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Emerging Therapies in IPM
FOMA 2019 Weston, FL
• Robert David Ball, D.O.,M.S.
• Board Certified in Anesthesiology
• Board Certified in Pain Management by the American
Board of Anesthesiology
• Residency Training at State University of New
York/Upstate Medical University in Syracuse, NY
• OB Anesthesiology at Brigham and Women’s, Harvard
Medical School, Boston, MA
• Fellowship in Interventional Pain Management in Upstate
Medical University, Syracuse, NY
What is a Our Value Proposition?
Prevalence
• Low back pain affects at least 80% of people at
sometime throughout our lives and is the 5th most
common reason for physician visits.
• In any given year 90% of men and 95% of
woman have at least one headache. 15% have
had a severe migraine
Nett RB. Advances in migraine management. Program and abstracts of the 5th Annual
Association of Family Practice Physician Assistants Conference; November 19-23,
2003; San Antonio, Texas.
Manchikanti L. Singh V, Datta S, ,Cohen SP, Hirsch JA. Comprehensive Review
of Epidemiology, Scope, and Impact of Spinal Pain. Pain Physician 2009: 12:E35-E70.
Economic Burden
$0
$100
$200
$300
$400
$500
$600
$700
Chronic pain Heartdisease
Cancer Diabetes Obesity
Cost in
bill
ions o
f dolla
rs (
2010)
1. Institute of Medicine. Relieving pain in America: A blueprint for transforming
prevention, care, education, and research. 2011.
2. Wang Y, et al. Obesity 2008;16(10):2323-2330.
9
1 1
Complications with Chronic Pain
10
1. Institute of Medicine. Relieving pain in America: A
blueprint for transforming prevention, care, education,
and research. 2011.
2. Reid KJ, et al. Curr Med Res Opin. 2011;27:449-62.
3. Miller LR, Cano A. J Pain. 2009; 10(6):619-627.
4. Tang NKY, et al. Psych Med. 2006;36:575-586.
5. Bruehl S, et al. Clin J Pain. 2005;21(2):147-153.
6. Tang NKY, et al. J Sleep Res. 2007;16:85-1695.
7. Sullivan MD, et al. Pain. 2010;150(2):332-339.
8. Behavioral Health Coordinating Committee Prescription
Drug Abuse Subcommittee. Addressing prescription
drug abuse in the United States: current activities and
future opportunities. Accessed June 4, 2014..
9. Strine TW, Hootman JM. Arthritis Rhem.
2007;57(4):656-665.
In addition to the significant economic burden1 and negative
impact on quality of life,2 untreated chronic pain is associated
with physical and psychological complications3-6
Depression3 35% of chronic pain patients
vs 4.6% of the general study population
Suicide4
Suicide ideation
lifetime prevalence in
chronic pain patients, ~20%
vs 13.5% in the general population
Suicide attempts
lifetime prevalence in
chronic pain patients, 5-14%
vs 4.6% of the general population
Hypertension5 39% of chronic pain patients
vs 21% of the general population
Insomnia6 53% of chronic pain patients
vs 3% of pain-free controls
Overweight/obese9 62.7% of patients with low back/neck pain
vs 56.5% of the general population
Opioid misuse/abuse7,8 20-24% of chronic pain patients
vs 3.8% of the general population
Indications for Use: Spinal cord stimulation as an aid in the management of chronic,
intractable pain of the trunk and limbs
Risk of Doing Nothing
Pain Management is Essential
Treating
pain
SAVES
LIVES
Untreated
pain
ENDS
LIVES
General/family practitioner 70%
Orthopedist/orthopedic surgeon 27%
Neurologist/neurosurgeon 10%
Rheumatologist 9%
Internist 7%
Physiotherapist 6%
General surgeon 3%
Osteopath 2%
Pain Specialist 2%
Few Patients with Chronic Pain
Are Treated by Pain Management
Specialists Treatment of chronic
pain patients by a pain
specialist often results
in improved patient care
Recommended for
patients who don’t
respond to first-line
treatment
Partnership with
Community and
creating Referral
Network
1. Davies HTO, et al. J R Soc Med. 1994;87(7):382-385.
2. Dworkin RH, et al. Mayo Clin Proc. 2010;85(3 suppl): S3-S14.
3. Schulte E, et al. Eur J Pain. 2010;14(3):308.e1-308.e10.
4. Breivik H, et al. Eur J Pain. 2006;10(4):287-333.
Health Care Providers Treating
Chronic Pain Patients
CONSTANT EMPHASIS ON
INNOVATION AND
ADOPTION OF NEW
TECHNOLOGIES BOTH
MEDICAL AD PATIENT
ENGAGEMENT
TECHNOLOGIES.
MAINTAINING AN “URGENT
REFERRALS WELCOMED”
CULTURE
What is a Our Value Proposition?
Dr. Robert Ball Dr. Andrew
Cook
Treating Spinal Stenosis
MILD (Minimally Invasive Lumbar
Decompression
Ligamentum Flavum Hypertrophy
Superion Animation
Lumbar Spinal Stenosis Continuum of
Care
Vertiflex Bridges the MIS Gap
Conservative Treatment
Traditional Treatment
Mild Moderate Severe
Superion® Indirect Decompression
System
43
• Tissue-sparing midline approach – no removal of anatomical structures
• Outpatient/ASC friendly procedure
• Minimal blood loss and 20-30 minute operative time
• Short recovery period; home within hours
1. Minimally Invasive Access through a tube – the size of
a dime
2. Extension Blocking Mechanism - in a single step
deployment
3. Provides Indirect Decompression – requiring
only two stitches
Superion – A Least Invasive Option A World of Difference in
Invasiveness
Clinical Presentation of Lumbar Spinal Stenosis
• Sitting (flexion) relieves symptoms
• Extension provokes symptoms
• Pain / weakness in legs
• Patients lean forward while walking to ambulate more comfortably, “Shopping Cart“ sign
Superion® Indications and Exclusions • Key Indications
• Persistent leg/buttock/groin pain (neurogenic intermittent claudication) secondary to dx of moderate lumbar spinal stenosis
• Symptoms relieved in flexion
• Radiographic confirmation of moderate stenosis
• Significant Exclusions • Conditions warranting consideration of decompression or
fusion, e.g., significant instability, spondy >grade 1, spondylolysis
• Axial back pain only, fixed motor deficit, unremitting pain in any spinal position, significant peripheral neuropathy
• Severe osteoporosis, defined as DEXA score >2.5 below normal adult mean
Superion® Data from IDE Trial
47
©2016 Vertiflex, Inc. All rights reserved
Reimagining Spinal Stenosis Treatment
48
©2016 Vertiflex, Inc. All rights reserved
Reimagining Spinal Stenosis Treatment
49
Disc Biacuplasty
SUBHEAD GUIDE SUBHEAD GUIDE
BULLET GUIDE
BULLET GUIDE
HEADER GUIDE HEADER GUIDE
The DRG: A collection of bipolar cell bodies of neurons surrounded by
glial cells and the axons of the DRG sensory cells that form the primary
afferent sensory nerve
The Dorsal Root Ganglion: Review of Anatomy
DRG
Ventral Dorsal
L4
L5
DRG
Image from: Hogan Q. Reg Anesth Pain Med. 2010. Image from: Gray’s Anatomy (2005). Standring, S. (Ed.).
BULLET GUIDE BULLET GUIDE
HEADER GUIDE HEADER GUIDE
Pathological Cascade Leading to
Neuropathic Pain
DRG Activate surrounding
glia
Release proinflammatory cytokines
Ultimately stimulates neurons
Increased membrane excitability
Nerve Injury
at periphery
Dorsal horn Increased neuronal
discharge from primary sensory neurons
Increase EAA release
Increased ATP, NO release
Increased neural peptide release
The Peculiar Properties of the Dorsal
Root Ganglion
• Special structure:
DRG neurons have a
peculiar
pseudounipolar
morphology – unique
in the nervous system
• Unique Function: T-
junctions act as the
filter function for cell
transduction and
potential
neuromodulation target
• Highly Organized and
Selective: Small and
large soma consistent
with axonal specificity
of sensory
transduction therefore
dictating
electrophysiological
selectivity
• Specialized
Membrane
Characteristics:
Somata of many DRG
neurons have the
specialized membrane
characteristics
necessary for spike
initiation, and some
are even capable
of repetitive firing
• Minimal CSF:
Subdural structure with
minimal surrounding
CSF unlike the spinal
cord
Proximal Axon T-Junction Soma
Distal Axon
Devor, Pain Supplement 6. 1999.
Ramon y Cajal, et al. (Eds.) Histology. 1933.
The Importance of the T-Junction
Krames ES. Pain Medicine. 2014.
BULLET GUIDE BULLET GUIDE
HEADER GUIDE HEADER GUIDE
• Known mechanisms & processes:
DRGs are known target for pain relief
• Predictable & accessible location
in the epidural space within the neural
foramen: easy target for
neuromodulation by adapting current
SCS needle techniques
• Limited Cerebrospinal Fluid (CSF)
around the DRG allows the leads to
be closer to the anatomical target &
requires less energy to stimulate
(compared to conventional SCS)
• Separation of sensory & motor
nerve fibers prevents unintentional
stimulation
Why target the drg?
Image from: Gray’s Anatomy (2005). Standring, S. (Ed.).
BULLET GUIDE BULLET GUIDE
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Why target the drg? (cont’d)
Foot/Lower Leg/Low Back
Leg & Low Back
Lower & Upper Leg/Low Back
Upper Leg & Low Back
Hip/Groin/Waist/Back
Abdomen/Groin/Back
L5
L4
L3
L2
L1
T12
DRGs
Spinal Column
Well mapped & organized to corresponding anatomies – allowing for highly focused treatment of pain
BULLET GUIDE BULLET GUIDE
HEADER GUIDE HEADER GUIDE
DRG stimulation & Somatosympathetic
Reflexes
Sympathetic
Pre-Motor
Neuron
Baseline
1 month
Adapted from: Loewy and Spyer, Central Regulation of Autonomic Function, 1990.
BULLET GUIDE BULLET GUIDE
HEADER GUIDE HEADER GUIDE
Neuromodulation – The Future Spinal Cord Stimulation DRG
1. Deer et al, Neuromodulation 2014.
2. Cameron T. J Neurosurg. 2004
3. Kim DD, et al. Pain Physician. 2011
BULLET GUIDE BULLET GUIDE
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SHEATH delivery
BULLET GUIDE BULLET GUIDE
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Unstable Stimulation
• Susceptible to body position due to
variations in distance between
stimulation lead & target
• Lead migrations rates (percutaneous)
reported between 9-27%1,2,3
Unspecific Stimulation
• Broad Stimulation Coverage: targeting
spinal cord sensory nerves
• Unspecific to anatomical location of
pain/disease
• Energy is delivered to multiple types of
nerves, not just pain- or disease-specific
nerves
High Energy Usage
• Significant energy loss to surrounding
anatomy (i.e. cerebral spinal fluid, CSF)
before stimulation reaches target in
spinal cord
Current limitations of conventional scs
Conventio
nal SCS
DRG
1. Deer et al, Neuromodulation 2014.
2. Cameron T. J Neurosurg. 2004
3. Kim DD, et al. Pain Physician. 2011
SYSTEM INITIALS DIAGNOSIS
DRG M.H. Bilateral Diabetic Neuropathy
DRG A.B. Right Knee Post Surgical Chronic Pain
DRG H.H. Bilateral Neuropathy
SCS J.B. Replacement Competitive SCS system
SCS J.W. Low back and Limbs SCS
DRG C.R. Off label Chest T10 T8 placement
DRG R.E. Bilateral Neuropathy
DRG J.R. Right foot CRPS
SCS J.S. Low back and Limbs SCS
DRG L.C. Left Foot CRPS
DRG R.K. Right foot CRPS
DRG M.C. Right Knee Post Surgical Chronic Pain
SCS J.W. Bilateral Neuropathy
SCS S.P. Right Knee Post Surgical Chronic Pain
DRG B.P. Right Phantom limb pain
SCS D.E. Low back and Limbs SCS
SCS J.S. Right leg CRPS
DRG D.D Right foot post crush limb (fell off ladder)
DRG A.K. Right foot CRPS
DRG G.H. Groin
SCS J.W. Low back and Limbs SCS
DRG J.H. Right Foot post surgical
DRG S.H. Left Knee post surgical Chronic pain
DRG J.W. Right Hip Post Hip Replacement
DRG P.M. Right foot CRPS
DRG T.P. Right leg CRPS
DRG J.S. Right foot CRPS
DRG J.S. Groin Post Shoulder surgery pain
DRG K.T Right Knee Post Surgical Chronic Pain
DRG M.M. Left Foot CRPS
DRG J.W. Right Knee Post Surgical Chronic Pain
DRG M.H. Right foot post crush limb
DRG K.H. Right Knee Post Surgical Chronic Pain
DRG J.F. Post Laparoscopic Abdominoperineal Resection
SCS S.B. Low back and Limbs SCS
SCS G.M. Low back and Limbs SCS
86% trial to perm conversion including Off label cases 91% trial to perm conversion excluding off label
Dr. Ball Southwest Florida Pain
Case Data
Innovation • As Part of our
Mission Statement and Value Proposition:
• Innovation is key.
• Evaluate PRP and Stem Cell technologies and how this technology fits into our practice.
Thank you for your time!
• Thank you for all that you do!
Pudendal Nerve Block – Pelvic Pain