved extremity (mean loss of 11.7 degrees) compared to the placebo group (mean loss of 21.7 degrees), p=0.007. Moreover, there was a statistically significant difference in internal rotation, a mean loss of 13.3 degrees in the H-wave group and a mean loss of 23.3 degrees in the placebo group, p=0.006. There were no statistically significant differences between groups in postoperative strength. The authors also stated that there was no statistically significant difference on any of the other 4 range-of-motion variables. The study did not assess change in functional status or capacity.

Section Summary H-wave Electrical Stimulation

Two small controlled trials are insufficient to permit conclusions about the effectiveness of H-wave electrical stimulation as a pain treatment. Additional sham-controlled studies are needed from other investigators, preferably studies that are clearly blinded, specify the handling of any withdrawals, and provide long-term, comparative follow-up data. One small RCT represents insufficient evidence on the effectiveness of H-wave simulation for improving strength and function after rotator cuff surgery. No comparative studies have been published evaluating H-wave stimulation to accelerate wound healing. In addition, no studies were identified that evaluated H-wave stimulation for any clinical application other than those described above.

Threshold Electrical Stimulation

Validation of therapeutic electrical stimulation requires randomized, controlled studies that can isolate the contribution of the electrical stimulation from other components of therapy. Physical therapy is an important component of the treatment of cerebral palsy and other motor disorders. Therefore, trials of threshold electrical stimulation ideally should include standardized regimens of physical therapy. Randomized studies using sham devices are preferred to control for any possible placebo effect.

A randomized study published in 1997 included 44 patients with spastic cerebral palsy who had undergone a selective posterior lumbosacral rhizotomy at least 1 year previously. (11) All patients had impaired motor function, but some form of upright ambulation. Patients were randomly assigned to receive either a 12-month period of 8 to 12 hours of nightly electrical stimulation or no therapy. The principal outcome measure was the change from baseline to 12 months in the Gross Motor Function Measure (GMFM), as assessed by therapists blinded to the treatment. The patients and their parents were not blinded; the authors stated that the active device produced a tingling sensation that precluded a double-blind design. Patients were encouraged to maintain whatever ongoing therapy they were participating in. The type of physical therapy in either the control or treatment group was not described.

After 1 year, the mean change in the GMFM was 5.5% in the treated group, compared to 1.9% in the control group, a statistically significant difference. The authors state that this 3.6% absolute difference is clinically significant. For example, a child who was previously only able to rise and stand while pushing on the floor could now do so without using hands. While these results point to a modest benefit, the lack of control for associated physical therapy limits the interpretation.

Five additional studies were identified in the literature over the next 10 years, none of them demonstrating effectiveness. Dali and colleagues published the results of a trial that randomly assigned 57 children with cerebral palsy to receive either threshold electrical stimulation or a dummy device for a 12-month period. (12) Visual and subjective assessments showed a trend in favor of the treatment group, while there was no significant effect of therapeutic electrical stimulation in terms of motor function, range of motion, or muscle size. The authors concluded that therapeutic electrical stimulation was not shown to be effective in this study.

Two smaller randomized controlled studies found no improvement in muscle strength with electrical stimulation. In the van der Linden et al. study, 22 children with cerebral palsy were randomly assigned to receive 1 hour of electrical stimulation to the gluteus maximus daily over a period of 8 weeks to improve gait. No clinical or statistically significant between-group differences were found in measurements of hip extensor strength, gait analysis, passive limits of hip rotation, and section E of the GMFM. (13) Fehlings and colleagues also found no evidence of improved strength in 13 children with types II/III spinal muscular atrophy who were randomly assigned to either receive electrical stimulation or a placebo stimulator during a 12-month period. (14) A study of 24 patients with cerebral palsy demonstrated positive results for the subset that received stimulation combined with dynamic bracing; however, the effect did not last after discontinuing treatment. (15)

Kerr and colleagues randomly assigned 60 children with cerebral palsy to 1 hour daily neuromuscular stimulation (n=18), overnight threshold electrical stimulation (n=20), or overnight sham stimulation (n=22). (16) Blinded assessment following 16 weeks of treatment showed no difference among the groups, as measured by peak torque or by a therapist-scored gross motor function. A parental questionnaire on the impact of disability on the child and family showed improvement for the 2 active groups but not the sham control. Compliance in the threshold electrical stimulation group was 38%; compliance in the placebo group was not reported. Retrospective analysis indicated that the study would require 110 to 190 subjects to achieve 80% power for measures of strength and function.

A 2006 systematic review of electrical stimulation or other therapies given after botulinum toxin injection, conducted by the American Academy for Cerebral Palsy and Developmental Medicine, concluded that the available evidence is poor. (17)

In an UpToDate 2016 article the author notes that electrical stimulation has been used in an effort to increase muscle strength in children with cerebral palsy (CP). In neuromuscular electrical stimulation (NMES), electrical impulses of high intensity and short duration generate muscle contraction. In threshold electrical stimulation (TES), the stimulus is of lower intensity and does not generate muscle contraction; it is typically applied during sleep. While these approaches are appealing, several randomized trials have failed to show clinically significant improvement in muscle strength or function, although the numbers are small in these studies. Two systematic reviews suggest modest efficacy for electrical stimulation interventions, but acknowledged the limitations of the evidence base. (33)

Section Summary Threshold Electrical Stimulation

The studies published to date demonstrate that threshold electrical stimulation is not effective for treatment of spasticity, muscle weakness, reduced joint mobility, or motor function.

Microcurrent Electrical Stimulation

In a study by Korelo et al. (34) the authors evaluated the effect of microcurrent electrical stimulation on pain and area of venous ulcers. This pilot study for a single-blind controlled clinical trial, and was carried out at an outpatient clinic for a period of four weeks, 14 subjects with venous ulcers (mean age 62±9 years) were divided in two groups: microcurrent (n=8) and control group (n=6). Pain (by Visual Analogue Scale) and the ulcer area were measured by planimetry. There was a significant difference between the two groups with respect to pain (microcurrent group from 8.5 (6.5-9.75) to 3.5 (1-4.75) and control group from 7.5 (5.75-10) to 8.5 (5.5-10), p<0.01).

Non-significant changes were found with respect to ulcer area (planimetry by graph paper, p=0.41 and by Image J®, p=0.41). The authors concluded that the application of microcurrent improves the pain of patients with venous ulcers. However, the authors note that further research is needed to evidence the effectiveness of the microcurrent to accelerate the healing process. In addition, they suggest using other electric parameters, including intensity, application time and electrode positioning forms, as well as a larger number of application and longer follow-up time, with a view to the analysis of relapses.

Section Summary: Microcurrent Electrical Stimulation

The limited study evidence for microcurrent electrical stimulation demonstrate further research is needed to determine its effectiveness on pain and to accelerate the healing process.

Other Electrical Stimulation

Electroceutical Therapy

Based on the lack of published long-term outcomes from well-designed random controlled trials, conclusions cannot be reached concerning the effectiveness of electroceutical therapy.

Cranial Electrotherapy Stimulation (CES)

In 2010, O’Connell et al. conducted a Cochrane Review meta-analysis to evaluate the efficacy of non-invasive brain stimulation techniques in chronic pain. The authors concluded that there is insufficient evidence from which to draw firm conclusions regarding the efficacy of CES. The available evidence suggests that CES may be ineffective. There is a need for further, rigorously designed studies of all types of brain stimulation.

Galvanic Stimulation

In 2016 Volkening et al. (36) evaluated the effects of bipolar galvanic vestibular stimulation (GVS) on spatial neglect, extinction and verticality perception in 24 stroke patients. The GVS group received treatments of 1.5mA for 20 minutes with cathodes on the left and right mastoid, while the sham group received treatments of only 30 seconds with cathodes on the left mastoid.

There was a total of 10-12 treatments, one daily five days per week, for both groups, and all patients additionally received a standard therapy of smooth pursuit eye movement training.  The outcomes were Neglect test, visuo-tactile search task, subjective visual and tactile vertical, and these were assessed at baseline, immediately after treatment, and at two and four week follow-up visits. Neither group showed significant improvements in neglect symptoms.  In 2017 Williams et al. (37) published a systematic review (SR) evaluating non-invasive treatments for peripheral artery disease, which included intermittent pneumatic compression, electrical nerve (NMES), muscle stimulators, and galvanic electrical stimulation. Thirty-one papers were reviewed, two of which evaluated the impact of galvanic electrical stimulation on impaired perfusion and microvascular insufficiency or diabetic foot ulcers. The authors stated galvanic stimulation is not recommended.

Treatment for Dysphagia (i.e., VitalStim™)

VitalStim™ has Class II FDA approval, and clinical trials are underway to determine if VitalStim™ can move the voice box or the vocal folds in the larynx, to assess the feasibility of using extrinsic laryngeal muscle stimulation to elevate the larynx in a manner similar to that which occurs during normal swallowing, and to assess whether laryngeal elevation will assist in swallowing. A Medline search located one nursing journal article and no studies or other articles to support electrical stimulation for dysphagia.

In an UpToDate 2016 article the author notes that neuromuscular electrical stimulation involves direct stimulation of muscles to recruit motor units and increase muscle strength. A meta-analysis of seven trials found a small but significant improvement in swallowing overall but there was significant heterogeneity among the trials included. Further studies are needed to clarify the role of neuromuscular electrical stimulation in the treatment of oropharyngeal dysphagia. (34)

In a 2016 RCT by Bath et al. (38), 162 patients with a recent ischemic or hemorrhagic stroke and dysphagia were randomly assigned to PES or sham treatment given on 3 consecutive days. The primary outcome was swallowing safety, assessed using the PAS, at 2 weeks. Secondary outcomes included dysphagia severity, function, quality of life, and serious adverse events at 6 and 12 weeks. In the randomized patients, the mean age was 74 years, male 58%, ischemic stroke 89%, and PAS 4.8. The mean treatment current was 14.8 (7.9) mA and duration 9.9 (1.2) minutes per session. Based on previous data, 45 patients (58.4%) randomized to PES seemed to receive suboptimal stimulation. The PAS at 2 weeks, adjusted for baseline, did not differ between the randomized groups: PES 3.7 (2.0) versus sham 3.6 (1.9), P=0.60. Similarly, the secondary outcomes did not differ, including clinical swallowing and functional outcome. No serious adverse device-related events occurred. The authors concluded that in patients with subacute stroke and dysphagia, PES was safe but did not improve dysphagia. Undertreatment of patients receiving PES may have contributed to the neutral result. In addition, the authors noted that in view of the study discrepancy, and the potential risk of overestimating treatment effect from smaller studies, further studies are planned in stroke patients with severe dysphagia or those requiring intensive care including ventilation.

Treatment for Scoliosis

Electrical stimulation has been proposed as a non-surgical, conservative treatment for scoliosis; however, several studies have shown that electrical stimulation is not as effective as bracing for the treatment of scoliosis. In two separate studies, Allington (24) and Bowen (25), and Nachemson (23) found that bracing was more effective than electrical stimulation as treatment for scoliosis. Durham et al. (20) studied the results of 40 adolescent patients who were treated using the ScoliTron™ and found that electrical stimulation was ineffective in preventing curve progression for idiopathic scoliosis.

In an UpToDate 2016 article the author notes that there is a lack of high-quality evidence from randomized trials that electrical stimulation is an effective treatment. (35)

Treatment of Muscle Weakness

Jones et al. (35) conducted an update of a previously published review in the Cochrane Database of Systematic Reviews Issue 1, 2013 on neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Primary objective in this review was to evaluate the effectiveness of NMES on quadriceps muscle strength in adults with advanced disease. Secondary objectives were to examine the safety and acceptability of NMES, and its effect on peripheral muscle function (strength or endurance), muscle mass, exercise capacity, breathlessness, and health-related quality of life. The review included RCT’s in adults with advanced chronic respiratory disease, chronic heart failure, cancer, or HIV/AIDS comparing a programme of NMES as a sole or adjunct intervention to no treatment, placebo NMES, or an active control.

Eighteen studies (20 reports) involving a total of 933 participants with COPD, chronic respiratory disease, chronic heart failure, and/or thoracic cancer met the inclusion criteria for the update. All but one study that compared NMES to resistance training compared a programme of NMES to no treatment or placebo NMES. Most studies were conducted in a single centre and had a risk of bias arising from a lack of participant or assessor blinding and small study size. The quality of the evidence using GRADE comparing NMES to control was low for quadriceps muscle strength, moderate for occurrence of adverse events, and very low to low for all other secondary outcomes. NMES led to a statistically significant improvement in quadriceps muscle strength as compared to the control (12 studies; 781 participants; SMD 0.53, 95% confidence interval (CI) 0.19 to 0.87), equating to a difference of approximately 1.1 kg. An increase in muscle mass was also observed following NMES, though the observable effect appeared dependent on the assessment modality used (eight studies, 314 participants). Across tests of exercise performance, mean differences compared to control were statistically significant for the 6-minute walk test (seven studies; 317 participants; 35 m, 95% CI 14 to 56), but not for the incremental shuttle walk test (three studies; 434 participants; 9 m, 95% CI -35 to 52), endurance shuttle walk test (four studies; 452 participants; 64 m, 95% CI -18 to 146), or for cardiopulmonary exercise testing with cycle ergometry (six studies; 141 participants; 45 mL/minute, 95% CI -7 to 97). Limited data were available for other secondary outcomes, and the authors could not determine the most beneficial type of NMES programme. The authors recommend further research to understand the role of NMES as a component of, and in relation to, existing rehabilitation approaches.

Practice Guidelines and Position Statements

National Institute of Neurological Disorders and Stroke

According to the National Institute of Neurological Disorders and Stroke, many children and adolescents with cerebral palsy use some form of complementary or alternative medicine. Controlled clinical trials involving some of the therapies have been inconclusive or showed no benefit, and the therapies have not been accepted in mainstream clinical practice. Although there are anecdotal reports of some benefit in some children with cerebral palsy, these therapies have not been approved by the FDA for the treatment of cerebral palsy. Such therapies include hyperbaric oxygen therapy, special clothing worn during resistance exercise training, certain forms of electrical stimulation, assisting children in completing certain motions several times a day, and specialized learning strategies. (18)

American Heart Association/American Stroke Association (AHA/ASA)

In its Guidelines for Adult Stroke Rehabilitation and Recovery, the AHA/ASA state that NMES combined with therapy may improve spasticity, but there is insufficient evidence that the addition of NMES improves functional gait or hand use. The AHA/ASA guidelines are endorsed by the American Academy of Physical Medicine and Rehabilitation and the American Society of Neurorehabilitation. (39)

Summary of Evidence

There is limited evidence to demonstrate how well surface electrical stimulation techniques, addressed in this medical policy works for any indication. A search of peer reviewed literature conducted through April 2018 identified no clinical trial publications or significant scientific information for any additional surface electrical stimulation method or indication that would change the coverage position of this medical policy.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

64550, 97014, 97032

HCPCS Codes

E0744, E0745

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov.

References:

1. Food and Drug Administration. Warning letter. September 17, 1997. Available at: <http://www.fda.gov> (last accessed October 2010).

2. Blum K, Chen AL, Chen TJ et al. The H-Wave device is an effective and safe non-pharmacological analgesic for chronic pain: a meta-analysis. Adv Ther. 2008; 25(7):644-57. PMID: 18636234

3. Kumar D, Marshall HJ. Diabetic peripheral neuropathy: amelioration of pain with transcutaneous electrostimulation. Diabetes Care. 1997; 20(11):1702-5.

4. Kumar D, Alvaro MS, Julka IS et al. Diabetic peripheral neuropathy. Effectiveness of electrotherapy and amitriptyline for symptomatic relief. Diabetes Care. 1998; 21(8):1322-5. PMID: 9702441

5. Julka IS, Alvaro M, Kumar D. Beneficial effects of electrical stimulation on neuropathic symptoms in diabetes patients. J Foot Ankle Surg. 1998; 37(3):191-4. PMID: 9638542

6. Blum K, DiNubile NA, Tekten T, et al. H-Wave, a nonpharmacologic alternative for the treatment of patients with chronic soft tissue inflammation and neuropathic pain: a preliminary statistical outcome study. Adv Ther. 2006; 23(3):446-55. PMID: 16912027

7. Blum K, Chen TJ, Martinez-Pons M, et al. The H-Wave small muscle fiber stimulator, a nonpharmacologic alternative for the treatment of chronic soft-tissue injury and neuropathic pain: an extended population observational study. Adv Ther. 2006; 23(5):739-49. PMID: 17142209

8. Blum K, Chen AL, Chen TJ, et al. Healing enhancement of chronic venous stasis ulcers utilizing H-WAVE® device therapy: a case series. Cases J. 2010; 3:54. PMID: 20181141

9. Blum K, Chen AL, Chen TJ, et al. Repetitive H-wave device stimulation and program induces significant increases in the range of motion of post-operative rotator cuff reconstruction in a double-blinded randomized placebo controlled human study. BMC Musculoskelet Disord. 2009; 10:132. PMID: 19874593

10. H-Wave Electrical Stimulation. Archived. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual. November 2012. Durable Medical Equipment 1.01.13.

11. Steinbok P, Reiner A, Kestle JR. Therapeutic electrical stimulation (ThresholdES) following selective posterior rhizotomy in children with spastic diplegic cerebral palsy: a randomized clinical trial. Dev Med Child Neurol. 1997; 39(8):515-20. PMID: 9295846

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13. van der Linden ML, Hazlewood ME, Aitchison AM, et al. Electrical stimulation of gluteus maximus in children with cerebral palsy: effects on gait characteristics and muscle strength. Dev Med Child Neurol. 2003; 45(6):385-90. PMID: 12785439

14. Fehlings DL, Kirsch S, McComas A, et al. Evaluation of therapeutic electrical stimulation to improve muscle strength and function in children with types II/III spinal muscular atrophy. Dev Med Child Neurol. 2002; 44(11):741-4. PMID: 12418614

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Policy History:

Date Reason
10/1/2018 Document updated with literature review. The following changes were made: The wording “in the outpatient setting” was removed from the coverage statement: Surface electrical stimulation is considered experimental, investigational and/or unproven for any indication* in the outpatient setting including, but not limited to, any of the following: …” In addition, the following was added to the experimental, investigational and/or unproven indications: “Treatment of muscle weakness in adults with advanced disease (e.g. advanced chronic respiratory disease, chronic heart failure, cancer, or HIV/AIDS)”. References 34-39 added.
7/15/2017 Reviewed. No changes.
7/1/2016 Document updated with literature review. Coverage unchanged.
4/15/2015 Reviewed. No changes.
6/1/2014 Document updated with literature review. Coverage unchanged, however the following topics were removed from this policy and placed on separate Medical Policies as follows: * Transcutaneous Electrical Stimulation (TENS), including transcutaneous electrical modulation pain reprocessing (TEMPR), and conductive garments, see MED201.040; * Interferential (IF) Current Stimulation, see MED201.041; * Electrical Stimulation for the Treatment of Arthritis, see MED201.042; * Sympathetic Therapy, see MED201.043.
2/1/2012 CPT/HCPCS codes updated
12/1/2011 Document updated with literature review. Rational was completely revised. The following was changed: Transcutaneous electrical nerve stimulation (TENS) may be considered medically necessary for treatment of refractory chronic pain (e.g., chronic musculoskeletal* or neuropathic pain) that causes significant disruption of function, and pain is unresponsive to at least three (3) months of conservative medical therapy, including nonsteroidal anti-inflammatory medications, ice, rest, and/or physical therapy. (NOTE: It is recommended that the patient should have had a trial of transcutaneous electrical nerve stimulation (TENS) of at least 30 days to establish efficacy of the treatment and compliance in using the device on a regular basis.) All other uses of TENS remain experimental, investigational and unproven. Transcutaneous electrical modulation pain reprocessing (TEMPR) (e.g., scrambler therapy) is considered experimental, investigational and unproven.
2/15/2010 Policy was revised to remove functional neurostimulation from this document; that topic can now be found on Medical Policy MED201.033.
6/1/2009 Policy was updated with literature review. No change in coverage. Description, Rationale, and References were updated for Functional Neurostimulation. CPT coding was updated.
5/1/2008 Revised/Updated Entire Document
4/15/2007 Revised/Updated Entire Document
6/1/2006 Revised/Updated Entire Document
11/1/2005 New Medical Document

Archived Document(s):

Title:Effective Date:End Date:
Surface Electrical Stimulation07-15-201709-30-2018
Surface Electrical Stimulation07-01-201607-14-2017
Surface Electrical Stimulation04-15-201506-30-2016
Surface Electrical Stimulation06-01-201404-14-2015
Surface Electrical Stimulation02-01-201205-31-2014
Surface Electrical Stimulation12-01-201101-31-2012
Surface Electrical Stimulation02-15-201011-30-2011
Surface Electrical Stimulation06-01-200902-14-2010
Surface Electrical Stimulation05-01-200805-31-2009
Surface Electrical Stimulation04-15-200704-30-2008
Surface Electrical Stimulation06-01-200604-14-2007
Surface Electrical Stimulation11-01-200505-31-2006
Transcutaneous Electrical Nerve Stimulation (TENS)09-01-199910-31-2005
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