Spinal Cord Stimulation for the Treatment of Pain
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 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.
Spinal cord stimulation is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Dorsal root ganglion stimulation is considered investigational.
Spinal cord stimulation, either standard or high frequency, for the treatment of pain associated with conditions/diseases including, but not limited to, the following is considered investigational:
Plexus lesions caused by trauma or malignancy
Multiple sclerosis and spasticity disorders
Paraplegia and other spinal cord lesions
Nociceptive pain resulting from irritation to the nerves
Acute peripheral nerve injuries or deafferentation pain (related to central nervous system damage from stroke, spinal cord injury, surgery, entrapment, or scars)
Critical limb ischemia to forestall amputation
Any spinal cord stimulator utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Spinal cord stimulation (SCS) is considered medically appropriate if ALL of the following are met:
Indicated for ANY ONE of the following:
A trial treatment with temporarily implanted epidural spinal cord stimulator when ALL of the following are met:
Standard or high frequency spinal cord stimulation
Used for dorsal column stimulation
Neuropathic pain, including but not limited to, failed back surgery syndrome, complex regional pain syndrome (i.e., reflex sympathetic dystrophy), arachnoiditis, radiculopathies, phantom limb/stump pain, peripheral neuropathy.
Chronic intractable pain of the trunk or limbs
Other treatment modalities (e.g., pharmacologic, surgical, physical, or psychologic therapies) have been tried for at least 6 months and failed, or were judged unsuitable, or contraindicated
Revision surgery is not an option or would have low chance of success
No serious, untreated drug habituation exists
Individual has undergone careful screening, evaluation, and diagnosis by a multi-disciplinary team. Psychological evaluation obtained
A permanently implanted epidural spinal cord stimulator when ALL of the following are met:
Demonstration of pain relief for a duration of 5 - 10 days with temporarily implanted electrode
Standard or high frequency spinal cord stimulation
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Published evidence of well-designed randomized controlled trials in peer-reviewed journals is necessary to determine the long-term outcomes of treatment with dorsal root ganglion stimulation.
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. Medical Policy Reference Manual. (4:2018). Spinal cord and dorsal root ganglion stimulation (7.01.25). Retrieved May 15, 2018 from BlueWeb. (66 articles and/ or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for electrical nerve stimulators (160.7). Retrieved May 17, 2018 from 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.
Palmetto Government Benefit Administrators. (2018, February). Local Coverage Determination (LCD): Spinal Cord Stimulators for Chronic Pain (L37632). Retrieved May 15, 2018 from https://www.cms.gov.
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.
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.
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: 11/29/2018
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