Surface and percutaneous electrical stimulation devices emit low-level electrical impulses and have been used to treat pain associated with soft tissue injury, musculoskeletal conditions (i.e. osteoarthritis [OA]) or neuropathies, such as diabetic peripheral neuropathy. This document specifically addresses H-wave stimulation, interferential stimulation (IFS) therapy, microcurrent electrical nerve stimulation therapy (MENS), pulsed electrical stimulation (PES), percutaneous neuromodulation therapy (PNT) and sympathetic therapies. These devices differ in the type of electrical impulse they use.

Note: For other uses of electrical stimulation, please see the following related documents:

• CG-DME-03 Neuromuscular Stimulation in the Treatment of Muscle Atrophy
• CG-DME-04 Electrical Nerve Stimulation, Transcutaneous, Percutaneous
• DME.00022 Functional Electrical Stimulation (FES); Threshold Electrical Stimulation (TES)
• MED.00046 Electrical Stimulation and Electromagnetic Therapy for Wound Healing

Investigational and Not Medically Necessary:

H-wave electrical stimulation devices are considered investigational and not medically necessary to reduce pain from all causes including, but not limited to, pain associated with diabetic peripheral neuropathy.

Interferential therapy (IF) devices are considered investigational and not medically necessary for all indications, including, but not limited to providing relief of pain associated with soft tissue injury, musculoskeletal disorders, or to enhance wound or fracture healing.

Microcurrent electrical nerve stimulation devices (e.g., MENS, MET) are considered investigational and not medically necessary for all indications, including but not limited to decreasing pain and facilitating healing.

Pulsed electrical stimulation is considered investigational and not medically necessary for all indications, including, but not limited to, the treatment of osteoarthritis.

Percutaneous neuromodulation therapy is considered investigational and not medically necessary for all indications.

Sympathetic therapy is considered investigational and not medically necessary for all indications.

General Considerations

Validation of the treatment effectiveness of electrical stimulation devices typically requires randomized controlled trials. For example, any treatment of a painful condition is likely associated with a placebo effect; therefore blinded and placebo-controlled randomized controlled trials are necessary to determine whether any improved outcome surpasses that associated with the treatment effects. Electrical stimulation devices have also been used to promote wound healing. Wound healing usually involves a multimodal approach consisting of debridement, antibiotic therapy, appropriate nutrition, treatment of the underlying etiology of the wound and other therapies as appropriate for the individual. Therefore, randomized controlled trials are needed to isolate the treatment effect of electrical stimulation as one component in the overall treatment of wounds. The following review focuses on the results, when available, of randomized controlled trials.

H-wave Electrical Stimulation Devices

H-wave devices have been investigated as a treatment for a variety of symptoms including pain from diabetic peripheral neuropathy, muscle spasms, temporomandibular joint (TMJ) dysfunction, reflex sympathetic dystrophy, and healing of wounds such as diabetic peripheral ulcers.

The early medical literature describes two randomized trials comparing active H-wave electrical stimulation for the treatment of diabetic peripheral neuropathy. Kumar and Marshall (1997) selected 31 individuals with type 2 diabetes and painful peripheral neuropathy in both lower extremities lasting at least two months. Individuals were excluded if they had vascular insufficiency of the legs or feet, or specified cardiac conditions. Individuals were randomly assigned to the active group (n=18) or the sham group (n=13). Both groups were instructed to use their devices thirty 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 if the participants, investigators, or both were blinded or if any participant withdrew from the study. 

The second study published by Kumar and colleagues (1998) compared H-wave electrical stimulation with sham stimulation among individuals who did not adequately respond to an initial four week trial of a tricyclic antidepressant. A total of 14 individuals were randomized to active stimulation group and nine individuals to sham stimulation. Stimulation therapy lasted 12 weeks, with outcomes assessed by an investigator blinded to group assignment at 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 (p=0.03). It is unclear, however, if the participants were blinded to the type of device, and, the report does not include if any participants withdrew from the study.

A later report from this group (Julka, 1998) described a case series of 34 individuals who continued H-wave electrical stimulation for over one year and achieved a 44% reduction in symptoms. These small controlled trials are insufficient to permit conclusions about the effectiveness of H-wave electrical stimulation for diabetic peripheral neuropathy.

Blum and colleagues (2006) reported on the results of a cross sectional, observational study consisting of a 10-item survey that assessed the therapeutic response to the H-wave device of 6774 individuals with chronic soft-tissue injury or neuropathic pain. The H-wave Customer Service Questionnaire measured each individual's subjective assessment of the device's effectiveness regarding decreased or eliminated need for pain medication, increased functioning and activity, and 25% or greater overall improvement. On a 10-unit visual analog scale (VAS) ranging from 0-100%, 75% of the study participants reported a reduced or eliminated need for pain medication; 79% reported improved functional capacity or activity; and 78% reported 25% or greater reduction of pain. The study results suggest that the use of H-wave may provide an alternative to standard pharmacologic treatment of chronic soft tissue and neuropathic pain. However, limitations of this study include lack of randomization and placebo control and the use of self-reported data. A subsequent meta-analysis by Blum and colleagues (2008) included five studies; two of them were randomized controlled trials that were previously considered. The authors concluded that their findings "are encouraging and support the H-Wave device as a potential non-pharmacological alternative in the management of chronic inflammatory and neuropathic pain conditions" and suggest the need for more rigorous controlled studies.

Additional sham-controlled studies are needed from other investigators, preferably studies that are clearly blinded, specify the handling of withdrawals, and provide long-term, comparative follow-up data to permit conclusions about the effectiveness of this modality for the treatment of diabetic neuropathy.

The effect of H-wave on range of motion and strength testing was assessed in a randomized double-blind, placebo-controlled study of 22 individuals who underwent rotator cuff reconstruction (Blum, 2009). Both groups received the same device treatment instructions. Group I was given H-wave to utilize for one hour twice a day for 90 days postoperatively. Group II was given the same instructions with a placebo device. Strength testing and range of motion were assessed between the groups preoperatively, 45 days postoperatively, and 90 days postoperatively by using an active/passive scale for five basic ranges of motion. The authors reported that individuals who received H-wave compared to placebo demonstrated, on average, significantly improved active range of motion at 45 and 90 days postoperatively (p=0.007 and p=0.007, respectively). Active internal rotation also demonstrated significant improvement compared to placebo at 45 and 90 days postoperatively (p=0.007 and p=0.006, respectively). There was no significant difference between the two groups for strength testing. The authors concluded that H-wave compared to placebo induced a significant increase in range of motion in the management of rotator cuff reconstruction, however, interpretation of these results is preliminary and warrants further confirmation in a larger randomized, double-blind, placebo-controlled study.

There is insufficient evidence in the peer-reviewed medical literature to support the efficacy of H-wave devices for any other indication.

Interferential Stimulation (IFS) Therapy Devices

In a 1987 study, Taylor and colleagues randomized 40 individuals with TMJ syndrome or myofascial pain syndrome to undergo either active or placebo IFS. 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. In 1999, van der Heijden and colleagues randomized 180 individuals with soft tissue shoulder disorders to undergo therapy in one of the following groups in addition to a program of exercise therapy: 1) IFS therapy plus ultrasound; 2) active IFS therapy plus dummy ultrasound; 3) dummy IFS therapy plus active ultrasound; 4) dummy IFS therapy plus dummy ultrasound (i.e., the placebo group); or 5) no adjuvant therapy. Principal outcome measures include 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 IFS therapy nor ultrasound proved to be effective as an adjuvant to exercise therapy.

Werners and colleagues (1999) reported on the results of a randomized study of 152 individuals with low back pain to either treatment with IFS therapy or traction. There was no placebo control group. Outcomes were based on the results of the Oswestry Disability Index and a pain VAS. The authors reported that both groups recorded improvements over a three-month period; there was no statistically significant difference in outcomes between the 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 (2001) studied a group of 60 individuals with back pain randomly assigned to one of three groups: 1) IFS therapy of the painful area; 2) IFS therapy of the spinal nerve; and 3) a control group that received no IFS therapy. There was no placebo control group. Placement of the IFS therapy electrodes over the spinal nerve, compared to the painful area, resulted in a significantly larger reduction in disability scores. However, the lack of a placebo group limits interpretation of these data. In a subsequent randomized trial, Hou and colleagues (2002) studied a combination of therapies in a group of 119 individuals with myofascial disease and active trigger points, including hot packs, "stretch and spray," ischemic compression, myofascial release, and IFS therapy. The authors reported that IFS therapy may have some benefit for relieving myofascial pain when used in conjunction with hot packs and ROM exercises; however, there was no control or placebo group, thus limiting interpretation of the data.

A randomized controlled trial by Defrin and colleagues (2005) studied 62 individuals treated with IFS therapy for osteoarthritic knee pain. Individuals were randomized to one of four active treatment groups or two control groups (sham or non-treated). Acute pre- versus post-treatment reductions in pain were found in all active groups but not in either control group. This study was limited in drawing conclusions due to the small number of participants.

A randomized double-blind trial compared IFS therapy or horizontal therapy (HT) with sham stimulation in 105 older women with chronic low back pain due to multiple vertebral fractures (Zambito, 2007). All participants received a full therapeutic exercise program. The proportion of individuals who improved did not achieve statistical significance for the IFS group. In summary, the two studies that included a placebo control (Taylor, 1987; van Heijden, 1999) failed to show a significant treatment effect. Interpretation of the other four randomized controlled trials is limited by the lack of a placebo control and the small number of participants in the trials. The results of a randomized double-blind, placebo-controlled trial of home-based, IFS therapy in individuals who had undergone anterior cruciate ligament (ACL) reconstruction, meniscectomy, or knee chondroplasty demonstrated statistically significant improvement in reduced pain, decreased edema, and accelerated recovery of knee function. Limitations of this study include the possible overestimation of some of the statistical differences in the analyses of multiple comparisons, resulting in a potential bias of the treatment effect (Jarit, 2003).

Poitras and Brosseau (2008) conducted a structured systematic review of management of back pain with therapeutic modalities including transcutaneous electrical nerve stimulation (TENS) and IFS current. The authors found no eligible studies on which to base recommendations for IFS therapy. Clinical practice guidelines from the American College of Physicians and the American Pain Society concluded that there was insufficient evidence to recommend IFS therapy for the treatment of low back pain (Chou, 2007).

Fuentes and colleagues (2010) published a systematic review and meta-analysis of studies evaluating the efficacy of IFS therapy for the management of musculoskeletal pain. Twenty randomized controlled trials met the inclusion criteria; fourteen of the trials reported data that could be included in the pooled meta-analysis. IFS therapy as a stand-alone intervention was not found to be more effective than placebo or an alternative intervention. A pooled analysis of two studies comparing IFS therapy alone and placebo did not find a statistically significant difference in pain intensity on completion of the treatment; 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 IFS therapy 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. In a pooled analysis of five studies comparing IFS therapy 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 IFS therapy 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 IFS therapy versus the co-intervention cannot be determined, and it does not control for potential placebo effects. The authors concluded that the results must be considered with caution due to the low number of studies that used IFS therapy alone. In addition, the heterogeneity across studies and methodological limitations prevent conclusive statements regarding analgesic efficacy.

A 2005 California Technology Assessment Forum (CTAF) recommendation states that IFS therapy for the treatment of musculoskeletal pain does not meet CTAF Technology Assessment Criteria for safety, effectiveness, and improvement in health outcomes. "Validated treatments for musculoskeletal pain include medication as necessary, such as acetaminophen, nonsteroidal anti-inflammatory agents, muscle relaxants or opioids; discourage bed rest, consider spinal manipulation for pain relief and refer for exercise therapy (Koes, 2001). To date, IFS has not been shown to be as beneficial as the alternatives for the treatment of musculoskeletal pain."

Microcurrent Electrical Nerve Stimulation (MENS) Therapy Devices

Bertolucci and Grey (1995) compared the efficacy of MENS therapy to mid-laser and laser placebo treatment of 48 individuals with TMJ pain. There was a difference in pain and functional outcomes between laser and MENS therapy with laser being slightly higher; however, the difference was not statistically significant. There was no data to suggest whether the effect was durable and whether the effects continued with repeated use.

There has been interest in using MENS therapy in the treatment of migraine headaches. However, there are no double-blind, randomized controlled clinical trials of MENS therapy  in the treatment of migraine. MENS therapy  has been addressed in a few small randomized controlled trials and case series for conditions such as chronic nonspecific back pain (Koopman, 2009), delayed onset muscle soreness (Curtis, 2010), diabetes mellitus (Lee, 2009), fibromyalgia, generalized pain, hypertension (Lee, 2009), multiple sclerosis, and unhealed wounds (Lee, 2009). None of these studies are large controlled clinical trials designed to test the effectiveness of MENS therapy against a placebo device. Therefore, based on the lack of available evidence, reasonable conclusions cannot be reached about the effectiveness of MENS therapy on pain management.

In summary, there is insufficient evidence in the peer-reviewed medical literature to draw conclusions regarding the safety, efficacy, and utility of MENS therapy to decrease pain and facilitate healing for any condition.

Pulsed Electrical Stimulation (PES) Devices

PES has been used to decrease pain and joint damage and improve function in individuals with OA or rheumatoid arthritis (RA). The proponents of the BioniCare^® device (BioniCare Medical Technologies, Inc., Sparks, MD) theorize that PES devices can facilitate bone formation and cartilage repair and alter inflammatory cell function. There is currently insufficient evidence in the peer-reviewed literature to conclude that PES provides any significant health benefit to individuals with OA and RA.

Zizic and colleagues (1995) reported on a multicenter, double-blind, randomized, placebo-controlled trial of PES to assess pain relief and functional improvements in 78 individuals with OA of the knee. Individuals used the BioniCare^® or placebo device for six to ten 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 study 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 participant self-assessment of pain and function and physician global evaluation of the participants' condition. The authors reported that the BioniCare^® group had statistically significant improvement, defined as improvement of equal to or greater than 50%, 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 the authors report short-term improvements with PES using the BioniCare^® device, additional larger, long-term studies are warranted. The Zizic trial was included in a review of electromagnetic fields for the treatment of OA (Hulme, 2002) that concluded there may be some benefit in the use of electrical stimulation, but further studies are needed. The review also noted the Zizic trial was rated of high quality but it did not describe the randomization process, was funded by the manufacturer, and did not focus on outcomes of clinical significance.

Farr and colleagues (2006) conducted an open-label, prospective study of the safety and efficacy of PES in 288 individuals who had failure, contraindications or intolerance to other nonsurgical treatment modalities for OA. Participant and physician global evaluation and participant-self assessment of knee pain were treatment outcomes measured using a five-point Likert scale (1= no symptoms; 5= very severe symptoms). The authors reported significant improvement in all efficacy variables (p<0.001) and that treatment effects were greater in individuals who used the PES device for more than 750 hours versus those who used it for shorter periods (p<0.001). A reduction in the use of NSAIDs was reported in a subgroup of 86 individuals who recorded daily NSAID use at baseline and during treatment. Forty-five percent of the individuals (39 of 86) reduced their NSAID use by 50% or more, with approximately 19% (16 of 86) discontinuing their NSAIDs entirely. Transient rash was the most common adverse event. The authors suggested that PES may improve symptoms in some individuals with OA who have failed other nonsurgical treatment modalities. This industry-sponsored study, however, is limited in drawing conclusions due to the lack of randomization, blinding, and a control group.

Garland and colleagues (2007) conducted a randomized, double-blind, controlled study to evaluate the clinical effectiveness of PES in 58 individuals with moderate to severe knee OA. The primary study outcome measures included: 1) the percent change from baseline on a 0-100 VAS measuring global self-evaluation by study subjects of arthritis symptoms in the treated knee, 2) the percent change from baseline of pain and other symptoms, and 3) the percent change from baseline on the Western Ontario and McMaster Universities (WOMAC) pain, stiffness, and function subscales. Individuals were randomly assigned an active (n=39) or placebo (n=19) device in a 2:1 active to placebo ratio. Based on the percentage of individuals in each treatment group who experienced 50% or greater improvement in each primary outcome, three of five primary outcome measures showed a statistically significant difference. The authors suggested that the use of PES in the treatment of individuals with knee OA may improve symptoms when compared to placebo. This study is limited in drawing conclusions due to the small sample size.

In summary, there is insufficient evidence in the peer-reviewed published literature to support the efficacy of PES devices for decreasing pain and improving function in individuals with OA and RA. Methodologically sound, well-designed randomized, double-blind, controlled trials with larger populations are required before any clinical benefits can be suggested from the use of PES when compared to other established treatment modalities.

Percutaneous Neuromodulation Therapy (PNT) Devices

PNT is described as a variation of PENS developed as a treatment for chronic or intractable neck and back pain. Of the five randomized controlled trials addressing back pain that were identified in the peer-reviewed  literature, four were randomized crossover trials by one group of investigators (two studies by Ghoname, 1999; Hamza, 1999; White, 2001); the other study was a randomized controlled trial by a second group of investigators (Weiner, 2003). Results of these studies suggest that PNT reduces low back pain and disability due to this pain; however, the randomized crossover studies also provided evidence that these benefits were temporary since pain reoccurred between treatment sessions and during one-week periods in which treatment was stopped before a change in treatment conditions. Although pain relief was more durable in the randomized controlled trial, this study (Weiner, 2003) involved only 34 individuals and three months of follow-up and it did not employ treatment parameters found optimal in earlier studies. It is not clear why benefits of neuromodulation therapy seemed to be more durable in the randomized controlled trial compared with the randomized crossover trials. Potential explanations include a longer sustained period of treatment, adjunct use of physical therapy, and enrollment of individuals with less severe back disorders in the randomized controlled trial.

In a single-blinded study, Kang and colleagues (2007) randomized 70 individuals with knee OA to stimulation (at the highest tolerable intensity) or placement of electrodes (without stimulation). Individuals in the sham group were informed that they would not perceive the normal "pins and needles" with this new device. Individuals received one treatment and were followed up for one week. The neuromodulation group had 100% follow-up; seven of 35 (20%) individuals from the sham group dropped out. VAS pain scores improved immediately after active (from 5.4 to 3.2) but not sham (5.6 to 4.9) treatments. VAS scores (4.6 vs. 5.2) were not significantly different for the two groups at 48 hours after treatment. Changes in the WOMAC scale were significantly better for the category of stiffness (one point change vs. 0 point change) but not for pain or function at 48 hours. Measures of satisfaction in the study participants were significantly higher in the neuromodulation group (e.g., 77% vs. 11% good to excellent) at up to one-week follow-up. Interpretation is limited by the discrepancy between participant satisfaction ratings and 48-hour VAS pain scores, and the differential loss to follow-up in the two groups. These results raise questions about the effectiveness of the blinding and the contribution of short-term pain relief and placebo effects to these results. Questions also remain about the duration of the treatment effects. Larger double-blind studies with a more effective sham condition and longer follow-up are needed.

In summary, there continues to be insufficient evidence in the peer-reviewed literature to support the use of PNT for the indication of pain reduction. 

Sympathetic Therapy

Sympathetic therapy is a patented method of delivering electrostimulation via peripheral nerves to create a "special" form of stimulation of the sympathetic nervous system. It incorporates dual interfering waveforms with specific electrode placement on the upper and lower extremities (eight electrodes per treatment). Electrodes are placed bilaterally over dermatomes, thus accessing the autonomic nervous system via the peripheral nervous system.

A literature search identified only one small, non-randomized study by Guido and colleagues (2002). A total of 20 individuals with chronic pain and peripheral neuropathies were treated daily with the Dynatron STS™ (Dynatron Corporation, Salt Lake City, UT) for 28 days. Pain was reported as moderate to severe by 11 of 15 individuals prior to treatment, with a decrease in pain reported by six of the individuals at conclusion of the treatment. The author did not report on the reason why five of the 20 individuals did not provide self-reports of pain severity. For these 15 individuals who remained in the study, the authors reported the mean cumulative VAS scores for multiple locations of pain decreased from 107.8 to 45.3. However, drawing conclusions concerning the efficacy of Dynatron STS for the management of chronic, intractable pain is limited due to the small participant population, lack of a randomized control group, placebo effects and lack of data on pain severity in a quarter of the subjects in this study. There is a lack of additional peer-reviewed literature concerning the efficacy of sympathetic therapy in terms of pain relief or for any other indication. Consequently, no conclusions can be drawn regarding the usefulness of this modality in terms of improving health outcomes or quality of life in individuals with moderate to severe pain.

Description of Technologies

H-wave Electrical Stimulation Devices

H-wave devices are classified by the U.S. Food and Drug Administration (FDA) as a powered muscle stimulator "intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area." H-wave is used in both low frequency and high frequency settings. The H-WAVE^® Muscle Stimulator device (Electronic Waveform Lab, Inc., Huntington Beach, CA) received FDA 510(k) clearance as a Class II device in 1997.   

Interferential Stimulation Therapy Devices

Interferential stimulation (IFS) therapy, also referred to as interferential therapy (IFT), is a type of electrical stimulation that uses paired electrodes of two independent circuits carrying high-frequency (4,000 Hz) and medium-frequency (150 Hz) alternating currents. The superficial electrodes are aligned on the skin. It is believed that IFS permeates the tissues more effectively, with less unwanted stimulation of cutaneous nerves, and is more comfortable than TENS. IFS therapy devices are regulated by the FDA as Class II devices, with more than 50 instruments receiving 510(k) clearance.

Microcurrent Electrical Nerve Stimulation Devices

MENS therapy involves the application of a very precise, low, tightly controlled electrical current to specific points on the body. These points of low electrical resistance correspond with classical acupuncture points. Proposed uses include chronic and acute pain, swelling, TMJ dysfunctions, post-operative care, sports injuries and arthritis. The MICROCURRENT (Precision MICROCURRENT, Inc., Newberg, OR) has received FDA 510(k) clearance as a Class II device.

Pulsed Electrical Stimulation Devices for the Treatment of Osteoarthritis

In 2003, the FDA cleared the BioniCare^® Stimulator BIO-1000™, indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with OA of the knee that has not adequately responded to NSAID therapy. The BioniCare^® BIO-1000™ device is applied to the knee and can be worn under clothing and during sleep. The device should be used at least six hours per day. A low-amplitude pulsed electric field is delivered to the area surrounding the knee, which is purported to provide improvement in knee pain and function.

Percutaneous Neuromodulation Therapy Devices

An electrical stimulation device identified as Percutaneous Neuromodulation Therapy™ Nerve Stimulation System (Vertis Neuroscience, Inc, Vancouver, WA) received FDA 510(k) clearance in 2002. The clearance order stated that the therapy is "indicated for symptomatic relief and management of chronic or intractable pain and/or as an adjunctive treatment for the management of post-surgical pain and post-trauma pain." Its primary indication is for low back pain and spinal pain. The procedure involves the insertion of pairs of electrodes into the skin of the lower back area with the intent of stimulating nerve fibers that lie in the deep tissues. Treatments may be given several times a week, typically for about 30 minutes at a time.

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 IFS therapy, 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 on the feet, legs, arms, and hands. Electrical current is then induced with beat frequencies between 0-1000Hz.  Treatment may include one hour of daily treatments in the physician's office followed by home treatments if the initial treatment was effective. The Dynatron STSÔ device (Dynatronics Corporation, Salt Lake City, UT) and companion home device, Dynatron STSÔ Rx, are devices that deliver sympathetic therapy and have received FDA 510(k) clearance.

Types of Devices Used for Treatment

     H-wave Electrical Stimulation Devices

• H-Wave^® Muscle Simulator (Electronic Waveform Lab, Inc., Temeculah, CA)

   Interferential Stimulation Therapy Devices

Microcurrent Electrical Nerve Stimulation Devices

Percutaneous Neuromodulation Therapy Devices 

• Deepwave^® Percutaneous Neuromodulation Pain Therapy System (Biowave Corporation, Norwalk, CT)
• Vertis PNT™ System (Vertis Neuroscience, Inc., Vancouver, WA)

Pulsed Electrical Stimulation Devices

• BioniCare^® BIO-1000™ System (BioniCare Medical Technologies, Inc., Sparks, MD)

Sympathetic Therapy

• Dynatron STS™ and Dynatron STS™ Rx (Companion Home Device) (Dynatronics Corporation, Salt Lake City, UT)

Visual analog scale (VAS): A pain assessment tool that helps an individual describe the intensity of their pain by marking on a line their level of discomfort; a VAS is a straight line with the left end of the line representing no pain and the right end of the line representing the worst pain.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the code listed below for all indications, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications

1. Bertolucci LE, Grey T. Clinical comparative study of microcurrent electrical stimulation to mid-laser and placebo treatment in degenerative joint disease of the temporomandibular joint. Cranio. 1995; 13(2):116-120.
2. 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.
3. 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):644-657.
4. 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):739-749.
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):446-455.
6. Curtis D, Fallows S, Morris M, McMakin C. The efficacy of frequency specific microcurrent therapy on delayed onset muscle soreness. J Bodyw Mov Ther. 2010; 14(3):272-279.
7. Defrin R, Ariel E, Peretz C. Segmental noxious versus innocuous electrical stimulation for chronic pain and the effect of fading sensation during treatment. Pain. 2005; 115(1-2):152-160.
8. Farr J, Mont MA, Garland D, et al. Pulsed electrical stimulation in patients with osteoarthritis of the knee: follow up in 288 patients who had failed non-operative therapy. Surg Technol Int. 2006; 15:227-233.
9. Fuentes JP, Armijo Olivo S, et al. Effectiveness of interferential current therapy in the management of musculoskeletal pain: a systematic review and meta-analysis. Phys Ther. 2010; 90(9):1219-1238.
10. 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):630-637.
11. Ghoname ES, Craig WF, White PF, et al. Percutaneous electrical nerve stimulation for low back pain: a randomized crossover study. JAMA. 1999; 281(9):818-823.
12. Ghoname ES, Craig WF, White PF, et al. The effect of stimulus frequency on the analgesic response to percutaneous electrical nerve stimulation in patients with chronic low back pain. Anesth Analg. 1999; 88(4): 841-846.
13. Guido EH. Effects of sympathetic therapy on chronic pain in peripheral neuropathy subjects. Am J Pain Manage. 2002; 12(1):31-34.
14. Hamza MA, Ghoname EA, White PF, et al. Effect of the duration of electrical stimulation on the analgesic response in patients with low back pain. Anesthesiology. 1999; 91(6):1622-1627.
15. Hou CR, Tsai LC, Cheng KF, et al. Immediate effects of various physical therapeutic modalities on cervical myofascial pain and trigger-point sensitivity. Arch Phys Med Rehabil. 2002; 83(10):1406-1414.
16. Hurley DA, Minder PM, McDonough SM, et al. Interferential therapy electrode placement technique in acute low back pain: a preliminary investigation. Arch Phys Med Rehabil. 2001; 82(4):485-493.
17. Jarit GJ, Mohr KJ, Waller R, Glousman RE. The effects of home interferential therapy on post-operative pain, edema, and range of motion of the knee. Clin J Sport Med. 2003; 13(1):16-20.
18. Julka IS, Alvaro M, Kumar D. Beneficial effects of electrical stimulation on neuropathic symptoms in diabetes patients. J. Foot Ankle Surg. 1998; 37(3):191-194.
19. Kang RW, Lewis PB, Kramer A, et al. Prospective randomized single-blinded controlled clinical trial of percutaneous neuromodulation pain therapy device versus sham for the osteoarthritic knee: a pilot study. Orthopedics. 2007; 30(6):439-445.
20. Koes BW, van Tulder MW, Ostelo R, et al. Clinical guidelines for the management of low back pain in primary care: an international comparison. Spine. 2001; 26(22):2504-2513.
21. Koopman JS, Vrinten DH, van Wijck AJ. Efficacy of microcurrent therapy in the treatment of chronic nonspecific back pain: a pilot study. Clin J Pain. 2009; 25(6):495-499.
22. Kumar D, Alvaro MS, Julka IS, Marshall HJ. Diabetic peripheral neuropathy. Effectiveness of electrotherapy and amitriptyline for symptomatic relief. Diabetes Care. 1998; 21(8):1322-1325.
23. Kumar D, Marshall HJ. Diabetic peripheral neuropathy: amelioration of pain with transcutaneous electrostimulation. Diabetes Care. 1997; 20(11):1702-1705.
24. Lee BY, Al-Waili N, Stubbs D, et al. Ultra-low microcurrent in the management of diabetes mellitus, hypertension and chronic wounds: report of twelve cases and discussion of mechanism of action. Int J Med Sci. 2009; 7(1):29-35.
25. 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):226-233.
26. Taylor K, Newtow RA, Personius WJ, et al. Effects of interferential current stimulation for treatment of subjects with recurrent jaw pain. Phys Ther. 1987; 67(3):346-350.
27. van der Heijden GJ, Leffers P, Wolters PJ, et al. No effect of bipolar interferential electrotherapy and pulsed ultrasound for soft tissue shoulder disorders: a randomized controlled trial. Ann Rheum Dis. 1999; 58(9):530-540.
28. Weiner DK, Rudy TE, Glick RM, et al. Efficacy of percutaneous electrical nerve stimulation for the treatment of chronic low back pain in older adults. J Am Geriatr Soc. 2003: 51(5):599-608.
29. Werners R, Pynsent PB, Bulstrode CJK.  Randomized trial comparing interferential electrotherapy with motorized lumbar traction and massage in the management of low back pain in a primary care setting. Spine. 1999; 24(15):1579-1584.
30. White PF, Ghoname EA, Ahmed HE, et al. The effect of montage on the analgesic response to percutaneous neuromodulation therapy. Anesth Analg. 2001; 92(2):483-487.
31. 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(11):1541-1545.
32. Zizic TM, Hoffman KC, Holt PA, et al.  The treatment of osteoarthritis of the knee with pulsed electrical stimulation. J Rheumatol. 1995; 22(9):1757-1761.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American College of Rheumatology (ACR). Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000; 43(9):1905-1915.
2. California Technology Assessment Forum (CTAF). Interferential stimulation for the treatment of musculoskeletal pain. October 19, 2005. Available at: http://www.ctaf.org/section/assessment. Accessed on March 14, 2011.
3. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Services provided for the diagnosis and treatment of diabetic sensory neuropathy with loss of protective sensation (Diabetic Peripheral Neuropathy). NCD #70.2.1. Effective July 1, 2002. Available at: http://www.cms.hhs.gov. Accessed on March 14, 2011.
4. 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):478-491.
5. Hulme J, Robinson V, DeBie R, et al. Electromagnetic fields for the treatment of osteoarthritis. Cochrane Database Syst Rev. 2002; (1): CD003523.
6. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). 510(k) Database. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed on March 14, 2011.
7. U.S. Food and Drug Administration (FDA). Warning letter. Re: H-Wave Powered Muscle Stimulator, K915230. September 17, 1997. Available at: http://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/1997/UCM065904.pdf. Accessed on March 14, 2011.

1. U.S. National Library of Medicine. National Institutes of Health. MedlinePlus. Diabetic neuropathy. Updated April 19, 2010. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000693.htm. Accessed on March 14, 2011.

H-wave Therapy
Interferential Stimulation (IFS) Therapy
Microcurrent Electrical Nerve Stimulation (MENS)
Percutaneous Electrical Stimulation (PES)
Percutaneous Neuromodulation Therapy (PNT)
Pulsed Electrical Stimulation (PES)
Sympathetic Therapy

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.