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

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©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

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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.).

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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.

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• 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.).

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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

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DRG stimulation & Somatosympathetic

Reflexes

Sympathetic

Pre-Motor

Neuron

Baseline

1 month

Adapted from: Loewy and Spyer, Central Regulation of Autonomic Function, 1990.

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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

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SHEATH delivery

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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