BlueCross BlueShield of Tennessee Medical Policy Manual

Spinal Cord 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 neuropathic pain in the trunk or limbs. 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.

Dorsal root ganglion (DRG) are located between spinal nerves and the spinal cord on the posterior root and play an important role in neuropathic pain perception. Two examples of systems targeting the dorsal root ganglion have received approval or clearance from FDA. The Freedom® Spinal Cord Stimulator is a wireless injectable stimulator for treating chronic, intractable pain of the trunk and/or lower limbs. The device can be placed to target the spinal cord or dorsal root ganglion. The Axium® is an implanted system that delivers electrical stimulation to the dorsal root ganglion.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

For individuals with treatment-refractory chronic pain of the trunk and limbs who have received spinal cord stimulation (SCS), high-frequency SCS or dorsal root ganglion (DRG) stimulation the evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

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)

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 Association of Neurological Surgeons. (2018). Spinal cord stimulation. Retrieved May 21, 2018 from www.aans.org.

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.

BlueCross BlueShield Association. Evidence Positioning System. (5:2019). Spinal cord and dorsal root ganglion stimulation (7.01.25). Retrieved May 10, 2019 from https://www.evidencepositioningsystem.com/. (66 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for electrical nerve stimulators (160.7). Retrieved April 15, 2019 from http://www.cms.gov.

Deer, T.R., Levy, R.M., Kramer, J., Poree, L., Amirdelfan, K., Grigsby, E., et al. (2017). 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. Pain, 158 (4), 669-681. (Level 2 evidence)

ECRI Institute. Emerging Technology Evidence Report. (2017, November). Dorsal root ganglion neurostimulation for treating complex regional pain syndrome types I and II. Retrieved May 17, 2018 from ECRI Institute. (155 articles/guidelines reviewed)

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

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). 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)

Kapural, L. Yu, C., Doust, M. W., Gliner, B. E., Vallejo, R., Sitzman, B. T., et al. (2016). 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, 79 (5), 667-678. (Level 1 evidence)

Kapural, L., Peterson, E., Provenzano, D.A., & Staats, P. (2017). Clinical evidence for spinal cord stimulation for failed back surgery syndrome (FBSS): systematic review. Spine, 42 (Suppl 14), S61-S66. Abstract retrieved May 17, 2018 from PubMed database.

National Institute for Health and Care Excellence. (2008, October; last updated February 2014). Technology appraisal guidance: Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin. Retrieved May 17, 2018 from http://www.nice.org.uk. 

National Institute of Health. (2018, November). Brain and spinal stimulation therapies for phantom limb pain: a systematic review. Health Technology Assessment, No. 22.62. Retrieved April 16, 2019 from PubMed database.

Perruchoud, C., Eldabe, S., Batterham, A., Madzinga, G., Brookes, M., Durrer, A., et al. (2016). Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study. Neuromodulation, 16 (4), 363-369. Abstract retrieved April 24, 2017 from PubMed database.

The Neuromodulation Appropriateness Consensus Committee. International Neuromodulation Society. (2018, September). The neuromodulation appropriateness consensus committee on best practices for dorsal root ganglion stimulation. Retrieved April 16, 2019 from PubMed database.

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.

Visnjevac, O., Costandi, S., Patel, B.A., Azer, G., Agarwal, P., Bolash, R., & Mekhail, N.A. (2017). A comprehensive outcome-specific review of the use of spinal cord stimulation for complex regional pain syndrome. Pain Practice, 17 (4), 533-545. Abstract retrieved May 17, 2018 from PubMed database.

Vuka, I., Marcius, T., Dosenovic, S., Hamzic, L.F., Vucic, K., Sapunar, D., et al. (2019). Neuromodulation with electrical field stimulation of dorsal root ganglion in various pain syndromes: a systematic review with the focus on participant selection. Journal of Pain Research, 12, 803-830. (Level 3 evidence)

Winifred S. Hayes, Inc. Health Technology Brief. (2017, December; last search update November 2018). Dorsal root ganglion stimulation for the treatment of complex regional pain syndrome. Retrieved April 15, 2019 from www.Hayesinc.com/subscribers (43 articles and/or guidelines reviewed)

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)

ORIGINAL EFFECTIVE DATE:  3/1980

MOST RECENT REVIEW DATE:  11/30/2019

ID_BT

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