Transcript Types of Pain

Medtronic Pain Therapies
Referral Strategies for Managing Chronic Pain
© Medtronic, Inc. 2008
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Agenda
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Types of Pain
Common Chronic Pain Conditions
Introduction to Medtronic Neurostimulation
Introduction to Medtronic Intrathecal Drug Delivery
Patient Selection
Neurostimulation Clinical Evidence
Intrathecal Drug Delivery Clinical Evidence
Role of Interventional Pain Specialist
Case Study
© Medtronic, Inc. 2008
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Types of Pain
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Pain Definitions
• The IASP defines pain as “an unpleasant sensory and
emotional experience associated with actual or perceived
tissue damage or described in terms of such damage”1
• Pain can be classified according to primary etiology2
– Neuropathic
– Nociceptive
– Mixed neuropathic and nociceptive
• All types of pain can also be classified by duration3
– Acute: less than 6 weeks
– Sub-acute: between 6 weeks and 3 months
– Chronic: lasting > 3-6 months
© Medtronic, Inc. 2008
1
Merskey H, Bogduk N, eds. Classification of Chronic Pain, 2nd Ed. IASP Press Seattle, 1994
2 Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374
3 Koes BW, et al. Br Med J. 2006;332:1430-1434
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Types of Neuropathic Pain
• Direct nerve root injury: radiculopathy
– Battered root syndrome
– Perineural fibrosis
– Intrafascicular fibrosis
– Adhesive arachnoiditis
• Peripheral deafferentation
– Phantom limb pain
– Sympathetic-mediated pain syndrome
– Herpetic neuralgia
– Diabetic polyneuropathy
• Central deafferentation-thalamic stroke
© Medtronic, Inc. 2008
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374
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Types of Nociceptive Pain
• Mechanical low back pain
– Discogenic pain
– Joint pain
• Facet joint
• Sacroiliac joint
– Pseudoarthrosis
– Osteoporosis
– Musculoskeletal trauma
© Medtronic, Inc. 2008
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374
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Combined Nociceptive and
Neuropathic Pain
• Failed Back Surgery Syndrome (FBSS)*
• Idiopathic chronic pain syndrome
• Cancer pain
*Also referred to as “post-surgical chronic back pain”
© Medtronic, Inc. 2008
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374
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Chronic Pain
• Continuous or intermittent pain that has
persisted for at least 3-6 months
• Severe chronic pain results in high
disability and severe limitation of ability to
work or complete daily activities
© Medtronic, Inc. 2008
Smith BH, et al. Fam Pract. 2001;18:292-299
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Many Americans Suffer
• Approx. 30 million Americans suffer from moderate to
severe non-cancer-related chronic pain1
• Chronic pain results in over 40 million doctor visits and 515
million lost workdays annually2
• Approx. 300,000 back surgeries are performed in the U.S.
per year to treat chronic lumbar pain with failure rates as
high as 40%3
• The success rate decreases significantly with each
subsequent back surgery4
© Medtronic, Inc. 2008
1. Chronic Pain in America: Roadblocks to Relief, avail at www.ampainsoc.org; 2. Business Week, March 1, 1999; 3. Deer T, et al. Pain Med. 2004; 5:6-13;
4. Miller B, et al. Pain Practice. 2005;5:190-202
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Common Chronic
Pain Conditions
© Medtronic, Inc. 2008
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Chronic Pain Conditions
• Post-surgical chronic back pain or failed back
• Radicular pain syndrome or radiculopathies resulting in pain
secondary to failed back or herniated disk
• Postlaminectomy pain
• Multiple back operations
• Unsuccessful disk surgery
• Degenerative disk disease, herniated disk pain refractory to
conservative and surgical interventions
• Peripheral causalgia
• Epidural fibrosis
• Arachnoiditis or lumbar adhesive arachnoiditis
• Complex regional pain syndrome, reflex sympathetic
dystrophy or causalgia
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Complex Regional Pain Syndrome
(CRPS)
• Chronic pain syndrome characterized by severe pain with
autonomic changes in the painful region
• Affects up to 1.2 million Americans1-3
• Develops in response to a traumatic physical event (e.g.,
accident or medical procedure)
• May respond to neurostimulation therapy
© Medtronic, Inc. 2008
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Stanton-Hicks MD. An update interdisciplinary clinical pathway for CRPS: report of an expert panel. Pain Practice 2002; vol 2, no. 1. 1-16; 2 Reflex
Sympathetic Dystrophy Syndrome Association (RSDA). CRPS Treatment Guidelines. June 2006; 3 RSDA. CRPS/RSD Fact Sheet, CRPS Treatment
Guidelines. June 2006
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Failed Back Surgery Syndrome
• Structural causes can be identified
post-operatively by CT scan, MRI,
myelogram, or x-ray
• If no structural cause can be found,
persistent pain may be
neuropathic—caused by the
prolongation of the original condition
and/or by the additional physical
impact of invasive surgery
• Patients may be candidates for
neurostimulation therapy
© Medtronic, Inc. 2008
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Pain Management Treatment Options
Patients With Chronic Pain
Often Seek a Myriad of
Opinions and See
Numerous Physicians of
Varying Disciplines for
Treatment
Oral Meds
Chiropractic
Care
Nerve
Blocks
Fixation
Surgery
Corticosteroid
Injections
Repeated
Surgeries
Physical
Therapy
© Medtronic, Inc. 2008
De Andrés J, Van Buyten J-P. Pain Practice. 2006;6:39-45
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Barriers to Effective Pain Management
Factors
Barriers
Healthcare
System
• Low priority given to pain management
• Insurance company resistance
• Inconsistent availability of interventions
Healthcare
Professionals
• Insufficient knowledge of interventional pain management
• Lack of pain assessment skills
• Fear of regulatory oversight
• Overestimation of risk associated with prescribing opioids
Patients
• Problems in reporting pain
• Reluctance to take opioids
• Inability to comply with complex pain management
programs
© Medtronic, Inc. 2008
Lyn ME, Coyne PJ, Watson AC. Pain Management Issues for Cancer Survivors. Cancer Practice. May/June 2002;
Vol. 10, Suppl.1
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Is Oral Opioid Therapy Effective
for Chronic Pain?
• Short-term efficacy
– RCTs and observational studies demonstrate
improvement in pain
– No evidence to support dosing >180 mg
morphine equivalent per day
• Long-term efficacy
– No RCTs for longer than 8 months
– Overall evidence is weak
– No evidence of improved function
© Medtronic, Inc. 2008
Ballantyne JC, Mao J. N Engl J Med, 2003;349:1943-1953
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Pain Treatment Ladder
Device therapies are now
considered earlier in the
treatment continuum
© Medtronic, Inc. 2008
Stamatos JM, et al. Live Your Life Pain Free, October 2005. Based on the interventional pain management experience of
Dr. John Stamatos
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Introduction to
Medtronic Neurostimulation
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Neurostimulation Therapy
• Delivers small electrical signals to the
epidural space
• Inhibits pain signals before they reach
the brain and replaces them with a
tingling sensation that covers the
specific areas where pain was felt
• Indicated for treatment of chronic,
intractable pain of the trunk and/or
limbs, including unilateral or bilateral
pain
© Medtronic, Inc. 2008
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Neurostimulation Indication
Medtronic Neurostimulation Systems are
indicated for treatment of chronic,
intractable pain of the trunk and/or limbs,
including unilateral or bilateral pain
© Medtronic, Inc. 2008
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History of Neurostimulation
1962
1967
1970s
1980
1982
Today
First carotid sinus nerve stimulator
First “dorsal column” stimulator
Spinal cord stimulator widely used
Medtronic introduces first programmable
electrode system in U.S.
First clinical implant of Itrel® totally
implantable neurostimulator
More than 100,000 patients have received
Medtronic neurostimulation therapy for
chronic pain
© Medtronic, Inc. 2008
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Benefits of Neurostimulation
• An effective method of pain control for many
patients
• Reduces or eliminates pain medications
• Non-destructive and less invasive than surgical
alternatives
• Reversible – can be discontinued or surgically
removed
• Systems reprogrammable without surgery
• Trial helps assess patient response
• Patient control within physician-set limits
© Medtronic, Inc. 2008
Kumar K, Nath RK, Toth C. Deep Brain Stimulation for Intractable Pain: A 15-year experience. Neurosurgery. 1997
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Neurostimulation Trial
• Pain Therapy Trial provides an opportunity to
measure the effectiveness of neurostimulation
without making a long-term commitment
– Gauge patient response
– Provide an adjustment period
– Explore therapy parameters
– Improve therapy cost-effectiveness
• The goal is at least a 50% reduction in pain
without intolerable side effects
– Patient-specific goals may include less pain
reduction but improved quality of life
© Medtronic, Inc. 2008
Kumar K, et al. Neurosurgery. 2006;58:481-496
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Neurostimulation Trial
• A percutaneous lead is positioned
in the epidural space on the dorsal
aspect of the spinal cord at the
appropriate nerve root level(s)
• Electrical current from the lead
generates paresthesias that can be
adjusted in intensity and location to
achieve the best pain coverage
• Leads are attached to an external
pulse generator which supplies the
current
• Patients can adjust stimulation to
meet pain management needs
© Medtronic, Inc. 2008
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Neurostimulation Implantation
• An incision is made over the spine to
place lead
• A pocket is formed under the skin to
hold the neurostimulator
• The lead is tunneled under the skin
and connected to the neurostimulator
• The lead is connected to the
neurostimulator, incisions are closed,
and the procedure is complete
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Neurostimulation Procedure
Overview
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Some Risks of Neurostimulation
• Lead migration resulting in loss of pain
relief
• Intermittent or uncomfortable stimulation
• Stimulation in the wrong location
• Neurological damage during procedure
• Risk of infection at implantation
For complete list of risks/complications, refer to product package insert
© Medtronic, Inc. 2008
North R, Kidd D, Zahurak M, et al. Neurosurgery. 1993;32:384-395.
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RESTOREULTRA® System
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Introduction to
Medtronic Intrathecal
Drug Delivery
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Intrathecal Drug Delivery (IDD) Therapy
• IDD therapy involves the
delivery of pain medicine in
the intrathecal space
• The pump is connected to a
thin, flexible catheter; both
are implanted under the skin
• Smaller doses of medication
are needed for effective pain
relief because drug is
delivered directly to the pain
receptors
© Medtronic, Inc. 2008
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Synchromed® II Drug Infusion
System Indications
• Chronic intrathecal infusion of preservative-free
morphine sulfate sterile solution in the treatment
of chronic intractable pain
• Also indicated for chronic intrathecal infusion of
Lioresal® Intrathecal (baclofen injection) for
severe spasticity, chronic epidural infusion of
preservative-free morphine sulfate sterile
solution in the treatment of chronic intractable
pain, and chronic intrathecal infusion of
preservative-free ziconotide sterile solution for
the management of severe chronic pain
© Medtronic, Inc. 2008
Lioresal® is a registered trademark of Novartis Pharmaceuticals, Inc.
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History of Intrathecal Drug Delivery
1982
1988
1991
Today
• First clinical implant of programmable
pump (became SynchroMed pump) for
intrathecal morphine
• Market release of implantable
programmable SynchroMed Pump (IV
use for cancer chemotherapy)
• Market release of SynchroMed Pump
(intrathecal morphine for cancer pain
and non-malignant pain)
• More than 100,000 patients worldwide
have a Medtronic pump for chronic pain
© Medtronic, Inc. 2008
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Approximate Equivalent Daily
Doses of Morphine
Route of Administration
Relative Potency (mg)*
Oral
Intravenous
Epidural
Intrathecal
300
100
20
1
*Relative approximations based on clinical observations
© Medtronic, Inc. 2008
Lamer TJ: Mayo Clin Proc. May 1994;69(5):473-80.
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Benefits of IDD Therapy
• Pain relief for patients who have not received adequate
relief with conventional therapies
• Reduction in adverse effects from oral opioids such as
nausea, vomiting, sedation, and constipation
• Decreased or elimination of oral analgesics
• Increased ability to perform activities of daily living
• Patient control within physician-set limits
• May be effective for patients who do not experience relief
from neurostimulation therapy
© Medtronic, Inc. 2008
Lamer TJ: Mayo Clin Proc. May 1994;69(5):473-80; Paice JA, et al: J Pain Symptom Manage.1996;11(2):71-80.
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IDD Trial
• The purpose of the trial is to assess the efficacy
and side effects of intrathecal morphine
• Trialing methods include
– Continuous epidural
– Continuous intrathecal
– Bolus epidural
– Bolus intrathecal
• Patients who report at least 50% reduction in
pain may be candidates for long-term therapy
© Medtronic, Inc. 2008
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IDD Implantation
• An incision is made over the spine for
insertion of the catheter
• A pocket is formed under the skin to hold
the IDD pump
• The catheter is tunneled under the skin
and connected to the IDD pump,
incisions are closed, and the procedure is
complete
© Medtronic, Inc. 2008
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Implant Procedure for IDD
© Medtronic, Inc. 2008
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IDD Therapy Risks
•
•
•
•
•
•
Programming error
Drug concentration error
Surgical complications, such as infection
Catheter could become dislodged or blocked
The pump could stop working
Other side effects may occur
For complete list of risks/complications, refer to product package insert
© Medtronic, Inc. 2008
Onofrio BM, Yaksh TL. J Neurosurg 1990;72:200-209; Winkelmueller M, Winkelmueller W. J Neurosurg 1996;85:458-467;
Paice JA, Penn RD, Shott S. J Pain Symptom Manage 1996;11(2):71-80
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SynchroMed II Infusion System
© Medtronic, Inc. 2008
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Medtronic Pain Therapy Portfolio
The most comprehensive line of medical
devices for management of chronic pain
• Neurostimulation
– Rechargeable and Nonrechargeable neurostimulation
systems
– mySTIM® patient programmer
• Intrathecal Drug Delivery
– Programmable pump
– myPTM™
© Medtronic, Inc. 2008
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Patient Selection
© Medtronic, Inc. 2008
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Indications for Neurostimulation and
Intrathecal Drug Delivery Therapy
© Medtronic, Inc. 2008
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362. Refer to full prescribing information for Medtronic
Neurostimulation Systems and Synchromed® II and Isomed® Drug Infusion Systems
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Patient Selection Considerations
• Patients who have neuropathic pain in a
concordant anatomic distribution respond best
to neurostimulation (NS) therapy
• Patients who have nociceptive pain in a
concordant distribution respond best to
Intrathecal Drug Delivery (IDD)
• Patients who do not respond well to NS may be
candidates for IDD therapy
© Medtronic, Inc. 2008
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.
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Patient Selection Checklist
 Failure of oral/transdermal opiate use or
undesirable side effects
 More conservative therapies have failed
 An observable pathology exists that is
concordant with the pain complaint
 Further surgical intervention is not indicated
 No serious untreated drug habituation exists
 Psychological evaluation and clearance for
implantation has been obtained
 No contraindications to implantation exist
 Refer Patient for a Pain Therapy Trial
© Medtronic, Inc. 2008
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.
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Neurostimulation
Clinical Evidence
© Medtronic, Inc. 2008
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Medtronic PROCESS Study
• Primary outcome
– Number of patients with ≥50% leg pain relief at 6
months (≥50% reduction in leg VAS)
• Secondary outcomes evaluated at 1, 3, 6, 9, 12, 18
and 24 months
– Pain relief (leg and axial back VAS)
– Quality of life (SF-36 and EQ-5D)
– Function (Oswestry Disability Index)
– Patient satisfaction
– Need for drug or non-drug therapy for pain
– Time away from work
– Adverse events
© Medtronic, Inc. 2008
Kumar, et al. Pain 2007
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Clinically Significant Leg Pain Relief
Key Findings:
≥50% leg pain relief
at 24 months,
continued greater
effect with SCS* in
the per treatment/ITT
analyses over 24
months
*SCS (spinal cord
stimulation) is a term for
neurostimulation
© Medtronic, Inc. 2008
Kumar, et al. Pain 2007; n = 100
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Significant Improvement in Function
Key Findings: Significant improvement in function (Oswestry Disability
Index) in SCS+CMM group over 24 months
© Medtronic, Inc. 2008
Kumar, et al. Pain 2007; n = 100
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Significant Improvement
in Quality of Life
Key Findings:
Significant
improvement in
SCS+CMM group in
7/8 domains of QoL
(SF-36) over 24
months
Visual Analog Scale (VAS)
© Medtronic, Inc. 2008
Kumar, et al. Pain 2007
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High Satisfaction
Key Findings:
Treatment
satisfaction
among patients
continuing
SCS+CMM at 24
months
© Medtronic, Inc. 2008
Kumar, et al. Pain 2007; n = 100
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Long-Term Pain Relief
Key Findings:
Pain Relief (%)
100
75
61.3
59.3
50
25
0
Patients (%)
FBSS with unilateral limb pain
61.3% of failed back
surgery syndrome
patients with
bilateral limb pain
and 59.3% of
patients with
unilateral limb pain
reported >50%
FBSS with bilateral limb pain
© Medtronic, Inc. 2008
Kumar, et al. Neurosurgery 2006
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Neurostimulation is Most Effective
When Considered Early
90%
85%
78%
80%
Success Rate (%)
70%
60%
50%
42%
35%
40%
30%
20%
10%
9%
11-15
>15
10%
0%
<2
2-5
5-8
8-11
Time Until Intervention (Yrs)
© Medtronic, Inc. 2008
Kumar K, et al. Neurosurg. 2006;58;481-496
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More Effective than Repeat Surgery
Key Findings:
Among patients available for
long-term follow up, SCS was
significantly more successful
than reoperation: 9 (47%) of
19 patients randomized to
SCS and 3 (12%) of 26
patients randomized to
reoperation achieved at least
50% pain relief and were
satisfied with treatment
© Medtronic, Inc. 2008
North, et al. Neurosurgery 2005 ; n=45
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10-Year Experience:
Improvement %
Neurostimulation Improves Quality of Life
50%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
Increased
Ability to
Independence
Relax
Daily
Activities
27%
Leisure
Time
27%
Social
Activities
30%
42%
44%
QoL Parameters
© Medtronic, Inc. 2008
Van Buyten J-P, et al. Eur J Pain 2001;5:299-307; n=125 pain cases; P<0.01 for all activities
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Intrathecal Drug Delivery
Clinical Evidence
© Medtronic, Inc. 2008
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Back and Leg Pain Relief
Key Findings:
Numeric back pain
ratings decreased
>48%, and leg pain
ratings decreased
by 32% at 12-month
follow up
© Medtronic, Inc. 2008
Deer, et al. Pain Medicine 2004; n=136
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Successful Disability Reduction
Key Findings:
Successful disability
reduction was
reported in 60% of
patients at 6 months
and in 66% at 12
months
© Medtronic, Inc. 2008
Deer, et al. Pain Medicine 2004; n=136
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Decreased Use of Pain Medications
88.2% of
patients were
taking systemic
opioids at
baseline
Key Findings:
At 6 months, 65% of
patients decreased
their use of systemic
opioids from baseline
At 12 months, 42% of
patients decreased
their usage compared
with the 6-month
follow up
© Medtronic, Inc. 2008
Deer, et al. Pain Medicine 2004; n=136
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Overall Global Pain Relief
Key Findings:
Number of Patients
Overall pain relief
of ≥50% was
reported by 82% of
patients (40 of 49)
Global Pain Relief (%)
© Medtronic, Inc. 2008
Roberts, et al., European Journal of Pain; n=88
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Clinical Evidence Summary
Neurostimulation
• Clinically significant leg
pain relief
• Significant improvement
– Function
– Quality of life
• High satisfaction
• Long-term pain relief
• Most effective when
considered early
• More effective than
repeat surgery
Intrathecal Drug Delivery
• Back and leg pain relief
• Successful disability
reduction
• Decreased use of pain
medication
• Overall pain relief
© Medtronic, Inc. 2008
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Clinical Evidence Risks
As with any surgical procedure, neurostimulation and
IDD involve the risk of infection. Lead migration is the
most common complication associated with
neurostimulation,1 while intrathecal catheters can
fracture, kink, and migrate.2 For a complete list of
adverse events for implantable therapies, see the
appropriate product labeling.
© Medtronic, Inc. 2008
1. Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review J Neurosrug (Spine 3)
100:254-267, 2004; 2. Staats P. Complications of intrathecal therapy. Pain Medicine 2008; 9(S1):S102-S107
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Role of Interventional
Pain Specialist
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A Multidisciplinary Team Approach
Complex Patient Problem = Interdisciplinary Management
Physiological
Factors
Social
Factors
Psychological
Factors
Cross-Dialogue Is Imperative for
Successful Pain Management
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Practice Management Collaboration
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Interventional Pain Specialist
Pain Management Approach
• Recognizes unique benefits of technological advances
and interventions
• Communicates with all concerned parties to ensure best
treatment possible
• Develops follow-up plan once pain successfully treated
• Collaborates with referring physician when treatment
overlaps with general health care
• Follows up with referring physician once pain is controlled
© Medtronic, Inc. 2008
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Interventional Pain Specialist
Key Questions
•
•
•
•
•
What types of pain are treated?
How are services offered?
Which treatments are offered?
What type of follow-up is offered?
Does the pain specialist:
– Provide 24/7 coverage?
– Have privileges at your admitting hospital?
– Provide inpatient coverage for hospitalized
patients?
© Medtronic, Inc. 2008
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Interventional Pain Specialist
Referral Criteria
•
•
•
•
Multiple symptoms or pain sources
Conservative therapies not working
Patient’s functional status deteriorated
Uncomfortable prescribing or monitoring
opioids
© Medtronic, Inc. 2008
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Device Therapy Referral
Interventional Pain Specialist Role
• Conduct a thorough patient history and physical
exam
• Develop an interventional pain treatment plan
• Conduct a Medtronic Pain Therapy trial
• Perform the Medtronic Pain Therapy
implantation or refer after the trial
• Develop a follow-up plan with the patient
© Medtronic, Inc. 2008
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Summary
• With today’s treatments, patients should not
have to wait for effective pain relief
• By partnering, we can help patients find the right
pain treatment
• Together we can improve the quality of life for
chronic pain patients
• Our decisions may change the course of a
patient’s life
© Medtronic, Inc. 2008
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Case Study
© Medtronic, Inc. 2008
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Case Study
Male, 45, office manager, no major psychosocial issues
• One spine surgery to treat herniated disc
• Referred from primary care physician to address axial back
pain and secondary radicular pain that persists six months
following anatomically corrective surgery
• Average back pain score (VAS) of 80/100 with diminished
functional capacity
• Relief from physical rehabilitation therapy was not satisfactory
• Unsuccessfully treated with neuropathic pain agents and two
systemic opioids, patient experienced extreme sedation and
constipation
• Treated with nerve block series but relief was temporary
© Medtronic, Inc. 2008
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SynchroMed® Infusion System
Brief Summary
•
•
•
•
•
•
Indications:
US: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the
treatment of chronic intractable pain, chronic intrathecal infusion of preservative-free ziconotide sterile solution for the
management of severe chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for
the management of severe spasticity; chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the
treatment of primary or metastatic cancer. Outside of US: Chronic infusion of drugs or fluids tested as compatible
and listed in the product labeling.
Contraindications:
When infection is present; when the pump cannot be implanted 2.5 cm or less from the surface of the skin; when
body size is not sufficient to accept pump bulk and weight; when contraindications exist relating to the drug; drugs
with preservatives. Do not use the Personal Therapy Manager accessory to administer opioid to opioid-naïve
patients or to administer ziconotide.
Warnings:
Comply with all product instructions for initial preparation and filling, implantation, programming, refilling,
and injecting into the catheter access port (CAP) of the pump. Failure to comply with all instructions can
lead to technical errors or improper use of implanted infusion pumps and result in additional surgical
procedures, a return of underlying symptoms, or a clinically significant or fatal drug under- or overdose.
Refer to the appropriate drug labeling for specific under- or overdose symptoms and methods of management. Avoid
using short wave (RF) diathermy within 30 cm of the pump or catheter. Diathermy may produce significant
temperature rises in the area of the pump and continue to heat the tissue in a localized area. If overheated, the pump
may over infuse the drug, potentially causing a drug overdose. Effects of other types of diathermy (microwave,
ultrasonic, etc.) on the pump are unknown. An inflammatory mass that can result in serious neurological impairment,
including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients on intraspinal
therapy carefully for any new neurological signs or symptoms. For intraspinal therapy, use only preservative-free
sterile solution indicated for intraspinal use. Use only Medtronic components indicated for use with this system.
Failure to firmly secure connections can allow drug or cerebrospinal fluid (CSF) leakage into tissue and result in
tissue damage or inadequate therapy. A postoperative priming bolus should not be programmed if the pump is a
replacement and the catheter has not been aspirated.
© Medtronic, Inc. 2008
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SynchroMed® Infusion System
Brief Summary continued
Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening
procedures. Physicians must be familiar with the drug stability information in the technical manual and must understand the dose relationship to
drug concentration and pump flow rate before prescribing pump infusion. Implantation and ongoing system management must be performed by
individuals trained in the operation and handling of the infusion system. Inform patients of the signs and symptoms of drug under- or overdose,
appropriate drug warnings and precautions regarding drug interactions, potential side effects, and signs and symptoms that require medical
attention. Instruct patients to notify their clinician of travel plans, to return for refills at prescribed times, avoid activities such as strenuous
exercise or contact sports that jar, impact, twist, or stretch the body, to always carry their Medtronic device identification card, to avoid
manipulating the pump through the skin, and to notify healthcare professionals of the implanted pump before medical tests/procedures. Patients
must consult their physician before engaging in activities involving pressure or temperature changes (e.g., scuba diving, saunas, hot tubs,
hyperbaric chambers, flights, skydiving, etc.) Inform patients that pump has an Elective Replacement Indicator (ERI) that sounds when the
pump is nearing its end of service. When the alarm sounds, patients must contact their doctor to schedule pump replacement.
Precautions:The pump is ethylene oxide sterilized. Do not use if the product or package is damaged, the sterile seal is broken, or the “Use By” date
has expired. Do not reuse or resterilize the pump; it is intended for “single use only.” Do not expose the pump to temperatures above 43°C or
below 5°C. Consider use of peri- and post-operative antibiotics for pump implantation, for any subsequent surgical procedure, or if infection is
present. For patients prone to CSF leaks, clinicians should consider special procedures, such as a blood patch. Follow instructions for emptying
and filling the pump during a replacement or revisions that require removal of the pump from the pocket. Explant the pump postmortem if
incineration is planned (to avoid explosion), or if local environmental regulations mandate removal. Return explanted devices to Medtronic for
analysis and safe disposal. Do not implant a pump dropped onto a hard surface or showing signs of damage. Implant the pump less than 2.5
cm from the surface of the skin. Ensure pump ports will be easy to access after implant, that the catheter is not kinked and secured well away
from pump ports before suturing. Keep the implant site clean, dry, and protected from pressure or irritation. If therapy is discontinued for an
extended period of time, fill the reservoir with preservative-free saline in intraspinal applications or appropriate heparinized solution (if not
contraindicated) in vascular applications. The magnetic field or telemetry signals produced by the programmer may cause sensing problems
and inappropriate device responses with an implantable pacemaker and/or defibrillator. Electromagnetic interference (EMI) is an energy field
generated by equipment found in the home, work, medical, or public environments. Most EMI normally encountered will not affect the operation
of the pump. Exceptions include: injury resulting from heating of the pump which can damage surrounding tissue (diathermy, MRI), system
damage which can require surgical replacement or result in loss/change in symptom control (defibrillation, electrocautery, high-output
ultrasonics, radiation therapy), and operational changes to the pump causing the motor to stop, loss of therapy, return of underlying symptoms,
and require confirmation of pump function (diathermy, high magnetic field devices, hyperbaric/hypobaric conditions, magnetic resonance
imaging (MRI)). MRI will temporarily stop the pump motor’s rotor due to the magnetic field of the MRI scanner and suspend drug infusion during
MRI exposure which will cause the pump alarm to sound. The pump should resume normal operation upon termination of MRI exposure. Prior
to MRI, the physician should determine if the patient can safely be deprived of drug delivery. If not, alternative delivery methods for the drug can
be utilized during the MRI scan. Prior to scheduling an MRI scan and upon its completion, pump status should be confirmed.
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SynchroMed® Infusion System
Brief Summary continued
Adverse Events:
Include, but are not limited to, cessation of therapy due to end of device service life or component failure, change in flow
performance due to component failure, inability to program the device due to programmer failure, CAP component
failure; inaccessible refill port due to inverted pump, pocket seroma, hematoma, erosion, infection, post-lumbar
puncture (spinal headache), CSF leak, radiculitis, arachnoiditis, bleeding, spinal cord damage, meningitis (intrathecal
applications), anesthesia complications, damage to the pump, catheter and catheter access system due to improper
handling and filling before, during, or after implantation; change in catheter performance due to catheter kinking,
disconnection, leakage, breakage, occlusion, dislodgement, migration, or catheter fibrosis; body rejection
phenomena, surgical replacement of pump or catheter due to complications; local and systemic drug toxicity and
related side effects, complications due to use of unapproved drugs and/or not using drugs in accordance with drug
labeling, or inflammatory mass at the tip of the catheter.
!USA Rx Only
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Neurostimulation Systems for Pain
Therapy Disclosure
Brief Summary: Product Technical Manuals and Programming Guides must be reviewed prior to use for detailed
disclosure.
Indication for Use - Chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
Contraindications: Diathermy. Warnings: Defibrillation, diathermy, electrocautery, MRI, RF ablation, & therapeutic
ultrasound can result in unexpected changes in stimulation, serious patient injury or death. Rupture/piercing of
neurostimulator can result in severe burns. Electrical pulses from the neurostimulator may result in an inappropriate
response of the cardiac device. Precautions: The safety and effectiveness of this therapy has not been established
for: pediatric use, pregnancy, unborn fetus, or delivery. Follow programming guidelines & precautions in product
manuals. Avoid activities that stress the implanted neurostimulation system. EMI, postural changes, & other activities
may cause shocking/jolting. Adverse Events: Undesirable change in stimulation; hematoma, epidural hemorrhage,
paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at
implant site, loss of pain relief, chest wall stimulation, & surgical risks.
For full prescribing information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at
www.medtronic.com. Rx Only. November, 2007
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Thank You
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