Transcript The Crisis of Pain in America

Our Role in the Management of
Chronic Pain



Speaker/consultant for St. Jude’s; also
receiving research grants
Speaker/stock holder for Insys Therapeutics
Speaker/consultant for Central Avenue
Pharmacy
Confidenti
al. For
Internal
Use Only.
Do Not
Distribute





Understand the impact that pain, specifically
chronic pain, has on our society
Discuss pharmacological approach to pain
management
Review neuromodulation as it pertains to
interventional pain management
Determine when interventional approaches to
pain management are appropriate
Discuss surgical implants for pain management
BURDEN OF CHRONIC PAIN IN THE
UNITED STATES
Affects 100 million Americans
(more than heart disease, cancer and diabetes combined)1
Costs society up to $635 billion annually1
Associated with 40 million doctor visits annually2
Results in 515 million lost workdays annually2
40% of all work absences are related to low back pain3
1. Institute of Medicine. Relieving pain in America: A blueprint for
transforming prevention, care, education, and research. 2011.
2. Rich SJ. Adv Stud Pharm. 2009;6(4):115-119.
3. Manchikanti L, et al. Pain Physician. 2009;12:699-802.
4
Cost in billions of dollars (2010)
CHRONIC PAIN IS AMONG THE TOP
COSTLY CONDITIONS
IN
THE
UNITED
STATES
$700
$600
$500
$400
$300
$200
$100
$0
Chronic
pain
Heart
disease
Cancer
1
Diabetes
1
Obesity
1
2
1
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.
5

The National Health Expenditure reached $2.5 trillion in 2009 and
is expected to reach $4.5 trillion in 20191
$US billions
$5.0
$4.0
$3.0
$2.0
$1.0
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
The Affordable Care Act includes measures to reduce waste in health care
spending, including Medicare and Medicaid fraud and abuse, resulting in an
anticipated savings of $7 billion over 10 years2
1. Centers for Medicare and Medicaid Services. National Health Expenditure
Projections 2009-2019. Accessed April 23, 2014.
2. Orszag PR, Emanuel EJ. N Engl J Med. 2010;363;7:601-603.
6
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
35% of chronic pain patients
vs 4.6% of the general study population
Depression3
Suicide ideation
lifetime prevalence in
chronic pain patients, ~20%
vs 13.5% in the general population
Suicide4
39% of chronic pain patients
vs 21% of the general population
Hypertension5
53% of chronic pain patients
vs 3% of pain-free controls
Insomnia6
62.7% of patients with low back/neck pain
vs 56.5% of the general population
Overweight/obese9
20-24% of chronic pain patients
vs 3.8% of the general population
Opioid misuse/abuse7,8
1.
2.
3.
4.
5.
6.
Institute of Medicine. Relieving pain in America: A
blueprint for transforming prevention, care, education,
and research. 2011.
Reid KJ, et al. Curr Med Res Opin. 2011;27:449-62.
Miller LR, Cano A. J Pain. 2009; 10(6):619-627.
Tang NKY, et al. Psych Med. 2006;36:575-586.
Bruehl S, et al. Clin J Pain. 2005;21(2):147-153.
Tang NKY, et al. J Sleep Res. 2007;16:85-1695.
Suicide attempts
lifetime prevalence in
chronic pain patients, 5-14%
vs 4.6% of the general population
7.
8.
9.
Sullivan MD, et al. Pain. 2010;150(2):332-339.
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..
Strine TW, Hootman JM. Arthritis Rhem.
2007;57(4):656-665.
7
THE BENEFITS OF SENDING PATIENTS TO
PAIN SPECIALISTS
Goals of Pain Physicians
Treating Chronic Pain
Types of Pain Treated
by Pain Physicians
Establish accurate diagnosis
Improve patient care1
Chronic back, neck, shoulder,
trunk, and limb pain
Increase activity levels2
Neuropathic pain
Improve functional life activities2
Post-surgical pain syndromes
Reduce disability, return patients
back to work2
Failed back surgery syndrome
Decrease overutilization of
opioids2
Degenerative disc disease
Reduce emotional distress, such
as depression and anxiety2
Cancer pain
Arthritis
Complex regional pain
Decrease the use of
medical resources2
1. Davies HTO, et al. J R Soc Med. 1994;87(7):382-385.
2. Clark TS. BUMC Proceedings. 2000;13:240-243.
8
A Changing Paradigm for the Management of
Chronic Pain
 The historical approach to chronic pain treatment involves sequential testing of multiple analgesics,
with interventional therapies (eg, spinal cord stimulation) as “last resort”1
 In a new, simplified, patient-centric approach, interventional therapies are earlier in the treatment
continuum2
New Approach to Chronic Pain Treatment
Aggressive Care
(Step 3)
Less
Less Conservative
Conservative -Moderate Care (Step 2)
Chronic opioid maintenance
Intrathecal therapy
Surgical intervention
Conservative Care
(Step 1)
Physical therapy
OTC pain medications
Psychological therapy
NSAIDs
9
Injection therapies†
Neuroablation
Low dose opioids
Low-dose
Spinal cord stimulation
TENS
Neurolysis
Spinal
cord stimulation
Thermal procedures
Neurolysis
Thermal procedures
CONFIDENTIAL – For Internal Use Only. Do Not Distribute
US-2001416 A EN (06/14)
1. Kaplan R. J Support Oncol. 2010;8:62-63.
2. Poree L, et al. Neuromodulation. 2013;16(2):125-141.
MORTALITY AND COSTS RELATED TO OPIOID MISUSE
AND OVERDOSE IN THE UNITED STATES
The percentage of drug overdose deaths related to opioids doubled from
1999 to 20101
Opioid overdose is responsible for more than 16,000 deaths annually1
Non-medical opioid use is associated with $75.2 billion in insurance costs per year2
Rate of Opioid Overdose Deaths (per 100,000)1
6
5
Rate
4
3
2
1
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Year
http://www.cdc.gov/homeandrecreationalsafety/overdose/hhs_rx_abuse.html
1. 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.
2. Coalition Against Insurance Fraud. Prescription for peril: how insurance fraud finances theft and abuse of
addictive prescription drugs. Accessed April 22, 2014.
10
RISKS ASSOCIATED WITH OPIOID THERAPY
Overdose-related deaths1
16,651 deaths/year
Non-medical use rate1
3.8% of the US population
Insurance costs of non-medical use2
$72.5 billion/year
Constipation/bowel dysfunction3
~41% of chronic opioid users
Endocrine effects
(opioid-induced androgen deficiency4)
Affects ~5 million men taking opioids for
chronic pain in the US
Immunologic challenges5
May be associated with immunosuppression
Ataxic breathing during sleep6
~70% of chronic opioid users
1. 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.
2. Coalition Against Insurance Fraud. Prescription for peril:
how insurance fraud finances theft and abuse of addictive
prescription drugs. Accessed April 22, 2014.
3. Kalso E , et al. Pain. 2004;112:372-80.
4. Colameco S, Coren JS. J Am Osteopath Assoc. 2009;109:20-24.
5. Ballantyne JC. South Med J. 2006;99:1245-1255.
6. Walker JM, et al. J Clin Sleep Med. 2007;3(5):455-461.
7. Taylor RS, et al. Spine. 2005;30(1):152-160.
8. Frey ME, et al. Pain Physician. 2009;12:379-397.
11
Long-Term Pain Affects Most of Your Patients
(Peter D. Hart Research Associates)
 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
Types and Definitions of Pain
 Acute pain
 Accompanies tissue injury or pathology
 Comes on quickly and lasts a short time
 Varies in severity and intensity
 Chronic pain
 Continues a month or more beyond usual recovery
period
 Goes on for months or years due to a chronic
condition
 Difficult to define onset
Types and Definitions of Pain
 Nociceptive pain
 Caused by irritation to special nerve endings
(nociceptors)
 Can be dull or sharp
 Can be mild or severe
 Neuropathic pain
 Caused by a malfunction of the nervous system
 The result of injury, disease, or trauma
 Can be sharp, intense, and constant
 Can be dull, aching, and throbbing
Failed Back Surgery Syndrome
 Back and/or leg pain that recurs or persists following
seemingly successful back surgery
 Surgical goals not met
 Patient goals not met
Diabetic Peripheral Neuropathy (Belgrade)
 Simultaneous decreased sensation in the distal
extremities in patients with diabetes
 Manifested by loss of sharp vs. light touch discrimination,
numbness, and tingling in combination with burning pain
Intrathecal Pump as a therapy for chronic,
intractable pain.
 Significant decrease in oral opioid need.
 Trial can be single injection or epidural catheter.
 Combination of local anesthetics, alpha-blockade, and/or
opioids create synergistic effects.
 New medications (ie. ziconitide – calcium channel
blocker) create new opportunities and abilities to control
chronic pain.
 Pump can be accessed easily and effectively
programmed to control pain medication in microliters.
SCS as an Advanced Treatment for Pain
History of Neurostimulation (Glindenberg)
 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.
Courtesy of Dr. Thomas Simopolous, Boston, MA
Neuromodulation Devices
(Electrical Stimulators and Drug Pumps)
Allow the delivery of very small, precise doses of electricity
or drugs directly to targeted nerve sites.
What is Spinal Cord Stimulation (SCS)?
Tenets of SCS




Comprehensive trial
Customizable system components
Optimized efficiency in programs and design
Team approach to patient care
SCS Phases
 Trial period
 Permanent implant
Advantage of an SCS Trial
 One big advantage of SCS over other pain management
therapies is that it can be tested on patients before an
SCS device is permanently implanted
 The trial gives the pain management physician important
information for determining which of the two SCS
systems, conventional or rechargeable, is appropriate for
a specific patient
About the SCS Trial
 A short outpatient procedure during which the physician
places one or more leads in the space over the spinal
cord
 The patient is generally awake during the procedure so
that he or she can provide feedback to the physician
regarding exact placement
 A lead connects to a device that can be worn on a belt.
The device will contain a variety of programs
About the Trial System
Trial Lead
Trial Cable
Trial
Generator/Programmer
Lengths of Trials
 Short-term trials
 1 to 3 days
 3 to 5 days
 Long-term trials
 7 to 10 days
Trial Diary
 Can be used as a guide to determine the device type and
the parameters that were favored during the trial
 Helps patients get involved in their therapy
Patient/Device Criteria
Conventional IPG
Rechargeable IPG
Power requirements
Low to moderate
Moderate to high
Frequency requirements
Low
Low to moderate
Disease state
Stable
Likely to progress
Coverage needs
(contacts/leads)
8 contacts on
1 or 2 leads
8 or 16 contacts on
1-4 leads
Compliance
(motivation and ability)
Requires very little
interaction
High—due to
recharging protocol
Competence
(physical or mental)
Appropriate for all levels
Higher level required
Skin sensitivity
Patients with high
sensitivity
Patients with moderate
to low sensitivity
Implant size
Moderate to large sizes
Small to moderate size
Implant longevity
2-7 years
5-10 years
Patient interface
Easier to use
Requires management
Lead Family
The 5-Column Paddle Lead
 Designed to provide greater lateral electrode coverage and
nerve fiber selectivity
 Provides five columns of the smallest electrodes on the market,
for greater specificity and programming flexibility
Lateral Electrode Coverage
40% of patients have a spinal cord 1-2 mm off midline (Holsheimer)
2 mm
*Approx. 4.5 mm
2 mm
8.5 mm of lateral electrode coverage needed
*At T9
Improved Lateral Current Steering
Actual Clinical Results
Certain programming configurations on the 5-column paddle lead may
be able to isolate paresthesia within the dermatome itself. (Feler)
The diagrams above depict actual patient-reported stimulation effects with a 5-column paddle lead.
SCS Studies
Reduction in pain
Author
No. Patients
Follow-Up
Results
Kumar
410
8 years
74% had ≥50% relief
North
19
3 years
47% had ≥50% relief
Barolat
41
1 year
50%-65% had good/excel. relief
Van Buyten
123
3 years
68% had good/excel. relief
Alò
80
30 months (2.5 years)
Mean pain scores declined from 8.2
at baseline to 4.8
Cameron
747
up to 59 mos.
62% had ≥50% relief or significant
reduction in pain scores
SCS Studies
Reduction in medication
Author
No. Patients
Follow-Up
Results
North
19
3 years
50% reduced their med use
Van Buyten
123
3 years
as a group reduced the medication use
by >50%
Cameron
766
up to 84 mos.
45% reduced their med use
Taylor
681
n/a
53% no longer needed analgesics
SCS Studies
Improvement in daily activities
Author
No. Patients
Follow-Up
Results
Barolat
41
1 year
As a group, significant improvements in
function and mobility
North
19
3 years
As a group, improvements in a range of
activities
SCS Studies
Return to work
Author
No. Patients
Follow-Up
Results
Van Buyten
123
3 years
31% returned to work
Taylor
1133
n/a
40% returned to work
Dario
23
3 years
35% returned to work
Spinal Cord Stimulation (SCS)
SCS can be used to manage neuropathic pain that arises
from:
 CRPS (Complex Regional Pain Syndromes I and II)
Peripheral neuropathy (Diabetic, Post-Chemo,
Idiopathic)
 SCS can be used in the treatment of pain, numbness, and circulatory
deficits with associated small-fiber peripheral neuropathy (SFPN)—
with or without a diagnosis of diabetes mellitus (DM).
 Twenty-five percent of Americans are either diabetic or pre-diabetic
(20 million and 60 million, respectively). SFPN is a significant
comorbid process, with onset of DM occurring at a mean of 5 years
after diagnosis of SFPN, with a range of 3 months to 20 years. This
suggests patients may have SFPN in the absence of diagnosed DM.
SCS treatment have been shown to be successful in providing >70%
pain relief in over 80% of patients with pain attributable to SFPN. 52%
reported significant reduction in medication usage. 90% of patients
had reversal of sensory loss. Whether this is permanent or is due to
continuous SCS in unclear. Trophic change improvement with
increased circulation associated with SCS has also been well
documented. However, to our current knowledge, reversal of sensory
loss in SFPN patients from SCS has not been well-studied.
Ischemic/Neuropathic Limb Pain
 Primary erythromelalgia or Mitchell’s disease is a rare neurovascular
condition causing severe neuropathic pain. Often times, treatment for
this rare condition is difficult, and can involve neuropathic pain
medications, sodium channel blockers, lumbar sympathetic blocks,
and spinal interventions. Although peripheral neuropathy has been
well studied and treated with spinal cord stimulation, using it for
treatment of erythromelalgia is novel.
Now… For the FUN STUFF!!!
OFF-LABEL USE of the
Spinal Cord Stimulator
Intractable, chronic, tension/cluster/
migraine/sinus headaches / Occipital
Neuralgia/ Temporal Arteritis
Chronic headache disorders are among the most debilitating
medical conditions worldwide with an estimated prevalence
of 47% of all adults having suffered at least one episode of
headache in the past 12 months. 10% of people are affected
by migraine alone. Up to 4% of the entire world’s adult
population suffer from headaches for 15 days each month!
(Data from the WHO, updated October, 2012:
http://www.who.int/mediacentre/factsheets/fs277/en/)
These headache states are often refractory to conventional
drug therapy. An emerging treatment for these patients in
whom medical management is insufficient is the implantation
of subcutaneous electrodes.
Sacral nerve stimulation can be a successful treatment for chronic Pelvic,
Perineal, Rectal, Post-Radiation Prostitis pain. In addition, it is a viable
therapeutic option for patients with pelvic pain that have failed spinal cord
stimulation trials with lead placement in the thoracic epidural space.
Angina Pectoris / Thoracic Chest Wall Pain
MORE off-label use of the SCS:
• Trigeminal Neuralgia/Facial Pain/TMJ
Syndrome
• Post-Herpetic Neuralgia (PHN)
• Neck/thoracic pain with/without
cervical/thoracic radiculopathy
• Phantom limb pain
• Hyperhidrosis
• Neurogenic Bladder
Chronic Abdominal Pain / Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a disorder that leads to debilitating
symptoms including abdominal pain and cramping and changes in
bowel movements affecting approximately 1 in 6 people. As causes for
this condition continue to evolve, studies have linked visceral
hypersensitivity and spinal nociceptor hyper excitability between the
gastrointestinal system and nervous system.
The technical goals of electrical stimulation for pain management have
been to mask the perception of pain with stimulation-induced
paresthesia by disrupting pain signaling to the brain as well as
determining what drugs can be co-administered to enhance analgesia. A
more recent focus has been the optimization of electrical parameters for
treating neuropathic pain. Few studies have examined the modulatory
effect of an electrical field applied near the spinal cord on gene
expression. More recently, studies are showing that SCS has the ability
to modulate both pro- and anti-inflammatory gene expression,
particularly in interleukin-1ß (IL-1ß), interleukin-10 (IL-10), IL-6, and the
glia activation marker GFAP, with increasing current. This fosters a
better understanding of the mechanism behind SCS-induced analgesia.
Future of Neuromodulation:
 Dorsal Root Ganglion Stimulation
 Vagus Nerve Stimulation (for Epilepsy… or…
??Weightloss??)
 Burst waveform stimulation
 High frequency stimulation
 BONUS STIM???!!!
References
Aló K, Yland M, Charnov, J, Redko V. Multiple program spinal cord stimulation in the treatment of chronic pain:
follow-up of multiple program SCS. Neuromodulation. 1999;2(4):266 272.
Arnst, C. Conquering pain: new discoveries and treatments offer hope. Business Week. Available at:
http://www.businessweek.com/1999/99_09/b3618001.htm. Accessed January 11, 2009.
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.
Belgrade, Miles J; Cole, B. Eliot; McCarberg, Bill H. McLean, Michael J. Diabetic Peripheral Neuropathic Pain:
Case Studies. April 2006;81(4l,suppl):S26-S32.
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.
Dario A, Fortini G, Bertollo D, Bacuzzi A, Grizzetti C, Cuffari S. Treatment of Failed Back Surgery Syndrome.
Neuromodulation. 2001;4:105-110.
Gildenberg PL. History of electrical neuromodulation for chronic pain. Pain Medicine. 2006;7(S1):S7-S13
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.
References
Feler C, Garber J. Selective dermatome activation using a novel five-column spinal cord stimulation paddle lead: a case
series. Poster presented at: Annual meeting of the North American Neuromodulation Society; December 3-5, 2009, Las
Vegas, NV.
Hill, Catherine L., Gill, Tiffany K., Menz Hylton B., Taylor, Anne W. Journal of Foot and Ankle Research. 2008,
1:2doi:10.1186/1757-1146-1-2.
Holsheimer J, den Boer JA, Struijk JJ, Rozeboom AR. MR assessment of the normal position of the spinal cord
in the spinal canal. AJNR Am J Neuroradiol. 1994;15(5):951-959
Mironer E, Bernstein C, Ghodsi A, et al. Evidence for long-term efficacy of SCS in patients with FBSS or CRPS I or II. Poster
presented at: North American Neuromodulation Society; December 3-6, 2009; Las Vegas, Nevada.
Nicosia, Mareesa. Chronic pain sufferers hit hard by the spiraling economy. The Saratogian. May 3, 2009. Available at:
http://www.saratogian.com/articles/2009/05/03/news/doc49fd09f938b25829273434.prt. Accessed on January 11, 2010.
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.
Pain Management. Drug War Facts. Available at: http://www.drugwarfacts.org/cms/node/59. Accessed on:
January 11, 2009.
Pain Surveys. American Pain Foundation. Available at: http://www.painfoundation.org/newsroom/reporterresources/pain-surveys.html. Accessed on: January 11, 2009.
Peter D. Hart Research Associates. Americans talk about pain: a survey among adults nationwide. August 2003.
Available at: http://www.researchamerica.org/uploads/poll2003pain.pdf. Accessed January 19, 2010.
References
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.
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.
Zeigler, Dan MD Treatment of Diabetic Neuropathy and Neuropathic Pain. Diabetes Care. Feb 2008;Volume 31,
Supplement 2, pg S255.
THANK YOU FOR YOUR TIME
The End
Questions?
54