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Spinal Cord Stimulation

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • About Spinal Cord Stimulation

    Details

    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:

    • An effective alternative when conventional therapies and systemic pain medications provide inadequate pain relief or intolerable side effects
    • A reasonable alternative to consider before performing irreversible, neurodestructive surgical procedures1
    • A cost-effective intervention2-3 generally covered and paid for by payers nationwide4-5

    Potential Benefits

    Published studies have shown that when used by carefully selected patients with chronic pain, spinal cord stimulation may offer the following benefits:

    • Long-term pain relief6,7
    • Improved quality of life6,7
    • More effective than repeat surgery for persistent radicular pain after lumbosacral spine surgery8
    • Successful pain disability reduction7
    • More cost-effective than conventional medical management and reoperation9

    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 the industry's most widely used neurostimulation devices.

    • Better Pain Relief – 88.7%* of patients reported better pain relief with AdaptiveStim vs. conventional stimulation10,11
    • Access to MRI Scans on Any Part of the Body – Only Medtronic pain neurostimulation systems provide safe access to 1.5 Tesla MRI scans on any part of the body. (Under specific conditions; requires SureScan® implantable neurostimulator and Vectris® leads. Refer to MRI Guidelines for complete list of conditions.)
    • Quality and Safety – Medtronic has more than 30 years of experience innovating, refining, and implementing neurostimulator technologies, and ranks at the very top of the medical device industry for quality, safety, and trust. View product performance data.

    * 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.


    Components of a Spinal Cord Stimulation System

    A spinal cord stimulation system consists of 2 implanted components:

    • Neurostimulator – Rechargeable or non-rechargeable implanted power source that generates electrical pulses according to programmable neurostimulation parameters and features
    • Lead – A set of thin wires with a protective coating and electrodes near the tip (percutaneous lead) or on a paddle (surgical lead). The electrodes transmit the electrical pulses to the stimulation site

    SCS Product Family - RestoreSensor, MyStim, NVision

    Two external components to a spinal cord stimulation system allow the therapy to be customized for each patient:

    • 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

     

    References
    1. Chan CW, Peng P. Failed Back Surgery Syndrome. Pain Medicine. 2011 Apr;12(4):577-606.
    2. Manchikanti, L, Boswell MV, et al. Comprehensive review of therapeutic interventions in managing chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):E123-98.

    Indications

    A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs – including unilateral or bilateral pain associated with the following conditions:

    • Failed Back Syndrome (FBS) or low back syndrome or failed back
    • Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk
    • Postlaminectomy pain
    • Multiple back operations
    • Unsuccessful disk surgery
    • Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions
    • Peripheral causalgia
    • Epidural fibrosis
    • Arachnoiditis or lumbar adhesive arachnoiditis
    • Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia
    References
    1. Chan CW, Peng P. Failed Back Surgery Syndrome. Pain Medicine. 2011 Apr;12(4):577-606.
    2. Manchikanti, L, Boswell MV, et al. Comprehensive review of therapeutic interventions in managing chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):E123-98.

    Diagnosis and Treatment

    If left unattended, pain can stimulate many physiological and emotional reactions that can have detrimental effects on the patient and family. Chronic pain that is not managed may:

    • Be associated with anxiety and depression
    • Lead to economic hardship
    • Increase stress

    Patients are looking for better treatment options to help relieve their chronic pain, and most types of pain can be treated.


    Identifying Appropriate Patients for Medtronic Chronic Pain Therapies

    Medtronic offers two therapies for the relief of chronic pain: spinal cord stimulation and targeted drug delivery.

    Below are examples of chronic pain conditions that can be treated with spinal cord stimulation and/or targeted drug delivery. View a comprehensive list of conditions and supporting references.

    scs-tdd-compare-chart


    SCS Is More Effective When Considered Earlier1

    A retrospective chart review concluded that the success rate of neurostimulation decreases from 85% with a delay of <2 years to approximately 9% with a delay of >15 years.

    scs-effective-early


    Screening Trial

    A screening trial allows patients to assess their response to spinal cord stimulation prior to device implantation. Patients who experience a significant improvement in symptoms from the screening trial may be candidates for the long-term therapy.

    The screening trial:

    • Offers an opportunity to gauge patient response prior to device implantation
    • Is nondestructive
    • Is typically performed over a 3- to 7-day period

    Resources for Diagnosis and Treatment

    Use the resources on this website to take the next step.

     

    References
    1. Chan CW, Peng P. Failed Back Surgery Syndrome. Pain Medicine. 2011 Apr;12(4):577-606.
    2. Manchikanti, L, Boswell MV, et al. Comprehensive review of therapeutic interventions in managing chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):E123-98.
    3. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132:179-188.
    4. 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;63:762-770.
    5. Kumar K, Hunter G, Demaria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year experience. Neurosurgery. 2006;58(3):481-496.

    Adaptive Stimulation

    Medtronic AdaptiveStim® technology delivers better pain relief: 88.7%* of patients reported better pain relief vs. conventional stimulation.1,2

    • Automatically adapts to a patient's changing postural therapy needs
    • Automatically maintains optimal therapy around the clock
    • Automatically collects objective patient activity data to support clinical decisions

    * 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.


    Pain Is Dynamic

    Pain isn't static. It moves and changes as your patients do. Conventional stimulation requires patients to manually adjust their stimulation to avoid discomfort when changing positions. To restore comfort, some patients may manually change the amplitude to address the source of their discomfort — spinal cord movement in relation to the stimulation field. Other patients may simply endure the discomfort or avoid these positions.

    stim-field-th
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    Stimulation Field

    (:23)

    This animation shows how the spinal cord moves in and out of the stimulation field as a patient changes body position.

    For better pain relief, stimulation should automatically adapt to the dynamic nature of pain.


    Spinal Cord Movement Results in Varying Levels of Tissue Activation

    As the patient changes position, the spinal cord moves relative to the electrodes — as much as 3 mm from a supine to a prone position.3 When amplitude is set in today's neurostimulation systems, it generates a constant stimulation field. The cord moves in and out of the field based on body position.

    This causes varying levels of tissue activation, leading to uncomfortable or insufficient stimulation. To accommodate for this, the patient can increase or decrease amplitude to get the right stimulation for the right neural targets associated with the position.

    Varying Amplitude Stimulation4

    Varying AmplitudeC hart

    For consistent activation of the dorsal column (DC), amplitude may change as the spinal cord moves.

    • 71% of patients experience uncomfortable stimulation when changing positions5
    • 75% of patients surveyed said they would be interested or very interested in a solution that would automatically adapt as they continuously move5

    The Solution to Uncomfortable or Inadequate Stimulation Due to Position Change

    AdaptiveStim reduces the need for patients to manually adjust their stimulation parameters when changing positions. AdaptiveStim recognizes and remembers the correlation between a change in body position and the level of stimulation needed. It records and stores the frequency of posture changes, providing feedback to clinicians to help understand how a patient's stimulation requirements change over time.

    Developed by Medtronic, AdaptiveStim is exclusively available with the RestoreSensor® neurostimulator. Medtronic is the first to integrate accelerometer technology into spinal cord stimulation.

    Using three-axis accelerometer technology similar to what is used in smart phones and gaming devices, AdaptiveStim:

    • Listens and senses when the patient changes position
    • Learns from previous experience and remembers the patient's last comfortable setting for upright (standing or sitting), lying down, or upright and active (e.g., jogging)
    • Responds by automatically adjusting stimulation to the patient's chosen setting

    The use of a low-power accelerometer allows for minimal effect on the recharging interval compared to other Medtronic Restore® family neurostimulators. In addition, the accelerometer achieves a highly reliable, repeatable performance standard, so patients can expect a specific response from their device. RestoreSensor records the patient's activity data. This objective data supports and informs clinical decisions.

    An FDA-approved clinical study proved the effectiveness of RestoreSensor and its AdaptiveStim technology. Study results can be found in the Clinical Summary for Advanced Pain Therapy Using Neurostimulation for Chronic Pain.


    Personalized Pain Management

    AdaptiveStim technology allows clinicians to optimize all programming parameters: amplitude, electrodes, pulse width and rate to maintain optimal therapy energy by position.

    AdaptiveStim® HD is a family of programming options to deliver higher pulse density through combinations of frequency and pulse width within current specifications. Amplitude should continue to be titrated to levels consistent with that individual patient's pain relief and preferred sensation.

    The utilization of the full range of available programming parameters has been facilitated by the birth of rechargeable devices and the broader acceptance of recharging burden by patients. The ability to adjust these parameters allows the clinician to maximize therapeutic outcomes (pain relief), minimize adverse effects of stimulation (e.g., discomfort or uncomfortable sensations), and account for battery life considerations.

     

    References
    1. Medtronic advanced pain therapy using neurostimulation for chronic pain. Clinical Summary, 2011. M221494A006.
    2. 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.
    3. Holsheimer J, den Boer A, Struijk JJ, Rozeboom AR. MR assessment of the normal position of the spinal cord in the spinal canal. AJ NR Am J Neuroradiol. 1994;15(5):951-959.
    4. Molnar G, Panken C, Kelley K. Effects of spinal cord movement and position changes on neural activation patterns during spinal cord stimulation. Abstract. American Academy of Pain Medicine. San Antonio, TX: Feb. 3-6, 2010.
    5. Kuechmann C, Valine T, Wolfe D. Could automatic position-adaptive stimulation be useful in spinal cord stimulation? Abstract. Pain in Europe VI (EFIC), Lisbon, Portugal: Sept. 9-12, 2009.

    Objective Activity Data

    Now, for the first time, clinicians can access objective activity data to assess, evaluate, and optimize a patient’s neurostimulation experience. AdaptiveStim® Diary, exclusively available with RestoreSensor®, provides objective data regarding patient activity to support and inform clinical decisions.

    positiontrend-th
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    Assess Patient Response to Neurostimulation with Position Trend Data

    Position trend indicates the average amount of time a patient spends in each position per day between programming sessions. The 24-hour averages are displayed graphically in percentages or details in hh:mm format to help assess the patient’s response to neurostimulation therapy:

    • Is he/she spending more or less time in a specific position?
    • How do his/her reported position changes correspond to the position trends captured in AdaptiveStim Diary?

    restingtrend-th
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    Evaluate Effect on Neurostimulation on Patient Rest with Resting Trend Data

    With Resting Trend, clinicians know the average number of times a patient changes from one lying position to another each day between programming sessions. This data helps to evaluate how neurostimulation affects the patient’s rest:

    • Do changes in his/her lying positions correlate with any patient-reported sleep quality issues?
    • Has neurostimulation therapy affected his/her restfulness?

    adjustmentsummary
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    Optimize Neurostimulation Settings with Adjustment Summary Data

    This summary shows the number of times the patient programmer was used to adjust amplitude in each position based on the last session – for all groups or an individual group. This data helps clinicians to optimize patient neurostimulation settings for his/her lifestyle:

    • Are there positions that are more or less challenging?
    • Can this data be used to fine tune therapy programming for specific positions?

    Get Unprecedented Insight into Patient Activity

    Objective activity data augments subjective patient feedback and patient medication usage. Combined, they lead to potentially better therapy outcomes by:

    • Enabling better one-to-one personalized medicine
    • Promoting a more meaningful physician-patient dialogue
    • Assisting with setting and tracking specific goals

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