About the therapy Spinal cord stimulation

An intervention for chronic back and/or leg pain

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 experience pain relief.

Spinal cord stimulation may be:

  • An effective alternative when conventional therapies and systemic pain medications provide inadequate pain relief or intolerable side effects
  • More cost-effective than conventional medical management (CMM) in the long term1,2, and is generally covered by payers nationwide3

Potential benefits

Published studies have shown that when used by patients with appropriate indications, spinal cord stimulation may offer the following benefits:

  • Long-term pain relief2,4,5
  • Improved quality of life4,5
  • More effective than repeat surgery for persistent radicular pain after lumbosacral spine surgery6
  • Reduction in pain related disability4
  • More cost-effective than CMM and reoperation1,2,7
  • Multiple studies have shown some patients treated with spinal cord stimulation may be able to reduce oral opioid use8-10 

Potential risks

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 advantages

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.

  • Consistent therapy experience– Inceptiv™ closed-loop technology senses† and responds, automatically adjusting stimulation moment-to-moment based on neural response to maintain consistent therapy during all patient activities
  • Superior back pain relief — with proven, DTM™ SCS waveform11, ‡
  • Unmatched MRI access — Medtronic neurostimulators offer SureScan™ MRI technology enabling safe MRI scans on any part of the body§
  • Unrivaled device performance — Inceptiv™ and Intellis™ rechargeable devices offer 95% capacity at nine years and Vanta™ recharge-free neurostimulator offers ~2x the longevity than competitive PC devices at comparable settings∆
  • Designed for comfort: Inceptiv™ SCS is the smallest and thinnest rechargeable, implantable device

Components of spinal cord stimulation system

A spinal cord stimulation system consists of:

  • Neurostimulator — Rechargeable or non-rechargeable generators produce electrical pulses
  • Lead(s) - One or more thin wires transmit electrical pulses from the neurostimulator to the epidural space. Percutaneous leads feature cylindrical electrodes evenly spaced near the tip of the wire. Surgical leads feature flat electrodes distributed across a paddle
  • Clinician Programmer — Used to program the implanted neurostimulator
  • Patient Programmer — Empowers patients by giving them a way to manage their pain relief — within preset physician parameters — to optimize outcomes
  • Wireless External Neurostimulator — Mimics the therapy delivered by the implantable neurostimulator during procedures and trials
Learn about neurostimulators
SCS family image

† Sensing signals may not be measurable in all cases.
‡ DTM SCS superior outcomes demonstrated using open-loop SCS therapy
§ MR Safety Triangle Under specific conditions. Refer to product labeling for full list of conditions.
∆ Settings used from Proclaim™ clinician manual. Nominal settings 12 hours per day: 50-Hz frequency. 225-μs pulse width, and 5-mA amplitude at 500-ohms impedance. Energy modeling is the same for model 3660 and model 3670. Settings from Boston Scientific's Alpha™ IFU. Programmed at 4.1mA, 280us. 40Hz. 1 area, 730 Ohms, 2 contacts.

1

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. 

2

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.

3

Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7). www.cms.gov. Accessed March, 2017. 

4

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. 

5

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. 

6

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. 

7

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.

8

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]).

9

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)

10

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).

11

Fishman, M, Cordner, H, Justiz, R, Provenzano, D, Merrell, C, Shah, B, et al. Twelve-month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain. Pain Pract. 2021; 21: 912–923.