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Spinal Cord Stimulation for the Treatment of Chronic Pain. John Talley Parrot, MD. Disclosure Slide. I have no financial relationships with any commercial interest related to the content of this activity I am a faculty consultant for Medtronics and Synthes / AO Spine.

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Spinal Cord Stimulation for the Treatment of Chronic Pain

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Spinal Cord Stimulation for theTreatment of Chronic Pain

John Talley Parrot, MD


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DisclosureSlide

  • I have no financial relationships with any commercial interest related to the content of this activity

  • I am a faculty consultant for Medtronics and Synthes / AO Spine


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Just So I Didn’t Forget My Questions Doctor Parrott


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Chronic Pain

  • Lifetime prevalence > 70%

    (Damkot DK, Pope MH, Lord J, Frymoyer JW.The relationship between work history, work environment and low back pain in men. Spine 9:395, 1984.)

  • US 1 year prevalence rate—5-20%

    (Cunningham LS, Kelsey JL: Epidemiology of musculoskeletal impairments and associated disability. Am J Public Health. 74:574, 19848.Deyo RA, Tsui-Wu Y-J: Descriptive Epidemiology of low back pain and its related medical care in the United States. Spine 12; 264-268, 1987.)

  • Annual direct medical costs $25 billion

    (Frymoyer JW, Cats-Baril WL. An overview of incidences and costs of low back pain. Orthop Clin North America 1991; 22:263-71.)

  • Most common cause of disability < 45 y/o

    • 2.4 million disabled

  • Return To Work = 0 after 2 yr absence d/t LBP

    (Bigos SJ, Bettie MC: The impact of spinal disorders in industry. The Adult Spine. New York, Raven Press, 1991.)


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Chronic Pain

  • 725k lumbar fusions/discectomies 2000

    (Agency for Healthcare Research and Quality. Healthcare Cost & Utilization Project (HCUP). Accessed May 10, 2007, at

    http://www.ahrq.gov/data/hcup/)

  • 30k-40k lumbar laminectomy patients/yr obtain no relief or recurrence of symptoms

    (Keane GP. Failed low back surgery syndrome. In: Cole AJ, ed. The low back pain handbook. Phila- delphia: Mosby; 1997:269–81. )


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Long-Term Pain Affects Most of Your Patients

  • 3 out of 4 Americans have experienced chronic or recurring pain or have a family member who has experienced such pain

  • Almost 62% of pain sufferers have had their pain for a year or more

  • A majority of adults (57%) have experienced chronic or recurring pain, including 54% of adults aged 18–34

    Reference: Americans Talk about Pain, conducted by Peter D. Hart Research Associates for Research!America, August 2003.


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Millions of Americans Suffer With Pain…

  • 50 million Americans are partially or totally disabled by chronic pain

  • 9 out of 10 Americans (aged 18 and older) suffer with pain at least once a month

  • 77% of pain patients strongly agree that new options are needed to treat their pain

  • 50% of Americans (aged 65 and older) suffer daily pain

    Reference: Pain in America: A Research Report, conducted by the Gallup Organization for Merck, June 1999.


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“Failed Back Surgery Syndrome”

Heterogenous group of disorders

Specific diagnosis neither implicit or explicit

Multiple possible explanations

Persistent/recurrent/new LBP or lower limb pain

Multiple etiologies

(Slipman - Pain Med 2002, Schoferman -Pain Med 2002, Bernard - Spine 1993, Long J. - NS 1988)

Epidemiology


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Slipman CW. Etiologies of Failed Back Surgery Syndrome, Pain Medicine 2002;3(3):200-214


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Nociceptive Pain

Somatic pain arises from:

Bone and joint

Muscle

Skin

Connective tissue

Aching or throbbing

Localized

Visceral pain arises from:

Visceral organs such as GI tract and pancreas

Tumor involvement

Obstructive


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Neuropathic Pain

Abnormal processing of sensory input by the peripheral or central nervous system

Centrally generated pain

Peripherally generated pain

Dorsal Root Ganglion (DRG)

Nerve Root


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Neuropathic Radicular Pain

http://www.netterimages.com/image/list.htm?page=2&s=spinal%20cord; image 1317)


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Mixed Pain

Many patients have a combination of both nociceptive and neuropathic pain

Disease or trauma has damaged both nerve cells and other tissues


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History of Neurostimulation

One of the earliest uses of electricity in medicine was for pain relief.

Around 15 A.D., Scribonius reported that a torpedo fish could be used to apply an electrical charge to patients to relieve pain.

Reference: Gildenberg PL. History of electrical neuromodulation for chronic pain. Pain Medicine. 2006;7(S1):S7-S13


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What is Spinal Cord Stimulation?


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Therapeutic Algorithm

Third Tier

Second-Tier

  • Neurostimulation

  • Surgical Intervention

First Tier

  • Diagnostic blocks

  • Therapuetic proc.s

Diagnosis

  • Physical Therapy

  • NSAIDS

  • Analgesics

  • Imaging

  • EMG/NCS


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Neuromodulation Devices

Allow the delivery of very small, precise doses of electricity

or drugs directly to targeted nerve sites.


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Precise delivery of small doses of electricity directly to targeted nerve sites

Neuromodulation DevicesElectrical Stimulators


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Spinal Cord Stimulation (SCS)

Implanted medical device that delivers electrical pulses to nerves in the dorsal aspect of the spinal cord that can interfere with the transmission of pain signals to the brain and replace them with a more pleasant sensation called paresthesia.


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C FIBER

INHIBITORYINTERNEURON

PROJECTION NEURON

AaAb FIBERS

CNS Pain Management (Theory)

  • Gate Control Theory

  • Melzack and Wall, 1968


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C FIBER

INHIBITORYINTERNEURON

PROJECTION NEURON

AaAb FIBERS

Gate Control Theory

  • When sensory impulses are greater than pain impulses

  • “Gate” in the spinal cord closes preventing the pain signal from reaching the brain

Sensory

Pain


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C FIBER

INHIBITORYINTERNEURON

PROJECTION NEURON

AaAb FIBERS

Gate Theory and SCS

SCS system implanted near dorsal column stimulates the pain-inhibiting nerve fibers masking painful sensation with a tingling sensation (paresthesia)

Sensory

SCS

Gate

Pain


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Tenets of SCS

Comprehensive trial

Customizable system components

Optimized efficiency in programs and design

Team approach to patient care

Anesthesia Pain Physician

Orthopedic Spine / Neurosurgeon

SCS Medical Device Clinical Representatives


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Advantages of SCS Therapy

Safe

Testable **

Non-destructive

Mostly reversible

Long-term cost is low


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Disadvantages of SCS Therapy

Refractory on some patients

Potential equipment failure

Short-term costs can be high, but are reimburseable via Medicare, workers compensation, and the private payer community

Long term follow-up required via anesthesia pain management, and / or SCS medical device clinical representation

Steep learning curve for procedure


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Overall Goals of SCS Therapy

Position electrode in area of specific neural target

Generate electrical field at target nerve to create paresthesia that overlaps painful area(s)

Program stimulation parameters for maximum effectiveness, patient comfort, and energy efficiency

Reduce medication, restore function and improve quality of life

Return patient to work


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Factors Influencing Therapy Success

Clinical

Indications

Pain etiology

Pain distribution

Patient factors

SCS Device

Sufficient coverage

Targeting of electrical field

Sustainability of therapy

27

© 2010 St. Jude Medical, Inc. All rights reserved.


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Clinical Factors

Indication

Responsive to SCS

Disease Etiology

Disease likely to progress should have device with “extra capacity”

Pain Distribution

Multi site and broad pain patterns often require more leads and electrodes

Patient Factors

Anatomy

Physiology

Selection


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Device Factors

Stimulation Coverage

Paresthesia is delivered to entire painful segment(s)

Precision of Stimulation

Not delivered to extraneous sites but masks the pain with a tolerable sensation

Sustainability of Therapy

Sustained over the painful anatomical segment


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How Are Clinical Factors Evaluated?

Patient Selection Process

Correctly diagnosed

Failed lower level therapies

Successfully passed psyche evaluation

Patient is motivated

Patient is educated


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How Are Device Factors Evaluated?

During a Temporary SCS Trial

Leads are implanted

External power source is used to evaluate

Pain relief

Paresthesia coverage

Power requirements

Programming needs

System requirements (Rechargeable Or Conventional)


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SCS Phases

Trial

Permanent implant


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Trials

One advantage of SCS over the other pain management or surgical therapies is that it can be tested on patients before an SCS device is permanently implanted.

The trial gives the implanting physician important information for determining which of the three SCS systems is appropriate for a specific patient.


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Trials

A spinal cord stimulation trial involves

A short outpatient procedure during which the implanting physician places one or more leads in the space over the spinal cord.

The patient is awake during the procedure so that he or she can provide feedback to the physician regarding exact placement.

The lead connects to a device that can be worn on a belt. The device may contain a variety of programs.


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Trial System

Trial Lead

Trial Cable

Trial Generator/

Programmer


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Length of Trials

Trial length determined by daily verbal patient verbal

Anesthesia pain physician staff – daily telephone calls

SCS clinical representatives – daily telephone calls and office visit for adjustment intra-trial if needed

Short-term trials

2 to 5 days

Long-term trials

5 to 7 days


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The Patient’s Role in Trials

The patient should:

Have a working knowledge of the SCS trial device

Understand movement restrictions

Reduce bending at the waist

Reduce lifting over the head

Understand the sensations to be expected

Be able to document his or her responses, pain level, and functional changes

Be reasonably active


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Patient/Device Criteria


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Single Or Dual Trial Leads


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Paddle Lead Arrays

Tripolar Paddle Array

Penta Five Column Array


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SCS Studies

Reduction in pain

Kumar K, Hunter G Demeria D. Spinal Cord Stimulation in Treatment of Chronic Benign Pain: Challenges in Treatment Planning and Present status, a 22-Year Experience. Neurosurgery. 2006;58:481-496.

North RB,Kidd DH, Farrokhi F,Piantadosi SA. Spinal Cord Stimulation versus Repeated Lumbosacral Spine Surgery for Chronic Pain: a Randomized Controlled Trial in Patients with Failed Back Surgery Syndrome. Pain.2007;132:179-188.

Barolat G, Oakley JC, Law JD, North RB, Ketick B, Sharan A. Epidural Spinal Cord Stimulation with a Multiple Electrode Paddle Lead is Effective in Treating Intractable Low Back Pain. Neuromodulation. 2001;4:59-66.

Van Buyten JP,Van Zundert J,Vueghs P, Vanduffel L. Efficacy of Spinal Cord Stimulation : 10 Years of Experience in a Pain Centre in Belgium. Eur J Pain. 2001;5:299-307.

Cameron T. Safety and Efficacy of Spinal Cord Stimulation for the Treatment of Chronic Pain: A 20-Year Literature Review. J Neurosurg Spine. 2004;100(3):254-267.


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SCS Studies

Reduction in medication

North RB,Kidd DH, Farrokhi F,Piantadosi SA. Spinal Cord Stimulation versus Repeated Lumbosacral Spine Surgery for Chronic Pain: a Randomized Controlled Trial in Patients with Failed Back Surgery Syndrome. Pain.2007;132:179-188.

Van Buyten JP,Van Zundert J,Vueghs P, Vanduffel L. Efficacy of Spinal Cord Stimulation : 10 Years of Experience in a Pain Centre in Belgium. Eur J Pain. 2001;5:299-307.

Cameron T. Safety and Efficacy of Spinal Cord Stimulation for the Treatment of Chronic Pain: A 20-Year Literature Review. J Neurosurg Spine. 2004;100(3):254-267.

Taylor RS, Van Buyten JP, Buchser E. Spinal Cord Stimulation for Chronic Back and Leg Pain and Failed Back Surgery Syndrome: A Systematic Review and Analysis of Prognostic Factors. Spine. 2005;30:152-160.


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SCS Studies

Improvement in daily activities

Barolat G, Oakley JC, Law JD, North RB, Ketick B, Sharan A. Epidural Spinal Cord Stimulation with a Multiple Electrode Paddle Lead is Effective in Treating Intractable Low Back Pain. Neuromodulation. 2001;4:59-66.

North RB,Kidd DH, Farrokhi F,Piantadosi SA. Spinal Cord Stimulation versus Repeated Lumbosacral Spine Surgery for Chronic Pain: a Randomized Controlled Trial in Patients with Failed Back Surgery Syndrome. Pain.2007;132:179-188.


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SCS Studies

Return to work

Van Buyten JP,Van Zundert J,Vueghs P, Vanduffel L. Efficacy of Spinal Cord Stimulation : 10 Years of Experience in a Pain Centre in Belgium. Eur J Pain. 2001;5:299-307.

Taylor RS, Van Buyten JP, Buchser E. Spinal Cord Stimulation for Chronic Back and Leg Pain and Failed Back Surgery Syndrome: A Systematic Review and Analysis of Prognostic Factors. Spine. 2005;30:152-160.

Dario A, Fortini G, Bertollo D, Bacuzzi A, Grizzetti C, Cuffari S. Treatment of Failed Back Surgery Syndrome. Neuromodulation. 2001;4:105-110.


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Questions?


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