1. 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 chronic, intractable pain not responsive to other methods of treatment.  However, TENS is considered experimental and investigational for acute pain (less than three months duration) other than post-operative pain. TENS is also considered experimental and investigational for acute and chronic headaches, deep abdominal 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.

2. 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 one month but not to exceed two 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.

3. 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 cannot 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 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; or 

   • The member has a medical need for rehabilitation strengthening following an injury where the nerve supply to the muscle is intact.

4. Aetna considers stellate ganglion blockade using TENS experimental and investigational because its clinical value has not been established.

5. 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 for these indications has not been established.

6. Aetna considers percutaneous electrical nerve stimulation (PENS) (also known as percutaneous neuromodulation) medically necessary DME for 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.

   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.

7. 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 
   • There is objective evidence of pathology (e.g., electromyography), and 
   • There is no psychological contraindication to peripheral nerve stimulation, and;
   • Member is not addicted to drugs (per American Society of Addiction Medicine guidelines), and;

   • A 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.

8. 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 reduce pain from causes other than chronic diabetic peripheral neuropathy; or 
   • To reduce edema; or 
   • To accelerate healing; or 

   • To treat chronic pain due to ischemia.

9. 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.

10. Aetna considers sympathetic therapy (Dynatronics Corporation, Salt Lake City, UT) experimental and investigational since its effectiveness has not been established.

11. 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."

12. Aetna considers BioniCare (pulsed electrical stimulation) experimental and investigational for the treatment of osteoarthritis and all other indications because its effectiveness has not been established.

13. 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.

14. 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.

Note: Below is a list of CPBs that address other types of electrical stimulation:

175 - High-Frequency Pulsed Electromagnetic Stimulation

191 - Vagus Nerve Stimulation

194 - Dorsal Column Stimulation

208 - Deep Brain Stimulation

223 - Urinary Incontinence Treatments

302 - Electrical Stimulation (Salitron System) for Xerostomia

327 - Infertility (discusses electroejaculation)

343 - Bone Growth Stimulators

398 - Idiopathic Scoliosis Treatments (discusses surface electrical muscle stimulation)

406 - Tinnitus Treatments (discusses the use of TENS)

469 - Transcranial Magnetic Stimulation and Cranial Electrical Stimulation

676 - Electrical Stimulation for Nausea, Vomiting, and Motion Sickness (ReliefBand)

677 - Functional Electrical Stimulation and Neuromuscular Electrical Stimulation (for spinal cord injury, stroke, diaphragmatic pacing, neurogenic bladder, cerebral palsy, and Bell’s palsy)

678 - Gastric Pacing / Gastric Electrical Stimulation

679 - Electrical Stimulation for Levator Syndrome

680 - Electrical Stimulation for Chronic Ulcers.

The following are brief descriptions of various types of electrical stimulation discussed in this CPB:

A transcutaneous electrical nerve stimulator (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).

Interferential Stimulation (IFS) is characterized by two 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 two currents is usually held at 4000 Hz, and the other can be held constant or varied over a range of 4001 to 4100 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.

Percutaneous Electrical Nerve Stimulation (PENS) (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 low back pain and therapeutic exercise for chronic, subacute, and post-surgical low back pain; transcutaneous electrical nerve stimulation 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 low back pain, 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 our 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 low back pain.  While some herbals appear to have modest analgesic benefits, insufficient evidence exists to definitively recommend their use.  Drug-herb interactions must also be considered.  Some evidence exists to support the superiority of homeopathic remedies over placebo for treating osteoarthritis and rheumatoid arthritis.  The benefits of spinal manipulation for persistent low back and neck pain have not been convincingly shown to outweigh its risks.  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 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 low back pain; 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 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 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 overcomes the disadvantages of other electrotherapy machines.  It allows the therapist to apply two 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.

TENS:

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).

Interferential Stimulation:

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 randomised 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 low back pain 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 low back pain are cognitive-behavioral therapy, exercise, spinal manipulation, and inter-disciplinary rehabilitation.  For acute low back pain, the only therapy with good evidence of efficacy is superficial heat.

H-Wave Stimulation:

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, 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.

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 reinserted 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 minutes. 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 visual analog scores 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.

A recent 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.

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 two 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.  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.

BioniCare (Pulsed 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 per day for four 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 one 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 minutes in the active device group and increased 2 minutes 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 randomized controlled clinical trials (RCTs) of pulsed electromagnetic field therapy for knee osteoarthritis: two RCTs scored 5 points for validity, one scored 4 and two scored 3. The investigators found that none of the individual studies reported a statistically significant difference between treatments for pain. Only one 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% confidence interval -1.02 to -0.14). For all studies combined, there was no significant difference between interventions in pain (weighted mean difference -0.66, 95% confidence interval -1.67 to 0.35) or function (weighted mean difference -0.70, 95% confidence interval -1.92 to 0.52).

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 visual analog scale (VAS) scores in 5 patients with chronic pain (e.g., ilioinguinal neuralgia, discogenic low back pain, 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.

Appendix

TENS Unit Supplies

• A four-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 one 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 two 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.