• Sympathetic Therapy - electrical current is applied via peripheral nerves with electrodes placed on the upper and lower extremities. This is theorized to relieve pain by creating a "unique" form of stimulation of the sympathetic nervous system. Devices used for sympathetic therapy include the Dynatron STS.
• Percutaneous Neuromodulation Therapy (PNT) for Back Pain - electrical current is applied through electrodes inserted deep into the paraspinal tissues. This is theorized to stimulate peripheral nerves which, in turn, alter the activity of the spinal nerves transmitting the pain signals. The Vertis PNT Unit is an example of a device used for this form of electrotherapy.
• Cranial Electrotherapy Stimulation (CES) - this form of electrotherapy is also known as transcranial electrical stimulation, cranial trancutaneous electrical nerve stimulation, and neuroelectric therapy. Low levels of electrical current are applied through electrodes that clip onto the ear lobes or attach behind the ears. Examples of devices under this category include Alpha-Stim CS, Liss Cranial Stimulator, HealthPax HP-1, and Transcranial Electrotherapy Stimulator-A (TESA).[Please refer to a separate policy on Cranial Electrotherapy Stimulation and Auricular Electrostimulation (Policy #136 under the Treatment Section).]
• Electroceutical Neuron Blockade - also known as non-invasive neuron blockade and bioelectric nerve block, uses much higher electrical frequencies than TENS This is claimed to result in blockade of axonal transmissions and thus, significant relief of pain.
• Auriculotherapy Stimulation - it is claimed that reflex points on the external ear have the capability to alter neuromuscular and neuropathic disorders associated with descending pain inhibitory pathways of the central nervous system. Electrical stimulation of these specific points is thought to produce site specific neural responses in different regions of the brain resulting in analgesia. An example includes the Kim-Stim device.
• Non-Thermal Pulsed High Frequency Electromagnetic Energy - claimed to be effective in reducing post-operative edema and pain, and also in accelerating wound healing. Diapulse is an example.
• Pulsed Electrical Stimulation (PES) – this form of electrotherapy is claimed to improve symptoms of osteoarthritis of the knee by stimulating cartilage growth and repair, and/or reducing pain impulses traveling to the brain. The BioniCare Bio-1000 system by BioniCare Medical Technologies, Inc. is an example of a device under this category.
• Peripheral Subcutaneous Field Stimulation (PSFS, also called peripheral nerve field stimulation or target field stimulation) - it is intended to treat chronic neuropathic pain. Leads are placed subcutaneously within the area of maximal pain. Permanent implantation is preceded by a percutaneous stimulation trial. The mechanism of action of PSFS is not known. Theories include an increase in endogenous endorphins and other opiated-like substances, modulation of smaller A-delta and C fibers with stimulation of large-diameter A-beta fibers, local stimulation of nerve endings in the skin, local anti-inflammatory and membrane depolarizing effect, or a central action via antegrade activation of A-beta nerve fibers.

• Neuromuscular Electrical Stimulation (Policy #014 in the DME Section)
• Electrical Stimulation for Wound Healing (Policy #069 in the Treatment Section)
• Interferential Stimulation (Policy # 044 in the DME Section)
• Cranial Electrotherapy Stimulation and Auricular Electrostimulation (Policy #136 in the Treatment Section)

A. Noninvasive electrical stimulation using a TENS, H-wave stimulation, microcurrent therapy, or high voltage pulsed galvanic therapy device (except those devices which are classified under policy statement #3 below) is considered medically necessary in the management of intractable or persistent musculoskeletal or neuropathic pain.

When medical necessity has been established for continued therapy (i.e., documented reduction in pain and increase in functional activity) with any of the above noninvasive electrical stimulation modalities beyond one (1) month, a device for self-administration in the home should be utilized. Please refer to policy statement #4 for further guidelines.
[Please refer to a separate medical policy in the DME Section on Neuromuscular Electrical Stimulation (NMES) - policy #014.]

B. The use of TENS is considered investigational for the:
• prevention of migraine headaches or for the treatment of headaches
• management of acute postoperative pain - as an adjunct to drugs or as an alternative to drug therapy.

• Sympathetic Therapy (e.g., Dynatron)
• Percutaneous Neuromodulation Therapy (PNT) (Vertis PNT Unit)
• Cranial Electrotherapy Stimulation (CES), Transcranial Electrical Stimulation, Cranial Transcutaneous Electrical Nerve Stimulation, Neuroelectric Therapy (e.g., Alpha-Stim CS, Liss Cranial Stimulator, HealthPax HP-1, TESA).
  [Please refer to a separate policy on Cranial Electrotherapy Stimulation and Auricular Electrostimulation (Policy #136 under the Treatment Section).]
• Electroceutical Neuron Blockade, Non-Invasine Neuron Blockade, Bioelectric Nerve Block.
• Auriculotherapy Stimulation (e.g., Kim-Stim)
• Intramuscular Stimulation (IMS)
• Pulsed Electrical Stimulation (PES) (e.g., BioniCare Bio-1000 system)
• Sequential Stimulation (e.g., RS-4i, RS-4M, RS-2s sequential stimulators)
• Peripheral Subcutaneous Field Stimulation (PSFS, also called peripheral nerve field stimulation or target field stimulation)
• Low Frequency Ultrasonic Diathermy (e.g., PainShield)

• it must be prescribed by the treating physician;
• the device may be initially rented for a 2-month trial period;
• continued coverage beyond the 2-month trial period requires validation of medical necessity based on documentation of effectiveness by the treating physician.

A. The garment is FDA approved.
B. It is ordered by the treating physician for the delivery of medically necessary noninvasive electrotherapy to treat pain. [For garments used in conjunction with functional neuromuscular stimulation to provide ambulation, please refer to a separate policy on Neuromuscular Stimulation (policy #014 under the DME Section of this database).]
C. At least one of the following medical indications exist:
1. The area to be stimulated is so large or the required frequency so great that the conventional electrodes, wires and tape are not feasible.
2. The sites to be treated are otherwise inaccessible.
3. The member has a documented skin problem that precludes the use of the usual materials.
4. The member requires stimulation beneath a cast.

A, The noninvasive electrotherapy device is considered medically necessary for use at home by the member.
B. The treating healthcare provider has submitted a new order including the reason for replacement of the device, and a statement of medical necessity for continued use of the device.
C. The device is malfunctioning, non-repairable, and out-of-warranty.
D. Cost to repair the device exceeds cost of a replacement device.

Replacement or repair of a device that has been misused or abused by the member or member's caregiver, or that was sold/discarded/loaned to other parties is not considered medically necessary. Furthermore, replacement for the purpose of upgrading to a device with advanced technology or to a next-generation device is also not considered medically necessary.

Replacement of a lost/stolen device will be reviewed on a case-by-case basis.

For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP Coverage:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE:

Headache
A 2004 Cochrane review assessed noninvasive physical treatments for chronic/recurrent headache. Twenty-two studies with a total of 2628 patients (age range, 12-78 years) met inclusion criteria. Reviewers included 5 types of headache and various noninvasive treatments including spinal manipulation, electromagnetic fields, and a combination of TENS and electrical neurotransmitter modulation. Combination TENS and electrical neurotransmitter modulation had weak evidence of effectiveness for migraine headache. Both combination treatment and TENS alone had weak evidence of effectiveness for the prophylactic treatment of chronic tension-type headache. Reviewers concluded that, although these treatments appear to be associated with little risk of serious adverse events, clinical effectiveness and cost-effectiveness of noninvasive physical treatments could require further research using scientifically rigorous methods.

The Cefaly device is a TENS headband device intended for the prophylactic treatment of migraine in patients 18 years of age or older. Clinical information on Cefaly was supplied by 2 studies: the Prevention of Migraine using the STS Cefaly (PREMICE) trial (2013); and a European postmarketing surveillance study (2013). PREMICE was a double-blind, sham-controlled randomized trial conducted at 5 tertiary care headache clinics in Belgium. Sixty-seven patients were randomized to active (n=34) or sham (n=33) neurostimulation for 3 months, and 59 (88%) completed the trial on protocol. No serious adverse events occurred, although 1 patient discontinued the trial because of a reported device-caused headache. After a 1-month run-in period, patients were instructed to use the device daily for 3 months. Adherence was recorded by the TENS device. Ninety stimulation sessions were expected, but on average, 56 sessions were completed by the active group, and 49 were completed by the sham group. Primary outcome measures were changes in the number of migraine days and the percent of responders.

The authors presented both intention-to-treat and per-protocol analyses, but we only discuss the intention-to-treat. The reduction in the number of migraine days (run-in vs 3-month) was 2.06 (95% CI, -0.54 to -3.58) for the TENS group and 0.32 (-0.63 to +1.27) for the sham group; this difference was not statistically significant (p=0.054). The proportion of responders (≥50% reduction in the number of migraine days/month) was 38% (95% CI, 22% to 55%) in the TENS group and 12% (95% CI, 1% to 23%) in the sham group (p=0.014). The number of migraine attacks from the run-in period to the 3-month evaluation was significantly lower for the active TENS group (decrease of 0.82 in the TENS group vs 0.15 in the sham group, p=0.044). Moreover, the number of headache days was lower in the TENS group than in the sham group (decrease of 2.5 vs 0.2, p=0.041). Patients in the active TENS group reported a 36.6% reduction in the number of acute antimigraine drugs taken compared with a 0.5% reduction in the sham group (p=0.008). Severity of migraine days did not differ significantly between groups.

Participants rated their satisfaction with treatment more highly in the active group (70.6%) than in the sham group (39%). During postmarketing surveillance, 53% (1226/2313) of participants were satisfied with the device and willing to continue using it. Ninety-nine (4%) participants reported a complaint with the device, but none was a serious adverse event. The most commonly reported adverse events included: insomnia in 4 (0.2%) participants, reversible forehead skin irritation in 5 (0.2%) participants, headache after a TENS session in 12 (0.5%) participants, sleepiness during a Cefaly session (0.5%), and a dislike of how the device felt, leading to discontinuation in 29 (1.3%) participants.

Surgical Pain
A large RCT on postsurgical TENS was published by Rakel et al in 2014. This double-blind study compared TENS once or twice daily for 6 weeks with sham TENS and with standard care to reduce pain during rehabilitation in 317 patients who had undergone total knee arthroplasty. The primary outcome was pain intensity during range of motion and during walking (as measured by a 21-point numeric rating scale on postoperative day 1 and week 6). Secondary outcomes were pain intensity at rest, hyperalgesia, and function. Intention-to-treat analysis showed that patients who used TENS during exercises had less pain compared with standard care in the near postoperative period, but there was no significant difference in subjective pain compared with patients who used sham TENS. There was also no significant difference between the active and control groups when tested at 6 weeks. This trial, which found no benefit of TENS over placebo or sham, had good methodologic quality and a low risk of bias.

In 2017, Ramanathan et al published a prospective RCT of 66 patients having undergone total knee arthroplasty who were assigned to active or placebo TENS; patients used the device as needed for 2 hours with 30 minutes of rest afterward and had follow-up visits 2, 4, and 6 weeks after surgery. For the primary outcome, reduction of opioid intake, no significant difference was observed between active and placebo TENS groups (p=0.60); this was also the case for secondary outcomes, which included assessment of pain, function, and clinical outcomes. The trial was limited by a high withdrawal rate (of 116 patients enrolled, only 66 completed) and a lack of uniformity in the device settings chosen by patients. The authors found no significant benefit of TENS treatment following total knee arthroplasty.

Smaller studies with higher risk of bias have tended to support the use of TENS. In a 2008 double-blind RCT of 40 patients undergoing inguinal herniorrhaphy, two 30-minute sessions of TENS at 2 and 4 hours after surgery (vs sham) reduced both analgesic use and pain scores when measured up to 24 hours postsurgery. A 2014 patient-blinded study post abdominal surgery (N=55) found that application of TENS for 1 h/d resulted in a significant reduction in pain, particularly at rest, measured both during and immediately after treatment compared with sham TENS. Pulmonary function (vital capacity, cough peak flow) was also significantly better in the active TENS arm. Another assessor-blinded study (2015) of TENS in 74 living kidney donors found a modest reduction in pain at rest and during the measurement of pulmonary function 1 day postoperatively. A 2012 single-blinded randomized trial with 42 patients assessed the analgesic effect of TENS after laparoscopic cholecystectomy. Pain improved by a median of 2.4 points of 10 after TENS compared with 0.4 points after placebo treatment. The relative risk of nausea and/or emesis was 2.2 times greater for patients in the placebo group.

It is unclear whether the differences in findings between the Rakel RCT and the smaller RCTs were due to increased risk of bias in small studies, or to the differences in time since surgery or type of surgery. One could conclude with relative certainty that TENS has no greater effect than placebo on pain measured at least 1 day following total knee arthroplasty. Additional study is needed to determine the effect of TENS in the immediate postoperative period after other types of surgery.]

________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Electrotherapies in Pain Management
Apha-Stim CS
Auriculotherapy Stimulation
Bio-1000 System
Bioelectric Nerve Block
BioniCare Bio-1000 System
Cranial Electrotherapy Stimulation
Cranial Electrostimulation Therapy
CES (Cranial Electrotherapy Stimulation)
Dynatron STS
Electroceutical Neuron Blockade
H-Wave Electrical Stimulation
H Wave Electrical Stimulation
HealthPax HP-1
High Voltage Pulsed Galvanic Therapy
IMS (Intramuscular Stimulation)
Intramuscular Stimulation
Kim-Stim Device
Liss Cranial Stimulator
Low Frequency Ultrasonic Diathermy (e.g., PainShield)
Microcurrent Therapy
Non-Thermal Pulsed High Frequency Electromagnetic Energy
Pain Management, Electrotherapies in
PainShield (Low Frequency Ultrasonic Diathermy)
PENS
Percutaneous Electrical Nerve Stimulation
Percutaneous Neuromodulation Therapy
PES (Pulsed Electrical Stimulation)
PNT (Percutaneous Neuromodulation Therapy)
Pulsed Galvanic Therapy, High Voltage
Pulsed Electrical Stimulation
Stimulation, Electrical in Pain Management
Sympathetic Therapy
TENS
Transcranial Electrotherapy Stimulator-A
Transcutaneous Electrical Nerve Stimulation
Vertis PNT
Peripheral Subcutaneous Field Stimulation
Peripheral Nerve Field Stimulation
Target Field Stimulation

References:
1. Centers for Medicare and Medicaid. National Coverage Determination for Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Post-Operative Pain (10.2) 1995; http://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=10.2&bc=gAAAAAAAAAAA&. Accessed February 10, 2015.

2. Centers for Medicare and Medicaid. National Coverage Determination for Transcutaneous Electrical Nerve Stimulators (TENS) (280.13). 1995; http://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=280.13&bc=gAAAAAAAAAAA&. Accessed February 10, 2015.

3. Centers for Medicare and Medicaid. Decision Memo for Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain (CAG-00429N) 2012; http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=256. Accessed February 10, 2015.

4. ECRI. Health Technology Assessment Information Service (HTAIS) Hotline Report. Transcutaneous Electrical Nerve Stimulation (TENS) for Back Pain. Updated 11/30/2005.

5. ECRI. Windows on Medical Technology. Interferential Current Therapy for Low-Back Pain. Issue No. 100. September 2003.

6. ECRI. Health Technology Assessment Information Service (HTAIS) Hotline Report. Microcurrent Electrical Nerve Stimulation (MENS) for Pain Management. Updated 08/19/03.

7. Smith RB. Microcurrent therapies: emerging theories of physiological information processing. NeuroRehabilitation 2002;17(1):3-7.

8. Seroussi R. Effectiveness of Percutaneous Neuromodulation Therapy on Patients with Chronic and Severe Low Back Pain. Presented at the Association of Academic Physiatrists, Annual Educational Conference. Las Vegas, Nevada. March 1, 2002.

9. Borg-Stein Joanne, Seroussi R, Fowler B, et al. Percutaneous Neuromodulation Therapy for Low Back Pain Patients with Subacute Radiating Pain. . Presented at the Association of Academic Physiatrists, Annual Educational Conference. Las Vegas, Nevada. March 1, 2002.

10. Condon JF, Revord J, Schmitt S, et al. A multicenter Trial of Percutaneous Neuromodulation Therapy for Low Back Pain Patients with a Subacute Duration of Lowere Extremity Pain. . Presented at the Association of Academic Physiatrists, Annual Educational Conference. Las Vegas, Nevada. March 1, 2002.

11. Ghoname EA, Craig WF, White PF, et al. Percutaneous Electrical Nerve Stimulation for Low Back Pain. JAMA 1999 Mar;281:818-823.

12. ECRI. Health Technology Assessment Information Service (HTAIS) Hotline Report. Percutaneous Neuromodulation Therapy (PNT) for Back Pain. Updated 06/18/03.

13. White PF, Ghoname EA, Ahmed HE, et al. The effect of montage on the analgesic response to percutaneous neuromodulation therapy. Anesth Analg 2001 Feb;92(2):483-7.

14. White PF, Craig WF, Vakharia AS, et al. Percutaneous neuromodulation therapy: does the location of electrical stimulation effect the acute analgesic response? Anesth Analg 2000 Oct;91(4):949-54.

15. Shah RV, Ericksen JJ, Lacerte M. Interventions in Chronic Pain Management. 2. New Frontiers: Invasive Nonsurgical Interventions. Arch Phys Med Rehabil 2003 Mar;84 Suppl 1:S39-44.

16. ECRI. Health Technology Assessment Information Service (HTAIS) Hotline Report. Cranial Electrotherapy Stimulation (CES) for Anxiety, Depression, and Insomnia. Updated 02/05/03.

17. Gabis L, Shklar B, Geva D. Immediate influence of transcranial electrostimulation on pain and beta-endorphin blood levels: an active placebo-controlled study. Am J Phys Med Rehabil 2003 Feb;82(2):81-5.

18. Smith RB. Cranial electrotherapy stimulation in the treatment of stress related cognitive dysfunction, with an eighteen month follow up. Journal of Cognitive Rehabilitation 1999;17(6):14-18.

19. Oleson T. Auriculotherapy stimulation for neuro-rehabilitation. NeuroRehabilitation 2002;17(1):49-62.

20. Chu J. Dry Needling (Intramuscular Stimulation) in Myofascial Pain Related to Lumbosacral Radiculopathy. Eur J Phys Med Rehabil 1995;5(4):106-121.

21. Gunn CC, Milbrandt WE, Little AS, et al. Dry Needling of Muscle Motor Points for Chronic Low-Back Pain. Spine 1980;5(3):279-291.

22. Lewit K. The needle effect in the relief of myofascial pain. Pain 1979;6:83-90.

23. Bertoti DB. Electrical Stimulation: A Reflection on Current Clinical Practices. Asst Technol 2000;12:21-32.

24. ECRI. Health Technology Assessment Information Service (HTAIS) Hotline Report. Electric Stimulation Using the Micro-Z Stimulator with Electro-Mesh Garments for Treatment of Diabetic Neuropathy, Ulcers and Pain. Updated 7/9/02.

25. ECRI. Health Technology Assessment Information Service (HTAIS) Hotline Report. Pulsed Electrical Stimulation (PES) for Osteoarthritis of the Knee. Updated 08/25/2005.

26. ECRI Institute. Health Technology Assessment Information Service (HTAIS). Custom Hotline Report: H-wave Stimulation Therapy for Increased Circulation and Pain Management. Updated 02/27/2007.

27. Mironer YE, Hutcheson JK, Satterthwaite JR et al. Prospective, two-part study of the interaction between spinal cord stimulation and peripheral nerve field stimulation in patients with low back pain: development of a new spinal-peripheral neurostimulation method. Neuromodulation 2011; 14(2):151-4; discussion 55.

28. Sator-Katzenschlager S, Fiala K, Kress HG et al. Subcutaneous target stimulation (STS) in chronic noncancer pain: a nationwide retrospective study. Pain Pract 2010; 10(4):279-86.

29. Verrills P, Vivian D, Mitchell B et al. Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. Pain Med 2011; 12(9):1395-405.

30. Keskin EA, Onur O, Keskin HL, et al. Transcutaneous electrical nerve stimulation improves low back pain during pregnancy. Gynecol Obstet Invest 2012; 74(1):76-83.

31. Hurlow A, Bennett MI, Robb KA, et al. Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database Syst Rev 2012; 3:CD006276.

32. Dailey DL, Rakel BA, Vance CG, et al. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperanalgesia while restoring central inhibition in primary fibromyalgia. Pain 2013;154(11):2554-62.

33. Lauretti GR, Chubaci EF, Mattos AL. Efficacy of the use of two simultaneously TENS devices for fibromyalgia pain. Rheumatol Int 2013;33(8):2117-22.

34. Schneider MP, Tellenbach M, Mordasini L, et al. Refractory chronic pelvic pain syndrome in men: can transcutaneous electrical nerve stimulation help? BJU int 2013;112(2):E159-63.

35. Vance CG, Rakel BA, Blodgett NP, et al. Effects of transcutaneous electrical nerve stimulation on pain, pain sensitivity, and function in people with knee osteoarthritis: a randomized controlled trial. Phys Ther 2012;92(7):898-910.

36. Chen WL, Hsu WC, Lin Y, et al. Comparison of intra-articular hyaluronic acid injections with transcutaneous electric nerve stimulation for the management of knee osteoarthritis: a randomized controlled trial. Arch Phys Med Rehabil 2013;94(8):1482-9.

37. Palmer S, Domaille M, Cramp F, et al. Transcutaneous electrical nerve stimulation as an adjunct to education and exercise for knee osteoarthritis: a randomized controlled trial. Arthritis Care Res (Hoboken) 2014;66(3):387-94.

38. Schoenen J, Vandersmissen B, Jeangette S, et al. Migraine prevention with a supraorbital transcutaneous stimulator: arandomized controlled trial. Neurology 2013;80(8):697-704.

39. Magis D, Sava S, d'Elia TS, et al. Safety and patient's satisfaction of transcutaneous supraorbital neurstimulation (tSNS) with the Cefaly(R) device in headache treatment: a survey of 2,313 headache sufferers in the general population. J Headache Pain 2013;14:95.

40. Oosterhof J, Wilder-Smith OH, de Boo T, et al. The long-term outcome of transcutaneous electrical nerve stimulation in the treatment of patients with chronic pain: a randomized, placebo-controlled trial. Pain Pract 2012;12(7):513-22.

41. Bjersa K, Andersson T. High frequency TENS as a complement for pain relief in postoperative transition from epidural to general anesthesia after pancreatic resection. Complement Ther Clin Prac 2014;20(1):5-10.

42. Kayman-Kose S, Arioz DT, Tklas H, et al. Transcutaneous electrical nerve stimulation (TENS) for pain control after vaginal delivery and cesarean section. J Matern Fetal Neonatal Med 2014.

43. Simpson PM, Fouche PF, Thomas RE, et al. transcutaneous electrical nerve stimulation for relieving acute pain in the prehospital setting: a systematic review and meta-analysis of randomized-controlled trials. Eur J Emerg Med 2014;21(1):10-7.

44. Martelleti P, Jensen RH, Antal A, et al. Neuromodulation of chronic headaches: position statement from the European Headache Federation. J Headache Pain 2013;14(1):86.

45. McAlindon TE, Bannuru RR, Sullivan MC, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage 2014;22(3):363-88.

46. Raphael JH, Raheem TA, Southall JL, et al. Randomized double-blind sham-controlled crossover study of short-term effect of percutaneous electrical nerve stimulation in neuropathic pain. Pain Med 2011;12(10):1515-22.

47. Wanich T, Gelber J, Rodeo S, et al. Percutaneous neuromodulation pain therapy following knee replacement. J Knee Surg 2011;24(3):197-202.

48. Bril V, England J, FRansklin GM, et al. Evidence-based guideline: Treatment of painful diabetic neuropathy: a report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology 2011;76(20):1758-65.

49. Lara-Palomo IC, Aguilar-Fernandez ME, Mataran-Penarrocha GA, et al. Short-term effects of interferential current electromassage in adults with chronic non-specific low back pain; a randomized controlled trial. Clin Rehabil 2012.

50. Facci LM, Nowotny JP, Tormem F, et al. Effects of trancutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical trial. Sao Paulo Med J 2011;129(4):206-16.

51. Atamaz FC, Durmaz B, Baydar M, et al. Comparison of the efficacy of transcutaneous electrical nerve stimulation, interferential currents, and shortwave diathermy in knee osteoarthritis: a double-blind, randomized, controlled, multicenter study. Arch Phys Med Rehabil 2012;93(5):748-56.

52. Gundog M, Atamaz F, Kanyilmaz S, et al. Interferential current therapy in patients with knee osteoarthritis. Am J Phys Med Rehabil 2011, Epub before print.

53. McRoberts WP, Wolkowitz R, Meyer DJ, et al. Peripheral nerve field stimulation for the management of localized chronic intractable back pain: results from a randomized controlled study. Neuromodulation 2013;16(6):565-75.

54. Kloimstein H, Likar R, Kern M, et al. Peripheral Nerve Field Stimulation (PNFS) in Chronic Low Back Pain: A prospective Multicenter Study. Neuromodulation 2013.

55. Verrilis P, Rose R, Mitchell B, et al. Peripheral Nerve Field Stimulation for Chronic Headache: 60 Cases and Long-Term Follow-Up. Neuromodulation 2013.

56. Verrilis P, Vivian D, Mitchell B, et al. Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. Pain Med 2011;12(9):1395-405.

57. National Institute for Health and Care Excellence. IPG451 Peripheral nerve-field stimulation for chronic low back pain: guidance. 2013. Available online at: http://www.nice.org.uk/guidance/IPG451/chapter/1-guidance.

58. Blum K, Chen AL, Chen TJ, et al. Healing enhancement of chronic venous stasis ulcers utilizing H-WAVE device therapy: a case series. Cases J 2010;3:54.

59. Blum K, Chen AL, Chen TJ, et al. Repetitive H-wave device stimulation and program induces significant increases in the range of motion of post operative rotator cuff reconstruction in a double-blinded randomized placebo controlled human study. BMC Musculoskelet Disord 2009;10:132.

60. O'Connell NE, Wand BM, Marston L, et al. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev 2010;(9):CD008208.

61. Tan G, Rintala DH, Jensen MP, et al. Efficacy of cranial electrotherapy stimulation for neuropathic pain following spinal cord injury: a multi-site randomized controlled trial with a secondary 6-month open-label phase. J Spinal Cord Med 2011;34(3):285-96.

62. Shill HA, Obradov S, Katsnelson Y, et al. A randomized, double-blind trial of transcranial electrostimulation in early Parkinson's disease. Mov Disord 2011;26(8):1477-80.

63. Holzer A, Leitgeb U, Spacek A, et al. Auricular acupuncture for postoperative pain after gynecological surgery: a randomized controlled trial. Minerva Anestesiol 2011;77(3):298-304.

64. U.S. Food and Drug Administration. De Novo Classification Request for Cefaly Device. 2012. Available online at: http://www.accessdata.fda.gov/cdrh_docs/reviews/K122566.pdf. Last accessed Dec.1, 2014.

65. Bronfort G, Nilsson N, Haas M et al. Non-invasive physical treatments for chronic/recurrent headache. Cochrane Database Syst Rev 2004; (3):CD001878.

66. Schoenen J, Vandersmissen B, Jeangette S et al. Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial. Neurology 2013; 80(8):697-704.

67. Magis D, Sava S, d'Elia TS et al. Safety and patients' satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly(R) device in headache treatment: a survey of 2,313 headache sufferers in the general population. J Headache Pain 2013; 14:95.

68 DeSantana JM, Walsh DM, Vance C et al. Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain. Curr Rheumatol Rep 2008; 10(6):492-9.

69. Silva MB, de Melo PR, de Oliveira NM et al. Analgesic effect of transcutaneous electrical nerve stimulation after laparoscopic cholecystectomy. Am J Phys Med Rehabil 2012; 91(8):652-7.

70. National Institute for Health and Care Excellence (NICE). IPG 450. Percutaneous electrical nerve stimulation for refractory neuropathic pain. 2013; http://www.nice.org.uk/guidance/ipg450. Accessed April, 2015.

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Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

64550
64999
0278T
0282T
0283T
0285T

E0720
E0730
E0731
E0745
G0283
K1004