BlueCross BlueShield of Tennessee Medical Policy Manual

Spinal Cord Stimulation / Peripheral Subcutaneous Field Stimulation for the Treatment of Pain

DESCRIPTION

Standard spinal cord stimulation (SCS; also known as dorsal column stimulation) delivers low-frequency electrical stimulation percutaneously into the epidural space of the spinal cord to block the sensation of pain for individuals with chronic pain in the trunk or limbs. The neurophysiology of pain relief after SCS is uncertain. SCS has been proposed for a wide variety of chronic refractory pain conditions, including pain associated with cancer, failed back pain syndromes, arachnoiditis, and complex regional pain syndrome. An additional SCS modality is high-frequency spinal cord stimulation, which uses electrical stimulation at 10-kHz, and is sometimes referred to as HF-10 therapy.

Spinal cord stimulation devices consist of implantable electrodes, a receiver/transducer, and a programmable transmitter that may be worn externally or may be fully implanted. An initial trial period of approximately 5-10 days is usually required, and if considered successful would be followed by implantation of the permanent spinal cord stimulator. Clinical trials typically define ‘success’ as a 45-50% or greater reduction in pain scores at the end of the 5-10 day trial period, even if that reduction was not sustained.

Modifications in the SCS electrode placement have also been proposed to treat a variety of chronic intractable pain syndromes. In one modification known as peripheral subcutaneous field stimulation (PSFS), leads are placed subcutaneously within the area of maximal pain. The targeted area may include the occipital/craniofacial area for treatment of migraines or occipital neuralgia. Other proposed uses include placement to treat low back pain, neck and shoulder pain, fibromyalgia, and post herpetic neuralgia. There are no FDA devices approved for this use, so SCS devices used in this way would be considered ‘off-label’.

Dorsal root ganglion stimulation involves placing a miniaturized neurostimulator at the individual nerve root, where the dorsal root ganglion is located. Some of these devices are wireless and can be injected rather than surgically placed. They have been proposed for the treatment of pain in the trunk or limbs.

POLICY

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MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Prospective controlled trials comparing peripheral subcutaneous field stimulation with placebo or alternative treatment modalities are needed to determine the efficacy of this treatment for chronic pain. Currently the evidence is insufficient to determine the effects of the technology on health outcomes.

Randomized controlled studies that are blinded and with a sham-control as well as a spinal cord stimulator control group are needed to demonstrate the safety and/or effectiveness of dorsal root ganglion neurostimulators.

SOURCES

Al-Kaisy, A., Van Buyten, J. P., Smet, I., Palmisani, S., Pang, D., & Smith, T. (2013). Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study. Pain Medicine, 2013. (Level 3 evidence - Industry supported)

American Academy of Pain Medicine (2008, June) Position statement on spinal cord neurostimulation. Retrieved June 13, 2017 from http://www.painmed.org/research/position-statements.

American Society of Interventional Pain Physicians. (2013). An update of comprehensive evidence-based guidelines for interventional techniques of chronic spinal pain. Part II: guidance and recommendations. Retrieved May 12, 2016 from www.painphysicianjournal.com.

Bicket, M., Dunn, R., and Ahmed, S. (2016, December) High-frequency spinal cord stimulation for chronic pain: pre-clinical overview and systematic review of controlled trials. Pain Medicine. 2016 Dec;17(12):2326-2336. (Level 2 evidence)

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2016). Spinal cord stimulation (7.01.25). Retrieved May 6, 2016 from BlueWeb. (44 articles and/ or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2016). Peripheral subcutaneous field stimulation (7.01.139). Retrieved April 24, 2017 from BlueWeb. (7 articles and/ or guidelines reviewed)

Cahaba Government Benefit Administrators®, LLC (2017, March) Local Coverage Determination (LCD): Surgery: Spinal Cord Stimulators for Chronic Pain (L36879). Retrieved June 26, 2017 from https://www.cms.gov.

Deer, T., Levy, R., Kramer, J., Poree, L., Amirdelfan, K., Grigsby, E., et. al. ( 2017, April) Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial (the ACCURATE Study). Pain Journal. Vol. 159, No 4; 669-681. (Level 2 evidence – Industry sponsored)

European Academy of Neurology (2016) EAN guidelines on central neurostimulation therapy in chronic pain conditions. European Journal of Neurology. 2016, 23: 1489-1499.

Fricke, E., Eckert, S., Dongas, A., Fricke, H., Preuss, R., Lindner, O., et al. (2009). Myocardial perfusion after one year of spinal cord stimulation in patients with refractory angina. Nuclear Medicine, 48 (3), 104 - 109. (Level 4 evidence)

Grider, J., Manchikanti, L., Carayannopoulos, A., Sharma, M. L., Balog, C. C., Harned, M. E., et al. (2016). Effectiveness of spinal cord stimulation in chronic spinal pain: a systematic review. Pain Physician, 19, E33-E54. (Level 2 evidence)

Kapural, L. Yu, C., Doust, M. W., Gliner, B. E., Vallejo, R., Sitzman, B. T., et al. (2015, October). Novel 10-kHz high-frequency therapy (HF10 Therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: the SENZA-RCT randomized controlled trial. Anesthesiology, 123 (4), 851-860. (Level 1 evidence - Industry sponsored)

Kapural, L. Yu, C., Doust, M. W., Gliner, B. E., Vallejo, R., Sitzman, B. T., et al. (2016, November) Comparison of 10-kHz high-frequency and traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: 24-month results from a multicenter, randomized, controlled pivotal trial. Neurosurgery Vol. 79, No. 5, 667-678. (Level 1 evidence - Industry sponsored)

Kinfe, T. M., Pintea, B., Link, C., Roeske, S., Guresir, E., Guresir, A. et al. (2016). High frequency (10 kHz) or burst spinal cord stimulation in failed back surgery syndrome patients with predominant back pain: preliminary data from a prospective observational study. Neuromodulation, 19 (3), 268-275. Abstract retrieved May 13, 2016 from PubMed database.

Lihua, P., Su, M., Zejun, Z., Ke, W., & Bennett, M. I. (2013). Spinal cord stimulation for cancer-related pain in adults Retrieved April 8, 2014 from http://www.thecochranelibrary.com

National Institute for Health and Care Excellence. (2011, November). Technology appraisal guidance: Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin. Retrieved September 6, 2011 from http://www.nice.org.uk. 

National Institute for Health and Care Excellence. (2013, March). Interventional procedural guidance: Peripheral nerve-field stimulation for chronic low back pain. Retrieved April 30, 2013 http://www.nice.org.uk.

Perruchoud, C., Eldabe, S., Batterham, A., Madzinga, G., Brookes, M., Durrer, A., et. Al (2016, July-August) Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study. Neuromodulation. Jul-Aug;16(4):363-9. Abstract retrieved April 24, 2017 from PubMed database.

Russo, M., Verrills, P., Mitchell, B., Salmon, J., Barnard, A., Santarelli, D. (2016, May-June) High frequency spinal cord stimulation at 10 kHz for the treatment of chronic pain: 6-month australian clinical experience. Pain Physician: May/June 2016: 19:267-280. (Level 4 evidence)

Stidd, D., Wuollet, A., Bowden, K., Price, T., Patwardhan, A., Barker, S., et al. (2012). Peripheral nerve stimulation for trigeminal neuropathic pain. Pain Physician Journal. (15), 22-33. (Level 4 evidence - Industry supported)

Taylor, R., DeVries, J., Buchser, E., & Dejongst, M. (2009). Spinal cord stimulation in the treatment of refractory angina: systematic review and meta-analysis of randomized controlled trials. BMC Cardiovascular Disorders, 9 (13). (Level 1 evidence)

U. S. Food and Drug Administration. Center for Devices and Radiological Health. (2015, May). Premarket Notification Database. P130022 (Nevro Senza™ Spinal Cord Stimulation System) Retrieved May 16, 2016 from http://www.accessdata.fda.gov.  

U. S. Food and Drug Administration. Center for Devices and Radiological Health. (2004, April). Premarket Notification Database. P030014 (Precision™ Spinal Cord Stimulation System). Retrieved October 9, 2009, from http://www.accessdata.fda.gov.

Van Buyten, J. Al-Kaisy, A., Smet, I., Palmisani, S., and Smith, T. (2013, January-February) High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter european clinical study. Neuromodulation. 2013 Jan-Feb; 16(1):59-65. Abstract retrieved April 24, 2017 from PubMed. database.

Viswanathan, A., Phan, P, & Burton, A. (2010) Use of spinal cord stimulation in the treatment of phantom limb pain: a case series and review of literature. Pain Practice, 10 (5), 479-484. (Level 3 evidence - Independent)

Wille, F., Breel, J., Bakker, E., and Hollmann, M. (2017, January) Altering conventional to high density spinal cord stimulation: an energy dose-response relationship in neuropathic pain therapy. Neuromodulation. Jan;20(1):71-80. Abstract retrieved April 24, 2017 from PubMed database.

Winifred S. Hayes, Inc. Medical Technology Directory. (2015, October; last search update September 2016). Spinal cord stimulation for relief of neuropathic pain. Retrieved April 25, 2017 from www.Hayesinc.com/subscribers. (84 articles and/or guidelines reviewed)

Yakovlev, A., Resch, B., & Karesev, S. (2010). Treatment of intractable hip pain after THA and GTB using peripheral nerve field stimulation: A case series. Wisconsin Medical Journal, 100 (3), 149-152. (Level 4 evidence - Independent)

ORIGINAL EFFECTIVE DATE:  3/1980

MOST RECENT REVIEW DATE:  8/23/2017   

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