Medical Policy

 

Subject: Electrical Stimulation as a Treatment for Pain and Related Conditions: Surface and Percutaneous Devices
Document #: DME.00011 Publish Date:    12/27/2017
Status: Revised Last Review Date:    11/02/2017

Description/Scope

This document specifically addresses auricular electrostimulation, H-Wave stimulation (H-Wave®, Electronic Waveform Lab, Inc., Huntington Beach, CA), interferential stimulation therapy, microcurrent electrical nerve stimulation, pulsed electrical stimulation (including pulsed electromagnetic field stimulation), percutaneous neuromodulation therapy, supraorbital transcutaneous neurostimulation, and sympathetic therapies. These devices differ in the type of electrical impulse they use.

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

Note: For additional information concerning acupuncture services, please see the following document:

Position Statement

Investigational and Not Medically Necessary:

  1. Auricular electrostimulation is considered investigational and not medically necessary for all indications including, but not limited to, treatment of acute and chronic pain.
  2. 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.
  3. 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.
  4. Microcurrent electrical nerve stimulation (MENS) devices are considered investigational and not medically necessary for all indications including, but not limited to, decreasing pain and facilitating healing.
  5. Pulsed electrical stimulation is considered investigational and not medically necessary for all indications including, but not limited to, the treatment of osteoarthritis.
  6. Percutaneous neuromodulation therapy is considered investigational and not medically necessary for all indications.
  7. Supraorbital transcutaneous neurostimulation is considered investigational and not medically necessary for all indications, including but not limited to, prophylactic treatment of episodic migraine headaches and treatment of acute migraine headaches, with or without aura.
  8. Sympathetic therapy is considered investigational and not medically necessary for all indications.
Rationale

Surface and percutaneous electrical stimulation devices emit low-level electrical impulses and have been used to treat pain associated with diabetic peripheral neuropathy and soft tissue injury, musculoskeletal conditions including osteoarthritis (OA) and rheumatoid arthritis (RA), to promote wound healing, and to improve postoperative function and range of motion.

Auricular Electrostimulation Devices

Auricular electrostimulation, also referred to as auricular electroacupuncture, is a type of ambulatory electrical stimulation of acupuncture points intended to provide continuous or intermittent stimulation over a period of several days. The primary indication for use of auricular electrostimulation is treatment of pain due to any cause. The peer-reviewed medical literature evaluating the use of auricular electrostimulation is limited to several randomized controlled trials comparing the P-Stim® device (NeuroScience Therapy Corp., San Dimas, CA) to other treatment modalities including: 1) conventional manual auricular acupuncture in individuals with chronic low back pain (Sator-Katzenschlager, 2004); 2) autogenic training (a psychological intervention) in individuals with RA (Bernateck, 2008); and 3) sham stimulation in women undergoing gynecologic surgery (Holzer, 2011). Conclusions drawn from these studies are limited by the small number of participants (Holzer, 2011; Sator-Katzenschlager, 2004), a high participant withdrawal rate, outcome measures reporting limited clinical improvement in pain intensity during the treatment period (Bernateck, 2008), and no significant difference between the active treatment and sham treatment groups in consumption of analgesics during the first 72 hours following gynecologic surgery (Holzer, 2011).

Michalek-Sauberer and colleagues (2007) conducted a prospective, randomized, double-blind, placebo-controlled trial of 149 participants, investigating the effects of the P-Stim device on pain and analgesic drug consumption in the first 48 hours after unilateral mandibular third molar tooth extraction performed under local anesthesia. The investigators reported no differences in reduction of pain intensity or analgesic consumption in either the active treatment group or sham treatment groups.

Schukro and colleagues (2014) evaluated the effects of auricular electrostimulation on obesity in females in a small prospective, randomized, placebo-controlled pilot study. A total of 56 individuals, 18 years of age or older with a Body Mass Index (BMI) greater than 25, were randomized to receive either active P-Stim (n=28) or placebo treatment with a “dummy” P-Stim device (n=28). The treatment was performed over 4 days (battery-life up to 96 hours), once weekly for 6 weeks, with a follow-up visit performed after 4 weeks. The authors reported a “relative reduction” in body weight and BMI as significantly greater in the treatment group versus the placebo group (p<0.001 for both measures). Additional randomized controlled trials are needed measuring long-term outcomes in a homogeneous group of participants to determine the durability of the treatment effect of P-Stim for the treatment of obesity.

Yeh and colleagues (2014) conducted a systematic review and meta-analysis of randomized controlled trials to assess the efficacy of auricular therapy (including auricular electroacupuncture) compared to sham therapy in 22 randomized controlled trials through May 2013; 13 trials were used for meta-analysis. Auricular electroacupuncture was found to be nonsignificant for pain reduction compared to sham or control (n=2 studies); however, only 19 subjects were included in the evaluable trials.

Tan and colleagues (2014) conducted a systematic review of 39 randomized and nonrandomized controlled trials and 4 case reports evaluating adverse events of auricular electrostimulation. The most frequently reported adverse events were local discomfort, pain, and skin irritation which were transient, mild, and tolerable. No serious adverse events were identified.

Zhao and colleagues (2015) performed a systematic review and meta-analysis of randomized controlled trials investigating the efficacy and safety of auricular therapy for chronic pain. In the 15 trials included in the meta-analysis, auricular therapy decreased pain intensity, especially for chronic low back pain and chronic tension headache. However, the lasting effect of auricular therapy began to diminish 3 months after the completion of treatment. Limitations of this analysis include significant heterogeneity and methodological flaws in the evaluated randomized clinical trials.

In summary, the available evidence in the peer-reviewed medical literature is insufficient to evaluate the treatment effect of auricular electrostimulation on improving health outcomes, including the treatment of acute and chronic pain and other conditions. To date, no evidence-based clinical practice guidelines recommend the use of auricular electrostimulation devices for any indication. Additional randomized studies with larger number of subjects measuring long-term outcomes are needed to evaluate the efficacy of this treatment approach.

H-Wave Electrical Stimulation Devices

H-Wave electrical stimulation 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 (Kumar and Marshall, 1997; Kumar, 1998) comparing active H-Wave electrical stimulation for the treatment of painful diabetic peripheral neuropathy. Both studies included small participant populations of 31 and 14 individuals, respectively. In the study by Kumar and Marshall (1997), outcomes were assessed using a pain-grading scale (ranging from 0 to 5). Both study 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 by Kumar and colleagues (1998) compared H-Wave electrical stimulation with sham stimulation among individuals who did not adequately respond to an initial 4-week trial of a tricyclic antidepressant for pain from diabetic peripheral neuropathy. Stimulation therapy lasted 12 weeks, with outcomes assessed by an investigator blinded to group assignment at 4 weeks after the end of treatment. As in the earlier study, mean pain grade in both groups improved significantly, but the difference between groups after treatment significantly favored active H-Wave stimulation (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.

Julka and colleagues (1998) described a case series of 34 individuals who continued H-Wave electrical stimulation for over 1 year and achieved a 44% reduction in symptoms. This single case series and the small controlled trials are limited in drawing conclusions about the effectiveness of H-Wave electrical stimulation for painful diabetic peripheral neuropathy due to the small number of participants and short-term outcome measurements. 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 painful diabetic peripheral neuropathy.

Blum and colleagues (2006a; 2006b) 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% to100%, 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 electrical stimulation 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.

The effect of H-Wave electrical stimulation 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 the H-Wave device to utilize for 1 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 electrical stimulation 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 days and 90 days postoperatively (p=0.007 and p=0.006, respectively). There was no significant difference between the 2 groups for strength testing. The authors concluded that H-Wave electrical stimulation 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 electrical stimulation for any other indication.

Interferential Stimulation (IFS) Therapy Devices

IFS for Low Back Pain

Two early studies that included a placebo control (Taylor, 1987; van Heijden, 1999) failed to show a significant treatment effect.

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 3-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 1 of 3 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 double-blind trial compared IFS therapy or horizontal therapy (HT) with sham stimulation in 105 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.

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).

Facci and colleagues (2011) published the results of a randomized controlled trial comparing IFS (n=50) and TENS (n=50) to a no-treatment control group (n=40) in persons with chronic low back pain. Participants were assessed by a blinded evaluator before and after completing 10, 30-minute treatment sessions over 2 weeks; participants in the control group were reassessed after 2 weeks. A total of 137 of 150 (91%) participants completed the intervention; analysis was intention-to-treat. The mean pain intensity, as measured by a 10-point VAS, decreased 4.48 cm in the IFS group, 3.91 cm in the TENS group, and 0.85 cm in the control group. There was no statistically significant difference in pain reduction in the active treatment groups. Both groups experienced significantly greater pain reduction than the control group. Since a sham treatment was not used, a placebo effect cannot be ruled out when comparing active to control treatments. In addition, findings from this study do not demonstrate equivalence between IFS and TENS; studies with larger numbers of participants that are designed as equivalence or non-inferiority trials would be needed before drawing this conclusion.

Albornoz-Cabello and colleagues (2017) performed a randomized, single-blinded controlled trial to assess the short-term efficacy of transregional IFS on pain perception and disability level in chronic non-specific low back pain. A total of 64 individuals from a private physiotherapy research clinic with low back pain of more than 3 months, with or without pain radiating to the lower extremities above the knee, were randomized 2:1 to an experimental group (n=44) or a control group (n=20). Transregional IFS was performed for participants in the experimental group, while the control group underwent a 'usual care' treatment (that is, massage, mobilization and soft-tissue techniques). All participants received up to 10 treatment sessions of 25 minutes over a 2-week period. The primary outcome measure was self-perceived pain assessed with a VAS score; secondary outcomes were measured with the Oswestry Low Back Disability Index. Evaluations were collected at baseline and after the intervention protocol. Significant between-group differences were reported for interferential current therapy on pain perception (p=0.032) and disability level (p=0.002). Limitations of this study include the single-blinded study design, small number of participants, and short-term outcome measurements.

Franco and colleagues (2017) conducted a two-arm randomized controlled trial with 6 months of follow-up to determine whether IFS therapy before Pilates exercises was more effective than placebo in individuals with chronic nonspecific low back pain. A total of 148 participants between the ages of 18 and 80 years with chronic nonspecific low back pain were allocated into 2 groups: active IFS plus Pilates or placebo IFS plus Pilates. In the first 2 weeks, participants were treated for 30 minutes with active or placebo IFS. In the following 4 weeks, 40 minutes of Pilates exercises were added after the application of the active or placebo IFS. A total of 18 sessions were offered during 6 weeks. The primary outcome measures were pain intensity, pressure pain threshold, and disability measured at 6 weeks after randomization. No significant differences were found between the groups for pain (0.1 points; 95% confidence interval [CI], -0.9 to 1.0 points), pressure pain threshold (25.3 kPa; 95% CI, -4.4 to 55.0 kPa), and disability (0.4 points; 95% CI, -1.3 to 2.2). The investigators concluded that active IFS before Pilates exercise was not more effective than placebo IFS in individuals with chronic nonspecific low back pain.

In 2016, the Agency for Healthcare Research and Quality (AHRQ) (Chou, 2016) published a comparative effectiveness review on noninvasive treatments for acute or subacute low back pain. A total of 156 studies were included with most trials enrolling individuals with pain symptoms of at least moderate intensity (for example, > 5 on a 0- to 10-point numeric rating scale for pain). The review evaluated pharmacotherapy and physical modalities including interferential therapy, PENS, and TENS. Four studies investigated interferential therapy for subacute to chronic low back pain. No study evaluated harms of interferential therapy. The review concluded there was insufficient evidence due to methodological limitations and study imprecision to determine the treatment effects of interferential therapy versus other interventions, or interferential therapy plus another intervention versus the other interventions alone. Additional research was recommended “…to understand optimal selection of treatments, effective combinations and sequencing of treatments, and effectiveness of treatments for radicular low back pain.”

IFS for Musculoskeletal Pain

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. A total of 20 randomized controlled trials met the inclusion criteria; 14 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 2 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 (for example, 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 (that is, 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.

Acedo and colleagues (2014) compared the muscle relaxation of the upper trapezius induced by the application of TENS and IFS in individuals with chronic nonspecific neck discomfort. A total of 64 individuals randomly assigned to a TENS or IFS received 3 consecutive days of treatment. Efficacy was assessed by electromyography (EMG) in the third week and after the end of treatments. Pain was assessed using a VAS at baseline (before TENS or IFS application) and at the end of the study. EMG assessment data were similar between groups. Those in the IFS group had a significant trapezius relaxation after 3 IFS applications when compared to baseline and intermediate evaluations (p<0.05). Both groups showed an improvement at the end of the study when compared to baseline (p<0.05). Limitations of this study include the small sample size, short duration of treatment, and lack of long-term measurement of outcomes demonstrating durability of the treatment effect.

Suriya-amarit and colleagues (2014) studied the immediate effects of IFS on shoulder pain and pain-free passive range of motion (PROM) of the shoulder in a double-blind, placebo-controlled clinical trial of individuals (n=30) with hemiplegic shoulder pain. In the IFS group, participants received treatment for 20 minutes with an amplitude-modulated frequency at 100 Hz with an increase in current intensity until the participants felt a strong tingling sensation. The primary outcome measurements were pain intensity and pain-free PROM of the shoulder until the onset of pain, measured at baseline and immediately after treatment. Participants reported a greater reduction in pain during the most painful movement after treatment with IFS than with placebo (p<0.05). The IFS group showed a greater improvement in post treatment pain-free PROM than the placebo group in shoulder flexion (p<0.01), abduction (p<0.01), internal rotation (p<0.01), and external rotation (p<0.01). Limitations of this study include the small sample size, an inability to generalize the results to the stroke population as a whole, and short-term effects of IFS treatment; therefore, the long-term effects of IFS treatment in individuals with hemiplegic shoulder pain is unknown.

Dissanayaka and colleagues (2016) compared the effectiveness of TENS and IFS both in combination with hot pack, myofascial release, active range of motion exercise, and a home exercise program on subjects with myofascial pain syndrome. A total of 105 subjects with an upper trapezius myofascial trigger point were randomized to one of three therapeutic regimens (n=35 each group): 1) control group: “standard care” with hot pack, active range of motion exercises, myofascial release, and a home exercise program with postural advice; 2) TENS with standard care; or, 3) IFS with standard care. All interventions were administered 8 times during 4 weeks at regular intervals. Pain intensity and cervical range of motion were measured at baseline, immediately after the first treatment, before the eighth treatment, and 1 week after the eighth treatment. The IFS group showed significant improvement in the outcome measurements when compared to the standard care group (p<0.05); however, significant immediate and short-term improvements were reported with TENS and standard care compared to IFS and standard care with respect to pain intensity and cervical range of motion (p<0.05).

IFS for OA and other Knee Pain

The results of a randomized double-blind, placebo-controlled trial of IFS therapy in 87 study subjects divided into 6 treatment or sham treatment groups based on 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 small study groups, possible overestimation of the statistical differences in the analyses of multiple comparisons, resulting in a potential bias of the treatment effect (Jarit, 2003).

A randomized controlled trial by Defrin and colleagues (2005) studied 62 individuals treated with IFS therapy for OA knee pain. Individuals were randomized to 1 of 4 active treatment groups or 2 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. Conclusions from this study are limited due to the small number of participants.

Gundog and colleagues (2011) compared the effectiveness of different amplitude-modulated frequencies of IFS and sham IFS on knee OA. Participants (n=60) were randomly assigned to 1 of 4 groups: 3 IFS groups at frequencies of 40 Hz, 100 Hz, and 180 Hz, or sham IFS. Treatments were performed 5 times a week for 3 weeks on both groups. During the sham treatment, placement of the pads was the same and duration was the same without the application of electrical stimulation. The primary outcome measurement was pain intensity assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC). Mean WOMAC scores 1 month after treatment were 7.2, 6.7, and 7.8 in the 40 Hz, 100 Hz, and 180 Hz groups, respectively, and 16.1 in the sham IFS group (p<0.05 compared to the active treatment groups). A secondary outcome reported as pain on movement showed significantly higher benefit in the active treatment groups compared to the sham IFS group. Using a 100-point VAS score 1 month after treatment, the mean VAS score was 16.0, 17.0 and 22.5 in the 40 Hz, 100 Hz, and 180 Hz groups, respectively, and 58.5 in the sham group. There were no significant differences in outcomes among the 3 active treatment groups. Limitations of this study include small study size, the lack of reporting the number of participants assigned to each study group and follow-up rates that were not measured beyond 1 month after treatment.

Atamaz and colleagues (2012) conducted a double-blind randomized controlled trial comparing the efficacy of IFS, TENS, and shortwave diathermy in 203 individuals with knee OA. Participants were randomized to 1 of 6 groups, 3 with active treatment and 3 with sham treatment. The primary outcome was a 0 to 100 VAS assessing knee pain. Other outcomes included range of motion, time to walk 15 meters, paracetamol intake, the Nottingham Health Profile (NHP) and WOMAC scores. At 1-, 3-, and 6-month follow-up, a statistically significant difference was not reported among the 6 groups in the VAS pain score, the WOMAC pain score, or the NHP pain score. The WOMAC function score, time to walk 15 meters, and the NHP physical mobility score did not differ significantly among groups at any of the follow-up assessments. At the 1-month follow-up, paracetamol intake was significantly lower in the IFS group than the TENS group.

IFS for Other Conditions

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. There was no statistically significant difference in the outcomes between the 2 groups. In 1999, van der Heijden and colleagues randomized 180 individuals with soft tissue shoulder disorders to undergo therapy in 1 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 (that is, the placebo group); or 5) no adjuvant therapy. Principal outcome measures included recovery, functional status, chief complaint, pain, clinical status, and range of motion at 6 weeks after the therapy had been completed and at intervals up to 1 year. The authors reported that neither IFS therapy nor ultrasound proved to be effective as an adjuvant to exercise therapy.

Koca and colleagues (2014) assessed the effectiveness of IFS and TENS therapies in the management of symptoms associated with idiopathic carpal tunnel syndrome. In this single-blind trial, participants were randomized to 1 of 3 groups: splint therapy, TENS, or IFS (n=25 per group). Participants in the TENS and IFS groups had a total of 15 therapy sessions (5 per week) lasting 20 minutes each. All participants were permitted to use paracetamol as needed during the study, except on assessment days. A total of 63 of 75 participants (84%) completed the study. The study investigators assessed a number of outcomes but did not specify primary end points. Participants in the IFS group had significantly greater improvement than those in the TENS and splint groups on most reported clinical outcomes, including pain measured on a 10-point VAS (p<0.01 for the comparison between IFS and each of the other groups), symptom severity, and functional capacity. Limitations of this study include the small sample size and high drop-out rate.

Suh and colleagues (2014) evaluated IFS in the treatment of 42 adults with symptomatic, chronic stroke plantarflexor spasticity. In this single-blind trial, participants were randomized to a single 60-minute session with IFS or a placebo IFS treatment following 30 minutes of standard rehabilitation. In the placebo treatment, electrodes were attached but current was not applied. Outcomes were measured immediately before and 1 hour after the intervention. The primary outcomes were gastrocnemius spasticity measured on a 0 to 5 Modified Ashworth Scale and 2 balance-related measures: the Functional Reach Test and the Berg Balance Scale. Gait speed was measured using a 10-meter walk test, and gait function was assessed with the Timed Up and Go Test. The IFS group performed significantly better than the placebo group on all outcomes (p<0.05 for each comparison). Limitations of the study were that outcomes were only measured 1 hour after the intervention and no data were available on long term effects of the treatment intervention.

Summary

The American College of Occupational and Environmental Medicine (ACOEM, 2011) has published several guidelines on the use of IFS as follows:

A significant number of randomized controlled trials using IFS for musculoskeletal conditions vary in the adjunct treatments that are used, comparison groups, types of controls, and outcome measures. Other methodological limitations in these trials include use of multiple treatment modalities without the ability to isolate the effect of IFS or inadequate placebo control. At this time, there is insufficient or limited evidence in the peer-reviewed medical literature to draw conclusions regarding the efficacy of IFS therapy to decrease pain and facilitate healing for any condition.

Microcurrent Electrical Nerve Stimulation (MENS) 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 age-dependent muscle weakness (Kwon, 2017), chronic nonspecific back pain (Koopman, 2009), delayed onset muscle soreness (Curtis, 2010), diabetes mellitus (Gossrau, 2011; Lee, 2009), fibromyalgia (Moretti, 2012), 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, conclusions cannot be reached about the effectiveness of MENS therapy on pain management.

To date, there is insufficient evidence to date 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) (including Pulsed Electromagnetic Stimulation) Devices

PES and pulsed electromagnetic stimulation devices (also referred to as pulsed short-wave electromagnetic field stimulation [PEMF]) have been used to decrease pain and joint damage and improve function in individuals with OA or RA. The proponents of the BioniCare® PES device (BioniCare Medical Technologies, Inc., Sparks, MD) theorize that PES devices can facilitate bone formation and cartilage repair and alter inflammatory cell function.

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 6 to 10 hours daily for 4 weeks and were allowed to continue 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 4 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 Cochrane review of pulsed electromagnetic fields for the treatment of OA (Hulme, 2002), concluding 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 industry-sponsored, 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 5-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. A total of 45% 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 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, 3 of 5 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.

Ozguclu and colleagues (2010) investigated the effect of PEMF in a double-blind randomized controlled trial of 40 individuals with knee OA. Participants with an average pain intensity of 40 or more on a 100-mm VAS were randomly assigned to receive PEMF or sham PEMF in addition to physical therapy. Sessions included 20-minute hot pack, 5-minute ultrasound, and 30-minute PEMF or sham and were provided 5 times per week for 2 weeks, along with isometric knee exercises performed at home. After 2 weeks, both groups showed improvement in pain and functional scores; there were no significant differences between the 2 groups. Limitations of this trial include lack of an inactive control group, a short follow-up period (final assessment was at the end of 2-week treatment), and the potential for a placebo effect as the control device generated some heat.

Fary and colleagues (2011) reported results from a randomized double-blind sham-controlled trial of PES in 70 individuals with OA of the knee. The device used in this study was a commercially available TENS unit that was modified to provide PES. Participants were instructed to apply the device for a minimum of 6 hours a day. In the placebo group, the device turned itself off after 3 minutes. After 26 weeks of treatment, 59% of participants using the active device and 36% of controls had achieved target usage based on self-maintained logs. Intention-to-treat analysis showed a statistically significant improvement in VAS for pain over 26 weeks in both groups, but no difference between groups (VAS of 20 vs. 19 for controls on a 100-mm scale). There was no significant difference between groups in the proportion of participants who achieved a clinically relevant 20-mm improvement in VAS pain score at 26 weeks (56% vs. 44% of controls). There were no significant differences between groups for changes in WOMAC pain, stiffness, and function scores, short-form 36 (SF-36) physical and mental component summary scores, participant’s global assessment of disease activity, or activity measures. The authors concluded that in these participants with clinically and radiographically significant OA of the knee, 26 weeks of PES was no more effective than placebo.

Fukada and colleagues (2011) evaluated 121 women with knee OA in a double-blind randomized controlled trial using the short-wave electrical field Diatermed II stimulation device (Carci, Sao Paulo, Brazil) for 9 sessions over 3 weeks on 4 treatment groups: 1) low-dose (19-minute treatment); 2) high-dose (38-minute treatment); 3) placebo; or 4) no-treatment control. Pain and function were measured with a numeric rating scale (NRS) and the Knee Osteoarthritis Outcome Score (KOOS) at baseline, immediately after treatment, and at 1-year follow-up. Participants and the physical therapist evaluator were blinded throughout the 1-year follow-up except for those in the untreated or control groups. Both the low- and high-dose groups exhibited significantly greater improvement than the control groups in the NRS (NRS decreased from 7.7 to 6.9 in the placebo group, from 7.1 to 3.8 in the low-dose group, and from 6.7 to 4.6 in the high-dose group) and KOOS subscales immediately after treatment. The percentage of participants who achieved the minimal clinically important difference of 2 points on the NRS was 15% in the control group, 15% in the placebo group, 75% in the low-dose group, and 50% in the high-dose group. The low-dose group (but not the high-dose group) maintained significant improvement on 3 of 5 KOOS subscales at the 1-year follow-up. Limitations of this study include a high dropout rate of 36% as participants were either lost to follow-up, received other therapies, or had a total knee replacement).

Negm and colleagues (2013) performed a meta-analysis including seven small sham controlled randomized controlled trials (n=459 participants) examining PES or PEMF for the treatment of knee OA. Five of the trials were conducted outside of the United States, and only the trial by Fary and colleagues (2011) was considered to be at low risk of bias. There was no significant difference between the active and sham groups for the outcome of pain. Physical function was significantly higher with PES or PEMF stimulation, with a standardized mean difference of 0.22. The internal validity of the included studies is limited due to a number of factors, including a high risk of bias and inconsistency in the reported results. All of the studies had small sample sizes with wide confidence intervals around outcomes, leading to imprecise estimates of the treatment effect.

In a Cochrane review, Li and colleagues (2013) performed a meta-analysis of nine studies (n=636 participants) (including Fary, 2011; Garland, 2007; Nelson, 2013) evaluating the use of PES and PEMF stimulation for treating OA. The meta-analysis found that participants who were randomized to PES or PEMF stimulation rated their pain relief as greater than sham-treated participants by 15.10 more on a scale of 0 to 100; however, no statistically significant effect was found on function or quality of life. In three studies, a high risk of bias was identified for incomplete outcome data. For all nine studies, the authors noted there were inadequacies in reporting of study design and conduct, making it unclear whether there was bias due to selective outcome reporting.

Nelson and colleagues (2013) reported on a randomized, double-blind, placebo-controlled pilot study using the Palermo device in 34 participants with OA. Participants included in this study had knee pain with confirmed articular cartilage loss, an initial VAS score of 4 or more, and had at least 2 hours of daily standing activity in a physical occupation. Participants were instructed to use the electromagnetic device for 15 minutes twice daily; the total number of sessions used was recorded by the device. An average 80 of 84 possible sessions were recorded. Participants were asked to self-report the maximum daily VAS pain score on a 10-cm line for weeks 1, 2, 5 and 6. At the end of the study, 3 active treatment and 7 sham participants dropped out due to a lack of perceived benefit. At baseline, there was no significant difference in VAS between the active (6.8) and sham (7.1) treatment groups. Using intention-to-treat analysis with last observation carried forward, the average decrease in VAS was statistically significant (2.7) in the active treatment group and not statistically significant (1.5) in the sham group. At the end of the study, the maximum VAS decreased by 39% in participants receiving active treatment and 15% in the sham group. The difference between groups (4.19 vs. 6.11) was statistically and clinically significant. Limitations of this study include the small sample size and use of a non-FDA cleared treatment device.

In 2013, the American Academy of Orthopaedic Surgeons (AAOS) published guidelines on the treatment of OA of the knee. Due to the overall inconsistent finding for electrotherapeutic modalities, the AAOS was unable to make a recommendation for or against the use in individuals with symptomatic OA of the knee. The strength of the recommendation was inconclusive.

Zeng and colleagues (2015) performed a systematic review and meta-analysis of 27 trials involving six types of electrical stimulation therapy for pain relief in individuals with knee OA. Bayesian network meta-analysis was used to combine both the direct and indirect evidence on treatment effectiveness. Use of IFS was reported as the only significantly effective treatment in terms of both pain intensity and change in pain score at last follow-up time point when compared with the control group. IFS demonstrated the greatest probability of being the best option among the six treatment methods (including high-frequency TENS, low-frequency TENS, neuromuscular electrical stimulation [NMES], PES, and noninvasive interactive neurostimulation [NIN]) in pain relief; however, limitations of this analysis include the heterogeneity and small number of included trials, presenting a potential risk to the validity of results.

Wuschech and colleagues (2015) evaluated 10-minute daily treatment with the MAGCELL® ARTHRO (Physiomed® Elektromedizin, Germany) in a semi-randomized, double-blind, sham-controlled study of 57 subjects with OA. Due to efficacy at the interim analysis, only the first 26 subjects underwent randomization; the remainder was assigned to the active treatment group, although subjects and assessors remained blinded to treatment. Treatment was performed for 5 minutes, twice daily over 18 days. In the sham group, WOMAC total score was 56.9 at baseline and 56.2 at follow-up. In the active PEMF group, WOMAC total score decreased from 65.4 to 42.9. Intention-to-treat analysis showed that the active PEMF group had a clinically and statistically significant reduction in pain (p<0.001) on the WOMAC score compared to the sham group. Stiffness (p=0.032) and disability in daily activities (p=0.005) on the WOMAC score were also significantly reduced in the active PEMF group. Limitations of this study include the small sample size and whether it was sufficiently powered to draw meaningful conclusions, as the power analysis indicated that 28 participants would be needed per group. To date, the MAGCELL ARTHRO device has not received FDA 510(k) clearance for use in the treatment of any condition.

Bagnato and colleagues (2016) evaluated the effectiveness of a wearable PEMF device in the management of pain in knee OA. In this randomized, double-blind, sham-controlled trial, 60 subjects were treated with 12 hours of nightly ActiPatch® therapy (BioElectronics Corporation, Frederick, MD). After 1 month of treatment, there was a clinically significant decrease (25.5%) in VAS pain scores in the PEMF group compared with a 3.6% reduction in the sham group (effect size, -0.73; 95% CI, -1.24 to -0.19). WOMAC total score was reduced by 18.4% in the active treatment group compared to 2.3% for controls (effect size, -0.34; 95% CI, -0.85 to 0.17). SF-36 Physical Component Summary scores also improved significantly with nightly PEMF. Limitations of this study include the small number of subjects and lack of long-term efficacy outcomes.

Dundar and colleagues (2016) performed a randomized, double-blind, sham-controlled trial of 40 subjects who received either conventional physical therapy or physical therapy and PEMF therapy for knee OA pain. The investigators reported there was no additional treatment benefit after 20 minutes of adjuvant PEMF therapy on pain reduction as measured by either the VAS or WOMAC pain scales.

In summary, there is insufficient evidence in the peer-reviewed published literature to support the efficacy of PES and PEMF devices for decreasing pain and improving function in individuals with OA and RA. The conclusions drawn from the available studies are limited by methodological limitations and inconsistency of the study results. No published studies for RA were identified. 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 1 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 1-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 3 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 1 week. The neuromodulation group had 100% follow-up; 7 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 2 groups at 48 hours after treatment. Changes in the WOMAC scale were significantly better for the category of stiffness (1 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 (77% vs. 11% good to excellent) at up to 1-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 2 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.

Supraorbital Transcutaneous Neurostimulation

Prophylactic Treatment of Migraine Headache

Schoenen and colleagues (2013) evaluated the safety and effectiveness of trigeminal neurostimulation in migraine headache prevention using the supraorbital transcutaneous stimulator, the Cefaly device (STX-Med., Herstal, Belgium). The multicenter prospective, double-blind, sham-controlled trial (PREMICE study) randomized 67 adults (18-65 years) who experienced two or more migraine headache attacks (with or without aura) per month and had not taken any preventive antimigraine medications in the 3 months prior to initiating use with the Cefaly device. After a 1-month run-in, participants were randomized 1:1 to active or sham stimulation applied 20 minutes daily for 3 months. Primary outcomes measures included a change in migraine days and at least 50% reduction in migraine days. A total of 59 of the 67 randomized participants were included in the intent-to-treat analysis. The primary outcome measure was reported as a non-significant greater decrease in migraine days per month (active: 6.94 vs. 4.88 [-2.06]; sham: 6.54 vs. 6.22 [-0.32]; p=0.054); however, the 50% responder rate was significantly greater in the active treatment group than in the sham group (38% vs. 12.1%; p=0.023). Monthly migraine attacks (p=0.044), monthly headache days (p=0.041), and monthly acute antimigraine drug intake (p=0.007) were also significantly reduced in the treatment group but not in the sham group. The investigators reported no adverse events (AEs) in either group. A greater proportion of participants in the active treatment group were moderately or very satisfied with the Cefaly device (71% vs. 39%). Limitations of this study include the small number of participants and the likelihood of bias as potential unblinding to treatment may have occurred during the trial. The investigators noted that the stimulation electrodes of the active device could be painful to finger touch while the sham device electrodes would not be painful. In addition, there were apparent differences between the two groups at baseline, as participants randomized to the treatment group were of younger (average) age and had a shorter duration of migraine attacks.

A second randomized trial using the Cefaly device was done in healthy volunteers and had no migraine-specific outcomes (Piquet, 2011). The investigators used a cross-over design to evaluate potential sedative side effects of supraorbital nerve stimulation based on prior studies, finding that high frequency stimulation resulted in a “…decrease in vigilance and attention” compared with low frequency stimulation (p<0.001). The high frequency stimulation (120 Hz) was twice that of the typical frequency recommended clinically for the Cefaly device (60 Hz).

Treatment of Acute Migraine Headache

Data collected from a satisfaction survey described the observational experience of 2313 individuals with migraine headaches from France, Belgium, and Switzerland who used the Cefaly device for 40 days (Magis, 2013). The rate of reported AEs was 4.3%, and 2% (n=46) of users stopped treatment with the device due to AEs. The most common AE reported was intolerance to the paresthesias felt during electrical stimulation (1.3% of users). Other common AEs included sleepiness (0.5%), headache following treatment (0.5%), and forehead skin irritation (0.2%). A total of 53% of users elected to purchase the device after the trial period; the remainder returned the device. For those individuals who returned the device, 59% used it for the recommended length of time during the rental period, similar to the utilization duration observed in the randomized trial.

Chou and colleagues (2017) performed a prospective, open-label pilot study of 30 individuals who experienced acute migraine attacks with or without aura. Participants at a single clinic site were treated with a 1 hour session of trigeminal nerve stimulation with the Cefaly device. Pain intensity was scored using a VAS before the treatment, after the treatment session, and at 2 hours after treatment initiation. Participants were allowed to take rescue migraine medication with treatment recorded at 2 and 24 hours. The primary outcome was the mean change in pain intensity after the 1 hour treatment compared to baseline, which was reported as significantly reduced by 57.1% after the 1 hour Cefaly treatment (-3.22 ± 2.40; p<0.001) and by 52.8% at 2 hours (-2.98 ± 2.31; p<0.001). No participants took rescue medication within the 2 hour observation phase; however, 34.6% of participants used a rescue mediation within the 24 hour follow-up. No adverse events were reported. A limitation of drawing conclusions from this pilot study was the small sample size, open-label design, lack of blinding to treatment, and no control group.

In September 2017, the FDA cleared the Cefaly Acute device, a substantially equivalent device to the predicate Cefaly device, as an external trigeminal nerve stimulator for use in the treatment of adults ≥ 18 years of age with migraine attacks, with or without aura. The FDA 510(k) clearance was based on results from a multicenter, randomized, double-blind, placebo-controlled Acute Treatment of Migraine With e-TNS trial (ACME; NCT02590939). According the clinicaltrial.gov website, eligible participants were 18 to 65 years (mean age, approximately 40 years), had a history of episodic or chronic migraine with or without aura meeting the diagnostic criteria in ICHD-III beta (v.2013) with the exception of “complicated migraine”, experienced a migraine attack lasting for at least 3 hours with migraine pain intensity stabilized for at least 1 hour, and not have taken an acute migraine medication within the past 3 hours. Study participants were randomly assigned 1:1 to a single treatment with active or sham stimulation. The primary endpoint was the mean change in VAS pain score at 1 hour compared to baseline. Secondary endpoints included change in VAS pain scores at 2 and 24 hours from baseline, and the proportion of participants who did not use pain medications at these time points. To date, the ACME trial results are unpublished in the peer-reviewed medical literature.

Other Considerations

The Quality Standards Subcommittee of the American Academy of Neurology (AAN) and American Headache Society (AHS) updated their evidence-based recommendations for use of pharmacologic treatment for episodic migraine prevention in adults. The guidelines do not address the use of any type of Cefaly device for prevention of episodic migraines or the treatment of acute migraine headache (Silberstein, 2012).

In summary, there is insufficient evidence in the peer-reviewed published medical literature demonstrating a significant net health benefit on the use of any type of Cefaly device for the prevention of migraine headaches or the treatment of acute migraine headaches, with or without aura. Outcomes from peer-reviewed published randomized controlled trials of large sample populations with blinding of participants are needed to determine if supraorbital transcutaneous neurostimulation with any Cefaly device improves health outcomes when compared to existing therapies for prevention of episodic migraine headaches or the treatment of acute migraine headaches, and to assess longer-term safety and adverse effects.

Sympathetic Therapy

Sympathetic therapy is a patented method of delivering electrostimulation via peripheral nerves to create a unique 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 6 of the individuals at conclusion of the treatment. The author did not report on the reason why 5 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.

Background/Overview

Auricular Electrostimulation Devices

Auricular electrostimulation, or electroacupuncture, is a type of ambulatory electrical stimulation of acupuncture points on the ear over several days. Point stimulation by P-Stim is proposed for use in the treatment of: 1) preoperative, intraoperative and postoperative acute pain therapy (including dental procedures); 2) chronic pain syndromes associated with back pain, cervical syndrome, fibromyalgia, migraine headaches, sciatic-related pain; and, 3) pain associated with OA and RA. Other proposed uses include treatment of anxiety, depression, and special fields of anesthesia. P-Stim is generally well tolerated and can be combined with other forms of therapy.

According to the manufacturer and the U.S. Food and Drug Administration (FDA) 510(k) clearance summary (March 30, 2006), P-Stim is a single-use miniaturized, battery-powered, low frequency transcutaneous electrical nerve stimulator with a pre-programmed frequency, pulse, and duration for the stimulation of auricular acupuncture points. The device is worn behind the ear with a self-adhesive electrode patch. A selection stylus that measures electrical resistance is used to identify three auricular acupuncture points. The P-Stim device connects to the three acupuncture needles with caps and stainless steel wires. The device is powered by three zinc air batteries, each with a voltage of 1.4 V, and is preprogrammed to be on for 180 minutes, then off for 180 minutes, with a maximum battery life of up to 96 hours. The indications for use of P-Stim (and the FDA 510(k) cleared, substantially equivalent devices) are in the practice of acupuncture by qualified practitioners of acupuncture. All three devices have similar operating principles as electrical nerve stimulators including a single output channel and mode with similar pulse width and frequencies.

Supraorbital Transcutaneous Neurostimulation

The Cefaly device was cleared by the FDA in March 2014 as a Class II “transcutaneous electrical nerve stimulator (TENS)” de novo device for prophylactic (preventive) treatment of episodic migraine headaches (that is, migraine headaches occurring less than 15 times a month) in adults 18 years of age or older. On September 15, 2017, the FDA cleared the Cefaly Acute device as substantially equivalent to the predicate device (Cefaly) for use during an acute migraine attack with or without aura. 

The externally worn nerve stimulator is applied to the forehead using a self-adhesive electrode positioned bilaterally over the upper branches of the trigeminal nerve. The battery-powered headband device is intended to stimulate the upper branches of the trigeminal nerve in order to reduce the frequency of migraine attacks. The device consists of two distinct components: an electrical pulse generator (EPG) and a self-adhesive electrode. The Cefaly EPG is made of ABS plastic and consists of electrical circuits controlled by firmware and powered by two 1.5V batteries. The front of the Cefaly EPG has a single button that is used to turn the device on/off and adjust the intensity of the electrical stimulus during a treatment session. Visual and auditory indicators inform the user when the device is on or off and assists in troubleshooting if the device it is not working properly (for example, the device indicates if batteries need replacement and if electrical connection between device and skin is unacceptable). The back side of the Cefaly EPG has two metal blades that serve to electrically connect it to the Cefaly electrode.

A treatment session begins by attaching the Cefaly electrode to the middle of the forehead and fastening the Cefaly EPG to the electrode. When the on/off button is depressed, a pulsatile electrical stimulus is applied for 20 minutes. During the first 14 minutes, the intensity of the stimulus gradually increases until it reaches a maximum. At any time while the stimulus intensity is increasing, the user can press the button on the front of the device to select an intensity that is lower than the maximum, and it will remain constant at this lower value for the remainder of the treatment session. The device turns the stimulus off automatically after 20 minutes, or alternatively, the user can stop a treatment session by pressing the button twice or simply removing the device from their forehead.

According to the manufacturer, the following are limitations of use of the device:

H-Wave Electrical Stimulation Devices

H-Wave devices are classified by the 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.

IFS Therapy Devices

IFS therapy, also referred to as interferential therapy (IF/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.

MENS 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.

PES and PEMF Devices

In 2003, the FDA cleared the BioniCare Stimulator BIO-1000™ (now called the BioniCare Knee System with the OActive Knee Brace), 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 6 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.

The OrthoCor™ Active Knee System™ (OrthoCor Medical, Arden Hills, MN) uses PEMF energy at a radiofrequency of 27.12 MHz to treat pain. The OrthoCor Knee System received 510(k) marketing clearance (K091996, K092044) from FDA in 2009 and is classified as a shortwave diathermy device for use other than applying therapeutic deep heat. It is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue and for the treatment of muscle and joint aches and pain associated with overexertion, strains, sprains, and arthritis. The system includes single-use packs (pods) that deliver hot or cold and are supplied in packets of 15. The predicate devices are the OrthoCor (K091640) and Ivivi Torino II™ (K070541).

The SofPulse® (Models: 912-M10, and Roma3, Torino II™; Ivivi Health Sciences, LLC, Montvale, NJ) received 510(k) marketing clearance (K070541) in 2008 as short-wave diathermy devices that apply electromagnetic energy at a radiofrequency of 27.12 MHz. The devices are indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Palermo is another name for a device marketed by Ivivi Health Sciences. To date, this device has not been cleared by the FDA for use in the treatment of any condition.

PNT 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 1 hour of daily treatments in the physician’s office followed by home treatments if the initial treatment was effective. The Dynatron STS device (Dynatronics Corporation, Salt Lake City, UT) and companion home device, Dynatron STS Rx, are devices that deliver sympathetic therapy and have received FDA 510(k) clearance.

Types of Devices Used for Treatment

Auricular Electrical Stimulation Devices

H-Wave Electrical Stimulation Devices

IFS Therapy Devices

Brand Name

Manufacturer

BioStim® INF, INF Plus™

BioMedical Life Systems, Inc., Vista, CA

Endomed 433, 582, 982 Interferential Stimulators

Enraf Nonius B.V., Rotterdam, The Netherlands

Flex-IT™

EMSI, Alexander, VA

Soleo Galva Electrotherapy System

Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany

IF 4000

ProMed Specialties, Huntingdon Valley, PA

IF 8000

Biomotion, Madison, AL

NEO GeneSys 2k-2®

Sanexas Intl., GMBH, Blaustein, GM

FastStart® ICT, OrthoStim3™, SurgiStim3™, VQ™ Vector

VQ OrthoCareSM, Irvine, CA

RSJ, RS JC, RS-4i® Sequential Stimulator; RS-2i® Interferential Stimulator

RS Medical, Vancouver, WA

Siemens Stereodynator® 828 & 928

Gbo Medizintechnik AG, Rimbach, Germany

PRO ElecDT® 2000, VacuPulls/VasoPulse

Hako-Med, USA, Inc., Honolulu, HI

Vectorsurge 4 Interferential Therapy Unit-VS 460

Metron Medical-Australia PL, Victoria, Australia

MENS Devices

Brand Name

Manufacturer

Algonix®

Medilab GmbH & Co., Germany

Alpha-Stim®100

Electromedical Products International, Inc., Mineral Wells, TX, USA

Electro-Myopulse 75 L, Electro-Myoscope 85P, Myopulse 75C

Biomedical Design Instruments, U.S.A.

MICROCURRENT (Precision Microcurrent)

Precision Distributing, Inc. (Microcurrent Technology), Vancouver, WA

Micro Plus™ Microcurrent Electrical Nerve Stimulator

BioMedical Life Systems, Inc. Vista, CA

PNT Devices 

PES and PEMF Stimulation Devices

Supraorbital Transcutaneous Neurostimulation

Sympathetic Therapy

Definitions

 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.

Coding

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 codes listed below for all indications, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

64999

Unlisted procedure, nervous system [when specified as percutaneous neuromodulation therapy]

 

 

HCPCS

 

E0762

Transcutaneous electrical joint stimulation device system, includes all accessories (PES)

E1399

Durable medical equipment, miscellaneous [when specified as auricular electrostimulation, H-Wave, microcurrent stimulation, PNT or sympathetic therapy devices, or headband device for trigeminal nerve stimulation for migraines]

S8130

Interferential current stimulator, 2 channel

S8131

Interferential current stimulator, 4 channel

S8930

Electrical stimulation of auricular acupuncture points; each 15 minutes of personal one-on-one contact with the patient

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Acedo AA, Luduvice Antunes AC, et al. Upper trapezius relaxation induced by TENS and interferential current in computer users with chronic nonspecific neck discomfort: an electromyographic analysis. J Back Musculoskelet Rehabil. 2015; 28(1):19-24.
  2. Albornoz-Cabello M, Maya-Martin J, Dominguez-Maldonado G, et al. Effect of interferential current therapy on pain perception and disability level in subjects with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2017; 31(2):242-249.
  3. Atamaz FC, Durmaz B, Baydar M, et al. Comparison of the efficacy of transcutaneous electrical nerve stimulation, interferential currents, and shortwave diathermy in knee osteoarthritis: a double-blind, randomized, controlled, multicenter study. Arch Phys Med Rehabil. 2012; 93(5):748-756.
  4. Bagnato GL, Miceli G, Marino N, et al. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology (Oxford). 2016; 55(4):755-762.
  5. Bernateck M, Becker M, Schwake C, et al. Adjuvant auricular electroacupuncture and autogenic training in rheumatoid arthritis: a randomized controlled trial. Auricular acupuncture and autogenic training in rheumatoid arthritis. Forsch Komplementmed. 2008; 15(4):187-193.
  6. 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.
  7. 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.
  8. 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.
  9. 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. 2006a; 23(5):739-749.
  10. 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. 2006b; 23(3):446-455.
  11. Chou DE, Gross GJ, Casadei CH, Yugrakh MS. External trigeminal nerve stimulation for the acute treatment of migraine: open-label trial on safety and efficacy. Neuromodulation. 2017; 20(7):678-683.
  12. 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.
  13. 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.
  14. Dissanayaka TD, Pallegama RW, Suraweera HJ, et al. Comparison of the effectiveness of transcutaneous electrical nerve stimulation and interferential therapy on the upper trapezius in myofascial pain syndrome: a randomized controlled study. Am J Phys Med Rehabil. 2016; 95(9):663-672.
  15. Dundar U, Asik G, Ulasli AM, et al. Assessment of pulsed electromagnetic field therapy with Serum YKL-40 and ultrasonography in patients with knee osteoarthritis. Int J Rheum Dis. 2016; 19(3):287-293.
  16. Facci LM, Nowotny JP, Tormem F, et al. Effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical trial. Sao Paulo Med J. 2011; 129(4):206-216.
  17. 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.
  18. Fary RE, Carroll GJ, Briffa TG, Briffa NK. The effectiveness of pulsed electrical stimulation in the management of osteoarthritis of the knee: results of a double-blind, randomized, placebo-controlled, repeated-measures trial. Arthritis Rheum. 2011; 63(5):1333-1342.
  19. Franco KM, Franco YD, Oliveira NB, et al. Is interferential current before Pilates exercises more effective than placebo in patients with chronic nonspecific low back pain? A randomized controlled trial. Arch Phys Med Rehabil. 2017; 98(2):320-328.
  20. 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.
  21. 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.
  22. 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.
  23. 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.
  24. Gossrau G, Wahner M, Kuschke M, et al. Microcurrent transcutaneous electric nerve stimulation in painful diabetic neuropathy: a randomized placebo-controlled study. Pain Med. 2011; 12(6):953-960.
  25. Guido EH. Effects of sympathetic therapy on chronic pain in peripheral neuropathy subjects. Am J Pain Manage. 2002; 12(1):31-34.
  26. Gundog M, Atamaz F, Kanyilmaz S, et al. Interferential current therapy in patients with knee osteoarthritis: comparison of the effectiveness of different amplitude-modulated frequencies. Am J Phys Med Rehabil. 2012; 91(2):107-113.
  27. 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.
  28. Holzer A, Leitgeb U, Spacek A, et al. Auricular acupuncture for postoperative pain after gynecological surgery: a randomized controlled trail. Minerva Anestesiol. 2011; 77(3):298-304. 
  29. 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.
  30. 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.
  31. 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.
  32. 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.
  33. 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.
  34. Koca I, Boyaci A, Tutoglu A, et al. Assessment of the effectiveness of interferential current therapy and TENS in the management of carpal tunnel syndrome: a randomized controlled study. Rheumatol Int. 2014; 34(12):1639-1645.
  35. 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.
  36. 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.
  37. 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.
  38. Kumar D, Marshall HJ. Diabetic peripheral neuropathy: amelioration of pain with transcutaneous electrostimulation. Diabetes Care. 1997; 20(11):1702-1705.
  39. Kwon DR, Kim J, Kim Y, et al. Short-term microcurrent electrical neuromuscular stimulation to improve muscle function in the elderly: a randomized, double-blinded, sham-controlled clinical trial. Medicine (Baltimore). 2017; 96(26):e7407.
  40. 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.
  41. Magis D, Sava S, d'Elia TS, et al. Safety and patients' satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly® device in headache treatment: a survey of 2,313 headache sufferers in the general population. J Headache Pain. 2013; 14:95.
  42. Michalek-Sauberer A, Heinzl H, Sator-Katzenschlager SM, et al. Perioperative auricular electroacupuncture has no effect on pain and analgesic consumption after third molar tooth extraction. Anesth Analg. 2007; 104(3):542-547.
  43. Moretti FA, Marcondes FB, Provenza JR, et al. Combined therapy (ultrasound and interferential current) in patients with fibromyalgia: once or twice in a week? Physiother Res Int. 2012; 17(3):142-149.
  44. Negm A, Lorbergs A, Macintyre NJ. Efficacy of low frequency pulsed subsensory threshold electrical stimulation vs placebo on pain and physical function in people with knee osteoarthritis: systematic review with metaanalysis. Osteoarthritis Cartilage. 2013; 21(9):1281-1289.
  45. Nelson FR, Zvirbulis R, Pilla AA. Non-invasive electromagnetic field therapy produces rapid and substantial pain reduction in early knee osteoarthritis: a randomized double-blind pilot study. Rheumatol Int. 2013; 33(8):2169-2173.
  46. Ozuguclu E, Cetin A, Cetin M, et al. Additional effect of pulsed electromagnetic field therapy on knee osteoarthritis treatment: a randomized, placebo-controlled study. Clin Rheumatol. 2010; 29(8):927-931.
  47. Piquet M, Balestra C, Sava SL, Schoenen JE. Supraorbital transcutaneous neurostimulation has sedative effects in healthy subjects. BMC Neurology. 2011; 11:135.
  48. 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.
  49. Sator-Katzenschlager SM, Scharbert G, Kozek-Langenecker SA, et al. The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular acupuncture. Anesth Analg. 2004; 98(5):1359-1364.
  50. Sator-Katzenschlager SM, Szeles JC, Scharbert G, et al. Electrical stimulation of auricular acupuncture points is more effective than conventional manual auricular acupuncture in chronic cervical pain: a pilot study. Anesth Analg. 2003; 97(5):1469-1473.
  51. Sator-Katzenschlager SM, Wolfler MM, Kozek-Langenecker SA, et al. Auricular electro-acupuncture as an additional perioperative analgesic method during oocyte aspiration in IVF treatment. Hum Reprod. 2006; 21(8):2114-2120.
  52. Schoenen J, Vandersmissen B, Jeangette S, et al. Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial. Neurology. 2013; 80(8):697-704.
  53. Schukro RP, Heiserer C, Michalek-Sauberer A, et al. The effects of auricular electroacupuncture on obesity in female patients-a prospective randomized placebo-controlled pilot study. Complement Ther Med. 2014; 22(1):21-25.
  54. Suh HR, Han HC, Cho HY. Immediate therapeutic effect of interferential current therapy on spasticity, balance, and gait function in chronic stroke patients: a randomized control trial. Clin Rehabil. 2014; 28(9):885-891.
  55. Suriya-amarit D, Gaogasigam C, Siriphorn A, Boonyong S. Effect of interferential current stimulation in management of hemiplegic shoulder pain. Arch Phys Med Rehabil. 2014; 95(8):1441-1446.
  56. Tan JY, Molassiotis A, Wang T, Suen LK. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med. 2014; 2014:506758.
  57. 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.
  58. 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.
  59. 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.
  60. 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.
  61. 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.
  62. Wilson RD, Harris MA, Gunzler DD, Bennett ME, Chae J. Percutaneous peripheral nerve stimulation for chronic pain in subacromial impingement syndrome: a case series. Neuromodulation. 2014; 17(8):771-776; discussion 776.
  63. Wuschech H, von Hehn U, Mikus E, et al. Effects of PEMF on patients with osteoarthritis: results of a prospective, placebo-controlled, double-blind study. Bioelectromagnetics. 2015; 36(8):576-585.
  64. Yeh CH, Chiang YC, Hoffman SL, et al. Efficacy of auricular therapy for pain management: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014; 2014:934670.
  65. 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.
  66. Zeng C, Li H, Yang T, et al. Electrical stimulation for pain relief in knee osteoarthritis: systematic review and network meta-analysis. Osteoarthritis Cartilage. 2015; 23(2):189-202.
  67. Zhao HJ, Tan JY, Wang T, Jin L. Auricular therapy for chronic pain management in adults: a synthesis of evidence. Complement Ther Clin Pract. 2015; 21(2):68-78.
  68. 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 Academy of Orthopaedic Surgeons (AAOS). Treatment of osteoarthritis (OA) of the knee. 2013. Available at: http://www.aaos.org/research/guidelines/guidelineoaknee.asp. Accessed on August 21, 2017.
  2. American College of Occupational and Environmental Medicine (ACOEM). Occupational medicine practice guidelines. In: Hegman KT, editor(s). Evaluation and management of common health problems and functional recovery in workers. 3rd ed. Elk Grove Village, IL; 2011. Available at: http://www.guideline.gov/search/search.aspx?term=acoem. Accessed on August 21, 2017.
    1. Knee disorders
    2. Low back disorders
    3. Shoulder disorders.
  3. 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.
  4. 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: https://www.cms.gov/medicare-coverage-database/. Accessed on August 21, 2017.
  5. Chou R, Deyo R, Friedly J, et al. Noninvasive treatments for low back pain [Internet]. Comparative Effectiveness Review No. 169. Rockville (MD): Agency for Healthcare Research and Quality (US); February 2016. Available at: https://www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2178. Accessed on August 21, 2017.
  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):478-491.
  7. Hulme J, Robinson V, DeBie R, et al. Electromagnetic fields for the treatment of osteoarthritis. Cochrane Database Syst Rev. 2002;(1):CD003523.
  8. Li S, Yu B, Zhou D, et al. Electromagnetic fields for treating osteoarthritis. Cochrane Database Syst Rev. 2013;(12):CD003523.
  9. Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012; 78(17):1337-1345. Erratum in: Neurology. 2013; 80(9):871.
  10. 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 August 21, 2017.
Websites for Additional Information
  1. U.S. National Library of Medicine. National Institutes of Health. MedlinePlus. Diabetes and nerve damage. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000693.htm. Accessed on August 21, 2017.

Index

Auricular Electrostimulation
H-Wave Therapy
Interferential Stimulation (IFS) Therapy
Microcurrent Electrical Nerve Stimulation (MENS)
Percutaneous Neuromodulation Therapy (PNT)
Pulsed Electrical Stimulation (PES)
Pulsed Electromagnetic Field Stimulation (PEMF)
Supraorbital Transcutaneous Neurostimulation
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.

Document History

 

Status

Date

Action

 

 

Revised

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Revised INV & NMN statement for supraorbital transcutaneous neurostimulation. Updated Rationale, Background, References, and Websites for Additional Information sections.

 

 

Reviewed

11/03/2016

MPTAC review. Updated formatting in Position Statement section. Updated Description, Rationale, Background, References, Websites for Additional Information and Index sections.

 

 

Reviewed

11/05/2015

MPTAC review. Updated Description, Rationale, Discussion, Device tables, References, Websites for Additional Information, and Index sections. Removed ICD-9 codes from Coding section.

 

 

Revised

11/13/2014

MPTAC review. Added investigational and not medically necessary statement for supraorbital transcutaneous neurostimulation for all indications. Updated Rationale, Background, Coding, References, Index and Websites for Additional Information sections.

 

 

Revised

08/14/2014

MPTAC review. Added investigational and not medically necessary statement for auricular electrostimulation for all indications. Minor format changes throughout document. Updated Rationale, Background, Coding, References, Index and Websites for Additional Information sections.

 

 

Reviewed

05/15/2014

MPTAC review. Updated Rationale, References and Websites for Additional Information sections.

 

 

Reviewed

05/09/2013

MPTAC review. Updated Rationale, Background, References, and Websites for Additional Information.

 

 

Reviewed

05/10/2012

MPTAC review. Updated Description, Rationale, Background tables, References, Websites for Additional Information, and Index.

 

 

Reviewed

05/19/2011

MPTAC review. Updated Description, Rationale, Background, References, Websites for Additional Information, and Index.

 

 

Reviewed

05/13/2010

MPTAC review. Updated Discussion, Rationale, Coding, References, and Index.

 

 

Reviewed

05/21/2009

MPTAC review. Updated and clarified Description/scope of document. Updated Rationale, Background/Overview, product tables, Definitions, and References.

 

 

Reviewed

05/15/2008

MPTAC review. Updated Rationale, Background, Definitions, and References.

 

 

 

02/21/2008

The phrase “investigational/not medically necessary” was clarified to read “investigational and not medically necessary.” This change was approved at the November 29, 2007 MPTAC meeting.

 

 

Reviewed

05/17/2007

MPTAC review. Position Statements clarified. Rationale, Background, Index, and References updated. Product tables added.

 

 

Reviewed

06/08/2006

MPTAC annual review. Updated References.

 

 

 

01/01/2006

Updated Coding section with 01/01/2006 CPT/HCPCS changes.

 

 

 

11/22/2005

Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).

 

 

Revised

07/14/2005

Medical review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

 

Pre-Merger Organizations

Last Review Date

Document Number

Title

 

Anthem, Inc.

10/28/2004

DME.00011

Electrical Stimulation as a Treatment for Pain and Related Conditions: Surface and Percutaneous Devices

WellPoint Health Networks, Inc.

09/25/2004

2.07.12

Pulsed Electrical Stimulation in the Treatment of Osteoarthritis

 

12/2/2004

2.10.14

Sympathetic Therapy as a Treatment of Chronic Pain

 

04/28/2005

5.01.01

Inferential Current Stimulation