About the Therapy Spinal Cord Stimulation
As an intervention for chronic back and/or leg pain, spinal cord stimulation can be an effective alternative or adjunct treatment to other therapies that have failed to manage pain on their own. An implantable spinal cord stimulator delivers small electrical signals through a lead implanted in the epidural space. Pain signals are inhibited before they reach the brain. Instead of pain, patients may feel pain relief.
Spinal cord stimulation may be:
Published studies have shown that when used by carefully selected patients with chronic pain, spinal cord stimulation may offer the following benefits:
The most frequently reported problems following the surgery to implant a neurostimulation system include infection, lead movement, pain at the implant site, loss of therapy effect, and therapy that did not meet the patient's expectations. Refer to Indications, Safety, and Warnings for more details.
Medtronic's steadfast commitment to safety, testing, and reporting has led to the development of some of the industry's most widely used neurostimulation devices.
A spinal cord stimulation system consists of two implanted components:
RestoreSensor© Clinical Study compared AdaptiveStim stimulation to Medtronic conventional stimulation; 88.7% is based on analysis of one of two questions that comprised the primary endpoint of improved convenience and/or better pain relief. Percentage based on respondents who completed the pain relief question.
Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7). www.cms.gov. Accessed March, 2017.
Kumar K, Taylor RS, Jacques L, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63(4):762-770;discussion 770.
North RB, Kidd D, Shipley J, Taylor RS. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial. Neurosurgery. 2007;61(2):361-369.
Harke H, Gretenkort P, Ladleif HU, Rahman S. Spinal cord stimulation in sympathetically maintained complex regional pain syndrome type I with severe disability. A prospective clinical study. Eur J Pain. 2005:9(4);363-373.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-107.
Kemler MA, de Vet HC, Barendse GA, van den Wildenberg FA, van Kleef M. Effect of spinal cord stimulation for chronic complex regional pain syndrome Type I: five-year final follow-up of patients in a randomized controlled trial. J Neurosurg. 2008;108(2):292-298.
Taylor RJ, Taylor, RS. spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess Health Care. 2005;21(3):351-358.
Medtronic advanced pain therapy using neurostimulation for chronic pain. Clinical Summary, 2014. M221494A009.
Schultz D, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012;15(1):1-12.
Gee L, Smith HC, Ghulam-Jelani Z, et al. Spinal Cord Stimulation for the Treatment of Chronic Pain Reduces Opioid Use and Results in Superior Clinical Outcomes When Used Without Opioids. Neurosurgery. 2018. A nonrandomized prospective cohort study of SCS patients between September 2012 and August 2015 (N=86 [n=53 on opioids]).
Sharan AD, Riley J, Falowski S, et al. Association of Opioid Usage with Spinal Cord Stimulation Outcomes. Pain Med. December 2017. A non-randomized analysis of Truven Health Marketscan databases from January 2010 to December 2014 based on the first occurrence of an SCS implant (N= 5,476)
Pollard EM, Lamer TJ, Moeschler SM, et al. The effect of spinal cord stimulation on pain medication reduction in intractable spine and limb pain: a systematic review of randomized controlled trials and metaanalysis. Journal of Pain Research. 2019:12 1311–1324. A research review summarising SCS studies with respect to opioid use and a further metaanalysis of comparative SCS RCTs of 1 year or greater duration (N=489).