Clinical Policy Bulletin: Electrical Stimulation for Pain
Number: 0011
(Replaces CPBs 12, 335)
Policy
Aetna considers transcutaneous electrical nerve stimulators (TENS) medically necessary durable medical equipment (DME) when used as an adjunct or as an alternative to the use of drugs either in the treatment of acute post-operative pain in the first 30 days after surgery, or for certain types of chronic, intractable pain not adequately responsive to other methods of treatment including, as appropriate, physical therapy and pharmacotherapy. However, TENS is considered experimental and investigational for acute pain (less than 3 months duration) other than post-operative pain. TENS is also considered experimental and investigational for acute and chronic headaches, deep abdominal pain, hip fracture pain, neuropathic pain, pelvic pain, temporomandibular joint (TMJ) pain and all other indications because there is inadequate scientific evidence to support its efficacy for these specific types of pain.
Note: When TENS is used for acute post-operative or chronic intractable pain, Aetna considers use of the device medically necessary initially for a trial period of at least 1 month but not to exceed 2 months. The trial period must be monitored by the physician to determine the effectiveness of the TENS unit in modulating the pain. After this 1-month trial period, continued TENS treatment may be considered medically necessary if the treatment significantly alleviates pain and if the attending physician documents that the patient is likely to derive significant therapeutic benefit from continuous use of the unit over a long period of time. The physician's records must document a reevaluation of the member at the end of the trial period, must indicate how often the member used the TENS unit, the typical duration of use each time, and the results. The physician ordering the TENS unit must be the attending physician or a consulting physician for the disease or condition resulting in the need for the TENS unit. If the TENS unit produces incomplete relief, further evaluation with percutaneous electrical nerve stimulation (PENS) may be indicated. This coverage policy is consistent with Medicare DMERC guidelines.
Aetna considers a form-fitting conductive garment medically necessary DME only when it has been approved for marketing by the FDA, has been prescribed by a doctor for delivering TENS for one of the medically necessary indications listed above, and any of the following criteria is met:
The member can not manage without the conductive garment due to the large area or the large number of sites to be stimulated, and the stimulation would have to be delivered so frequently that it is not feasible to use conventional electrodes, adhesive tapes, and lead wires; or
The member has a medical need for rehabilitation strengthening following an injury where the nerve supply to the muscle is intact; or
The member has a skin problem or other medical conditions that precludes the application of conventional electrodes, adhesive tapes, and lead wires; or
The member requires electrical stimulation beneath a cast to treat disuse atrophy, where the nerve supply to the muscle is intact.
Aetna considers stellate ganglion blockade using TENS experimental and investigational because its clinical value has not been established.
Aetna considers interferential stimulation (e.g., RS-4i Sequential Stimulator) experimental and investigational for the reduction of pain and edema and all other indications because its effectiveness has not been established.
Aetna considers percutaneous electrical nerve stimulation (PENS) (also known as percutaneous neuromodulation) medically necessary DME for (i) up to a 30-day period for the treatment of members with chronic low back pain secondary to degenerative disc disease when PENS is used as part of a multi-modality rehabilitation program that includes exercise, and (ii) the treatment of members with diabetic neuropathy who failed to adequately respond to conventional treatments including three or more of the following groups of agents: anti-convulsants (e.g., pregabalin), anti-depressants (e.g., amitriptyline, and duloxetine), opioids (e.g., morphine sulphate and tramadol), and other pharmacological agents (e.g., capsaicin and isosorbide dinitrate spray).
Aetna considers PENS experimental and investigational for the treatment of chronic neck pain and all other indications because its effectiveness for these indications has not been established.
Aetna considers peripherally implanted nerve stimulators medically necessary DME for treatment of members with intractable neurogenic pain when all of the following criteria are met:
Member has chronic intractable pain, refractory to other methods of treatment (e.g., analgesics, physical therapy, local injection, surgery), and
Member is not addicted to drugs (per American Society of Addiction Medicine guidelines), and
There is no psychological contraindication to peripheral nerve stimulation, and;
There is objective evidence of pathology (e.g., electromyography), and;
Trial of transcutaneous stimulation was successful (resulting in at least a 50 % reduction in pain).
Note: Peripheral nerve stimulation is considered experimental and investigational for post-herpetic neuralgia and all other indications because its effectiveness for these indications has not been established.
Aetna considers H-WAVE ® type stimulators medically necessary DME for members who have failed to adequately respond to conventional treatments of diabetic peripheral neuropathy.
Note: Conventional therapies of diabetic peripheral neuropathy include analgesics, topical capsaicin cream, tricyclic anti-depressants, selective serotonin re-uptake inhibitors, anti-seizure medications such as carbamazepine (Tegretol), gabapentin (Neurontin), mexiletine (Mexitil), as well as normalization of blood glucose.
Aetna considers H-WAVE ® type stimulators experimental and investigational for all other indications including any of the following indications because their effectiveness for these indications has not been established.
To accelerate healing; or
To reduce edema; or
To reduce pain from causes other than chronic diabetic peripheral neuropathy; or
To treat chronic pain due to ischemia.
Aetna considers intramuscular stimulation experimental and investigational for the management of members with soft-tissue or neuropathic pain and all other indications because its effectiveness has not been established.
Aetna considers sympathetic therapy (Dynatronics Corporation, Salt Lake City, UT) experimental and investigational since its effectiveness has not been established.
Aetna considers electroceutical therapy (also known as bioelectric nerve block) experimental and investigational for the treatment of acute pain or chronic pain (e.g., back pain, diabetic pain, joint pain, fibromyalgia, headache, and reflex sympathetic dystrophy) or other indications because there is a lack of scientific evidence regarding the effectiveness of this technology.
Note: Other terms used to refer to electroceutical therapy devices include "non-invasive neuron blockade" devices, "electroceutical neuron blockade" devices, and "bioelectric treatment systems."
Aetna considers transcutaneous electrical joint stimulation devices (e.g., the BioniCare device) experimental and investigational for the treatment of osteoarthritis and all other indications because their effectiveness has not been established.
Aetna considers the Electro-Acuscope Myopulse Therapy System experimental and investigational for the treatment of pain and tissue damage and all other indications because its effectiveness has not been demonstrated in the peer-reviewed scientific literature.
Aetna considers electrical stimulation of the sacral nerve roots or lumbosacral plexus experimental and investigational for the treatment of chronic pelvic or abdominal pain or other indications because the effectiveness of these interventions has not been established.
Aetna considers microcurrent therapy experimental and investigational for the treatment of chronic back pain and all other indications because its effectiveness has not been established.
Aetna considers Scrambler therapy (also known as transcutaneous electrical modulation pain reprocessing)/the Calmare therapy device experimental and investigational for the treatment of chronic pain and other indications because of insufficient evidence regarding its effectiveness.
Aetna considers the InterX 1000 neurostimulator device experimental and investigational for the treatment of chronic pain and other indications because of insufficient evidence regarding its effectiveness.
Aetna considers peripheral subcutaneous field stimulation or peripheral nerve field stimulation (PNFS) experimental and investigational for the treatment of chronic pain and other indications (e.g., angina, notalgia paraesthetica) because of insufficient evidence regarding its effectiveness.
Aetna considers electro-therapeutic point stimulation (also known as microcurrent point stimulation) experimental and investigational for the treatment of chronic pain and other indications because of insufficient evidence regarding its effectiveness.
Note: Below is a list of CPBs that address other types of electrical stimulation:
A TENS is a device which utilizes electrical current delivered through electrodes placed on the surface of the skin to decrease the patient's perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorphins. A TENS unit must be distinguished from other electrical stimulators (e.g., neuromuscular stimulators) which are used to directly stimulate muscles and/or motor nerves. Transcutaneous electrical nerve stimulation is characterized by biphasic current and selectable parameters such as pulse rate and pulse width. In theory, TENS stimulates sensory nerves to block pain signals; it also stimulates endorphin production to help normalize sympathetic function. Most TENS units produce current of 1 to 80 microampere (mA), 9 V (average), 2 to 1000 Hz, with a pulse width of 250 to 400 microseconds (mS).
Transcutaneous electrical nerve stimulation has been widely used in the treatment of various types of pain. It has been shown that TENS is highly effective in alleviating pain and reducing analgesic medications following cesarean section, orthopedic and thoracic operations as well as mixed surgical procedures (AHCPR, 1992). Moreover, TENS has been found to be beneficial also to those who suffer from acute musculoskeletal pain (Long, 1991). On the other hand, the use of TENS in the treatment of chronic malignant pain is sparse and its effectiveness remains unproven. Studies by Ventafridda and colleagues (1979) reported that of the 159 cancer patients who experienced short-term pain relief with TENS therapy, 58 % of them found the treatment ineffective by day 10, and only 35 % of these subjects continued its use after 1 month. In another group of 37 patients, pain was markedly reduced in 96 % of them during the first 10 days of TENS treatment. However, pain reduction was found only in 33 % of the subjects during the second 10 days, and to only 11 % during the third 10 days. Physical mobility was improved initially in 76 % of patients, but dropped to 19 % by the end of 1 month (Ventafridda et al, 1979). The Canadian Coordinating Office for Health Technology Assessment evaluated the clinical value of TENS in pain management and concluded that there is little evidence of the effectiveness of TENS in treating chronic pain (1995).
In an evidence-based review, the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology evaluated the effectiveness of TENS in the treatment of pain in neurological disorders (Dubinsky and Miyasaki, 2010). There are conflicting reports of TENS compared to sham TENS in the treatment of chronic low back pain (LBP), with 2 Class II studies showing benefit, while 2 Class I studies and another Class II study not showing benefit. Because the Class I studies are stronger evidence, TENS is established as ineffective for the treatment of chronic LBP. On the other hand, TENS is probably effective in treating painful diabetic neuropathy (2 Class II studies. The authors concluded that (i) TENS is not recommended for the treatment of chronic LBP (Level A), and (ii) TENS should be considered in the treatment of painful diabetic neuropathy (Level B). They stated that further research into the mechanism of action of TENS is needed, as well as more rigorous studies for determination of efficacy.
Guidelines on treatment of LBP from the National Collaborating Centre for Primary Care (Savigny et al, 2009) found insufficient evidence for the use of TENS in LBP and recommended against its use for that indication.
In a Cochrane review, Mulvey et al (2010) evaluated the analgesic effectiveness of TENS for the treatment of phantom pain and stump pain following amputation in adults. These investigators searched MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, PsycINFO, AMED, CINAHL, PEDRO and SPORTDiscus (February 2010). Only randomized controlled trials (RCTs) investigating the use of TENS for the management of phantom pain and stump pain following an amputation in adults were included. Two review authors independently assessed trial quality and extracted data. It was planned that where available and appropriate, data from outcome measures were to be pooled and presented as an overall estimate of the effectiveness of TENS. No RCTs that examined the effectiveness of TENS for the treatment of phantom pain and stump pain in adults were identified by the searches. The authors concluded that there were no RCTs on which to judge the effectiveness of TENS for the management of phantom pain and stump pain. The published literature on TENS for phantom pain and stump pain lacks the methodological rigor and robust reporting needed to confidently assess its effectiveness. They stated that further RCT evidence is needed before such a judgment can be made.
Cheing and Luk (2005) examined the clinical effectiveness of high-frequency (HF) TENS for reducing hyper-sensitivity of the hand in patients with neuropathic pain. A total of 19 patients suffering from hand hyper-sensitivity were randomly assigned into either a treatment or a placebo group. A visual analog scale (VAS) and the Downey Hand Center Hand Sensitivity Test were used to measure the tactile tolerance of the hand. Grip strength was assessed by a grip dynamometer. Daily applications of electrical stimulation were provided for 2 weeks. Significantly lower pain scores were found in the treatment group than in the placebo group by day 7 and day 11. The ranking of 10 dowel textures of the Downey Hand Center Hand Sensitivity Test in the treatment group was significantly higher than in the placebo group by day 7 and day 11. However, no significant inter-group difference was found in grip strength.
The Ad hoc Committee of the Croatian Society for Neurovascular Disorders and the Croatian Medical Association's recommendations for neuropathic pain treatment (Demarin et al, 2008) stated that damage to the somatosensory nervous system poses a risk for the development of neuropathic pain. Such an injury to the nervous system results in a series of neurobiological events resulting in sensitization of both the peripheral and central nervous system. The diagnosis of neuropathic pain is based primarily on the history and physical examination finding. Although monotherapy is the ideal approach, rational poly-pharmacy is often pragmatically used. Several classes of drugs are moderately effective, but complete or near-complete relief is unlikely. Anti-depressants and anti-convulsants are most commonly used. Opioid analgesics can provide some relief but are less effective than for nociceptive pain; adverse effects may prevent adequate analgesia. Topical drugs and a lidocaine-containing patch may be effective for peripheral syndromes. Sympathetic blockade is usually ineffective except for some patients with complex regional pain syndrome. TENS was not mentioned as a therapeutic option.
Norrbrink (2009) assessed the short-term effects of HF and low-frequency (LF) TENS for neuropathic pain following spinal cord injury (SCI). A total of 24 patients participated in the study. According to the protocol, 50 % of the patients were assigned to HF (80 Hz) and 50 % to LF (burst of 2 Hz) TENS. Patients were instructed to treat themselves 3 times daily for 2 weeks. After a 2-week wash-out period, patients switched stimulation frequencies and repeated the procedure. Results were calculated on an intent-to-treat basis. No differences between the 2 modes of stimulation were found. On a group level, no effects on pain intensity ratings or ratings of mood, coping with pain, life satisfaction, sleep quality, or psychosocial consequences of pain were seen. However, 29 % of the patients reported a favorable effect from HF and 38 % from LF stimulation on a 5-point global pain-relief scale. Six of the patients (25 %) were, at their request, prescribed TENS stimulators for further treatment at the end of the study. The authors concluded that TENS merits consideration as a complementary treatment in patients with SCI and neuropathic pain. The mild benefits observed -- 29 % of subjects in the HF group and 38 % of subjects in the LF group could be a placebo effect.
Moharic and Burger (2010) examined if TENS improves small fiber function diminished because of painful diabetic neuropathy. A total of 46 patients with painful diabetic neuropathy were treated with TENS 3 consecutive hours a day for 3 weeks. Treatment effect was evaluated with cold, warm, cold pain and heat pain thresholds, vibration perception thresholds and touch perception thresholds. In all patients, thermal-specific and thermal pain sensitivity determination showed quantitative and qualitative abnormalities in all the measured spots. After the TENS therapy, no statistically significant changes in cold, warm, cold pain, heat pain, vibratory perception and touch perception thresholds were observed in the stimulated area. TENS did not alter C, Aδ nor Aβ fiber-mediated perception thresholds. The authors noted that the observed changes at thenar were probably because of central mechanisms. In general, analgesic mechanisms of TENS are likely to be complex.
Jin et al (2010) evaluated the effectiveness of TENS on diabetic peripheral neuropathy (DPN). Randomized controlled trials (RCTs) comparing TENS with routine care, pharmacological interventions or placebo devices on patients with symptomatic DPN, were identified by electronic and manual searches. Studies were selected and available data were extracted independently by 2 investigators. Meta-analysis was performed by RevMan 4.2.8 software. A total of 3 RCTs involving 78 patients were included in this study. The reductions in mean pain score were significantly greater in TENS group than in placebo TENS group in 4 weeks and 6 weeks follow-up [4 weeks, SMD-5.37, 95 % CI: -6.97 to -3.77; 6 weeks, SMD-1.01, 95 % CI: -2.01 to -0.01)], but not in 12 weeks follow-up [SMD-1.65, 95 % CI: -4.02 to 0.73]. TENS therapy was associated with significantly subjective improvement in overall neuropathic symptoms in 12 weeks follow-up [WMD-0.18, 95 % CI: -0.32 to -0.051]. No TENS-related adverse events were registered in TENS group. The authors concluded that TENS therapy may be an effective and safe strategy in treatment of symptomatic DPN. They stated that due to small sample and short-term treatment duration, large multi-center RCTs are needed to further evaluate the long-term effect of TENS on DPN.
Johnson and Bjordal (2011) stated that the management of neuropathic pain is challenging, with medication being the first-line treatment. Transcutaneous electrical nerve stimulation is a non-invasive, self-administered technique that is used as an adjunct to medication. Clinical experience suggested that TENS is beneficial providing it is administered at a sufficiently strong intensity, close to the site of pain. At present, there are too few RCTs on TENS for neuropathic pain to judge effectiveness. The findings of systematic reviews of TENS for other pain syndromes are inconclusive because trials have a low fidelity associated with inadequate TENS technique and infrequent treatments of insufficient duration. The use of electrode arrays to spatially target stimulation more precisely may improve the efficacy of TENS in the future.
In a systematic review, Abou-Setta (2011) reviewed the benefits and harms of pharmacological and non-pharmacological interventions for managing pain after hip fracture. A total of 25 electronic databases (January 1990 to December 2010), gray literature, trial registries, and reference lists, with no language restrictions were searched. Multiple reviewers independently and in duplicate screened 9,357 citations to identify RCT); non-RCTs; and cohort studies of pain management techniques in older adults after acute hip fracture. Independent, duplicate data extraction and quality assessment were conducted, with discrepancies resolved by consensus or a third reviewer. Data extracted included study characteristics, inclusion and exclusion criteria, participant characteristics, interventions, and outcomes. A total of 83 unique studies (64 RCTs, 5 non-RCTs, and 14 cohort studies) were included that addressed nerve blockade (n = 32), spinal anesthesia (n = 30), systemic analgesia (n = 3), traction (n = 11), multi-modal pain management (n = 2), neurostimulation (n = 2), rehabilitation (n = 1), and complementary and alternative medicine (n = 2). Overall, moderate evidence suggested that nerve blockades are effective for relieving acute pain and reducing delirium. Low-level evidence suggested that pre-operative traction does not reduce acute pain. Evidence was insufficient on the benefits and harms of most interventions, including spinal anesthesia, systemic analgesia, multi-modal pain management, acupressure, relaxation therapy, TENS, and physical therapy regimens, in managing acute pain. The authors concluded that nerve blockade seems to be effective in reducing acute pain after hip fracture. Sparse data preclude firm conclusions about the relative benefits or harms of many other pain management interventions (including TENS) for patients with hip fracture.
On June 8, 2012, the Centers for Medicare & Medicaid Services (CMS) rendered a decision memo for TENS for chronic LBP. It states that TENS is not reasonable and necessary for the treatment of CLBP under section 1862(a)(1)(A) of the Social Security Act. The CMS will only cover TENS if individuals are enrolled in an approved clinical study meeting specific requirements.
Interferential Stimulation:
Interferential stimulation (IFS) is characterized by 2 alternating-current sine waves of differing frequencies that "work" together to produce an interferential current that is also known as a beat pulse or alternating modulation frequency. One of the 2 currents is usually held at 4,000 Hz, and the other can be held constant or varied over a range of 4,001 to 4,100 Hz. Interferential currents reportedly can stimulate sensory, motor, and pain fibers. Because of the frequency, the interferential wave meets low impedance when crossing the skin to enter the underlying tissue. This deep tissue penetration can be adjusted to stimulate parasympathetic nerve fibers for increased blood flow. According to proponents, interferential stimulation differs from TENS because it allows a deeper penetration of the tissue with more comfort (compliance) and increased circulation.
It has been claimed that IFS is highly effective in reducing (i) pain and use of pain medications, (ii) edema and inflammation, (iii) healing time, as well as in improving (i) range of motion, (ii) activity levels, and (iii) quality of life. However, there are very few well designed studies such as randomized, double blind, controlled clinical trials that support such claims. Low (1988) stated that in spite of widespread agreement among physiotherapists that IFS has a marked pain relieving effect, there is a paucity of objective investigations into this analgesic effect. He claimed that both the therapeutic and physiological effects of interferential currents require further investigation. This notion is echoed by Goats (1990) who reported that evidence supporting the use of IFS in the control of edema appears mainly anecdotal. Reitman and Esses (1995) noted that there were no controlled studies proving the effectiveness of IFS. Indergand and Morgan (1995) reported that interferential current applied over the stellate ganglion did not change forearm hemodynamics in asymptomatic individuals. The authors stated that these findings challenged the concept that IFS can block sympathetic vasoconstrictor impulses in peripheral nerves.
In a randomized placebo controlled study, Van Der Heijden et al (1999) evaluated the effectiveness of bipolar interferential electrotherapy (ET) and pulsed ultrasound (US) as adjuvants to exercise therapy for soft tissue shoulder disorders (n = 180). Patients with shoulder pain and/or restricted shoulder mobility, because of soft tissue impairment without underlying specific or generalized condition, were randomised to receive (i) active ET plus active US; (ii) active ET plus dummy US; (iii) dummy ET plus active US; (iv) dummy ET plus dummy US; or (v) no adjuvants. Additionally, they received a maximum of 12 sessions of exercise therapy in 6 weeks. Measurements at baseline, 6 weeks and 3, 6, 9, and 12 months later were blinded for treatment. Outcome measures: recovery, functional status, chief complaint, pain, clinical status, and range of motion. At the 6th-week, 7 patients (20 %) without adjuvants reported very large improvement (including complete recovery), 17 (23 %) and 16 (22 %) with active and dummy ET, and 19 (26 %) and 14 (19 %) with active and dummy US. These proportions increased to about 40 % at the 3rd-months, but remained virtually stable thereafter. The authors concluded that neither ET nor US proved to be effective as adjuvants to exercise therapy for soft tissue shoulder disorders.
Jarit et al (2003) concluded that home IFS may help reduce pain, pain medication taken, and swelling while increasing range of motion in patients undergoing knee surgery. This could result in quicker return to activities of daily living and athletic activities. Drawbacks of this study were as follows: (i) while placebo subjects did consume more medications at all time points, the difference was only at some points, and (ii) a functional assessment scale was not used. The findings of this study need to be validated by further investigation. Furthermore, a technology assessment by the California Technology Assessment Forum (CTAF, 2005) concluded that interferential stimulation does not meet CTAF’s assessment criteria.
A review on non-pharmacological therapies (including IFS) for acute and chronic LBP by the American Pain Society and the American College of Physicians (Chou et al, 2007) concluded that therapies with good evidence of moderate efficacy for chronic or sub-acute LBP are cognitive-behavioral therapy, exercise, spinal manipulation, and inter-disciplinary rehabilitation. For acute LBP, the only therapy with good evidence of efficacy is superficial heat.
Guidelines on treatment of LBP from the National Collaborating Centre for Primary Care (Savigny et al, 2009) found insufficient evidence for the use of interferential stimulation in LBP and recommended against its use for that indication.
In a systematic review and meta-analysis, Fuentes et al (2010) analyzed the available information regarding the efficacy of IFS in the management of musculoskeletal pain. Randomized controlled trials were obtained through a computerized search of bibliographic databases (i.e., CINAHL, Cochrane Library, EMBASE, MEDLINE, PEDro, Scopus, and Web of Science) from 1950 to February 8, 2010. Two independent reviewers screened the abstracts found in the databases. Methodological quality was assessed using a compilation of items included in different scales related to rehabilitation research. The mean difference, with 95 % confidence interval (CI), was used to quantify the pooled effect. A chi-square test for heterogeneity was performed. A total of 2,235 articles were found. A total of 20 studies fulfilled the inclusion criteria; 7 articles assessed the use of IFS on joint pain; 9 articles evaluated the use of IFS on muscle pain; 3 articles evaluated its use on soft tissue shoulder pain; and 1 article examined its use on post-operative pain. Three of the 20 studies were considered to be of high methodological quality, 14 studies were considered to be of moderate methodological quality, and 3 studies were considered to be of poor methodological quality. Fourteen studies were included in the meta-analysis. The authors concluded that IFS as a supplement to another intervention seems to be more effective for reducing pain than a control treatment at discharge and more effective than a placebo treatment at the 3-month follow-up. However, it is unknown whether the analgesic effect of IFS is superior to that of the concomitant interventions. Interferential current alone was not significantly better than placebo or other therapy at discharge or follow-up. Results must be considered with caution due to the low number of studies that used IFS alone. In addition, the heterogeneity across studies and methodological limitations prevent conclusive statements regarding analgesic efficacy.
Percutaneous Electrical Nerve Stimulation (PENS):
Percutaneous electrical nerve stimulation (also known as percutaneous neuromodulation) uses acupuncture-like needles as electrodes. These needles are placed in the soft tissues or muscles at dermatomal levels corresponding to local pathology (needles are usually inserted above and below and into the central area of pain). A 5-Hz frequency with a pulse width of 0.5 mS is usually used. If relief is not attained within 15 minutes, the frequency may be lowered to 1 Hz. According to PENS proponents, the main advantage of PENS over TENS is that it bypasses the local skin resistance and delivers electrical stimuli at the precisely desired level in close proximity to the nerve endings located in soft tissue, muscle, or periosteum of the involved dermatomes.
Percutaneous electrical nerve stimulation has also been used in the treatment of neck pain; however, there is insufficient evidence to support its effectiveness for this indication. Harris and Susman (2002) stated that the Philadelphia Panel recently formulated evidence-based guidelines for selected rehabilitation interventions in the management of low back, knee, neck, and shoulder pain. The guidelines were developed with the use of a 5-step process: (i) define the intervention, (ii) collect evidence, (iii) synthesize results, (iv) make recommendations based on the research, and (v) grade the strength of the recommendations. Outpatient adults with low back, knee, neck, or shoulder pain without vertebral disk involvement, scoliosis, cancer, or pulmonary, neurological, cardiac, dermatological, or psychiatric conditions were included in the review. To prepare the data, systematic reviews were performed for low back, knee, neck, and shoulder pain. Therapeutic exercise, massage, transcutaneous electrical nerve stimulation, thermotherapy, ultrasound, electrical stimulation, and combinations of these therapies were included in the literature search. Studies were identified and analyzed based on study type, clinical significance, and statistical significance. The authors concluded that the Philadelphia Panel guidelines recommend continued normal activity for acute, uncomplicated LBP and therapeutic exercise for chronic, subacute, and post-surgical LBP; TENS and exercise for knee osteoarthritis; proprioceptive and therapeutic exercise for chronic neck pain; and the use of therapeutic ultrasound in the treatment of calcific tendonitis of the shoulder.
Weiner and Ernst (2004) reviewed common complementary and alternative treatment modalities for the treatment of persistent musculoskeletal pain in older adults. A critical review of the literature on acupuncture and related modalities, herbal therapies, homeopathy, and spinal manipulation was carried out. Review included 678 cases within 21 randomized trials and 2 systematic reviews of herbal therapies: 798 cases within 2 systematic reviews of homeopathy; 1,059 cases within 1 systematic review of spinal manipulation for LBP, and 419 cases within 4 randomized controlled trials for neck pain. The review of acupuncture and related modalities was based upon a paucity of well-controlled studies combined with the authors' clinical experience. Insufficient experimental evidence exists to recommend the use of traditional Chinese acupuncture over other modalities for older adults with persistent musculoskeletal pain. Promising preliminary evidence exists to support the use of percutaneous electrical nerve stimulation for persistent LBP. The authors noted that while the use of complementary and alternative modalities for the treatment of persistent musculoskeletal pain continues to increase, rigorous clinical trials examining their effectiveness are needed before definitive recommendations regarding the application of these modalities can be made.
According to the Washington State Department of Labor and Industries (2004), percutaneous neuromodulation therapy, also known as PENS, is a procedure intended to relieve and manage chronic or intractable LBP; chronic neck pain was not mentioned as an indication. Furthermore, a Cochrane review on electrotherapy for mechanical neck disorders (Kroeling et al, 2005) evaluated if electrotherapy relieves pain or improves function/disability in adults with mechanical neck disorders (MND). For the pain outcome, there was limited evidence of benefit, i.e., pulsed electromagnetic field (PEMF) therapy resulted in only immediate post-treatment pain relief for chronic MND and acute whiplash (WAD). Other findings included unclear or conflicting evidence (galvanic current for acute or chronic occipital headache; iontophoresis for acute, subacute WAD; TENS for acute WAD, chronic MND; PEMF for medium- or long-term effects in acute WAD, chronic MND); and limited evidence of no benefit (diadynamic current for reduction of trigger point tenderness in chronic MND, cervicogenic headache; permanent magnets for chronic MND; electrical muscle stimulation (EMS) for chronic MND). The authors concluded that in pain as well as other outcomes, the evidence for treatment of acute or chronic MND by different forms of electrotherapy is either lacking, limited, or conflicting.
Peripherally Implanted Nerve Stimulation:
Peripherally implanted nerve stimulation entails the placement of electrodes around a selected peripheral nerve. The stimulating electrode is connected by an insulated lead to a receiver unit that is inserted subcutaneously at a depth not greater than half an inch. Stimulation is elicited by a generator that is connected to an antenna that is attached to the skin surface over the receiver unit. Sciatic and ulnar nerves are often the sites of such an implantation.
H-Wave Stimulation:
H-wave stimulation delivers electrical stimulation in the form of milliamperage. H-wave stimulation is intended to emulate the H waveform found in nerve signals (Hoffman Reflex) and therefore enables greater and deeper penetration of a low frequency current, while using significantly less power than other machines. This allegedly makes H-Wave stimulation much safer, less painful and more effective than other forms of electrotherapy to date. The H-wave signal is a bipolar, exponential decaying waveform that supposedly overcomes the disadvantages of other electrotherapy machines. It allows the therapist to apply 2 treatments at the same time: (i) low-frequency muscle stimulation and (ii) high-frequency deep analgesic pain control (a "TENS" effect). Note: H-wave stimulation must be distinguished from the H-waves that are a component of electromyography.
The H-wave stimulator (Electronic Waveform Lab, Inc., Huntington Beach, CA) is an electrostimulation device that has been used to reduce pain and swelling associated with a variety of diseases and conditions. In a single-blinded clinical study, Kumar and Marshall (1997) evaluated the effectiveness of H-wave stimulation for the treatment of chronic (greater than 2 months) pain associated with diabetic (type 2) peripheral neuropathy (n = 31). Patients were randomly assigned to (i) H-wave stimulation, or (ii) sham treatment. The authors reported that H-wave treated patients exhibited greater symptomatic relief than their sham-treated counterparts. Moreover, it has also been shown that H-wave stimulation may be a useful adjunctive modality when combined with pharmacotherapy (e.g., amitriptyline) to augment symptomatic relief in patients with diabetic peripheral neuropathy (Julka et al, 1998; McDowell et al, 1999).
On the other hand, H-wave stimulators have not been shown to be effective in reducing pain from causes other than chronic diabetic peripheral neuropathy, or in reducing edema or swelling. In particular, H-wave stimulation has not been demonstrated to be effective in treating chronic pain due to ischemia. In the study by Kumar and Marshall (1997), patients with significant peripheral vascular disease were excluded from the trial. Furthermore, in a randomized controlled study (n = 112), McDowell et al (1995) reported that H-wave stimulation was not effective in reducing experimental ischemic pain.
A systematic evidence review concluded that H-wave stimulation had a moderate to strong effects in relieving pain, reducing pain medication use and increasing functionality in patients with chronic soft tissue inflammation or neuropathic pain (Blum et al, 2008). A critique of this systematic evidence review by the Centre for Reviews and Dissemination (CRD, 2009) concluded that "it is not possible to determine whether the results of this review are reliable" given its significant methodologic limitations. In particular, very limited details of the included studies were given in the review; in particular it was unclear which studies were randomized, no control interventions were detailed, and there were insufficient details on the outcome measures used. Although a validity assessment was performed, the results were not presented. "Given these omissions, it is difficult to assess either the internal or external validity of the results." The CRD noted that the authors of the systematic evidence review used meta-analysis to combine the results, but different measures of effect appeared to be combined in a single effect size. Insufficient details on the outcome measures used in the included studies meant that it was not possible to determine if this was appropriate or not. The CRD critique noted that, in addition to four authors of the systematic evidence review being independent consultants for Electronic Waveform Lab (the makers of the H-Wave device), 2 authors were members of the research groups responsible for conducting the primary studies.
Intramuscular Stimulation:
Intramuscular stimulation can be considered as a variation of acupuncture. It has been claimed to promote long-term relief in chronic neuropathic pain. Intramuscular stimulation utilizes the same sized needles as in acupuncture; they are inserted into the part of a shortened muscle where a nerve may be entrapped. This most often causes some local pain as the needle is re-inserted several times to release the nerve and lengthen the muscle. In general, treatments are administered once or twice weekly for 3 to 6 weeks. However, the clinical value of this invasive procedure has not been validated by randomized controlled studies.
Sympathetic Therapy (Dynatron):
Many chronic pain syndromes/conditions (e.g., peripheral neuropathies and reflex sympathetic dystrophy) are "sympathetically biased" and have no identifiable underlying cause(s).
Sympathetic Therapy is a non-invasive treatment protocol advocated for the symptomatic relief of patients with chronic pain. It is a patented method of delivering electrostimulation via peripheral nerves to create a "special" form of stimulation of the sympathetic nervous system. It incorporates dual interfering waveforms with specific electrode placement on the upper and lower extremities (8 electrodes/treatment). Electrodes are placed bilaterally over dermatomes, thus accessing the autonomic nervous system via the peripheral nervous system.
The treatment plan for Sympathetic Therapy includes clinical treatments followed by home therapy. Electrostimulation is administered by means of the Dynatron STS (a clinical unit) or the Dynatron STS Rx (a home unit). A software program is included with the clinical Dynatron unit to help doctors with electrode placement and to record patient progress. According to the manufacturer, electrostimulation delivered by the Dynatron is different from that provided by TENS. The key difference is in its application -- Dynatron applied within the Sympathetic Therapy protocol supposedly treats systemically while TENS treats transcutaneously at or near the primary pain location. Daily therapy sessions are needed to establish effectiveness of the treatment and to ascertain the most effective protocol for individual patients (20 or more sessions may be needed to complete this process). Each treatment session lasts about 60 mins. If the patient responds to treatment and the optimal protocol has been established, a home Dynatron unit may be prescribed to facilitate treatments over an extended period of time and, in most cases, indefinitely. If necessary, the patient may return to the clinic periodically for a follow-up visit to adjust the protocol or receive additional guidance in administering home therapy.
Guido (2002) reported on the effects of Sympathetic Therapy on 20 patients with chronic pain and peripheral neuropathies. Subjects were treated daily with the Dynatron STS for 28 days. At the beginning of the study, 11 of 15 patients reported being in moderate to severe pain, whereas by the end of treatment, 5 of 15 patients defined their pain as being moderate to severe. For these 15 patients, mean cumulative VAS for multiple locations of pain decreased significantly, from 107.8 to 45.3. (The authors stated, without further explanation, that self-reports of pain severity were unavailable for 5 of the 20 patients.) However, because the study did not include a randomized masked control group, placebo effects and other biases could affect results. In addition, the lack of data on pain severity in a quarter of the patients included in this study may have significantly biased the results. There are no published randomized controlled clinical trials of the effectiveness of Sympathetic Therapy in the management of patients with chronic intractable pain. Randomized controlled trials are needed to ascertain the clinical benefits of this treatment protocol in these patients.
An assessment (2003) conducted by the Washington State Department of Labor and Industries concluded that insufficient evidence exists to determine Dynatron STS’ effectiveness in the treatment of chronic pain.
Guidelines on management of chronic pain from the Work Loss Data Institute (2008) considered, but did not recommend, sympathetic therapy for chronic pain.
Electroceutical Therapy:
Electroceutical medicine entails the use of various electrical modalities. While certain "low-strength" electrical treatments such as transcutaneous electrical nerve stimulation (TENS) units may be safely used at home, electroceutical treatments use much higher electrical frequencies than TENS units (ranging from 1 to 20,000 Hz compared to 0.5 to 100 Hz used in TENS) and may only be prescribed and administered under the supervision of a healthcare provider experienced in this method of treatment.
Electroceutical therapy, also known as bioelectric nerve block, involves blockade of axonal transmissions. Electroceutical therapy has been used in the management of neuropathic pain (non-malignant pain) as well as pain associated with cancer (malignant pain). According to a manufacturer of an electroceutical nerve block device, the electroceutical treatment approach is based on the non-invasive application of controlled, specific parameter bioelectric impulses. Electrical current is altered via special step-down transformers into bioelectric impulses, which are designed to mimic the human bioelectric system. Currently, there are 2 distinctive electroceutical classifications: (i) stimulatory class in which repetitive action potentials are induced in excitable cells (depolarization and repolarization activity), and (ii) multi-facilitory class that produces biophysical effects without repetitive action potential propagation. The proper electroceutical class, dosage, regimen duration and anatomical placement of electrodes are determined by the individual patient's diagnosis.
Proponents of electroceutical therapy claim that its use has resulted in significant relief of pain and elimination or drastic reductions in patients' pain medication requirements, such that patients are able to resume their daily activities. However, there is a lack of scientific evidence to substantiate these claims. Guidelines from the Work Loss Data Institute (2008) considered, but did not recommend, electroceutical therapy for chronic pain.
Well-designed, randomized controlled clinical studies are needed to determine the usefulness of electroceutical therapy in the treatment of patients with acute or chronic pain.
Transcutaneous Electrical Joint Stimulation:
Transcutaneous electrical joint stimulation is also known as pulsed electrical stimulation; and the Bionicare device uses this type of electrical stimulation. Zizic et al (1995) evaluated the safety and effectiveness of pulsed electrical stimulation for the treatment of osteoarthritis (OA) of the knee (n = 78). Patients were treated 6 hours/day for 4 weeks. The investigators reported that patients treated with the active devices showed significantly greater improvement than the placebo group for all primary efficacy variables in comparisons of mean change from baseline to the end of treatment. Improvement of greater or equal to 50 % from baseline was shown in at least 1 primary efficacy variable in 50 % of the active device group, in 2 variables in 32 %, and in all 3 variables in 24 %. In the placebo group improvement of greater or equal to 50 % occurred in 36 % for one, 6 % for 2, and 6 % for 3 variables. Mean morning stiffness decreased 20 mins in the active device group and increased 2 mins in the placebo group (p < 0.05). No statistically significant differences were observed for tenderness, swelling, or walking time. The authors concluded that improvements in clinical measures for pain and function found in this study suggest that pulsed electrical stimulation is effective for treating OA of the knee. The investigators noted, however, that studies of the durability of results are warranted.
In a Cochrane review on pulsed electric stimulation for the treatment of OA (Hulme et al, 2002), the authors stated that current evidence suggests that electrical stimulation therapy may provide significant improvements for knee OA, but further studies are required to confirm whether the statistically significant results shown in these trials confer clinically significant and durable benefits.
A systematic evidence review by McCarthy et al (2006) concluded that pulsed electromagnetic field therapy is unlikely to benefit patients with knee osteoarthritis. The systematic evidence review identified 5 RCTs of pulsed electromagnetic field therapy for knee osteoarthritis: 2 RCTs scored 5 points for validity, 1 scored 4 and 2 scored 3. The investigators found that none of the individual studies reported a statistically significant difference between treatments for pain. Only 1 study (n = 83) with a low quality score of 3 reported a statistically significant difference between treatments in function (standardized mean difference -0.58, 95 % CI: -1.02 to -0.14). For all studies combined, there was no significant difference between interventions in pain (weighted mean difference -0.66, 95 % CI: -1.67 to 0.35) or function (weighted mean difference -0.70, 95 % CI: -1.92 to 0.52).
Fary and colleagues (2008) stated that OA of the knee is one of the main causes of musculoskeletal disability in the western world. Current available management options provide symptomatic relief (exercise and self-management, medication and surgery) but do not, in general, address the disease process itself. Moreover, adverse effects and complications with some of these interventions (medication and surgery) and the presence of co-morbidities commonly restrict their use. There is clearly a need to investigate treatments that are more widely applicable for symptom management and which may also directly address the disease process itself. The authors described the protocol of a double-blind, randomized, placebo-controlled, repeated measures trial to examine the effectiveness of pulsed electrical stimulation in providing symptomatic relief for people with OA of the knee over 26 weeks. A total of 70 subjects will be recruited and information regarding age, gender, body mass index and medication use will be recorded. The population will be stratified for age, gender and baseline pain levels. Outcome measures will include pain (100 mm VAS and WOMAC 3.1), function(WOMAC 3.1), stiffness (WOMAC 3.1), patient global assessment (100 mm VAS) and quality of life (SF-36). These outcomes will be measured at baseline, 4, 16 and 26 weeks. Activity levels will be measured at baseline and 16 weeks using accelerometers and the Human Activity Profile questionnaire. A patient global perceived effect scale (11-point Likert) will be completed at 16 and 26 weeks.
Electro-Acuscope Myopulse:
The Electro-Acuscope Myopulse Therapy System is an electronic device that has been used for a wide range of neuromuscular conditions. The Acuscope uses electricity to treat pain by stimulating the nervous system without puncturing the skin. The Myopulse, a companion instrument to the Acuscope, stimulates muscles, tendons and ligaments, reducing spasm, inflammation and strengthening tissue damaged by traumatic injury. This form of therapy purportedly helps the body heal itself by stimulating the supply of blood and oxygen to the involved area. The Electro-Acuscope Myopulse Therapy System has been used in the treatment of pain and many types of tissue damage including swelling, inflammation, and soreness. However there is insufficient scientific evidence to support its effectiveness.
Sacral Nerve Root and Lumbosacral Plexus Stimulation:
Electrical stimulation of the sacral nerves (sacral neuromodulation) or lumbosacral plexus has been used for painful conditions resulting from chronic abdominal, pelvic, genital, and anal pain syndromes (Kim, 2004). Specific conditions that have been treated include pain from interstitial cystitis, coccydynia, pyelonephritis, pancreatitis, rectal fugax, and vulvodynia.
Procedures allowing access to sacral and lumbosacral nerves include a retrograde (cephalocaudad) epidural approach and a sacral transforaminal approach. The transforaminal approach is mainly used for the treatment of urge urinary incontinence and urinary retention, while the retrograde approach has been used primarily for the treatment of pelvic pain.
Evidence for sacral nerve root and lumbosacral plexus stimulation is limited to case reports and small case series. Alo and colleagues (1999) reported that lumbar and sacral nerve root stimulation through the retrograde approach resulted in adequate paresthesia and effective pain relief as reflected by VAS scores in 5 patients with chronic pain (e.g., ilioinguinal neuralgia, discogenic LBP, failed back syndrome, and vulvodynia). These investigators concluded that further clinical trials are needed to assess the safety and long-term success rates of lumbar/sacral nerve root stimulation in the management of patients with chronic pain.
Anterograde sacral nerve root stimulation (SNRS) through the sacral hiatus is another method that has been tried for the treatment of pelvic pain. In a case report study, Falco et al (2003) found that anterograde SNRS provided good pain relief (as indexed by VAS scores) in a patient with chronic pelvic (rectal, coccygeal, and perineal) pain. The authors concluded that further investigation is needed before any conclusions can be rendered regarding the reliability of SNRS in the treatment of theses disorders.
Siegel and colleagues (2001) examined the effectiveness of transforaminal sacral nerve stimulation in patients with chronic intractable pelvic pain. After successful percutaneous trial stimulation, a neuroprosthetic sacral nerve stimulation device was surgically implanted in 10 patients with chronic intractable pelvic pain. Leads were placed in the S3 and S4 foramen in 8 and 2 cases, respectively. Patients were evaluated throughout the study using a patient pain assessment questionnaire on a scale of 0 (absence of pain) to 5 (excruciating pain). Pain was assessed at baseline, during test stimulation, and 1, 3 and 6 months after implantation of surgical lead. An additional long-term assessment was done at a median follow-up of 19 months. Of the 10 patients with the implant, 9 had a decrease in the severity of the worst pain compared to baseline at a median follow-up of 19 months. The number of hours of pain decreased from 13.1 to 6.9 at the same follow-up interval. There was also an average decrease in the rate of pain from 9.7 at baseline to 4.4 on a scale of 10 (always having pain) to 0 (never having pain). At a median of 19 months, 6 of 10 patients reported significant improvement in pelvic pain symptomatology. The authors concluded that these data imply that transforaminal sacral nerve stimulation can have beneficial effects on the severity and frequency of chronic intractable pelvic pain. They further stated that future clinical studies are necessary to determine the long-term effectiveness of this therapy.
The available evidence on sacral nerve root and lumbosacral plexus stimulation is insufficient to draw reliable conclusions about the effect of these interventions on chronic pelvic and abdominal pain.
Microcurrent Therapy:
Microcurrent therapy (MCT), also known as low-voltage microampere stimulation, is characterized by sub-sensory current that acts on the body’s naturally occurring electrical impulses to decrease pain and facilitate the healing process. It uses microamperage instead of milliamperage to drive its current into the injured site. Microcurrent therapy uses current between 1 and 1,000 microA at a voltage of 10 to 60 V, and a frequency of 0.5 to 100 Hz. It differs from TENS in that it uses a significantly reduced electrical stimulation. While TENS blocks pain, MCT acts on the naturally occurring electrical impulses to decrease pain by stimulating the healing process.
Koopman et al (2009) stated that MCT is a novel treatment for pain syndromes. The MCT patch is hypothesized to produce stimuli that promote tissue healing by facilitating physiologic currents. Solid evidence from randomized clinical trials is lacking. To assess the effectiveness of MCT in treating non-specific, chronic LBP, these researchers conducted a double-blind, randomized, cross-over, pilot trial. A total of 10 succeeding patients presenting with non-specific, chronic LBP were included. Patients started with 2, 9-day baseline period followed by a 5-day treatment periods. During the treatment periods, either a placebo or MCT (verum) patch was randomly assigned. Mean and worst pain scores were evaluated daily by a VAS. Furthermore, analgesic use, side effects, and quality of life were assessed after each period. Differences between the last 4 days of a treatment period and the baseline period were calculated. Differences between verum and placebo periods per patient were compared using paired-t tests. A 20-mm VAS score reduction was considered clinically relevant. The VAS score was lower during verum treatment, with a reduction (95 % CI) of -0.43 (-1.74; 0.89) in mean and -1.07 (-2.85; 0.71) in worst pain. Analgesic use decreased during verum treatment, except for non-steroid anti-inflammatory drug use, which increased. Quality of life improved during verum treatment. However, none of the findings was statistically significant. A positive trend in MCT use for aspecific, chronic LBP was reported. The authors stated that further investigations are needed to evaluate the significance and relevance of these findings.
Furthermore, the American Pain Society's clinical practice guideline on non-surgical interventional therapies for LBP (Chou et al, 2009) concluded that few non-surgical interventional therapies for LBP have been shown to be effective in randomized, placebo-controlled trials.
Scrambler Therapy/The Calmare Therapy Device:
Scrambler therapy (also known as transcutaneous electrical modulation pain reprocessing) is an electro-cutaneous nerve stimulation device that interferes with pain signal transmission by mixing a ''non-pain'' information into the nerve fibers. It consists of a multi-processor apparatus capable of simulating 5 artificial neurons that send out signals identified by the central nervous system as "no pain" via the application of surface electrodes on skin in the pain areas.
Marineo (2003) examined the effects of the Scrambler therapy in the treatment of drug-resistant oncological pain of the visceral/neuropathic type. A total of 11 terminal cancer patients (3 pancreas, 4 colon, 4 gastric) suffering from elevated drug resistant visceral pain were included in this study. The trial program was related to the first 10 treatment sessions. Subsequently, each patient continued to receive treatment until death. Pain measures were performed using the VAS before and after each treatment session and accompanied by diary recordings of the duration of analgesia in the hours following each single application. Any variation in pain-killing drug consumption was also recorded. All patients reacted positively to the treatment throughout the whole reference period. Pain intensity showed a significant decrease (p < 0.001), accompanied by a gradual rise both in the pain threshold and the duration of analgesia. Nine (81.8 %) of the patients suspended pain-killers within the first 5 applications, while the remaining 2 (18.2 %) considerably reduced the dosage taken prior to scrambler therapy. No undesirable side effects were observed. Compliance was found to be optimal. The authors concluded that these preliminary results obtained using scrambler therapy were extremely encouraging, both in terms of enhanced pain control after each treatment session and in view of the possible maintenance of effectiveness over time.
Sabato et al (2005) assessed the effectiveness of the Scrambler therapy in the treatment of neuropathic pain. A total of 226 patients, all suffering from intense drug-resistant neuropathic pain, were recruited for this trial. Inclusion criteria included neuropathic pain, very high baseline VAS. Exclusion criteria included pacemaker users, neurolithic blocks or neurolesive pain control treatment. The treated neuropathic pain syndromes were: failed back surgery syndrome (FBSS), post-herpetic neuralgia (PHN), trigeminal neuralgia, post-surgery nerve lesion neuropathy, pudendal neuropathy, brachial plexus neuropathy, LBP, and others. The trial program entailed 1 to 6 therapy sessions of 5 treatments, each one lasting 30 mins. Pain intensity was evaluated using VAS before and after each treatment. The statistical significance of VAS was measured using the paired t-test. The total results showed 80.09 % of responders (pain relief greater than 50 %), 10.18 % of partially responders (pain relief from 25 % to 49 %) and 9.73 % of no responders (patients with pain relief less than 24 % or VAS greater than 3). The authors concluded that the Scrambler therapy produced a statistically significant (p < 0.0001) pain relief in all treated neuropathies.
In a pilot study, Marineo et al (2012) compared guideline-based drug management with Scrambler therapy. A clinical trial with patients randomized to either guideline-based pharmacological treatment or Scrambler therapy for a cycle of 10 daily sessions was performed. Patients were matched by type of pain including post-surgical neuropathic pain, PHN, or spinal canal stenosis. Primary outcome was change in VAS pain scores at 1 month; secondary outcomes included VAS pain scores at 2 and 3 months, pain medication use, and allodynia. A total of 52 patients were randomized. The mean VAS pain score before treatment was 8.1 points (control) and 8.0 points (Scrambler). At 1 month, the mean VAS score was reduced from 8.1 to 5.8 (-28 %) in the control group, and from 8 to 0.7 points (-91 %) in the Scrambler group (p < 0.0001). At 2 and 3 months, the mean pain scores in the control group were 5.7 and 5.9 points, respectively, and 1.4 and 2 points in the Scrambler group, respectively (p < 0.0001). More relapses were seen in polyradicular pain than monoradicular pain, but re-treatment and maintenance therapy gave relief. No adverse effects were observed. The authors concluded that in this pilot randomized trial, Scrambler therapy appeared to relieve chronic neuropathic pain better than guideline-based drug management.
In a pilot study, Smith et al (2010) evaluated the impact on chemotherapy-induced peripheral neuropathy (CIPN) associated with the MC5-A Calmare therapy device. A total of 18 patients from 1 center received 1-hour interventions daily over 10 working days. Of 18 patients, 16 were evaluable. The mean age of the patients (4 men and 14 women) was 58.6 years and the duration of CIPN was 3 months to 8 years. The most common drugs used by these subjects were taxanes, platinum, and bortezomib. At the end of the study (day 10), a 20 % reduction in numeric pain scores was achieved in 15 of 16 patients. The pain score fell 59 % from 5.81 +/- 1.11 before treatment to 2.38 +/- 1.82 at the end of 10 days (p < 0.0001 by paired t-test). A daily treatment benefit was seen with a strong statistically significant difference between the pre- and post-daily pain scores (p < 0.001). Four patients had their CIPN reduced to zero. A repeated-measures analysis using the scores from all 10 days confirmed these results. No toxicity was seen. Some responses have been durable without maintenance. The authors concluded that patient-specific cutaneous electro-stimulation with the MC5-A Calmare device appears to dramatically reduce pain in refractory CIPN patients with no toxicity. They stated that further studies (determining effectiveness compared with sham or placebo treatment, and the need for maintenance therapy) are underway to define the benefit, mechanisms of action, and optimal schedule. The preliminary findings of this pilot study need to be validated by well-designed studies. There is a phase II clinical trial that examines the effectiveness of the MC5-A Scrambler therapy in reducing peripheral neuropathy caused by chemotherapy. http://clinicaltrials.gov/ct2/show/NCT00952848.
Ricci et al (2012) evaluated the effectiveness of an innovative neuromodulative approach to the treatment of chronic pain using electrical stimulus integrated with pharmacological support. The MC5-A Calmare is a new device for patient-specific cutaneous electro-stimulation which, by "scrambling" pain information with "no pain" information, aims to reduce the perception of pain intensity. These researchers prospectively treated 73 patients with cancer-related (n = 40) and non-cancer-related (n = 33) pain whose pain management was unsatisfactory. The primary objective of the study was to assess efficacy and tolerability of the device. Pain intensity was assessed daily with a Numerical Rating Scale (NRS) for the duration of treatment (2 weeks) and then on a weekly basis for the 2 weeks of follow-up. Mean pain value at T0 (pre-treatment value) was 6.2 [+/- 2.5 SD], 1.6 (+/- 2.0) (p < 0.0001) at T2 (after the 10th day of treatment), and 2.9 (+/- 2.6) (p < 0.0001) at T4 (after the second week of follow-up, i.e., 1 month after the beginning of treatment). Response after the second week of treatment showed a clear reduction in pain for both cancer (mean absolute delta of the reduction in NRS value = 4.0) and non-cancer (mean delta = 5.2) patients. The pain score had decreased by 74 % at T2. On the basis of pre-established response criteria, there were 78 % of responders at T2 and 81 % at T4. No side effects were reported. The authors concluded that these preliminary results suggested that cutaneous electro-stimulation with the MC5-A Calmare can be hypothesized as part of a multi-modality approach to the treatment of chronic pain. They stated that further studies on larger numbers of patients are needed to assess its efficacy, to quantify the effects of inter-operator variability, and to compare results obtained from the active device versus those from a sham machine.
The InterX 1000 Neurostimulator Device:
The InterX 1000 neurostimulator appears to be a hand-held, personal device for home use. It delivers interactive, high amplitude, high density stimulation to the cutaneous nerves, activating the body's natural pain relieving mechanisms (segmental and descending inhibition). However, there is insufficient evidence regarding its effectiveness for the treatment of chronic pain.
Peripheral Subcutaneous Field Stimulation:
Subcutaneous stimulation (peripheral nerve field stimulation/PNFS) is a novel neuromodulation modality that has increased in its utilization during the past decade. It consists of introducing a lead in the subdermal level to stimulate the small nerve fibers in that layer. Unlike other neuromodulation techniques including direct peripheral nerve stimulation, spinal cord stimulation (SCS), or deep brain stimulation, the precise target is not identified. Falco et al (2009) stated that relief of regional, non-appendicular pain, particularly LBP, through SCS has proven challenging. Recently, peripheral nerve stimulation (PNS), also known as PNFS depending on the stimulation area, has demonstrated efficacy for the treatment of well-localized, small areas of pain involving the abdomen, inguinal region, pelvis, face, occipital area, and low back. More widespread application of PNFS has been limited by its narrow field of coverage in a larger group of patients with diffuse or poorly localized pain.
McRoberts and Roche (2010) described a novel approach for the treatment of severe, chronic knee joint pain following total knee arthroplasty utilizing peripheral subcutaneous field stimulation (PSFS) and discussed the role of this treatment modality in patients with symptoms that are refractory to conventional pharmacologic, surgical, and physical therapies. These researchers presented 2 case reports of patients with chronic intractable knee pain where PNS via a permanent neurostimulating implant was introduced successfully. Both patients presented with persistent knee pain, for greater than 1 year, after having had total knee arthroplasty. Their symptoms failed to be alleviated by a variety of interventions including NSAIDS, oral anti-depressants, membrane stabilizers, opioids, physical therapy, surgical revisions, manipulation under anesthesia, local anesthetic patches, and TENS. In each case, direct stimulation of the knee was achieved utilizing a peripheral nerve stimulator via a peri-articular approach. Neuromodulation daily has produced both significant pain relief and functional improvement. Significant decreases in VAS pain scores and improvement in functional capacity were observed during the stimulation trial and during the follow-up after permanent implantation. The mean VAS score changed dramatically. The authors concluded that introduction of PSFS directly to the painful knee area is a novel and simple procedure that was extremely effective for the relief of pain and may provide a breakthrough in the treatment of chronic intractable knee pain following total knee arthroplasty. The peri-articular approach has several advantages, including only small incisions over the lateral and medial knee, proximal thigh and abdomen resulting in minimal strain on the lead array with flexion and extension contributing to overall stability of this system.
Yakovlev and Resch (2010) presented a case report describing application of PSFS to a patient with chronic intractable atypical facial pain (ATFP) that conventional treatment failed to ameliorate. The patient underwent an uneventful PSFS trial with percutaneous placement of 2 temporary 8-electrode leads (Medtronic Inc, Minneapolis, MN) placed subdermally over the left mandible. After experiencing excellent pain relief over the next 2 days, the patient was implanted with permanent leads and rechargeable generator 2 and a half weeks later and reported sustained pain relief at 12-month follow-up visit. Peripheral subcutaneous field stimulation provides an effective treatment option for patients suffering from chronic ATFP who have failed conservative treatment. The authors concluded that PSFS offers an alternative treatment option to select patients with intractable ATFP.
In a retrospective study, Yakovlev et al (2010) evaluated the effectiveness of PSFS for the treatment of chronic hip pain after total hip arthroplasty (THA) and greater trochanteric bursectomy (GTB). A total of 12 patients with chronic post-operative pain after THA and GTB underwent an uneventful PSFS trial with percutaneous placement of 2 temporary 8-electrode leads positioned in the subcutaneous tissue in the area of greatest pain, parallel to post-operative scar over the affected upper lateral thigh. After experiencing excellent pain relief over the next 2 days, the patients were implanted with permanent leads and rechargeable or non-rechargeable generator 2 to 4 weeks later. They reported sustained pain relief at 12-month follow-up visits. The authors concluded that PSFS provided an effective alternative treatment option for select patients with chronic post-operative pain after THA and GTB who have failed conservative treatment.
Ricciardo et al (2010) presented a case study to exemplify the application of PSFS in the treatment of recalcitrant notalgia paraesthetica. The patient was a 60-year old woman with severe and disabling notalgia paraesthetica. The itch persisted despite the use of several medications -- topical and oral. Following a successful trial of PSFS with a temporary electrode, 2 subcutaneous electrodes were inserted into the affected area with a battery implanted subcutaneously in her right buttock. The patient was reviewed at 5 months post-implantation. She reported a greater than 85 % improvement in her itch. She also reported a major improvement in her quality of life, with particular improvement in her ability to sleep through the night. This case illustrated the possible utilization of PSFS in the treatment of notalgia paraesthetica, which is a common yet poorly understood and treated condition. The authors stated that replication and controlled studies are needed to determine the general applicability of this approach.
Goroszeniuk et al (2012) reported the use of an alternative approach to neuromodulation of anginal pain using subcutaneous leads placed at the site of pain. In this case series, 5 patients with refractory angina received successful treatment with subcutaneous target stimulation -- peripheral subcutaneous field stimulation. This technique was able to provide good analgesia in 2 patients that had had poor pain relief from existing spinal cord stimulators. All 5 patients achieved significant pain relief with a reduction in symptoms and a decrease in the use of pain medication.
Burgher et al (2012) performed a retrospective review of consecutive patients evaluated from August 2009 to December 2010 who had undergone trial of subcutaneous (SQ) PNS with inter-lead stimulation for axial spine pain. Patients proceeding to implant were followed post-operatively with routine clinical visits and a survey form at last follow-up. Ultrasound was used intra-operatively to ensure placement of electrodes at the appropriate depth in patients with larger body mass index. Primary outcome was patient-reported pain relief at last follow-up. Literature review was conducted by searching MEDLINE (1948 to present) and through an unstructured review by the authors. A total of 10 patients underwent trial of SQ PNS and 6 proceeded to permanent implantation; 3 of the 6 (50 %) implanted patients preferred neurostimulation programming that included inter-lead stimulation ("cross-talk"). Average duration of post-operative follow-up was 4.5 months (range of 2 to 9 months). Average patient-reported pain relief at last follow-up was 45 % (range of 20 to 80 %). One patient required re-operation for migration. Patients not proceeding to implant had paresthesia coverage but no analgesia. The authors concluded that SQ PNS is a promising therapy for axial neck and back pain based on a small cohort of patients. Ultrasound was useful to assist with electrode placement at the most appropriate depth beneath the skin. While inter-lead stimulation has been preferred by patients in published reports, these investigators did not find it clearly influenced pain relief. The authors stated that future investigations should include a randomized, controlled study design, as well as defined implantation technique and neurostimulator programming algorithms.
Electro Therapeutic Point Stimulation:
Electro-therapeutic point stimulation (ETPS), also known as microcurrent point stimulation (MPS), employs a non-invasive device to administer low-frequency direct current to acupuncture points, motor/trigger points, and contracted muscle bands. The device (known as called the ETPS 1000) has an enhanced point finder that detects treatment points on the skin and applies brief, concentrated electrical microstimulation in short bursts. This modality/approach combines the principles of acupuncture, massage, physical therapy and microcurrent stimulation. The treatment can be self-administered by the patient at home. There is insufficient peer-reviewed evidence to support the safety and effectiveness of ETPS/MPS.
Aliyev and Geiger (2012) examined the effects of cell-stimulation therapy of lateral epicondylitis with frequency-modulated low-intensity electric current. Patients with lateral epicondylitis were subjected to a 12-week cell-stimulation therapy with low-intensity frequency-modulated electric current in addition to routine therapy. Patients in the control group received the same routine therapy and sham stimulation (the therapeutic apparatus was not energized). The effectiveness of MPS was estimated by comparing medical indices before therapy and at the end of a 12-week therapeutic course using a 10-point pain severity numeric rating scale (NRS) and Roles-Maudsley pain score. The study revealed high therapeutic efficiency of cell-stimulation with low-intensity electric current resulting probably from up-regulation of intracellular transmitters, interleukins, and prostaglandins playing the key role in the regulation of inflammation. The findings of this study need to be validated by well-designed studies with long-term follow-up.
Appendix
TENS Unit Supplies
A 4-lead TENS unit may be used with either 2 leads or 4 leads, depending on the characteristics of the member's pain. If it is ordered for use with 4 leads, the medical record must document why 2 leads are insufficient to meet the member's needs.
If 2 TENS leads are medically necessary, then a maximum of 1 unit of a TENS supply allowance (HCPCS Code A4595) would be considered medically necessary per month; if 4 TENS leads are necessary, a maximum of 2 units per month would be considered medically necessary. If the use of the TENS unit is less than daily, medical necessity of the TENS supply allowance is reduced proportionally. Note: A TENS supply allowance (HCPCS code A4595) includes electrodes (any type), conductive paste or gel (if needed, depending on the type of electrode), tape or other adhesive (if needed, depending on the type of electrode), adhesive remover, skin preparation materials, batteries (9 volt or AA, single use or rechargeable), and a battery charger (if rechargeable batteries are used).
Replacement of lead wires more often than every 12 months is rarely medically necessary.
Transcutaneous electrical nerve stimulation (TENS) device, 4 or more leads, for multiple nerve stimulation
ICD-9 codes covered if selection criteria are met:
338.18
Other acute postoperative pain
338.21 - 338.29
Chronic pain
338.4
Chronic pain syndrome
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
339.00 - 339.89
Other headache syndromes
346.00 - 346.93
Migraine
524.60 - 524.69
Temporomandibular joint disorders
625.0 - 625.9
Pain and other symptoms associated with female genital organs
784.0
Headache
789.00 - 789.09
Abdominal pain
820.00 - 821.39
Hip fractures [pain]
Other ICD-9 codes related to the CPB:
338.11
Acute pain due to trauma [not covered for acute pain (less than 3 months duration) other than post-operative pain, acute and chronic headaches, deep abdominal pain, hip fracture pain, neuropathic pain, pelvic pain, temporomandibular joint (TMJ) pain]
338.19
Other acute pain [not covered for acute pain (less than 3 months duration) other than post-operative pain, acute and chronic headaches, deep abdominal pain, hip fracture pain, neuropathic pain, pelvic pain, temporomandibular joint (TMJ) pain]
350.1 - 355.9
Mononeuritis [not covered for acute pain (less than 3 months duration) other than post-operative pain or neuropathic pain]
Form-fitting Conductive Garment:
HCPCS codes covered if selection criteria are met:
E0731
Form-fitting conductive garment for delivery of TENS or NMES (with conductive fibers separated from the patient's skin by layers of fabric)
ICD-9 codes covered if selection criteria are met (not all-inclusive):
728.2
Muscular wasting and disuse atrophy, not elsewhere classified
Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
L8685
Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686
Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension
L8687
Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688
Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension
L8689
External recharging system for battery (internal) for use with implantable neurostimulator, replacement only
L8695
External recharging system for battery (external) for use with implantable neurostimulator, replacement only
ICD-9 codes covered if selection criteria are met:
337.20 - 337.29
Reflex sympathetic dystrophy
354.0 - 355.9
Mononeuritis
907.2 - 907.5
Late effect of spinal cord injury, injury to nerve root(s), spinal plexus(s), and other nerves of trunk, injury to peripheral nerve of shoulder girdle and upper limb, or injury to peripheral nerve of pelvic girdle and lower limb
953.0 - 956.9
Injury to nerve roots and spinal plexus, injury to other nerve(s) of trunk, excluding shoulder and pelvic girdles, injury to peripheral nerve(s) of shoulder girdle and upper limb, or injury to peripheral nerve(s) of pelvic girdle and lower limb
ICD-9 codes not covered for indications listed in the CPB:
053.13
Postherpetic polyneuropathy
304.00 - 304.93
Drug dependence
Other ICD-9 codes related to the CPB:
250.60 - 250.63
Diabetes with neurological manifestations
337.1
Peripheral autonomic neuropathy in disorders classified elsewhere
729.1
Myalgia and myositis, unspecified
729.2
Neuralgia, neuritis, and radiculitis, unspecified
729.5
Pain in limb
H-Wave Type Stimulators:
No specific codes
Intramuscular stimulation:
CPT codes not covered for indications listed in the CPB:
64565
64580
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
HCPCS codes not covered for indications listed in the CPB:
E0762
Electro-Acuscope Myopulse Therapy:
No specific codes
Electrical stimulation of sacral roots or lumbosacral plexus:
CPT codes not covered for indications listed in the CPB:
64555
64561
64575
64581
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
789.00 - 789.09
Abdominal pain
789.6
Abdominal tenderness
789.9
Other symptoms involving abdomen and pelvis
Microcurrent Therapy:
No specific codes
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
724.2
Lumbago
724.5
Backache, unspecified
The above policy is based on the following references:
TENS/PENS:
Ventafridda V, et al. Transcutaneous stimulation in cancer pain. In: Advances in Pain Research and Therapy. Vol. 2. JJ Bonica, V Ventafridda, eds. New York, NY: Raven Press; 1979:509-515.
Deyo RA, Walsh NE, Martin DC, et al. A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain. N Engl J Med. 1990;322(23):1627-1634.
Long DM. Fifteen years of transcutaneous electrical nerve stimulation for pain control. Stereotact Funct Neurosurg. 1991;56(1):2-19.
Agency for Healthcare Policy and Research (AHCPR), Acute Pain Management Guideline Panel. Acute pain management: Operative or medical procedures and trauma. Clinical Practice Guideline No. 1. AHCPR Publication No. 92-0032. Rockville, MD: AHCPR; February 1992.
Lander J, Fowler-Kerry S. TENS for children's procedural pain. Pain. 1993;52(2):209-216.
Jacox A, Carr DB, Payne R, et al. Management of cancer pain. Clinical Practice Guideline No. 9. AHCPR Publication No. 94-0592. Rockville, MD: Agency for Health Care Policy and Research; March 1994.
Bigos S, Bowyer O, Braen G, et al. Acute low back problems in adults. Clinical Practice Guideline, No. 14. AHCPR Publication No. 95-0642. Rockville, MD: Agency for Health Care Policy and Research (AHCPR); December 1994.
Herman E, Williams R, Stratford P, et al. A randomized controlled trial of transcutaneous electrical nerve stimulation (CODETRON) to determine its benefits in a rehabilitation program for acute occupational low back pain. Spine. 1994;19(5):561-568.
Forster EL, Kramer JF, Lucy SD, et al. Effect of TENS on pain, medications, and pulmonary function following coronary artery bypass graft surgery. Chest. 1994;106(5):1343-1348.
Harvey M, Elliott M. Transcutaneous electrical nerve stimulation (TENS) for pain management during cavity preparations in pediatric patients. ASDC J Dent Child. 1995;62(1):49-51.
Reeve J, Corabian P. Transcutaneous electrical nerve stimulation (TENS) and pain management. Ottawa, ON: Canadian Coordinating Office for Health Technology Assessment (CCOHTA); April 1995. Available at: http://www.ccohta.ca/pubs/index.html. Accessed March 22, 2000.
U.S. Department of Health and Human Services, Health Care Financing Administration (HCFA). Technology Assessment Committee (TAC) minutes. November 5- 6, 1996. Baltimore, MD: HCFA; 1996. Available at: http://www.hcfa.gov/events/1196tmin.htm. Accessed March 22, 2000.
Carroll D, Tramèr M, McQuay H, et al. Randomization is important in studies with pain outcomes: Systematic review of transcutaneous electrical nerve stimulation in acute postoperative pain. Br J Anaesth. 1996;77(6):798-803.
Reeve J, Menon D, Corabian P. Transcutaneous electrical nerve stimulation (TENS): A technology assessment. Int J Tech Assess Health Care. 1996;12(2):299-324.
McQuay HJ, Moore RA, Eccleston C, et al. Systematic review of outpatient services for chronic pain control. Health Technol Assess. 1997;1(6):1-137.
van Tulder MW, Koes BW, Bouter LM. Conservative treatment of acute and chronic nonspecific low back pain: A systematic review of randomized controlled trials of the most common interventions. Spine. 1997;22(18):2128-2156.
Carroll D, Tramèr M, McQuay H, et al. Transcutaneous electrical nerve stimulation in labour pain: A systematic review. Br J Obstet Gynaecol. 1997;104(2):169-175.
Brodsky JB, Mark JB. Postthoracoscopy pain: Is TENS the answer? Ann Thorac Surg. 1997;63(3):608-610.
Benedetti F, Amanzio M, Casadio C, et al. Control of postoperative pain by transcutaneous electrical nerve stimulation after thoracic operations. Ann Thorac Surg. 1997;63(3):773-776.
McQuay HJ, Moore RA, Eccleston C, et al. Systematic review of outpatient services for chronic pain control. Health Technol Assess. 1997;1(6):i-iv, 1-135.
Moore SR, Shurman J. Combined neuromuscular electrical stimulation and transcutaneous electrical nerve stimulation for treatment of chronic back pain: A double-blind, repeated measures comparison. Arch Phys Med Rehabil. 1997;78(1):55-60.
Lampl C, Kreczi T, Klingler D. Transcutaneous electrical nerve stimulation in the treatment of chronic pain: Predictive factors and evaluation of the method. Clin J Pain. 1998;14(2):134-142.
Chabal C, Fishbain DA, Weaver M, Heine LW. Long-term transcutaneous electrical nerve stimulation (TENS) use: Impact on medication utilization and physical therapy costs. Clin J Pain. 1998;14(1):66-73.
Ghoname EA, Craig WF, White PF, et al. Percutaneous electrical nerve stimulation for low back pain: A randomized crossover study. JAMA. 1999;281(9):818-823.
Osiri M, Welch V, Brosseau L, et al. Transcutaneous electrical nerve stimulation for knee osteoarthritis. Cochrane Database Syst Rev. 2000;(4):CD002823.
Nnoaham KE, Kumbang J. Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database Syst Rev. 2008;(3):CD003222.
Price CIM, Pandyan AD. Electrical stimulation for preventing and treating post-stroke shoulder pain. Cochrane Database Syst Rev. 2000;(4):CD001698.
Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2002;(1):CD002123.
Brosseau L, Milne S, Robinson V, et al. Efficacy of the transcutaneous electrical nerve stimulation for the treatment of chronic low back pain: A meta-analysis. Spine. 2002;27(6):596-603.
U.S. Department of Veterans Affairs, Technology Assessment Program (VATAP). Transcutaneous electrical nerve stimulation. Bibliography. Boston, MA: VATAP; November 2001. Available at: http://www.va.gov/VATAP/publications.htm. Accessed January 17, 2006.
Harris GR, Susman JL. Managing musculoskeletal complaints with rehabilitation therapy: Summary of the Philadelphia Panel evidence-based clinical practice guidelines on musculoskeletal rehabilitation interventions. J Fam Pract. 2002;51(12):1042-1046.
Brosseau L, Yonge KA, Robinson V, et al. Transcutaneous electrical nerve stimulation (TENS) for the treatment of rheumatoid arthritis in the hand. Cochrane Database Syst Rev. 2003;(2):CD004377.
Weiner DK, Ernst E. Complementary and alternative approaches to the treatment of persistent musculoskeletal pain. Clin J Pain. 2004;20(4):244-255.
Bronfort G, Nilsson N, Haas M, et al. Non-invasive physical treatments for chronic/recurrent headache. Cochrane Database Syst Rev. 2004;(3):CD001878.
Washington State Department of Labor and Industries, Office of the Medical Director. Percutaneous neuromodulation therapy. Technology Assessment. Olympia, WA: Washington State Department of Labor and Industries; January 13, 2004. Available at: http://www.lni.wa.gov/ClaimsIns/Files/OMD/PensTa01132004.pdf. Accessed January 30, 2007.
Khadilkar A, Odebiyi DO, Brosseau L, et al. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database Syst Rev. 2008;(4):CD003008.
Robb KA, Bennett MJ, Johnson MI, et al. Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database Syst Rev. 2008;(3):CD006276.
Pichon Riviere A, Augustovski F, Alcaraz A, et al. Transcutaneous electrical nerve stimulation (TENS-PENS) for back pain. Report IRR No. 89. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (IECS); 2006.
Johnson M, Martinson M. Efficacy of electrical nerve stimulation for chronic musculoskeletal pain: A meta-analysis of randomized controlled trials. Pain. 2007;130(1-2):157-165.
Tricenturion LLC. Transcutaneous electrical nerve stimulators (TENS). Local Coverage Determination (LCD) No. L11506. DMERC Region A/B. Columbia, SC: Tricenturion; January 1, 2006.
Kroeling P, Gross A, Goldsmith CH, et al. Electrotherapy for neck pain. Cochrane Database Syst Rev. 2009;(4):CD004251.
Savigny P, Kuntze S, Watson P, et al. Low back pain: Early management of persistent non-specific low back pain. Full Guideline. London, UK: National Collaborating Centre for Primary Care and Royal College of General Practitioners; May 2009.
Desantana JM, Sluka KA, Lauretti GR. High and low frequency TENS reduce postoperative pain intensity after laparoscopic tubal ligation: A randomized controlled trial. Clin J Pain. 2009;25(1):12-19.
Walsh DM, Howe TE, Johnson MI, Sluka KA. Transcutaneous electrical nerve stimulation for acute pain. Cochrane Database Syst Rev. 2009;(2):CD006142.
Robb K, Oxberry SG, Bennett MI, et al. A Cochrane systematic review of transcutaneous electrical nerve stimulation for cancer pain. J Pain Symptom Manage. 2009;37(4):746-753.
Dubinsky RM, Miyasaki J. Assessment: Efficacy of transcutaneous electric nerve stimulation in the treatment of pain in neurologic disorders (an evidence-based review). Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2010;74(1):173-176.
Mulvey MR, Bagnall AM, Johnson MI, Marchant PR. Transcutaneous electrical nerve stimulation (TENS) for phantom pain and stump pain following amputation in adults. Cochrane Database Syst Rev. 2010;(5):CD007264.
Pichon Riviere A, Augustovski F, Garcia Marti S, et al. Electrical stimulation for the treatment of headaches [summary]. IRR No. 198. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (IECS); July 2010.
Cheing GL, Luk ML. Transcutaneous electrical nerve stimulation for neuropathic pain. J Hand Surg Br. 2005;30(1):50-55.
Demarin V, Basić-Kes V, Zavoreo I, et al; Ad hoc Committee of the Croatian Society for Neurovascular Disorders; Croatian Medical Association. Recommendations for neuropathic pain treatment. Acta Clin Croat. 2008;47(3):181-191.
Norrbrink C. Transcutaneous electrical nerve stimulation for treatment of spinal cord injury neuropathic pain. J Rehabil Res Dev. 2009;46(1):85-93.
Moharic M, Burger H. Effect of transcutaneous electrical nerve stimulation on sensation thresholds in patients with painful diabetic neuropathy: An observational study. Int J Rehabil Res. 2010;33(3):211-217.
Jin DM, Xu Y, Geng DF, Yan TB. Effect of transcutaneous electrical nerve stimulation on symptomatic diabetic peripheral neuropathy: A meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. 2010;89(1):10-15.
Johnson MI, Bjordal JM. Transcutaneous electrical nerve stimulation for the management of painful conditions: Focus on neuropathic pain. Expert Rev Neurother. 2011;11(5):735-753.
Abou-Setta AM, Beaupre LA, Rashiq S, et al. Comparative effectiveness of pain management interventions for hip fracture: A systematic review. Ann Intern Med. 2011;155(4):234-245.
Taylor K, Newton RA, Personius WJ, Bush FM. Effects of interferential current stimulation for treatment of subjects with recurrent jaw pain. Phys Ther. 1987;67(3):346-350.
Low JL. Shortwave diathermy, microwave, ultrasound and interferential therapy. In: Pain Management in Physical Therapy. PE Wells, et al., eds. Stamford, CT: Appleton & Lange; 1988; Ch. 11: 113-168.
Goats GC. Interferential current therapy. Br J Sports Med. 1990;24(2):87-92.
Shafshak TS, el-Sheshai AM, Soltan HE. Personality traits in the mechanisms of interferential therapy for osteoarthritic knee pain. Arch Phys Med Rehabil. 1991;72(8):579-581.
Latzanich CM, Gilmore R, Burke HB. Interferential current therapy for post-operative pain management. Contemp Pod Phys. November 1991, pp 7-9.
Agency for Healthcare Policy and Research (AHCPR), Acute Pain Management Guideline Panel. Acute pain management: Operative or medical procedures and trauma. Clinical Practice Guideline No. 1. AHCPR Publication No. 92-0032. Rockville, MD: AHCPR; February 1992.
Turner JA, Deyo RA, Loeser JD, et al. The importance of placebo effects in pain treatment and research. JAMA. 1994;271(20):1609-1614.
Reitman C, Esses SI. Conservative options in the management of spinal disorders, Part I. Bed rest, mechanical and energy-transfer therapies. Am J Orthop. 1995;24(2):109-116.
Indergand HJ, Morgan BJ. Effect of interference current on forearm vascular resistance in asymptomatic humans. Phys Ther. 1995;75(4):306-312.
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 randomised controlled trial. Ann Rheum Dis. 1999;58(9):530-540.
Palmer ST, Martin DJ, Steedman WM, Ravey J. Effects of electric stimulation on C and A delta fiber-mediated thermal perception thresholds. Arch Phys Med Rehabil. 2004;85(1):119-128.
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.
California Technology Assessment Forum (CTAF). Interferential stimulation for the treatment of musculoskeletal pain. Technology Assessment. San Francisco, CA: CTAF; October 19, 2005. Available at: http://ctaf.org/ass/viewfull.ctaf?id=65198186094. Accessed January 17, 2006.
Chou R, Huffman LH; American Pain Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: A review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007;147(7):492-504.
Savigny P, Kuntze S, Watson P, et al. Low back pain: Early management of persistent non-specific low back pain. Full Guideline. London, UK: National Collaborating Centre for Primary Care and Royal College of General Practitioners; May 2009.
Fuentes JP, Armijo Olivo S, Magee DJ, Gross DP. Effectiveness of interferential current therapy in the management of musculoskeletal pain: A systematic review and meta-analysis. Phys Ther. 2010;90(9):1219-1238.
H-WAVE® Type Stimulators:
Flatt DW. Resolution of a double crush syndrome. J Manipulative Physiol Ther. 1994;17(6):395-397.
McDowell BC, Lowe AS, Walsh DM, et al. The lack of hypoalgesic efficacy of H-wave therapy on experimental ischemic pain. Pain. 1995;61(1):27-32.
Kumar D, Marshall HJ. Diabetic peripheral neuropathy: Amelioration of pain with transcutaneous electrostimulation. Diabetes Care. 1997;20(11):1702-1705.
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.
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.
McDowell BC, McCormack K, Walsh DM, et al. Comparative analgesic effects of H-wave therapy and transcutaneous electrical nerve stimulation on pain threshold in humans. Arch Phys Med Rehabil. 1999;80(9):1001-1004.
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 Therapy. 2008;25(7):644-657.
Centre for Reviews and Dissemination (CRD). The H-wave device is an effective and safe non-pharmacological analgesic for chronic pain: A meta-analysis. Database of Abstracts of Reviews of Effectiveness. York, UK: University of York; 2009.
Peripheral Nerve Stimulation:
Cauthen JC, Renner EJ. Transcutaneous and peripheral nerve stimulator for chronic pain states. Surg Neurol. 1975;4(1):102-104.
Meyerson BA, Hakansson J. Alleviation of atypical trigeminal pain by stimulation of the Gasserian ganglion via an implanted electrode. Acta Neurochir Suppl (Wien). 1980;30:303-309.
Racz GB, Browne T, Lewis R Jr. Peripheral stimulator implant for treatment of causalgia caused by electrical burns. Tex Med. 1988;84(11):45-50.
Leak WD, Ansel AE. Neural stimulation: Spinal cord and peripheral nerve stimulation. In: Pain Medicine. A Comprehensive Review. PP Raj, ed. St. Louis, MO: Mosby; 1996; Ch. 32: 327-333.
Taub E, Munz M, Tasker RR. Chronic electrical stimulation of the gasserian ganglion for the relief of pain. J Neurosurg. 1997;86(2):197-202.
American Society of Addiction Medicine (ASAM). Definitions related to the use of opoids for the treatment of pain. Public Policy of ASAM. Chevy Chase, MD: ASAM; February 2001. Available at: http://www.asam.org/ppol/ paindef.htm. Accessed September 9, 2004.
Slavin KV. Peripheral nerve stimulation for the treatment of neuropathic craniofacial pain. Acta Neurochir Suppl. 2007;97(Pt 1):115-120.
Intramuscular Stimulation:
Chu J. Twitch-obtaining intramuscular stimulation (TOIMS) in acute partial radial nerve palsy. Electromyogr Clin Neurophysiol. 1999;39(4):221-226.
Chu J. The role of the monopolar electromyographic pin in myofascial pain therapy: Automated twitch-obtaining intramuscular stimulation (ATOIMS) and electrical twitch-obtaining intramuscular stimulation (ETOIMS). Electromyogr Clin Neurophysiol. 1999;39(8):503-511.
Chu J. Early observations in radiculopathic pain control using electrodiagnostically derived new treatment techniques: Automated twitch-obtaining intramuscular stimulation (ATOIMS) and electrical twitch-obtaining intramuscular stimulation (ETOIMS). Electromyogr Clin Neurophysiol. 2000;40(4):195-204.
Chu J, Gozon BS, Schwartz I. Twitch-obtaining intramuscular stimulation in reflex sympathetic dystrophy. Electromyogr Clin Neurophysiol. 2002;42(5):259-266.
Sympathetic Therapy (Dynatron):
Dynatronics Corp. Dynatron Sympathetic Therapy System (STS): Revolutionary Breakthrough in the Treatment of Pain [website]. Salt Lake City, UT: Dynatronics; 2001. Available at: http://www.chronicpainrx.com/dynatron/. Accessed January 14, 2002.
Rajala Rehab Products. Sympathetic Therapy System [website]. Pleasanton, CA: Rajala; 2001. Available at: http://www.rajala.com/cgi/catalog.pl?Electrotherapy. Accessed January 14, 2001.
Guido EH. Effects of sympathetic therapy on chronic pain in peripheral neuropathy subjects. Am J Pain Mgmt. 2002;12:31-34.
Hord ED, Oaklander AL. Complex regional pain syndrome: A review of evidence-supported treatment options. Curr Pain Headache Rep. 2003;7(3):188-196.
Washington State Department of Labor and Industries, Office of the Medical Director. Dynatron STS. Technology Assessment. Olympia, WA: Washington State Department of Labor and Industries; updated April 30, 2002. Available at: http://www.lni.wa.gov/omd/PdfDoc/DYNATRON.pdf. Accessed August 17, 2003.
Work Loss Data Institute. Pain (chronic). Corpus Christi, TX: Work Loss Data Institute; 2008.
Electroceutical Therapy:
Benchmark Integrative Medicine, LLC. Clinical electroceutical medicine [website]. Fayetteville, GA: Benchmark; 2002. Available at: http://www.benchmarkpain.com/page4.html. Accessed May 10, 2002.
Robertson M. Electroceutical nerve block [abstract]. Chronic Pain Solutions, Fall 1998. Available at: http://www.chronicpainsolutions.com/ nerveblock.htm. Accessed May 22, 2002.
Empire Medicare Services NJ. Facet joint nerve block. Medical Policy Bulletin Freedom of Information. Medicare News Brief - New Jersey (Part B). MNB-NJ-2001-2. New York, NY: Empire; April 2001. Available at: http://www.empiremedicare.com/NJBULL/njb2001-2/s129.htm. Accessed May 22, 2002.
Empire Medicare Services. Nerve blocks: paravertebral nerve blocks. Medicare Part B Medical Policy. Policy No. YPF# 180, Ysurg #43. New York, NY: Empire; May 1, 1999. Available at: http://www.empiremedicare.com/Newypolicy/policy/YSRG43r2.htm. Accessed May 22, 2002.
GHI Medicare Division. Nerve blocks/ paravertebral nerve blocks. Local Medical Necessity Policy. Policy No. SUR-1233. New York, NY: GHI Medicare; July 30, 1999. Available at: http://www.ghimedicare.com/lmrp2/sur-1233.html. Accessed May 22, 2002.
Lake Michigan Medical, Inc. Matrix Biokinetics, Inc. PROGeneSys System Electroceutical Treatment [website]. Chicago, IL: Lake Michigan Medical; 2002. Available at: http://lakemichiganmedical.com.control.interliant.com/Pain_Management9.html. Accessed May 10, 2002.
Work Loss Data Institute. Pain (chronic). Corpus Christi, TX: Work Loss Data Institute; 2008.
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.
Hulme J, Robinson V, DeBie R, et al. Electromagnetic fields for the treatment of osteoarthritis. Cochrane Database Syst Rev. 2002;(1):CD003523.
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.
McCarthy CJ, Callaghan MJ, Oldham JA. Pulsed electromagnetic energy treatment offers no clinical benefit in reducing the pain of knee osteoarthritis: A systematic review. BMC Musculoskelet Disord. 2006;7:51.
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.
Fary RE, Carroll GJ, Briffa TG, et al. The effectiveness of pulsed electrical stimulation (E-PES) in the management of osteoarthritis of the knee: A protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2008;9:18.
NHIC, Corp. Draft LCD for transcutaneous electrical joint stimulation devices. LCD ID No. DL28551. Durable Medical Equipment (DME) Medicare Administrative Carrier (MAC) Jurisdiction A. Hingham, MA: NHIC; 2008.
Rutjes AWS, Nüesch E, Sterchi R, et al. Transcutaneous electrostimulation for osteoarthritis of the knee. Cochrane Database Syst Rev. 2009;(4):CD002823.
Lumbosacral Plexus and Sacral Nerve Root Stimulation:
Alo KM, Yland MJ, Redko V, et al. Lumbar and sacral nerve root stimulation (NRS) in the treatment of chronic pain: A novel anatomic approach and neuro stimulation technique. Neuromodulation. 1999;2(1):23-31
Falco FJE, Rubbani M, Heinbaugh J. Anterograde sacral nerve root stimulation (ASNRS) via the sacral hiatus: Benefits, limitations, and percutaneous implantation technique. Neuromodulation. 2003;6(4):219-224.
Siegel S, Paszkievics E, Kirkpatrick C et al. Sacral nerve stimulation in patients with chronic intractable pelvic pain. J Urol . 2001;166(5):1742-1745.
Kim P. Advanced pain management techniques: An overview of neurostimulation. Expert Column. Medscape Neurol Neurosurg. 2004;6(1). Available at: http://www.medscape.com/viewarticle/473431. Accessed January 6, 2006.
Microcurrent Therapy:
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.
Chou R, Atlas SJ, Stanos SP, Rosenquist RW. Nonsurgical interventional therapies for low back pain: A review of the evidence for an American Pain Society clinical practice guideline. Spine. 2009;34(10):1078-1093.
Scrambler Therapy/The Calmare Therapy Device:
Marineo G. Untreatable pain resulting from abdominal cancer: New hope from biophysics? JOP. 2003;4(1):1-10.
Sabato AF, Marineo G, Gatti A. Scrambler therapy. Minerva Anestesiol. 2005;71(7-8):479-482.
Smith TJ, Coyne PJ, Parker GL, et al. Pilot trial of a patient-specific cutaneous electrostimulation device (MC5-A Calmare®) for chemotherapy-induced peripheral neuropathy. J Pain Symptom Manage. 2010;40(6):883-891.
Ricci M, Pirotti S, Scarpi E, et al. Managing chronic pain: Results from an open-label study using MC5-A Calmare® device. Support Care Cancer. 2012;20(2):405-12
Marineo G, Iorno V, Gandini C, et al. Scrambler therapy may relieve chronic neuropathic pain more effectively than guideline-based drug management: Results of a pilot, randomized, controlled trial. J Pain Symptom Manage. 2012;43(1):87-95.
Peripheral Subcutaneous Field Stimulation:
Falco FJ, Berger J, Vrable A, et al. Cross talk: A new method for peripheral nerve stimulation. An observational report with cadaveric verification. Pain Physician. 2009;12(6):965-983.
McRoberts WP, Roche M. Novel approach for peripheral subcutaneous field stimulation for the treatment of severe, chronic knee joint pain after total knee arthroplasty. Neuromodulation. 2010;13(2):131-136.
Yakovlev AE, Resch BE. Treatment of chronic intractable atypical facial pain using peripheral subcutaneous field stimulation. Neuromodulation. 2010;13(2):137-140.
Yakovlev AE, Resch BE, Karasev SA. Treatment of intractable hip pain after THA and GTB using peripheral nerve field stimulation: A case series. WMJ.2010;109(3):149-152.
Ricciardo B, Kumar S, O'Callaghan J, Boyce Z. Peripheral nerve field stimulation for pruritus relief in a patient with notalgia paraesthetica. Australas J Dermatol. 2010;51(1):56-59.
Goroszeniuk T, Pang D, Al-Kaisy A, Sanderson K. Subcutaneous target stimulation-peripheral subcutaneous field stimulation in the treatment of refractory angina: Preliminary case reports. Pain Pract. 2012;12(1):71-79.
Burgher AH, Huntoon MA, Turley TW, et al. Subcutaneous peripheral nerve stimulation with inter-lead stimulation for axial neck and low back pain: Case series and review of the literature. Neuromodulation. 2012;15(2):100-106; discussion 106-107.
Aliyev RM, Geiger G. Cell-stimulation therapy of lateral epicondylitis with frequency-modulated low-intensity electric current. Bull Exp Biol Med. 2012;152(5):653-655.
Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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