BlueCross and BlueShield of Montana Medical Policy/Codes
Surface Electrical Stimulation
Chapter: Medicine: Treatments
Current Effective Date: December 27, 2013
Original Effective Date: September 14, 2010
Publish Date: September 27, 2013
Revised Dates: October 11, 2012; September 13, 2013
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 different types of surface electrical stimulation.

Transcutaneous Electrical Nerve Stimulation (TENS)

Transcutaneous electrical nerve stimulation (TENS) uses an electronic device that applies electrical stimulation to the surface of the skin at the site of pain, and is usually used to relieve chronic intractable pain, post-surgical pain, and pain associated with post-trauma injury.  TENS has also been used to treat dementia by altering neurotransmitter activity and increasing brain activity, which is thought to reduce neural degeneration and stimulate regenerative processes.  TENS consists of an electrical pulse generator, usually battery operated, connected by wire to two or more electrodes, which are applied to the skin.

Since 1977, a large number of 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).

Transcutaneous Electrical Modulation Pain Reprocessing (TEMPR)

TEMPR is delivered in the same way as TENS, but instead of blocking pain signals, this therapy sends a “no pain” signal.  Competitive Technologies, Inc. manufactures a device called CALMARE® Pain Therapy Treatment, which has received 510(k) marketing clearance from the FDA as a multi-channel TENS device.  The company describes the Calmare Pain Therapy Treatment as “a non-invasive method for rapid treatment of high-intensity oncologic, neuropathic, and drug-resistant pain through a biophysical rather than a biochemical manner.  The method incorporates electromedical equipment for electronic nerve stimulation, and uses the nerve fiber as a passive means to convey a message of normality to the central nervous system (CNS) by a procedure defined as scrambling or tricking of information, which then enables the CNS to modify the reflex adaptive responses.”  The supposed advantage is that this is a multiprocessor apparatus able to simultaneously treat multiple pain areas in the individual.  The patient experiences longer "no pain" periods after each successive treatment.  TEMPR is administered in the doctor’s office under direct supervision of the physician, who provides an initial consultation to discern the most effective path for electrode placement.  Treatment applications are interactive between the patient and the provider, with the provider attending and making adjustments approximately every 10 minutes throughout the treatment session, which typically lasts an hour. 

Interferential (IF) Stimulation

Interferential stimulation (IF) uses paired electrodes of two independent circuits carrying medium-frequency alternating currents that work together to effectively stimulate large muscle fibers.  The electrodes are aligned on the skin so that the current flowing between each pair intersects at the underlying target.  IF therapy delivers higher currents than TENS, using two, four, or six electrodes, arranged in either the same plane for use on regions such as the back, or in different planes in complex regions such as the shoulder.  This stimulation method has been investigated as a technique to reduce pain, improve range of motion, and/or promote local healing following various tissue injuries; uses include pre- and post-orthopedic surgery, joint injury syndrome, cumulative trauma disorders, increasing circulation, and pain management.  There are no standardized protocols for the use of IF therapy; the therapy may vary according to the frequency of stimulation, the pulse duration, treatment time, and electrode-placement technique.  A number of interferential stimulator devices have received 510(k) marketing from the FDA; examples include the RS-4i™ Interferential (RS Medical) and Medstar™ 100 (MedNet Services). 

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.

H-wave Stimulation

H-wave stimulation differs from TENS in terms of its wave form; this is a unique form of electrical stimulation that uses a bi-polar and exponentially decaying wave form resulting in a pulse width measured in milliseconds rather than microseconds.  H-wave stimulation is said to accomplish reduction of edema and the reduction or elimination of pain, as well as assist wound healing.  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.”  Uses of the device not cleared by the FDA include, but are not limited to, treatment of diabetic neuropathy and wound healing.

Threshold Stimulation

Threshold electrical stimulation delivers low-intensity electrical stimulation to target spastic muscles during sleep.  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, as well as other motor disorders, such as spina bifida.

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

Sympathetic Therapy

Sympathetic therapy describes a type of electrical stimulation of the peripheral nerves that is designed to stimulate the sympathetic nervous system in an effort to "normalize" the autonomic nervous system and alleviate chronic pain.  Unlike TENS or IF electrical stimulation, sympathetic therapy is not designed to treat local pain, but is designed to induce a systemic effect on sympathetically induced pain.

Sympathetic therapy uses four intersecting channels of various frequencies with bilateral electrode placement in various locations on the feet, legs, arms, and hands, depending on the location of the patient's pain and the treatment protocols supplied by the manufacturer.  Electrical current is then induced with beat frequencies between 0 and 1000 Hz.  Treatment may include daily one-hour treatments in the physician's office, followed by home treatments if the initial treatment is effective.

The Dynatron® STS device and a companion home device, Dynatron STS® Rx, are devices that deliver sympathetic therapy.  These devices received FDA clearance in March 2001 through a 510(k) process.  The FDA-labeled indication is symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.

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.

Other Types of Electrical Stimulation

Treatment of Osteoarthritis, e.g., BioniCare™ BIO-1000

Osteoarthritis is characterized by degeneration of articular cartilage with proliferation and remodeling of subchondral bone.  Electrical stimulation has been used to improve functional status and relieve pain related to osteoarthritis and rheumatoid arthritis unresponsive to other standard therapies.  Electrical stimulation is provided by an electronic device that noninvasively delivers a low-voltage, monophasic electrical field to the target site of pain.  In basic research studies, pulsed electrical stimulation has been shown to alter chondrocyte-related gene expression in vitro and to have regenerative effects in animal models of cartilage injury.

The BioniCare™ BIO-1000 stimulator has received FDA clearance for marketing as a type of TENS device for use in osteoarthritis of the knee and rheumatoid arthritis of the hand.  The BioniCare™ Bio-1000 consists of an electrical stimulation device with electrical leads that are placed on the knee and thigh, and held in place with a lightweight, flexible wrap and Velcro fasteners.  The battery-powered device delivers small electrical currents of up to 12.0 volt output. The device is recommended to be worn for at least six hours per day; this can be done while sleeping.

The FDA’s 510(k) summary specifies that the BioniCare™ Stimulator, Model BIO-1000 is indicated for use as an adjunctive therapy in reducing the level of pain and for symptoms associated with both osteoarthritis of the knee and rheumatoid arthritis of the hand. 

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.

Conductive Garments

A conductive garment is a form-fitted, lycra-spandex garment containing electrodes, wires, and connectors that greatly simplify electrical stimulation therapy.  These are supplied in many forms, including sleeves for shoulder, arm, hip or leg; belts; shorts; vest; gloves; socks; or collar. These garments provide allowance for accurate placement of multiple electrodes without professional assistance, insurance that electrodes stay in position, and avoidance of skin irritation caused by adhesive on electrode pads.  There are many brands and styles available; two examples are Bioflex Wearable Therapy System™ and RS-FBG® full back garment.

Policy

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.

Coverage

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.

TENS is considered experimental, investigational and unproven for any other condition including, but not limited to:

  • Management of acute pain (e.g., postoperative or during labor and delivery);
  • Treatment of dementia..

Other surface electrical stimulation is considered experimental, investigational and unproven for any indication in the outpatient setting including, but are not limited to, any of the following:

  • Transcutaneous electrical modulation pain reprocessing (TEMPR) (e.g., scrambler therapy); or
  • Interferential (IF) stimulation; or
  • Microcurrent stimulation; or
  • Galvanic stimulation; or
  • H-wave stimulation; or
  • Threshold stimulation; or
  • Sympathetic therapy; 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) used for treatment of anxiety disorders, depression, substance abuse or any other mental health purposes (one example is Alpha-Stim®); and/or
  • Treatment of osteoarthritis (e.g., BioniCare™), or
  • Treatment of dysphagia (e.g., VitalStim™), or
  • Treatment of scoliosis (e.g., ScoliTron™).

Form-fitting conductive garments, e.g., vest, gauntlet, etc., are considered not medically necessary as they are considered convenience items.

Policy Guidelines

Although electroceutical therapy is also called bioelectric nerve block, it is a non-invasive, surface treatment.  CPT codes for “Introduction/Injection of Anesthetic Agent (Nerve Block)” (codes 64400 through 64530) are not appropriate to bill for electroceutical therapy.

Rationale

The rationale is based on Blue Cross Blue Shield Association (BCBSA) policies and Technology Evaluation Center (TEC) Assessments, as well as MEDLINE search for additional published, peer-reviewed studies.

Transcutaneous Electrical Nerve Stimulation (TENS)

A 1996 BCBSA TEC Assessment of TENS for the treatment of chronic and postoperative pain found that the evidence did not clearly show that the effects of TENS exceeded placebo effects.  An updated literature search in October 2002 identified several Cochrane Reviews of TENS.  One of the reviews, last amended in June 2000, addressed chronic pain due to a variety of conditions (e.g., osteoarthritis of the knee, rheumatoid arthritis of the wrist, pancreatic, myofascial trigger points, chronic back pain, temporomandibular joint pain, and a variety of nociceptive and neuropathic causes of pain).  A total of 19 randomized trials were judged as meeting study selection criteria, but due to heterogeneity of methods and inability to extract sufficient dichotomous pain outcomes data, it was concluded that meta-analysis was not possible, and the review of evidence was inconclusive.  The trials reviewed did not indicate which stimulation parameters were most likely to provide pain relief, or answer questions about long-term effectiveness.  The authors suggested a need for large, multicenter, randomized, controlled trials of TENS in chronic pain.

In a 2004 literature review update, two additional Cochrane Reviews were identified along with several randomized controlled trials (RCTs) on the use of TENS.  Neither the Cochrane Reviews nor any of the RCTs identified were sufficient to alter the previous conclusions.  The authors of the Cochrane reviews concluded that the evidence was inadequate to draw conclusions about the effects of TENS.

The policy previously examined the Cochrane reviews on TENS that had been published between 2000 and 2007.  Three additional Cochrane reviews were published or updated in 2008, addressing the topics of TENS for cancer pain, chronic low back pain, and other chronic pain conditions.  Another five Cochrane reviews were published or updated between 2009 and June 2010 on the topics of acute pain, labor pain, neck pain, phantom limb pain, and osteoarthritis of the knee.  In 2010, the American Academy of Neurology (AAN) published an evidence-based review of the efficacy of TENS in the treatment of pain in neurologic disorders, including low back pain and diabetic peripheral neuropathy.  The evidence on TENS for specific conditions is described below.

Chronic Pain

Low Back Pain

Cochrane reviews from 2005, updated in 2008, concluded that there is limited and inconsistent evidence for the use of TENS as an isolated treatment for low back pain.  For the treatment of chronic low back pain, four high-quality RCTs (585 patients) met the selection criteria.  There was conflicting evidence about whether TENS reduced back pain and consistent evidence from two of the trials (410 patients) indicated that it did not improve back-specific functional status.  The review concluded that the evidence available at this time did not support the use of TENS in the routine management of chronic low back pain.

In 2010, the American Academy of Neurology (AAN) published an evidence-based review of the efficacy of TENS in the treatment of pain in neurologic disorders.  The evidence on TENS for chronic low back pain of various etiologies (some neurologic) included two class I studies (prospective randomized trial with masked outcome assessment in a representative population) and three class II studies (randomized trial not meeting class I criteria or a prospective matched group cohort study in a representative population).  The class I studies compared TENS to TENS-sham with four or six weeks of treatment.  Although both studies were adequately powered to find at least a 20% difference in pain reduction by visual analog scale (VAS), after correction for multiple comparisons, no significant benefit was found for TENS compared to TENS-sham. In two of the three class II studies, no significant differences were found between TENS and TENS-sham.  In the third class II study, benefit was found in 1/11 patients treated with conventional TENS, 4/11 treated with burst-pattern TENS, and 8/11 treated with frequency-modulated TENS.  Overall, evidence was found to be conflicting.  Because the class I studies provide stronger evidence, the AAN considered the evidence sufficient to conclude that TENS is ineffective for the treatment of chronic low back pain.

Diabetic Peripheral Neuropathy

The AAN’s 2010 evidence-based review of the efficacy of TENS in the treatment of pain in neurologic disorders identified two class II studies comparing TENS to TENS-sham and one class III study that compared TENS to high-frequency muscle stimulation for patients with mild diabetic peripheral neuropathy.  The studies found a modest reduction in VAS for TENS compared to TENS-sham, with a larger proportion of patients feeling benefit with high-frequency muscle stimulation compared to TENS.  The authors concluded that on the basis of these two class II studies, TENS is probably effective in reducing pain from diabetic peripheral neuropathy, although there are presently no studies comparing TENS to other treatment options.

Cancer Pain

For the 2008 Cochrane review on TENS for cancer pain, only two RCTs (total of 64 participants) met the selection criteria for inclusion in the systematic review.  There were no significant differences between TENS and placebo in the included studies, and results of the review were considered inconclusive due to a lack of suitable RCTs.

Osteoarthritis of the Knee

A Cochrane review from 2000 found TENS and acupuncture-like TENS to be more effective than placebo for the treatment of knee osteoarthritis but indicated that due to heterogeneity of the included studies, more well-designed trials with adequate numbers of participants were needed to conclude effectiveness.  An updated Cochrane review from 2009 identified 14 additional trials, resulting in the inclusion of 18 small trials in 813 patients.  Eleven trials used TENS, four used interferential current stimulation, one trial used both TENS and interferential current stimulation, and two trials used pulsed electrostimulation.  The methodologic quality and the quality of reporting were found to be poor.  In addition, there was a high degree of heterogeneity among the trials and the funnel plot for pain was asymmetrical, suggesting both publication bias and bias from small studies.  The predicted difference in pain scores between electrostimulation and control was 0.2 cm on a 10-cm visual analog scale.  The effect of electrostimulation on function was small but potentially clinically relevant, and the evidence appeared to be less affected by biases associated with small sample size.  Overall, the evidence on TENS for pain relief in patients with osteoarthritis of the knee was considered to be inconclusive.

In 2007, Bjordal et al. published a meta-analysis on the short-term efficacy of physical interventions for osteoarthritic knee pain.  Included in the review were 11 studies (259 subjects on active therapy) using TENS, acupuncture-like TENS (AL-TENS), or interferential stimulation; 9 of the 11 studies were included in the meta-analysis reviewed above.  Combined data revealed a 19 mm improvement in VAS over placebo (a “slight improvement”), with a confidence interval ranging from 10 mm (a “minimal perceptible improvement”) to 28 mm (above the 20 mm threshold of an “important improvement”).  These results are similar to an earlier Cochrane review (overlap of six studies) on the use of TENS or AL-TENS for osteoarthritis of the knee.  The inclusion of two studies on interferential stimulation (with an unweighted average improvement in VAS of 34 mm over placebo) may also have increased the magnitude of the effect.  Considering that the potential for publication bias is high when combining a number of small studies in a meta-analysis (particularly when the effect is small), evidence of short-term relief of chronic musculoskeletal pain remains weak.  Results from these positive meta-analyses must also be balanced against other systematic reviews of musculoskeletal pain syndromes that found mixed and inconclusive results.

Rheumatoid Arthritis

Cochrane reviews from 2002 and 2003 concluded that results in patients with rheumatoid arthritis were conflicting.

Phantom Limb Pain

A 2010 Cochrane review found no RCTs on TENS for phantom pain and stump pain following amputation.  The authors concluded that the published literature on TENS for phantom limb pain in adults lacks the methodologic rigor and robust reporting needed to confidently assess its effectiveness and that further RCT evidence is required.

Neck Pain

Cochrane reviews from 2005 and 2009 evaluated various types of electrotherapy for neck pain.   Eighteen small trials (total of 1,043 subjects with neck pain) with 23 comparisons were included in the most recent (2009) systematic review.  The authors found very low quality evidence that TENS is more effective than placebo.

Headache

A 2004 Cochrane review assessed noninvasive physical treatments for chronic and/or recurrent headache.  Twenty-two studies with a total of 2,628 patients (age 12 to 78 years) met the inclusion criteria.  The review included five types of headache and various noninvasive treatments including spinal manipulation, electromagnetic fields, and a combination of TENS and electrical neurotransmitter modulation.  Combination TENS and electrical neurotransmitter modulation was found to have weak evidence of effectiveness for migraine headache.  Either the combination treatment or TENS alone had weak evidence of effectiveness for the prophylactic treatment of chronic tension-type headache.  The authors concluded that although these treatments appear to be associated with little risk of serious adverse effects, the clinical effectiveness and cost-effectiveness of noninvasive physical treatments requires further research using scientifically rigorous methods.

Mixed Chronic Pain Conditions

A 2008 Cochrane review updated the evidence on the use of TENS for the treatment of various chronic pain conditions, including rheumatoid arthritis with wrist pain, temporomandibular joint dysfunction, multiple sclerosis with back pain, osteoarthritis with knee pain, neuropathy, pancreatitis, and myofascial trigger points, and included 25 RCTs (1,281 patients).  Due to heterogeneity, meta-analysis was not possible; slightly more than half of the studies found a positive analgesic outcome in favor of active TENS treatments.  The authors concluded that the six studies added since the last version of this review did not provide sufficient additional information to change the conclusions and that the published literature lacks the methodologic rigor needed to make confident assessments of the role of TENS in chronic pain management.

An industry-sponsored meta-analysis by Johnson and Martinson included 38 randomized controlled comparisons (1,227 patients from 29 publications) of trans- or percutaneous electrical nerve stimulation for chronic musculoskeletal pain, using any stimulation parameters on any location (e.g., back, neck, hip, knee).  The data were converted to a percentage improvement in VAS scores, and then transformed into standardized mean differences (a continuous measure that adjusts for variability in different outcome measures).  Based on the combined standardized difference, the authors concluded that TENS provided pain relief “nearly three times” the pain relief provided by placebo.  There are a number of sources of bias in the analysis that seriously limit interpretation of the results.  First, the heterogeneity of the individual study results (I2 = 82%) raises questions about the appropriateness of combining these studies in a meta-analysis (e.g., previous discussion regarding the decision to not combine studies for the 2000 Cochrane review on chronic pain).  Further limiting interpretation is the transformation of data to standardized effect size, which appears to have led to discrepant effect sizes of otherwise similar results.  For example, comparison of the untransformed and transformed data shows that while two of the included trials (Deyo et al. 1990, and Machin et al. 1988), found similar percentage point differences in VAS between active and control groups (5% and 8%, respectively), the standardized effect sizes are not equivalent.

Positive standardized effect sizes from data that are not statistically or clinically significant (e.g., 47% vs. 42% change from baseline in Deyo et al.) also raises concerns about the appropriateness of the data transformation.  Inclusion of poor-quality studies is an additional concern, since several of the studies with the greatest effect sizes reported drop-out rates exceeding 25%.  Furthermore, bias for publication of small positive studies may not have been adequately addressed, since the “Fail-safe N” method used to assess publication bias is problematic.  

Another major limitation in interpretation of this meta-analysis is the absence of information about whether electrical nerve stimulation (ENS) results in a clinically meaningful improvement. For example, there was no discussion of the magnitude of the combined change in VAS scores or of the proportion of patients who achieved clinically meaningful improvements.  Examination of the data indicates that there was less than a 15% difference between the ENS and placebo groups (with an average difference of 4%) for 13 of the 38 (34%) comparisons.  The small effect observed in many of these small studies raises further questions about the contribution of publication bias to the meta-analysis.  Also at issue is the relative contribution of percutaneous ENS (PENS), since meta-regression found PENS to be more effective than TENS.  Given the substantial uncertainty regarding the appropriateness of the studies included and how the data were transformed, combined with questions regarding the clinical significance of the results, the results from this meta-analysis are considered inconclusive.

A 2006 randomized sham-controlled trial (163 patients with diverse pain states) reported that although no differences in VAS pain scores were observed, more patients were satisfied following 10 days (10-12 hours/day) of TENS (58%) than following use of a sham device (43%). Analysis of the results by type of pain (osteoarthritis-related, neuropathic, or bone/soft tissue/visceral) in a subsequent report showed no difference in patient satisfaction for the group with osteoarthritis and related disorders (39% vs. 31%, n=31, 26, both respectively) or in patients with neuropathic pain (63% vs. 48%, n=16, 25, both respectively), and greater satisfaction with TENS in the group of patients with injury of bone and soft tissue or visceral pain (74% vs. 48%, n=34, 31, both respectively).  The nearly 50% patient satisfaction rating in the sham control group suggests a strong nonspecific effect with this treatment protocol.

Acute Pain

Injury

One double-blind randomized, sham-controlled trial found that during emergency transport of 101 patients, TENS reduced post-traumatic hip pain with a change in visual analog scale (VAS) from 89 to 59, whereas the sham-stimulated group remained relatively unchanged (86 to 79). 

Surgical Pain

In a double-blind study, 40 patients undergoing inguinal herniorrhaphy were randomly assigned to active or placebo TENS for postsurgical pain.  Pain scores measured prior to the first treatment were 5.2 on a 10-point scale for the active TENS group and 5.3 for the placebo TENS group.  Two 30-minute sessions of TENS at 2 and 4 hours after surgery reduced both analgesic use and pain scores measured up to 24 hours after surgery (mean pain score of 0 vs. 3.4, respectively). Blinding appears to have been maintained, as 95% of subjects from both groups reported that they would use TENS again in the future to treat their pain.  Confirmation of these results is needed.

Dysmenorrhea

One 2002 Cochrane review of nine small, controlled trials found high-frequency TENS to be effective for the treatment of dysmenorrhea.

Labor and Delivery

A 2009 Cochrane review included 19 studies with 1,671 women.  Overall, there was little difference in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (risk ratio 0.41).  The review found limited evidence that TENS reduces pain in labor, and did not seem to have any impact (either positive or negative) on other outcomes for mothers or babies.  The authors concluded that although it is not clear that TENS reduces pain, they thought that women should have the choice of using TENS in labor if they think it will be helpful.

Mixed Acute Pain Conditions

A 2009 Cochrane review assessed the efficacy of TENS as a sole treatment for acute pain conditions that included procedural pain (e.g., cervical laser treatment, venipuncture, screening flexible sigmoidoscopy) and nonprocedure pain (e.g., postpartum uterine contractions and rib fractures).  Twelve RCTs involving 919 participants at entry were included.  A meta-analysis could not be performed due to insufficient data, and the authors were unable to make any definitive conclusions about the effectiveness of TENS as an isolated treatment for acute pain in adults.

Other

Dementia

Efficacy of TENS for dementia was considered inconclusive in a Cochrane review from 2003.

Stroke

Efficacy of TENS for shoulder pain after stroke was considered inconclusive in another Cochrane review from 2000.  In 2009, a randomized controlled trial with 109 hemiparetic stroke survivors reported a beneficial effect of TENS combined with exercise on walking (gait velocity and timed up and go test) after stroke.

Summary

In 2010, the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology (AAN) published an evidence-based review of the efficacy of TENS in the treatment of pain in neurologic disorders.  The AAN concluded that TENS is not recommended for the treatment of chronic low back pain due to lack of proven efficacy (level A, established evidence from two class I studies), and that TENS should be considered for the treatment of painful diabetic neuropathy (Level B, probably effective, based on two class II studies).

The American Pain Society and American College of Physicians published guidelines on therapies for acute and low back pain in 2007.  No recommendations for TENS were made; the panel concluded that TENS had not been proven effective for chronic low back pain.

The European Federation of Neurological Societies published 2007 guidelines on neurostimulation for neuropathic pain.  The task force was not able to arrive at conclusive recommendations, with only approximately 200 patients with different diseases, in studies using different parameters and comparators, and with variable results.  The task force concluded that standard high-frequency TENS is possibly (level C) better than placebo, and probably (level B) worse than acupuncture-like or any other kind of electrical stimulation.

The American Geriatrics Society’s 2002 guideline on the management of persistent pain in older persons indicated that TENS offers temporary relief and can be used as adjunctive therapy.  This recommendation was based on expert opinion and descriptive studies; clinicians “may or may not follow the recommendation.”

1997 Guidelines on chronic pain management from the American Society of Anesthesiologists recommend that an office or home trial of TENS should be considered as an early management option or as an adjunctive therapy because of its low complexity and low risk.

The American Medical Directors Association created a guideline in 1999 on management of pain for elderly patients in the long-term care setting.  Among complementary therapies, TENS is one for which “Although no scientific evidence supports the effectiveness of these therapies in elderly patients in the long-term care setting, they may be beneficial to some individuals.”

The Department of Defense, Veterans Health Administration, published clinical guidelines for the management of postoperative pain in May 2002.  These guidelines indicate that TENS may be useful for postoperative pain relief for a variety of procedures and sites.  Except for postoperative abdominal pain and pain from cholecystectomy, all of the recommendations are consensus based.  For postoperative abdominal pain and pain from cholecystectomy, the recommendations are based on at least one RCT and general agreement that TENS is acceptable.

Overall, evidence for the use of TENS from high quality trials remains inconclusive for most indications.  There is, on the other hand, weak evidence and strong clinical opinion that TENS can relieve chronic intractable pain in some patients.  Therefore, TENS may be considered medically necessary for the treatment of chronic pain if shown to be effective during a 30-day therapeutic trial.

Transcutaneous Electrical Modulation Pain Reprocessing (TEMPR)

Salahadin et al. conducted a pilot case series of 10 patients with failed back syndrome.  Patients received scrambler therapy treatment for 1 hour per day for 10 days.  The study concluded that this therapy appears to reduce pain in FBSS patients with no side effects, and further studies with more subjects are needed.

Marineo et al. conducted a pilot randomized, controlled study of 55 patients to determine if scrambler therapy relieved chronic neuropathic pain more effectively than guideline-based drug management over a 10-day cycle of sessions.  The study concluded that scrambler therapy appeared to relieve chronic neuropathic pain better than guideline-based pharmacological treatment.

There are five clinical trials of TEMPR at ClinicalTrials.gov: one is ongoing, not accepting new participants; three are in the recruitment phase; and one has not yet started recruiting patients.  Therefore TEMPR is considered experimental, investigational and unproven.

Interferential (IF) Stimulation

In 2010, Fuentes and colleagues published a systematic review and meta-analysis of studies evaluating the effectiveness of IF for treating pain.  A total of 20 studies met the following inclusion criteria: RCT; included adults diagnosed with a painful musculoskeletal condition; compared IFS (alone or as a co-intervention) to placebo; no treatment or an alternative intervention; and assessed pain on a numeric scale.  Fourteen of the trials reported data that could be included in a pooled analysis.  Interferential stimulation as a stand-alone intervention was not found to be more effective than placebo or an alternative intervention.  For example, a pooled analysis of two studies comparing IFC (IF current) alone and placebo did not find a statistically significant difference in pain intensity at discharge; the pooled mean difference (MD) was -1.17 (95% confidence interval [CI]:1.70 to 4.05).  In addition, a pooled analysis of two studies comparing IFC alone and an alternative intervention (e.g., traction or massage) did not find a significant difference in pain intensity at discharge; the pooled MD was -0.16, 95% CI: -0.62 to 0.31.  Moreover, in a pooled analysis of five studies comparing IFC as a co-intervention to a placebo group, there was a non-significant finding (MD=1.60, 95% CI: -0.13 to 3.34).  The meta-analysis found IFC plus another intervention to be superior to a control group (e.g., no-treatment).  A pooled analysis of three studies found an MD of 2.45 (95% CI: 1.69 to 3.22).  The latter analysis is limited in that the specific effects of IFC versus the co-intervention cannot be determined, and it does not control for potential placebo effects.

As with any treatment focused on pain relief, randomized, placebo-controlled trials are particularly important to determine if any treatment effect exceeds the expected treatment effect.

The two trials identified that compared IFC alone to placebo had relatively small sample sizes in each treatment group.  Defrin and colleagues included a total of 62 patients with osteoarthritic knee pain, randomly assigned to one of six groups (there were four active treatment groups and two control groups, sham and non-treated).  Acute pre- versus post-treatment reductions in pain were found in all active groups but not in either control group.  Stimulation resulted in a modest pre-treatment elevation of pain threshold over the four weeks of the study.  Taylor and colleagues randomly assigned 40 patients with temporomandibular joint syndrome or myofascial pain syndrome to undergo either active or placebo interferential therapy.  The principal outcomes were pain assessed by a questionnaire and range of motion (ROM).  There were no statistically significant differences in the outcomes between the two groups.

A systematic review, published in 2008, addressed management of back pain with therapeutic modalities including TENS and interferential current published in 2008.  The authors found no eligible studies on which to base recommendations for IFS.

Other representative trials are described below.

Taylor and colleagues randomized 40 patients with temporomandibular joint syndrome or myofascial pain syndrome to undergo either active or placebo IF stimulation.  The principal outcomes were pain assessed by a questionnaire and range of motion (ROM).  There was no statistically significant difference in the outcomes between the two groups. 

Van der Heijden and colleagues randomized 180 patients with soft tissue shoulder disorders to undergo therapy in one of five groups, in addition to a program of exercise therapy.  The five groups were: IF plus active ultrasound (US), IF plus dummy US, dummy IF plus active US, dummy IF plus dummy US (placebo group), and no adjuvant therapy.  Principal outcome measures included recovery, functional status, chief complaint, pain, clinical status, and range of motion at six weeks after the therapy had been completed and at intervals up to one year.  The authors reported that neither IF therapy nor US proved to be effective as adjuvants to exercise therapy.

Werners and colleagues reported on the results of a study that randomized 152 patients with low back pain to either treatment with IF therapy or traction; this study was not placebo controlled. Outcomes were based on the results of the Oswestry Disability Index and a pain visual analog scale.  The authors reported that both groups recorded improvements in both outcomes over a three month period; there was no statistically significant difference in outcomes between the two groups.  Without a placebo group, it is unknown whether the improvement is related to the natural history of the disease or any intervention.

Hurley and colleagues randomly assigned 60 patients with back pain to one of three groups: IF therapy of the painful area, IF therapy of the spinal nerve, and a control group, who received no IF therapy.  This study was not placebo controlled; lack of a placebo group limits interpretation of these data.

A randomized double-blinded trial compared IFS or horizontal therapy (HT) with sham stimulation in 105 older women with chronic low back pain due to multiple vertebral fractures.   All participants received a full therapeutic exercise program, and blinded evaluation revealed no differences between the groups following two weeks of active or sham stimulation.  However, the active stimulation groups showed post-treatment improvements of approximately 30% in VAS for pain and in the Backill score at the 6- and 14-week follow-up evaluations.  Analgesic consumption decreased by 47%, 57%, and 31%, in the IFS, HT, and control groups, respectively.  The proportion of patients who improved in the HT group was greater than in the sham HT group (odds ratio [OR]: 0.34; 95% CI: 0.13-0.91) but did not achieve statistical significance for the IFS group (OR: 0.49; 95% CI: 0.18-1.29).

Clinical practice guidelines from the American College of Physicians and the American Pain Society, published in 2007, concluded that there was insufficient evidence to recommend interferential stimulation for the treatment of low back pain.  In 2008, the American College of Occupational and Environmental Medicine (ACOEM) issued a guideline on management of chronic pain.  The guideline concluded that the evidence on the effectiveness of interferential stimulation for the treatment of complex regional pain syndrome (CRPS) is insufficient and the intervention is not recommended.

In summary, there is insufficient evidence from well-designed trials that interferential stimulation improves health outcomes for patients diagnosed with painful musculoskeletal conditions.  The limited amount of evidence from trials comparing IFC alone to a placebo intervention does not suggest benefit.  Other trials do not control for potential placebo effects and/or do not adequately evaluate the incremental effects of IFC beyond that of a co-intervention.  Therefore, interferential stimulation is considered experimental, investigational and unproven.

H-Wave Stimulation

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.  Five studies, two RCTs and three observational studies, met inclusion criteria.  Four of the studies used a measure of pain reduction.  In a pooled analysis of data from these four studies (treatment groups only), the mean weighted effect size was 0.59.  Two studies reported the effect of the H-Wave device on pain medication 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, compared active H-wave electrical stimulation with sham stimulation for treatment of diabetic peripheral neuropathy.  The authors selected 31 patients with Type II Diabetes and painful peripheral neuropathy in both lower extremities lasting at least two 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 four 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.

In another randomized study published by Kumar and colleagues in 1998 investigators compared active H-wave electrical stimulation with sham stimulation among patients treated initially with a tricyclic antidepressant.  The authors enrolled 26 patients with Type II Diabetes and painful peripheral neuropathy persisting for two months or more.  Exclusion criteria were similar to those used in the earlier study.  Amitriptyline was administered for four weeks initially, and those who had a partial response or no response were later randomly assigned to the two groups.  After excluding three amitriptyline responders, the active stimulation group included 14 patients, and the sham stimulation included nine 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 four 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 analog scale were similar.  It is unclear if 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 described a case series of 34 patients who continued H-Wave electrical stimulation for more than one 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).  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.  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 three patients with chronic diabetic leg ulcers who used the H-Wave device.

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.  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 one 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 four range of motion variables.  The study did not assess change in functional status or capacity.

Summary

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.  Thus, H-wave electrical stimulation is considered experimental, investigational and unproven.

Threshold Stimulation Rationale

Validation of therapeutic electrical stimulation requires controlled, randomized 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 in order to control for any possible placebo effect.

One randomized trial of threshold electrical stimulation has been published.  The study included 44 patients with spastic cerebral palsy who had undergone a selective posterior lumbosacral rhizotomy at least one year previously.  All patients had impeding motor function, but some form of upright ambulation.  Patients were randomized to receive either a 12-month period of 8-12 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 participation in their ongoing therapy; the type of physical therapy in either the control or treatment group was not described.   After one 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.

Dali and colleagues published the results of a trial that randomized 57 children with cerebral palsy to receive either threshold electrical stimulation or a dummy device for a 12-month period. 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.

To further support the investigational status of electrical stimulation for treatment of motor disorders, two smaller, randomized controlled studies found no improvement in muscle strength with electrical stimulation.  In van der Linden et al., no significant clinical or statistical differences were found in 22 children with cerebral palsy who were randomized to receive either electrical stimulation to the gluteus maximus over a period of eight weeks to improve gait, or no electrical stimulation or additional treatment.  Fehlings and colleagues also found no evidence of improved strength in 13 children with Types II/III spinal muscular atrophy who were randomized to receive either electrical stimulation or a placebo stimulator over a 12-month period.  Another 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.

Kerr and colleagues randomly assigned 60 children with cerebral palsy to one hour daily of neuromuscular stimulation (n=18), overnight threshold electrical stimulation (n=20), or overnight sham stimulation (n=22).  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 two 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.  

Summary

The studies published through August 2011 demonstrate that threshold electrical stimulation is not effective for treatment of spasticity, muscle weakness, reduced joint mobility, or motor function; therefore the treatment remains experimental, investigational and unproven.

Sympathetic Therapy

Ideally, assessment of therapies designed to treat chronic pain should be based on placebo-controlled trials to assess the magnitude of the expected placebo effect and to isolate the contribution of the active treatment.  Outcomes of interest might include reduction in pain medications, changes in scores of a visual analog scale (VAS), quality of life measures, daily activity levels, or return to work.

Dynatron® STS manufacturer, Dynatronics (Salt Lake City, UT), references two studies on their web site, one of which has been published in the peer-reviewed literature.  In the published study, Guido reported on the effects of sympathetic therapy in 20 volunteers suffering from chronic pain related to peripheral neuropathy.  The treatment protocol varied with the site of pain, i.e., upper versus lower extremity, and could vary from day to day.  Patients underwent daily therapy for 28 days.  At the end of the study, the mean global VAS scores were significantly reduced, although these data are not presented in a table or figure.  There was no control group.

In the unpublished study, Sacks and colleagues reported on a retrospective study of 197 patients with chronic pain of various origins including upper and lower extremity pain and migraine. Some patients reported multiple sites of pain, and each different site of pain was registered as a separate pain complaint, resulting in 227 patient records.  Of these, 91% reported mild pain relief with 33% reporting complete pain relief.  A total of 78% reported an increase in their daily living activities by 50% or more and 69% reported a decrease in medications.  No data were reported regarding the various etiologies of pain, prior treatment including baseline drug requirements, exact treatment protocol, the number of treatments, or how pain relief, activities of daily living, or other treatment outcomes were evaluated.  There was no control group.

A search of the MEDLINE database THROUGH August 2011 retrieved no published studies on sympathetic therapy.  Updated guidelines from the Work Loss Data Institute list sympathetic therapy as an intervention that is currently under study and not specifically recommended.  Therefore, sympathetic therapy remains experimental, investigational and unproven.

Electroceutical Therapy

A MEDLINE search through December 2005 failed to locate peer-reviewed studies on 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.

Other Electrical Stimulation Rationale

Treatment for Osteoarthritis  (i.e., BioniCare™)

While the FDA classified the BioniCare™ BIO-1000 as a TENS unit, the manufacturer has indicated it is really a new category of device since it uses a different array of proprietary electrical amplitudes than a TENS unit, and it does not function to stimulate nerves.  Rather, the BioniCare™ device reportedly stimulates chondrogenesis; in rabbit studies the manufacturer found the device generated the development of new hyaline cartilage.

Zizic et al. reported on a multicenter, double-blind, randomized, placebo-controlled trial of pulsed electrical stimulation to assess pain relief and functional improvements in 78 patients with osteoarthritis of the knee.  Patients used the BioniCare or placebo device for 6–10 hours daily for four weeks and were allowed to continue nonsteroidal anti-inflammatory drug (NSAID) therapy.  The placebo group used a dummy device that initially produced a sensation like the BioniCare device.  Both patient groups were instructed to dial down the level to just below the sensation threshold.  In the placebo group, the device would soon turn itself off.  The primary outcomes assessed at baseline and after four weeks of treatment included patient assessment of pain and function and physician global evaluation of the patient’s condition.  The authors reported that the BioniCare group had statistically significant improvement, defined as improvement of 50% or greater, in each of the primary outcomes assessed.  The authors also assessed six secondary outcomes including duration of morning stiffness, range of motion, knee tenderness, joint swelling, joint circumference, and walking time.  However, only a decrease in mean morning stiffness in the BioniCare group was statistically significant.  While this study reports short-term improvements with pulsed electrical stimulation using the BioniCare device, the authors note long-term studies are warranted.  In addition to longer term studies, larger studies would also be beneficial.  The Zizic et al. trial was included in a Cochrane review of electromagnetic fields for the treatment of osteoarthritis that concluded there may be some benefit, but further studies are needed.  The Cochrane review also noted that the Zizic et al. trial was rated of high quality, but it did not describe the randomization process; it was funded by the manufacturer; and it did not focus on outcomes of clinical significance.

Several studies have been reported as meeting presentations.  Results of a four-year study of the BioniCare device in 150 patients with moderate to severe knee osteoarthritis who were candidates for total knee arthroplasty were described in a poster presentation at the 2004 American Academy of Orthopaedic Surgeons meeting.  The poster presenters reported that patients using the BioniCare device avoided total knee arthroplasty over 50% of the time (p=0.0004) at 1-, 2-, 3-, and 4-year follow-up when compared to a matching group of 101 patients.  Study patients who avoided surgery also reported “significant improvements in pain scores (mean 40%), function (mean 38%), and physician global evaluation (mean 38%).”  The manufacturer is currently seeking publication of full results of this study.  Nevertheless, this study’s design fails to meet the study selection criteria outlined here in that it did not have a randomly assigned control group.  In November 2005, the BioniCare manufacturer also released data on 288 patients with knee osteoarthritis treated with the BioniCare device in an open-label prospective study.  The study participants experienced improvements in patient assessment of pain and global evaluation of disease activity and physician global evaluation of the patients' condition.  In addition, 45.4% reduced their use of NSAIDs by 50% or more.  However, this study is not published and also did not have a randomly assigned group.  Finally, data on treatment of rheumatoid arthritis of the hand using the BioniCare device were presented to the American College of Rheumatology in November 2005.  The presentation reported on a double-blind placebo-controlled trial of 89 patients with rheumatoid arthritis in which statistically significant improvements in patient assessment of pain, symptoms, and function and physician global evaluation of the patients' condition were seen after four weeks of treatment.  However, this study is also not published, and longer term, larger studies appear to be needed based on the information presented.

In 2007, an industry-sponsored, randomized, double-blind sham-controlled study of the BioniCare pulsed electrical stimulation device was reported for 58 patients with osteoarthritis of the knee was published.  Due to protocol violations from one of the centers (other new treatments were provided during the study) an additional 42 subjects were excluded from the analysis.  Patients were instructed to wear the devices for six hours or more each day (typically at night), and compliance, which was monitored with a timer in the device, was found to be similar in the two groups (63% to 66% of patients, respectively).  At the end of three months of use, the percentage of patients who improved 50% or more was greater with the active device group for patient global (39% vs. 5%, respectively), patient pain (44% vs. 16%, respectively), and Western Ontario & McMaster Universities Arthritis Index (WOMAC) pain (39% vs. 11%, respectively) subscales.  The percentage of patients who improved 50% or more on the WOMAC stiffness (28% vs. 5%, respectively) and WOMAC function (23% vs. 5%, respectively) subscales showed the same trend but did not reach statistical significance in this sample.  As indicated, longer-term larger controlled comparative studies are needed to evaluate this device.

Also reported was an observational study of pulsed electrical stimulation in 157 patients (recruited from 23 centers) with moderate to severe knee osteoarthritis who had received a recommendation for total knee arthroplasty (TKA).  Patients were instructed to use the electrical stimulation device for 6-10 hours per day.  The time to TKA was compared to a historical matched (age, gender, and weight) control group of 101 knee osteoarthritis patients treated at one of the centers.  Analysis showed that 60% of patients in the electrical stimulation group had deferred TKA at four years, compared with 35% in the historical control group.  Interpretation is limited due to the potential for higher motivation to avoid TKA in the subjects who agreed to participate in the study.

A 2008 publication by Fary and colleagues from Australia describes a protocol for a randomized controlled trial.

Cranial Electrotherapy Stimulation

Non-invasive brain stimulation techniques aim to induce an electrical stimulation of the brain in an attempt to reduce chronic pain by directly altering brain activity.  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.

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

VitalStim™ has Class I1 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. 

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 and Bowen, and Nachemson and Peterson found that bracing was more effective than electrical stimulation as treatment for scoliosis.  Durham et al. 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.

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. 

ICD-9 Codes
93.39
ICD-10 Codes
G89.21-G89.8, G89.4, G90.50-G90.59, M25.50-M25.579, G54.10-G54.18, M54.2, M54.30-M54.32, M54.40-M54.42, M54.5, M54.6, M54.81, M54.89, M54.9, M79.1, M79.2, R52
Procedural Codes: 64550, 97014, 97032, 0278T, A4556, A4557, A4595, A4630, E0720, E0730, E0731, E0744, E0745, E0762, G0283, S8130, S8131
References

Transcutaneous Electrical Nerve Stimulation

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  31. Khadilkar A, Odebiyi DO, Brosseau L et al. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database Syst Rev 2008; (4):CD003008.
  32. Robb KA, Bennett MI, Johnson MI et al. Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database Syst Rev 2008; (3):CD006276.
  33. Nnoaham KE, Kumbang J. Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database Syst Rev 2008; (3):CD003222.
  34. Ng SS, Hui-Chan CW. Does the use of TENS increase the effectiveness of exercise for improving walking after stroke? A randomized controlled clinical trial. Clin Rehabil 2009; 23(12):1093-103.
  35. Walsh DM, Howe TE, Johnson MI et al. Transcutaneous electrical nerve stimulation for acute pain. Cochrane Database Syst Rev 2009; (2):CD006142.
  36. Dowswell T, Bedwell C, Lavender T et al. Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Cochrane Database Syst Rev 2009; (2):CD007214.
  37. Kroeling P, Gross A, Goldsmith CH et al. Electrotherapy for neck pain. Cochrane Database Syst Rev 2009; (4):CD004251.
  38. Rutjes AW, Nuesch E, Sterchi R et al. Transcutaneous electrostimulation for osteoarthritis of the knee. Cochrane Database Syst Rev 2009; (4):CD002823.
  39. Dubinsky RM, Miyasaki J. Assessment: efficacy of transcutaneous electric nerve stimulation in the treatment of pain in neurologic disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2010; 74(2):173-6.
  40. Mulvey MR, Bagnall AM, Johnson MI et al. Transcutaneous electrical nerve stimulation (TENS) for phantom pain and stump pain following amputation in adults. Cochrane Database Syst Rev 2010; (5):CD007264.
  41. Transcutaneous Electrical Nerve Stimulator (TENS).  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 August) Durable Medical Equipment 1.01.09.

Transcutaneous Electrical Modulation Pain Reprocessing (TEMPR)

  1. Salahadin, A., et al.  The use of "Scrambler Therapy" for failed back surgery syndrome.  Pain Physician 2011; 14:E465-E491.
  2. Marineo, G., et al.  Scrambler therapy may relieve chronic neuropathic pain more effectively than guideline-based drug management: results of a pilot, randomized, controlled trial.  J Pain Syndrome Manage. 2011; (epub ahead of print).
  3. Competitive technologies, Inc.  Available at www.competitivetech.net (accessed 2011 October 25).
  4. ClinicalTrials.gov.   Available at www.clinicaltrials.gov (accessed 2011 October 25).

Interferential Stimulation

  1. Taylor, K., Newton, R.A., et al.  Effects of interferential current stimulation for treatment of subjects with recurrent jaw pain.  Physical Therapy (1987) 67(3):346-50.
  2. Van der Heijden, G.J., Leffers, P., et al.  No effect of bipolar interferential electrotherapy and pulsed ultrasound for soft tissue disorders: a randomised controlled trial.  Annals Rheumatology Disease (1999) 58(9):530-50.
  3. Werners, R., Pynsent, P.B., et al.  Randomized trial comparing interferential therapy with motorized lumbar traction and massage in the management of low back pain in a primary care setting.  Spine (1999) 24(15):1579-84.
  4. Hurley, D.A., Minder, P.M., et al.  Interferential therapy electrode placement technique in acute low back pain: a preliminary investigation.  Archives Physical Medicine Rehabilitation (2001) 82(4):485-93.
  5. Defrin R, Ariel E, Peretz C. Segmental noxious versus innocuous electrical stimulation for chronic pain relief and the effect of fading sensation during treatment. Pain 2005; 115(1-2):152-60.
  6. Chou R, Qaseem A, Snow V et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med 2007; 147(7):478-91.
  7. Zambito A, Bianchini D, Gatti D, et al. Interferential and horizontal therapies in chronic low back pain due to multiple vertebral fractures: a randomized, double blind, clinical study. Osteoporos Int 2007; 18:1541-5.
  8. Poitras S, Brosseau L. Evidence-informed management of chronic low back pain with transcutaneous electrical nerve stimulation, interferential current, electrical muscle stimulation, ultrasound, and thermotherapy. Spine J 2008; 8(1):226-33.
  9. American College of Occupational and Environmental Medicine. Chronic pain. Available at www.guidelines.gov (Accessed October 2010).
  10. Fuentes JP, Armijo Olivo S, Magee DJ et al. Effectiveness of interferential current therapy in the management of musculoskeletal pain: A systematic review and meta-analysis. Phys Ther 2010; 90(9):1219-38.
  11. Interferential Stimulation for Treatment of Pain.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 November) Durable Medical Equipment 1.01.24.

H-Wave Electrical Stimulation

  1. Food and Drug Administration. Warning letter. September 17, 1997. Available at www.fda.gov (accessed 2010 October).
  2. Kumar, D. and H.J. Marshall.  Diabetic peripheral neuropathy: amelioration of pain with transcutaneous electrostimulation.  Diabetes Care (1997) 20(11):1702-5.
  3. Kumar, D., Alvaro, M.S., et al.  Diabetic peripheral neuropathy.  Effectiveness of electrotherapy and amitriptyline for symptomatic relief.  Diabetes Care (1998) 21(8):1322-5.
  4. Julka, I.S., Alvaro, M., et al.  Beneficial effects of electrical stimulation on neuropathic symptoms in diabetes patients.  Journal Foot Ankle Surgery (1998) 37(3):191-4.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. H-Wave Electrical Stimulation.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 November) Durable Medical Equipment 1.01.13.

Threshold Electrical Stimulation

  1. Steinbok, P., Reiner, A., et al.  Therapeutic electrical stimulation (ThresholdES) following selective posterior rhizotomy in children with spastic diplegic cerebral palsy: a randomized clinical trial.  Developmental Medicine Childhood Neurology (1997) 39(8):515-20.
  2. Dali, C., Hansen, F.J., et al.  Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial.  Developmental Medicine Childhood Neurology (2002) 44(6):364-9.
  3. Fehlings, D.L., Kirsch, S., et al.  Evaluation of therapeutic electrical stimulation to improve muscle strength and function in children with types II/III spinal muscular atrophy.  Developmental Medicine Childhood Neurology (2002) 44(11):741-4.
  4. Van der Linden, M.L., Hazlewood, M.E., et al.  Electrical stimulation of gluteus maximus in children with cerebral palsy: effects on gait characteristics and muscle strength. Developmental Medicine Childhood Neurology (2003) 45(6):385-90.
  5. Ozer K, Chesher SP, Scheker LR. Neuromuscular electrical stimulation and dynamic bracing for the management of upper-extremity spasticity in children with cerebral palsy. Dev Med Child Neurol. 2006; 48(7):559-63.
  6. Kerr C, McDowell B, Cosgrove A et al. Electrical stimulation in cerebral palsy: a randomized controlled trial. Dev Med Child Neurol 2006; 48(11):870-6.
  7. Lannin N, Scheinberg A, Clark K. AACPDM systematic review of the effectiveness of therapy for children with cerebral palsy after botulinum toxin A injections. Dev Med Child Neurol 2006; 48(6):533-9.
  8. Threshold Electrical Stimulation as a Treatment of Motor Disorders.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 February) Durable Medical Equipment 1.01.19.

Sympathetic Therapy

  1. Guido, E.H.  Effects of sympathetic therapy on chronic pain in peripheral neuropathy subjects. American Journal Pain Management (2002) 12(1):31-4
  2. Sacks, Steven M. and Jo Ann Ernst.  Retrospective Study of Sympathetic Therapy for Pain Attenuation in 197 Patients.  http://www.chronicpainrx.com (Accessed May 2005).Chronic Pain Products.  Dynatron System Solutions.  Available at http://dynatronsys.com (accessed 2011 August).
  3. Pain.  Work Loss Data Institute 2006; National Guideline Clearinghouse.  Available at www.guideline.gov (accessed 2011 August).
  4. Sympathetic Therapy for the Treatment of Pain.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2008 March—Archived) Durable Medical Equipment 1.04.03.

Electrical Stimulation for the Treatment Of OA

  1. Lippiello, L., Chakkalakal, D., et al.  Pulsing direct current-induced repair of articular cartilage in rabbit osteochondral defects.  Journal Orthopedic Research (1990) 8:266-75.
  2. Zizic, T.M., Hoffman, K.C., et al.  The treatment of osteoarthritis of the knee with pulsed electrical stimulation. Journal of Rheumatology (1995) 22:1757-61.
  3. Hulme, J., Robinson, V., et al.  Electromagnetic fields for the treatment of osteoarthritis.  Cochrane Database System Review (2002) (1):CD003523.
  4. Pelland, L., Brosseau, L., et al.  Electrical stimulation for the treatment of rheumatoid arthritis (Cochrane Review).  In: The Cochrane Library, Issue 3, (2002).
  5. Cheing, G.L., Hui-Chan, C.W., et al.  Does four weeks of TENS and/or isometric exercise produce cumulative reduction of osteoarthritic knee pain?  Clinical Rehabilitation (2002) 16(7):749-60.
  6. Brosseau, L., Yonge, K.A., et al.  Transcutaneous electrical nerve stimulation (TENS) for the treatment of rheumatoid arthritis in the hand.  Cochrane Database System Review (2003) (3):CD004287.
  7. Ng, M.M., Leung, M.C., et al.  The effects of electro-acupuncture and transcutaneous electrical nerve stimulation on patients with painful osteoarthritic knees: a randomized controlled trial with follow-up evaluation.  Alternative Complementary Medicine (2003) 9(5):641-9.
  8. Cheing, G.L., Tsui, A.Y., et al.  Optimal stimulation duration of tens in the management of osteoarthritic knee pain.  Journal Rehabilitation Medicine (2003) 35(2):62-8.
  9. Mont, M.A., He, D.Y., Jones, L.C., et al. Abstract: The use of pulsed electrical stimulation (PES) to defer total knee arthroplasty (TKA) in patients with osteoarthritis (OA) of the knee. Presented at American Academy of Orthopaedic Surgeons annual meeting, March 2004.
  10. He DY, Jones LC, Hoffman KC et al. The use of electrical stimulation to avoid total knee arthroplasty. Poster Presentation at American Academy of Orthopaedic Surgeons’ 71 st Annual Meeting, March 10-14, 2004, San Francisco, California. Poster Board No. P170.
  11. OA Knee Data (various).  Bionicare Web Site. Available at www.bionicare.com (Accessed 2011 August).
  12. Caldwell J, Zizic T. Pulsed electrical stimulation (PES) treatment of hand rheumatoid arthritis (RA) improves patient pain, physician global evaluation of disease and patient functional assessment but causes a large placebo effect in tender and swollen joint counts. Presentation No. 1463; Poster Board No. 239. Presentation at American College of Rheumatology Annual Scientific Meeting, November, 2005, San Diego, California.
  13. Mont MA, Hungerford DS, Caldwell JR et al. Pulsed electrical stimulation to defer TKA in patients with knee osteoarthritis. Orthopedics 2006; 29(10):887-92.
  14. Garland D, Holt P, Harrington JT et al. A 3-month, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a highly optimized, capacitively coupled, pulsed electrical stimulator in patients with osteoarthritis of the knee. Osteoarthritis Cartilage 2007; 15(6):630-7.
  15. Bjordal JM, Johnson MI, Lopes-Martins RA et al. Short-term efficacy of physical interventions in osteoarthritic knee pain. A systematic review and meta-analysis of randomised placebo-controlled trials. BMC Musculoskelet Disord 2007; 8:51.
  16. Fary RE, Carroll GJ, Briffa TG et al. The effectiveness of pulsed electrical stimulation (E-PES) in the management of osteoarthritis of the knee: a protocol for a randomised controlled trial. BMC Musculoskelet Disord 2008; 9:18.
  17. Electrical stimulation for the treatment of arthritis.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 October Durable Medical Equipment 1.01.27.

Other Electrical Stimulation Modalities

  1. Durham, J.W., Moskowitz, A. et al.  Surface electrical stimulation versus brace in treatment of idiopathic scoliosis.  Spine (1990 Sep) 15(9):888-92.
  2. Bertrand, S.L., Drvaric, D.M., et al.  Electrical stimulation for idiopathic scoliosis.  Clinical Orthopedic Related Research (1992 Mar) (276):176-81.
  3. Mercola, Joseph M. and Daniel L. Kirsch.  The basis for microcurrent electrical therapy in conventional medical practice (Summer, 1995) Volume 8 Number 2.  Accessed May 12, 2005 at <www.harborside.com>. 
  4. Nachemson, A.L. and L.E. Peterson.  Effectiveness of treatment with a brace in girls who have adolescent idiopathic scoliosis. A prospective, controlled study based on data from the Brace Study of the Scoliosis Research Society.  Journal of Bone and Joint Surgery: America (1995 Jun) 77(6):815-22.
  5. Allington, N.J. and J.R. Bowen.  Adolescent idiopathic scoliosis: treatment with the Wilmington brace.  A comparison of full-time and part-time use.  Journal Bone and Joint Surgery: America (1996 Jul) 78(7):1056-62.
  6. Kirsch, D.L.  Cranial electrotherapy stimulation: a safe and effective treatment for anxiety (A review of the literature).  Medical Scope Monthly (1996 January) 3(1):1-16.
  7. Overcash, S.J.  Cranial electrotherapy stimulation in patients suffering from acute anxiety disorders.  American Journal of Electromedicine (1999) 16(1):49-51.
  8. Bowen, J.R., Keeler, K.A., et al.  Adolescent idiopathic scoliosis managed by a nighttime bending brace.  Orthopedics (2001 Oct) 24(10):967-70.
  9. Gilula, M.F., and P.R. Barach.  Letter to the Editor:  Cranial electrotherapy stimulation: a safe neuromedical treatment for anxiety, depression, or insomnia.  Southern Medical Journal (2004 December) 97(12):1.
  10. Chetney, R., and K. Waro.  A new home health approach to swallowing disorders.  Home Healthcare Nurse (Oct 2004) 22(10):703-7; quiz 708-9.
  11. Wearable Therapy Bioflex Therapeutic Neuromuscular Stimulation Systems.  Available at www.mypainmanager.com (accessed 2005 May 13).
  12. Electroceuticals Market.  Genesis Biomedical.  http://www.genbiomed.com (accessed on 2005 December 16).
  13. Gilula, M.F., and D.L. Kirsch.  Cranial electrotherapy stimulation review: a safer alternative to psychopharmaceuticals in the treatment of depression.  Journal of Neurotherapy (2005) 9(2):7-26.
History
 May 4, 2011 Clarified the policy statement regarding a medically necessary 30 day trial of TENS.  
 October 2012  Policy updated with literature review through June 2012.  References added and reordered.  Policy statements unchanges.  
September 2013 Policy formatting and language revised.  Title changed from "Transcutaneous Electrical Nerve Stimulation (TENS)" to "Surface Electrical Stimulation".  Combined the TENS unit and H-Wave Stimulation policies.
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Surface Electrical Stimulation