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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

    Medtronic spinal cord stimulation can be an effective, implantable alternative to other therapies used to manage chronic pain.1,2

    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 system delivers electrical pulses via a lead to nerves in the dorsal aspect of the spinal cord. Pain signals are inhibited before they reach the brain and replaced with a tingling sensation (parasthesia) that covers the specific areas where the pain was felt.

    A technology called AdaptiveStim® reduces the need for patients to manually adjust their stimulation parameters when changing positions. AdaptiveStim, exclusively available with RestoreSensor®, 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.

    A function of AdaptiveStim called AdaptiveStim Diary provides objective data regarding patient activity. Clinicians can use this data to assess, evaluate, and optimize a patient’s neurostimulation experience.

    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

    It is reassuring to know that most types of pain can be treated. Success in helping patients find relief depends on:

    • Understanding chronic pain and its treatment options
    • Educating patients about chronic pain and available treatments
    • Helping patients develop a treatment plan with realistic goals
    • Knowing when a patient should be referred to a pain management specialist or other medical or surgical specialty

    Potential Benefits

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

    • Effective – Spinal cord stimulation may provide significant and sustained reduction in leg and back pain and hope for a better quality of life3,4
    • Safe – When used as directed, safety has been demonstrated. Medtronic has more than 35 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
    • Ability to Test First– A screening test allows the patient to experience spinal cord stimulation on a temporary basis to assess response before implantation
    • Reduced Medication – Patients may be able to reduce oral pain medication doses and their associated side effects
    • Reversible – Unlike some surgeries, spinal cord stimulation is reversible. The system can be turned off or surgically removed
    • Programmable – Neurostimulators can be programmed to meet the specific needs of each individual patient. As pain patterns change, parameters can be adjusted to increase the effectiveness of the therapy

    Potential Risks

    The neurostimulation implant may be associated with adverse events, and each person’s experience may vary. Surgical risks include infection, pain at the implant site, and epidural bleeding. Device risks include corrective surgery, jolting or shocking, lead fracture, lead migration or lead dislodgement which may require reprogramming, or surgical replacement of leads. These events may result in uncomfortable stimulation, or loss of therapy.

    How Spinal Cord Stimulation Works

    An implantable system delivers electrical pulses via a lead to nerves in the dorsal aspect of the spinal cord. Pain signals are inhibited before they reach the brain and replaced with a tingling sensation (parasthesia) that covers the specific areas where the pain was felt.

    SCS Product Family - RestoreSensor, MyStim, NVision

    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

    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 – Medtronic empowers patients by giving them a way to manage their pain relief – within preset physician parameters – to optimize outcomes

    SCS Is More Effective When Considered Earlier5

    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 Test

    A screening test allows patients to assess their response to spinal cord stimulation prior to device implantation. Patients who experience at least a 50% improvement in symptoms from the screening test may be candidates for the long-term therapy.

    The screening test:

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

    Among all neurostimulation systems used to control chronic pain, patients may experience positional discomfort when they sit down, stand up, or lie down.

    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.

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    Stimulation Field

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

    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

    VaryingAmplitudeChart

    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
    • Patients want a solution to the problem of uncomfortable stimulation due to position change

    A new technology called 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 scan expect a specific response from their device.

    Learn more about adaptive stimulation

    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.

    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. 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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