Transcript Practice Growth Strategies - Medical Advanced Pain Specialists

Implementing CDC Guidelines:
Responsible Opioid Prescribing
Opioid Taper Tools
[email protected]
Mobile 941 744 6960
Objectives
• Understand the scope of appropriate
prescribing and the economics of opioids
• Understand the philosophy and research of
data that led to the CDC guidelines
• Understand how to implement the new
guidelines in a busy practice
National Overdose Deaths
Number of Deaths from Prescription Drugs
30,000
25,000
Total
Female
Male
• 47,055 US deaths from drug overdoses in 2014
• 61% from opioids including heroin
• Deaths related to prescription opiates increased by 16% to 18,893
20,000
15,000
10,000
5,000
0
Source: National Center for Health Statistics, CDC Wonder
Deaths from Heroin
(2001-2014: 6 fold increase)
12,000
10,000
8,000
6,000
4,000
2,000
0
Total
Female
Male
61% from opioids including heroin
Many of these individuals started off with prescription opioids!
Mostly men but recent surge in women’s death due to heroin
Deaths from Prescription Opioids
(2001-2014 : Increased 3.4 fold)
20,000
Total
Female
Male
18,000
16,000
14,000
12,000
10,000
8,000
6,000
4,000
2,000
0
Source: National Center for Health Statistics, CDC Wonder
Deaths from Prescription Benzodiazepines
2001-2014 : Increased 5 fold
9,000
Total
Female
Male
8,000
7,000
6,000
5,000
4,000
3,000
2,000
1,000
0
Source: National Center for Health Statistics, CDC Wonder
For Context: Deaths from
Cocaine
2001-2014 : Increased 42%
8,000
Total
Female
Male
7,000
6,000
5,000
4,000
3,000
2,000
1,000
0
Source: National Center for Health Statistics, CDC Wonder
US opioid Rx (2009): 238-257m1, 2
Unique US opioid patients: 32m3
Opioid patients at high
risk for overdose: 16m+1,4
ER visits: 500k5
Fatalities:
19k6
The majority of deaths
(60%) occur in patients
when they are given
prescriptions based on
prescribing guidelines
by medical boards2
1: SDI/Vector data – FDA presentation, July 2010;
2. Manchikanti L et al. Opioid epidemic in the US. Pain Physician 15: ES9-38; 2012
3. 2: Wolters Kluwer, 10/12
4. Leider et al, AJMC vol17, No.1
5. GAO Report: Rx Pain Reliever Abuse
6 CDC December 18, 2015 (2014 data)
825 Non medical users
130 misuse or abuse
32 Emergency room
visits
10 Hospital
admissions
1 Death
Where are the savings?
Where are the savings?
..Look at Opioid related costs
• $20.4 billion per year in 2009
– $2.2 billion direct costs
• inpatient, ED, MDs, ambulance
– $18.2 billion indirect costs
• lost productivity from absenteeism and mortality
• $37,274 cost per opioid overdose event
Inocencio TJ et al. Pain Medicine 2013
The opioid tolerant patient
Definitions and clinical implications
• Dependence: physical or psychological (risk of withdrawal)
• Tolerance: increased dosage to get original effect
• Addiction: aberrant drug-seeking, drug-taking behavior, compulsive drug use
• Pseudoaddiction: secondary to inadequate analgesia (similar behavioural
changes as with addiction)
• Withdrawal syndrome: predictable constellation of signs, symptoms following
rapid discontinuation of opioids
• Opioid Induced Hyperalgesia: neuroplastic change in pain perceptionparadoxical effect of opioid (decreased efficacy)
Under normal conditions
1. Normally pain is carried by A-delta and c-fibers
Under normal conditions
1. Normally pain is carried by small fibers: A delta and c fibers
2. Touch and proprioception are carried by the larger A beta fibers
Central Hypersensitization occurs due to:
1. Glutamate/NMDA receptor-mediated sensitization
2. Disinhibition: Interneurons and descending inhibitory pathways
3. Microglial activation: Morphine hyperalgesia
Opioid-induced hyperalgesia
• Occurs in 35-40% patients on opiates
• OIH results from the release of
inflammatory cytokines from glial cells,
inducing hyperalgesia.
• DNIC are dampened
•
•
•
Hooten WM, Lamer TJ, Twyner C. Opioid-induced hyperalgesia in community-dwelling adults with chronic pain. Pain.
2015; 156(6):1145–1152.
Suzan E, Eisenberg E, Treister R, Haddad M, Pud D. A negative correlation between hyperalgesia and analgesia in
patients with chronic radicular pain: Is hydromorphone therapy a double-edged sword? Pain Physician. 2013;
16(1):65–76.
Ram KC, Eisenberg E, Haddad M, Pud D. Oral opioid use alters DNIC but not cold pain perception in patients with
chronic pain - new perspective of opioid-induced hyperalgesia. Pain. 2008; 139(2):431–438.
Opioid-induced hyperalgesia
Following peripheral nerve injury, spinal release of danger-associated
molecular patterns (DAMPs) activates the Toll-like receptor 4 (TLR4)
signaling pathway, resulting in spinal microglial reactivity.
Opioids also activate TLR4, leading to release of pro-inflammatory
mediators (including Interleukin 1β [Il-1β] and Nuclear Factor NF-κB).
Previous research has described a “two-hit hypothesis of microglial
priming” in which the neuroinflammatory response is enhanced upon
secondary challenge.
In this model, peripheral nerve injury-related neuropathic pain is
considered 'hit 1;' this pain can be exacerbated by opioid treatment
(hit 2).
Wang X, Loram LC, Ramos K, et al. Morphine activates neuroinflammation in a manner parallel to endotoxin. Proc Natl
Acad Sci USA. 2012;109(16):6325-6330.
Frank MG, Baratta MV, Sprunger DB, Watkins LR, Maier SF. Microglia serve as a neuroimmune substrate for stress-induced
potentiation of CNS pro-inflammatory cytokine responses. Brain Behav Immun. 2007; 21(1):47–59.
Acute to Chronic Pain Cycle
Pathophysiology of Maintenance:
-Radiculopathy
-Neuroma traction
-Myofascial sensitization
-Brain pathology (loss, reorganization)
Psychopathology
of maintenance:
Acute injury
-Encoded anxiety
and pain
dysregulation
- PTSD
-Emotional
allodynia
-Mood disorderNeurogenic
Inflammation:
Secondary
Pathology:
-Muscle atrophy,
weakness;
-Bone loss;
-Depression
-Cortical atrophy
Central
sensitization
Disability
- Less active,
Kinesiophobia
- Decreased
motivation
- Increased
isolation
- Role
loss
Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain:
risk factors and
protective
Peripheral
Sensitization:
Na+ channels
Lower threshold
- Glial activation
- Pro-inflammatory
cytokines
factors.Expert Rev Neurother. 2009;9(5):723-44.
- blood-nerve barrier Yarnitsky D. Conditioned pain modulation (the diffuse noxious inhibitory control-like effect): its
relevance for acute and chronic pain states. Curr Opin Anaesthesiol. 2010;23(5):611-5.
Hermans L, Van Oosterwijck J, Goubert D, et al. Inventory of Personal Factors Influencing
dysruption
Conditioned Pain Modulation in Healthy People: A Systematic Literature Review. Pain Pract.
2016;16(6):758-69.
CDC Recommendations #1-3
Determining When to Initiate or Continue Opioids for Chronic Pain
1.
2.
3.
Nonpharmacologic therapy and non-opioid pharmacologic therapy are
preferred for chronic pain. Clinicians should consider opioid therapy only if
expected benefits for both pain and function are anticipated to outweigh
risks to the patient. If opioids are used, they should be combined as
appropriate.
Before starting opioid therapy for chronic pain, clinicians should establish
treatment goals with all patients, including realistic goals for pain and
function, and should consider how therapy will be discontinued if benefits
do not outweigh risks. Clinicians should continue opioid therapy only if
there is clinically meaningful improvement in pain and function that
outweighs risks to patient safety.
Before starting and periodically during opioid therapy, clinicians should
discuss with patient’s known risks and realistic benefits of opioid therapy
and patient and clinician responsibilities for managing therapy.
CDC Recommendations #4-7
Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation
4.
When starting opioid therapy for chronic pain, clinicians should prescribe immediaterelease opioids instead of extended-release/long-acting (ER/LA) opioids.
5.
When opioids are started, clinicians should prescribe the lowest effective dosage.
Clinicians should use caution when prescribing opioids at any dosage, should carefully
reassess evidence of individual benefits and risks when increasing dosage to ≥50
morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90
MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day.
6.
Long-term opioid use often begins with treatment of acute pain. When opioids are
used for acute pain, clinicians should prescribe the lowest effective dose of immediaterelease opioids and should prescribe no greater quantity than needed for the expected
duration of pain severe enough to require opioids. Three days or less will often be
sufficient; more than seven days will rarely be needed.
7.
Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of
starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate
benefits and harms of continued therapy with patients every 3 months or more
frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians
should optimize other therapies and work with patients to taper opioids to lower
dosages or to taper and discontinue opioids.
CDC Recommendations #8-12
Assessing Risk and Addressing Harms of Opioid Use
8.
Before starting and periodically during continuation of opioid therapy, clinicians should evaluate
risk factors for opioid-related harms. Clinicians should incorporate into the management plan
strategies to mitigate risk, including considering offering naloxone when factors that increase
risk for opioid overdose, such as history of overdose, history of substance use disorder, higher
opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present.
9.
Clinicians should review the patient’s history of controlled substance prescriptions using state
prescription drug monitoring program (PDMP) data to determine whether the patient is
receiving opioid dosages or dangerous combinations that put him or her at high risk for
overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and
periodically during opioid therapy for chronic pain, ranging from every prescription to every 3
months.
When prescribing opioids for chronic pain, clinicians should use urine drug testing before
starting opioid therapy and consider urine drug testing at least annually to assess for prescribed
medications, as well as other controlled prescription drugs and illicit drugs.
10.
11.
Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently.
8.
Clinicians should offer or arrange evidence-based treatment (usually medication-assisted
treatment with buprenorphine or methadone in combination with behavioral therapies) for
patients with opioid use disorder.
CDC advises that we use Best Practices:
Assess Benefits: 30% improvement in pain and function?
Without opioids
With Opioids
Average Pain
Score
Enjoyment of
Life
General
Activity
Total
Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal
important change. Spine (Phila Pa 1976) 2008;33:90–4.
Krebs EE, Lorenz KA, Bair MJ, et al. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med
2009;24:733–8.
CDC 2016 article advocates:
• Shorter acting, NOT longer acting drugs
– “Time-scheduled opioid use was associated with substantially higher
average daily opioid dosage than as-needed opioid use in one study”
• Avoidance of methadone
– “Methadone accounts for as much as a third of opioid-related
overdose deaths despite representing <2% of opioid prescriptions.”
Von Korff M, Merrill JO, Rutter CM, Sullivan M, Campbell CI, Weisner C. Time-scheduled vs. pain-contingent opioid dosing in chronic opioid therapy. Pain
2011;152:1256–62
Paulozzi L, Mack KA, Jones CM. Vital signs: risk for overdose from methadone used for pain relief—United States, 1999–2010. MMWR Morb Mortal Wkly
Rep 2012;61:493–7
CDC 2016:
• Naloxone is an opioid antagonist that can
reverse severe respiratory depression;
• its administration by lay persons, such as
friends and family of persons who experience
opioid overdose, can save lives.
• Naloxone precipitates acute withdrawal among
patients physically dependent on opioids.
Serious adverse effects, such as pulmonary
edema, cardiovascular instability, and seizures
have been reported but are rare at doses
consistent with labeled use for opioid
overdose. (Enteen et al)
Enteen L , Bauer J, McLean R, et al. Overdose prevention and naloxone prescription for
opioid users in San Francisco. J Urban Health 2010;87:931–41
Walley AY, Xuan Z, Hackman HH, et al. Opioid overdose rates and implementation of
overdose education and nasal naloxone distribution in Massachusetts: interrupted time
series analysis. BMJ 2013;346:f174
ttp://prescribetoprevent.org
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PDMP, UDS, Functional scores
Below 120 MEDD. Never above 200MEDD
The Pain Generator Must be Adequately Evaluated
Non-opioid Options Need to be Presented to the Patient
Patient Criteria for Long Term Opioid Therapy?
Required Documentation and Management on Initial and Subsequent Visits for Patients on, or Starting, Chronic Opioids
Alternative Pain Medications to Opioids
Addiction, Pseudoaddiction and Aberrant Behaviors Definitions
Tapering and Discontinuing Opioids
When should Subspecialty Consultation be Considered?
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New rules on toxicology-They need education perhaps from our lab!
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http://dwd.wisconsin.gov/wc/medical/pdf/CHRONIC%20OPIOID%20CLINICAL%20MANAGEMEN
T%20GUIDELINES%20.pdf
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PDMP, UDS, Functional scores
Below 120 MEDD. Never above 200 MEDD
The Pain Generator Must be Adequately Evaluated
Non-opioid Options Need to be Presented to the Patient
Patient Criteria for Long Term Opioid Therapy?
Required Documentation and Management on Initial and Subsequent Visits for Patients on, or
Starting, Chronic Opioids
Alternative Pain Medications to Opioids
Addiction, Pseudoaddiction and Aberrant Behaviors Definitions
Tapering and Discontinuing Opioids
When should Subspecialty Consultation be Considered?
New rules on toxicology-They need education perhaps from our lab!
http://dwd.wisconsin.gov/wc/medical/pdf/CHRONIC%20OPIOID%20CLINICAL%20MANAGEMENT%20GUIDELINES%20.pdf
https://www.dhs.wisconsin.gov/publications/p01127.pdf Accessed 8/7/16
https://www.dhs.wisconsin.gov/publications/p01127.pdf Accessed 8/7/16
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1) Identify and treat the cause of the pain, use non-opioid therapies
Use non-pharmacologic therapies (such as yoga, exercise, cognitive behavioral therapy and
complementary/alternative medical therapies) and non-opioid pharmacologic therapies
(such as acetaminophen and anti-inflammatories) for acute and chronic pain. Don’t use
opioids routinely for chronic pain. When opioids are used, combine them with nonpharmacologic or non-opioid pharmacologic therapy, as appropriate, to provide greater
benefits.
2) Start low and go slow
When opioids are used, prescribe the lowest possible effective dosage and start with
immediate-release opioids instead of extended-release/long-acting opioids. Only provide the
quantity needed for the expected duration of pain.
3) Close follow-up
Regularly monitor patients to make sure opioids are improving pain and function without
causing harm. If benefits do not outweigh harms, optimize other therapies and work with
patients to taper or discontinue opioids, if needed.
http://wbay.com/2016/08/03/in-pain-new-wi-guidelines-have-doctors-trying-alternative-treatments-instead-of-pain-pills/
1) Identify and treat the cause of the pain, use non-opioid therapies
Use non-pharmacologic therapies (such as yoga, exercise, cognitive behavioral therapy and
complementary/alternative medical therapies) and non-opioid pharmacologic therapies
(such as acetaminophen and anti-inflammatories) for acute and chronic pain. Don’t use
opioids routinely for chronic pain. When opioids are used, combine them with nonpharmacologic or non-opioid pharmacologic therapy, as appropriate, to provide greater
benefits.
2) Start low and go slow
When opioids are used, prescribe the lowest possible effective dosage and start with
immediate-release opioids instead of extended-release/long-acting opioids. Only provide the
quantity needed for the expected duration of pain.
3) Close follow-up
Regularly monitor patients to make sure opioids are improving pain and function without
causing harm. If benefits do not outweigh harms, optimize other therapies and work with
patients to taper or discontinue opioids, if needed.
http://wbay.com/2016/08/03/in-pain-new-wi-guidelines-have-doctors-trying-alternative-treatments-instead-of-pain-pills/
1) Determining when to initiate or continue opioids
-Selection of non-pharmacologic therapy, non-opioid pharmacologic therapy, opioid therapy
-Establishment of treatment goals
-Discussion of risks and benefits of therapy with patients
2) Opioid selection, dosage, duration, follow-up and discontinuation
-Selection of immediate-release or extended-release and long-acting opioids
-Dosage considerations
-Duration of treatment
-Considerations for follow-up and discontinuation of opioid therapy
3) Assessing risk and addressing harms of opioid use
-Evaluation of risk factors for opioid-related harms and ways to mitigate/reduce patient risk
-Review of prescription drug monitoring program (PDMP) data
-Use of urine drug testing
-Considerations for co-prescribing benzodiazepines
-Arrangement of treatment for opioid use disorder
http://wbay.com/2016/08/03/in-pain-new-wi-guidelines-have-doctors-trying-alternative-treatments-instead-of-pain-pills/
1) Determining when to initiate or continue opioids
• -Selection of non-pharmacologic therapy, non-opioid pharmacologic therapy, opioid therapy
• -Establishment of treatment goals
• -Discussion of risks and benefits of therapy with patients
2) Opioid selection, dosage, duration, follow-up and discontinuation
• -Selection of immediate-release or extended-release and long-acting opioids
• -Dosage considerations
• -Duration of treatment
• -Considerations for follow-up and discontinuation of opioid therapy
3) Assessing risk and addressing harms of opioid use
• -Evaluation of risk factors for opioid-related harms and ways to mitigate/reduce patient risk
• -Review of prescription drug monitoring program (PDMP) data
• -Use of urine drug testing
• -Considerations for co-prescribing benzodiazepines
• -Arrangement of treatment for opioid use disorder
http://wbay.com/2016/08/03/in-pain-new-wi-guidelines-have-doctors-trying-alternative-treatments-instead-of-pain-pills/
Opioid Risk Tool (ORT)
Evidence
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Provides excellent discrimination between high risk and low risk patients (Passik, et al, 2008).
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Exhibited a high degree of sensitivity and specificity for determining which individuals are at risk for opioid abuse (Webster & Webster, 2005).
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Patients categorized as high-risk on the ORT have an increased likelihood of future abusive drug-related behavior (Chou et al., 2009).
Stanford Protocol for using the
Opioid Risk Tool (ORT)
Low risk : Primary care, watchful for
development of aberrant drug behaviors
– increase risk category
Moderate risk : Frequent visits, limit
opioid quantities, treat comorbid
depression, sleep disturbance. Involve
psychologist, mind fullness training,
biofeedback
High Risk: All the above, strict contracts
– with plan for discontinuation of opioid
Rx, pill/patch counts, frequent UDT, use
of extended release medications and a
thought out referral network (detox
specialist , psychiatrist etc)
CDC Advises that we use Best Practices:
PDMP, lowest dose and only quantity needed.
Case 1:
55 yo with Post laminectomy syndrome.
Oxycontin 30 bid , Hydrocodone 10 mg qid prn.
You want to decrease 10%
Case 2:
29 yo in your practice on Methadone 10 tid,
Fentanyl 75 mcg TTS every 3 days needs to be
tapered
Higher dosages haven’t been shown to reduce pain over the long term.
Clinicians should explain in a nonjudgmental manner to patients already taking high opioid
dosages (≥90 MME/day) that there is now an established body of scientific evidence
showing that overdose risk is increased at higher opioid dosages.
Clinicians should avoid increasing opioid dosages to ≥90 MME/day or should carefully justify
a decision to increase dosage to ≥90 MME/day based on individualized assessment of
benefits and risks.
37
55 yo with Post laminectomy syndrome. Oxycontin 30 bid ,
Hydrocodone 10 mg qid prn. You want to decrease 10%
30mg X 2 =60 mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR
Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
55 yo with Post laminectomy syndrome. Oxycontin 30 bid ,
Hydrocodone 10 mg qid prn. You want to decrease 10%
30mg X 2 =60 mg
60 mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR
Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
55 yo with Post laminectomy syndrome. Oxycontin 30 bid ,
Hydrocodone 10 mg qid prn. You want to decrease 10%
30mg X 2 =60 mg
60 mg
90 mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR
Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
55 yo with Post laminectomy syndrome. Oxycontin 30 bid ,
Hydrocodone 10 mg qid prn. You want to decrease 10%
10 mg X 4 =40mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR
Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
55 yo with Post laminectomy syndrome. Oxycontin 30 bid ,
Hydrocodone 10 mg qid prn. You want to decrease 10%
10 mg X 4 =40mg
40mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR
Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
55 yo with Post laminectomy syndrome. Oxycontin 30 bid ,
Hydrocodone 10 mg qid prn. You want to decrease 10%
10 mg X 4 =40mg
40mg
40mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR
Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
55 yo with Post laminectomy syndrome. Oxycontin 30 bid ,
Hydrocodone 10 mg qid prn. You want to decrease 10%
10 mg X 4 =40mg
30mg X 2 =60 mg
40mg
40mg
60 mg
90 mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States,
2016. MMWR Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpkpod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
55 yo with Post laminectomy syndrome. Oxycontin 30 bid ,
Hydrocodone 10 mg qid prn. You want to decrease 10%
10 mg X 4 =40mg
30mg X 2 =60 mg
40mg
40mg
60 mg
90 mg
130mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR
Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
55 yo with Post laminectomy syndrome. Oxycontin 30 bid , Hydrocodone 10 mg qid
prn. MEDD calculated is 130 mg, and You want to decrease 10% to 115MEDD
10 mg X 4 =40mg
30mg X 2 =60 mg
40mg
40mg
60 mg
90 mg
130mg
= 0.9 X 130mg = 117mg , round to 115mg mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR
Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
29 yo in your practice on Methadone 10 tid, Fentanyl 75
mcg TTS every 3 days needs to be tapered
METHADONE’S DISPROPORTIONATE
LETHALITY AND NON LINEAR CONVERSION
47
29 yo in your practice on Methadone 10 tid, Fentanyl
75 mcg TTS every 3 days needs to be tapered
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States,
2016. MMWR Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpkpod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
29 yo in your practice on Methadone 10 tid, Fentanyl
75 mcg TTS every 3 days needs to be tapered
75 mcg TTS q 3 days
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States,
2016. MMWR Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpkpod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
29 yo in your practice on Methadone 10 tid, Fentanyl
75 mcg TTS every 3 days needs to be tapered
75 mcg TTS q 3 days
75 mcg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States,
2016. MMWR Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpkpod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
29 yo in your practice on Methadone 10 tid, Fentanyl
75 mcg TTS every 3 days needs to be tapered
75 mcg TTS q 3 days
75 mcg
180mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States,
2016. MMWR Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpkpod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
29 yo in your practice on Methadone 10 tid, Fentanyl
75 mcg TTS every 3 days needs to be tapered
10mg X 3 per day = 30 mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States,
2016. MMWR Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpkpod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
29 yo in your practice on Methadone 10 tid, Fentanyl
75 mcg TTS every 3 days needs to be tapered
10mg X 3 per day = 30 mg
30 mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States,
2016. MMWR Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpkpod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
29 yo in your practice on Methadone 10 tid, Fentanyl
75 mcg TTS every 3 days needs to be tapered
10mg X 3 per day = 30 mg
30 mg
240 mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States,
2016. MMWR Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpkpod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
29 yo in your practice on Methadone 10 tid, Fentanyl
75 mcg TTS every 3 days needs to be tapered
75 mcg TTS q 3 days
180 mg
10mg X 3 per day = 30 mg
240 mg
420 mg MEDD
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States,
2016. MMWR Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpkpod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
29 yo in your practice on Methadone 10 tid, Fentanyl 75 mcg
TTS every 3 days equals 420 MEDD and 90% of this is 380mg
75 mcg TTS q 3 days
1mg X 3 per day = 30 mg
180 mg
240 mg
420 mg MEDD
90% is 380 mg
1. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States,
2016. MMWR Recomm Rep 2016;65:1–49. http://www.cdc.gov/media/modules/dpk/2016/dpkpod/rr6501e1er-ebook.pdf
2 . Buprenorphine conversion based on CMS 2015. https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf
Tapering Cheat Sheet
CDC ADVOCATES:
“Prescribe short acting opioids…
lowest dose…taper dose.”
“Check that non-opioid therapies
tried and failed…that non-opioid
therapies are optimized”
PATIENT CONVERSATIONS….
1. Based on new CDC guidelines….
2. I believe that your risk is….
3. Because of the deaths and
societal problems….
4. I am now required to explore….
5. I am requesting a pain consult to
explore non-opiate options.
6. Your PDMP suggests….
7. Your UDS has some
inconsistencies.
Chronic Pain and the Use of Opioids
Chronic Back Pain is a Debilitating and Socioeconomic Issue in the U.S.
• Roughly 8% of the adult population suffers from chronic neuropathic pain1,
the majority being lower back pain.2
• Cost of chronic pain is $600 Billion annually in the US3
Opioids are a Commonly Used Tool in the Management of
Chronic Pain
– More than half of the people regularly treated with
prescription opioid analgesics have chronic low back
pain.4
– However, there is limited long-term evidence that
supports the use of opioids for the management of
chronic pain4
1. Torrance, N. The epidemiology of chronic pain of predominantly neuropathic origin. J Pain. 2006 Apr;7(4):281-9.
2. Johannes, CB. The prevalence of chronic pain in United States adults: results of an Internet-based survey. J Pain. 2010 Nov;11(11):1230-9.
3. Committee on Advancing Pain Research CaE, Medicine Io. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.
Washington, DC: The National Academies Press; 2011.
4. Ballantyne JC, Mao J. Opioid therapy for chronic pain. N Engl J Med November 13, 2003;349:1943-53
Opioid Therapy for Back Pain –
A Review of the Evidence
• Shaheed et. al conducted a meta-analysis of 20 studies (nearly
8000 patients) for opioids for chronic back pain
• Analysis conclusions:
– Opioid analgesics provide modest short-term pain relief
– Evidence on long-term efficacy is lacking.
– Overall, the efficacy of opioid analgesics in acute low
back pain is unknown.
Abdel Shaheed, A et al. Efficacy, Tolerability, and Dose-Dependent Effects of Opioid Analgesics for Low Back Pain: A Systematic Review and Meta-analysis.
JAMA Intern Med. 2016 May 23.
What happens to pain when tapered?
“The average percent reduction of opioid doses was 46% over a 12-month period.”
Harden P et al. Clinical Implications of Tapering Chronic Opioids in a Veteran Population Pain Medicine 2015
Contemporary Approach to Chronic Pain:
A More Flexible, Customized Approach
• Concurrent therapies
• Realistic expectations
Epidurals
Facets
SI Joint
Corrective
surgery
Discectomy
Fusion
Intrathecal
therapy or
neurostimulation
Physical
therapy,
TENS
NSAIDs,
OTC drugs
Lifestyle
modification
Long-term
oral
opioids
Chronic
Pain
Patient
Neuroablation
Prager J and Jacobs M. Evaluation of patients for implantable pain modalities: medical and behavioral assessment. Clin J Pain
2001 Sep;17(3):206-14.
62
Outcomes from Medical Advanced Pain Specialists Chronic Pain Program,
August 2004 to January 2010
Patients attending Medical Advanced Pain Specialists Chronic Pain Program are
evaluated on several measures at the time of their admission into the program and
again at discharge. Patients are evaluated again at 3 months, 6 months, and 12
months after the time of their discharge.
Patients are measured on the following:
Health care use (number of appointments for health problems made)
Pain ratings (self rated, 0-10)
Use of opioid medicine (both short-acting and long-acting medication)
SF-36 (self administered health survey)
Patient satisfaction questionnaires
Oswestry indices (self rated measures of disability)
Hours worked outside of the home.
The LIFE test, a behavioral measure of physical function developed by the
physical therapy department at Medical Advanced Pain Specialists
Outcomes from Medical Advanced Pain Specialists Chronic Pain Program,
August 2004 to January 2010
Short Acting Opioid Use
equanalgesic dose
0.70
0.60
0.50
0.40
0.30
*
*
*
*
0.20
0.10
0.00
admission discharge
3 month
6 month
12 month
time of measure
Figure 1. Health related appointments that patient
made in past 4 weeks (excluding appointments
for dental or eye care) n = 429
Analysis of variance significant at p<.001
*Significant difference from admission at
p<.001
Figure 2. Average amount of short acting opioid
used per day over the past 3 days. Vicodin,
percocet, MS IR and other short acting
medications are measured on equianalgesic scale.
Analysis of variance significant at p<.001
*Significant difference from admission at
p<.001
Outcomes from Medical Advanced Pain Specialists Chronic Pain Program,
August 2004 to January 2010
Self Rated Pain (0-10 scale)
1.00
7
0.80
*
0.60
a
*
*
0.40
0.20
0.00
admission
discharge
3 month
6 month
12 month
time of measurement
6.5
self rated pain
equianalgesic dose
Long acting Opioid Used
*
6
*
*
*
5.5
5
4.5
4
admission
discharge
3 month
6 month
12 month
time of measure
Figure 3. Average Long-acting opioid used per day
over the past 7 days. Oxycontin, Morphine,
methadone, fentanyl measured on equianalgesic
scale
*t-test difference from admission p<.001
at-test difference from admission, p=.056
Figure 4. Average self-rated pain: “how would
you rate your pain on a zero to ten scale, with
ten being ‘worst pain ever’ and zero being ‘no
pain at all’”? Patients rated themselves to within
½ number increments.
t-test of difference from admission is p <.01
LATE REFERRALS
(STANDARD CYCLE)
Step 1
Initial Pain
Step 2
Step 4
Refer EARLY to
Complimentary
Providers as
Needed
Early referrals
Diagnostic
Interventions
Obesity,
Smoking
Step 3
Treat the
Pain
Expectations should coincide with timing…
Late referrals…lessen chances for functional improvement
3
2
1
0
Severe
Moderate
Mild
None
EARLY referrals…improve chances for functional restoration
Ahrens SP, et al. Efficacy and Safety of Rizatriptan Wafer for the Acute Treatment of Migraine. Cephalagia. 1999;19:525–300.
Take Home Messages
• Utilize multimodal approach because CBT, adjuvants,
interventions, implantable can collectively decrease opioid
burden
• Based on CDC’s analysis of data from 2010-2015… utilize
lowest doses, PDMP, Naloxone, short acting opiates
• Interventional pain clinics do much more than injections
• Early on: Interventions are an alternative to opioids
• Later on: Interventions facilitate an opioid taper or decrease
Suboxone and Butrans
• Buprenorphine:Naloxone is 4:1
• 2mg/0.5mg…16mg/4mg
• Both induce withdrawals taken with a pure mu
agonist.
• Buprenorphine 3X binding to Naloxone
• Buprenorphine 7X longer half life than Naloxone
• Naloxone lower dose and shorter effect
• Highly effective in decreasing euphoria from mu
opioids
• 2mg SL Suboxone = to 20 mcg Butrans (Bupenorphine)
Select Cases
• Hip and knee Radiofrequency
• Nerve blocks for abdominal & pelvic pain
• SI Joint fusion vs RF
Hip Cases from last two weeks
EA is a 36 YO who works for Comfort
Keepers. Seen by Dr. Schwab and referred
by Dr. Nosier, seen 02/16. Nerve blocks
>50% relief, RFA April 2016. Able to walk,
get in and out of car. Repeated in Oct 2016
PA is a 51 YO referred by Dr. Scarlett , 100%
relief with GTB. Seen 10/11/6 for hip nerve
blocks .100% relief, Repeated 10/18/16: 100%
relief. RFA planned
Hip pain referral patterns
Kawaguchi M, et al. Percutaneous Radiofrequency
Lesioning of Sensory Branches of the Obturator and
Femoral Nerves for the Treatment of Hip Joint Pain. Reg
Anesth and Pain Medicine, 26:6, 2001:576–581
Patients with hip joint pain may suffer
from groin, thigh, and trochanteric pain.
Groin pain and thigh pain arise from the
articular branches of obturator nerves. A
trochanteric (lateral) pain arises mainly
from the articular branches of femoral
nerve
Knee Innervation:
Franco outlined course of genicular nerves
Masahiko Ikeuchi, Percutaneous Radiofrequency Treatment for Refractory Anteromedial Pain of Osteoarthritic Knees. Pain Medicine
2011; 12: 546–551
N=35, RF(N=18), Nerve block(N=17). Age 69-85
4, 8, 12 week follow up
Outcome measures: VAS, Western Ontario McMaster Universities(WOMAC) Osteoarthritis Index Score
Statistically significant pain relief (VAS) for the radiofrequency group at 4, 8, and 12 weeks
Woo-Jong Choi, Radiofrequency treatment relieves chronic knee osteoarthritis pain: A double-blind randomized controlled trial. (PAIN
2011;152 : 481–487
Genicular neurotomy vs. sham
N= 38, RF(N=19), sham(N=19), 61-75yo
1, 4, and 12 week follow up
Outcome measures: VAS, Oxford Knee Score
In the RF group 10/17(59%), 11/17(65%), and 10/17(59%) achieved at least 50% knee pain relief at 1, 4, and 12 weeks
respectively
Contemporary Approach to Chronic Pain:
A More Flexible, Customized Approach
Woo-Jong Choi, Radiofrequency treatment relieves chronic
knee osteoarthritis pain: A double-blind randomized controlled
trial. (PAIN 2011;152 : 481–487
Masahiko Ikeuchi, Percutaneous Radiofrequency Treatment for
Refractory Anteromedial Pain of Osteoarthritic Knees. Pain
Medicine 2011; 12: 546–551
76
Cooled-RF for post TKA knee pain
Menzies, R. D. and Hawkins, J. K. (2015), Analgesia and Improved Performance in a Patient Treated by Cooled Radiofrequency for Pain
and Dysfunction Postbilateral Total Knee Replacement. Pain Practice, 15: E54–E58.
Davies T et al. Prospective, multi-center, randomized, crossover clinical trial
comparing the safety and effectiveness of cooled radiofrequency ablation to
corticosteroid injection in the management of osteoarthritic knee pain.
Submitted to ASRA Sept 2016. p=0.0001 at 6 months
N=151
Randomized if
>50% relief with
blocks
67 cRFA
91% GPE
35.7 Oxford
74% had >50%
reduction in VAS at 6
months
78
71 IA Steroid
25% GPE
22.4 Oxford
16.2% had >50%
reduction in VAS at 6
months
Neuromodulation update
• 45 yo electrical engineer
• Presenting with axial back pain
– VAS 5/10 with daily variations
• History of previous fusion for lumbar radiculitis (5years prior)
• 150 mg of tramadol and daily low doses hydrocodone
• Pain localizes to the upper low back (above and at the scar)
• No raidation, bilateral, worsened by sitting, worse in the mornings,
worsened by physical activity (lifting his small children
• Work-up after MRI included negative MBBs, 2 unsuccessful TFESIs, 1
unsuccessful caudal ESI
“Failed back”
81
Traditional SCS: Reserved for extremity Pain
Published Prospective SCS Studies with > 6 mo follow-up
Leg Pain
Study
System
Schultz
2012
Medtronic
Restore
Sensor
North
2005
Kumar
2008
Medtronic
Itrel
Medtronic
Synergy
NR: Not reported
Trial
Patients Success
Predom
Leg Pain
Predom
Leg Pain
Predom
Leg Pain
Back Pain
Base
6m
12m
24m
Base
6m
12m
24m
VAS
5.9
4.3
NR
NR
NR
NR
NR
NR
Response
—
NR
NR
NR
NR
NR
NR
NR
N
76
71
NR
NR
NR
NR
NR
NR
VAS
NR
NR
NR
NR
NR
NR
NR
NR
Response
—
NR
NR
47%
NR
NR
NR
NR
N
24
24
NR
19
NR
NR
NR
NR
43/52
VAS
7.6
4
4.4
4.4
5.5
4.1
4.5
4.8
83%
Response
—
48%
38%
40%
—
NR
NR
NR
N
52
50
42
42
52
50
42
42
NA
17/24
71%
Superior Responder Rates with HF10 Therapy
Results better and more enduring
Leg Pain
100%
100%
84.3%
78.7%
76.4%
80%
60%
51.9%
51.3%
43.8%
40%
20%
Leg Pain Responder Rate
Back Pain Responder Rate
Back Pain
83.1%
80.9%
78.7%
80%
60%
55.0%
54.4%
51.3%
40%
20%
0%
0%
3
6
3
12
month
6
12
month
Test (HF10 therapy)
Control (Traditional SCS)
Analysis of permanent implant population
Superiority p-value <0.001
83
Pain Score was Primary Endpoint
100%
Superiority p-value < 0.001
Met Primary Endpoint
80.9%
80%
60%
42.5%
40%
• Average back pain of ≥5/10
• Average leg pain ≥5/10
• Severely disabled or
crippled as defined by an
Oswestry Disability Index
score of 41 ‒ 80 out of 100
• Primary endpoint involves 
50% back pain reduction at
3mo
20%
89
80
0%
Treatment group
(HF10 therapy)
Control group
(Traditional SCS)
Analysis of permanent implant population
Superior Responder Rates with HF10 Therapy
Results better and more enduring
At 12 months, mean back pain VAS decreased 66% with HF10 therapy compared
to a decrease of 45% for traditional SCS therapy
10
9
8
7
6
5
4
3
2
1
0
4.3
2.5
0
3
6
9
Assessment (months)
Control (Traditional SCS)
Back Pain Relief
(change in VAS score)
Back Pain (VAS score)
Test (HF10 therapy)
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
12
Superiority p-value <0.001
66.4%
44.7%
0
3
6
9
Assessment (months)
12
Analysis of permanent implant population
Superior ODI Improvements with HF10 Therapy
At 12 months, 63% of HF10 therapy subjects had minimal or moderate
disability compared with 46% of traditional SCS subjects
2%
100%
% Subjects with ODI Level
22%
10%
20%
35%
80%
44%
60%
40%
71%
77%
37%
20%
63%
46%
1%
9%
9%
Baseline
12 months
Baseline
CONTROL
(TRADITIONAL SCS)
Crippled
46%
Severe
17%
12 months
TEST
(HF10 THERAPY)
Moderate
Minimal
N = 171
ODI = OSWESTRY DISABILITY INDEX
SUPERIORITY DEMONSTRATED (P=0.03)
Analysis of permanent implant population
HF SCS: Decreased Opioid Use from 84mg to 27mg
% of patients using opioids
86%
34% reduction in # Pts
54%*
Mean mg morphine per patient
84
68% reduction in dose
57%*
29*
27*
Baseline
12 Month
24 Month
Baseline
12 Month
24 Month
N=72
N=68
N=65
N=72
N=68
N=65
Al-kaisy A, Van buyten JP, Smet I, Palmisani S, Pang D, Smith T. Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients
with chronic, low back pain: 24-month results of a prospective multicenter study. Pain Med. 2014;15(3):347-54.
Kapural L, Yu C, Doust MW, et al. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord
Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015;123(4):851-60.
* p-value < 0.001
HF SCS: Decreased Opioid Use from 84 mg to 27 mg
% of patients using opioids
86%
34% reduction in # Pts
54%*
Mean mg Morphine per patient
84
68 % reduction in dose
57%*
29*
27*
Baseline
12 Month
24 Month
Baseline
12 Month
24 Month
N=72
N=68
N=65
N=72
N=68
N=65
* p-value < 0.001
US and EU multicenter RCT trials
Al-Kaisey et al Pain Medicine 2014; 15: 347–354
Kapural et al Anesthesiology 2015; 123:851-60
84 MEDD
8.4 VAS LBP
112 MEDD
7.4 VAS LBP
27 MEDD
3.3 VAS LBP
87 MEDD
2.5 VAS LBP
2 year follow up 72 patients, FDA Trial HF Spinal stimulation
Decreased Opioid Use from 84mg to 27mg
Mean mg morphine per patient
% of patients using opioids
86%
84
34% reduction in # Pts
54%*
68% reduction in dose
57%*
29*
27*
Baseline
12 Month
24 Month
Baseline
12 Month
24 Month
N=72
N=68
N=65
N=72
N=68
N=65
Kapural et al. (Senza trial) Anesthesiology 2015
* p-value < 0.001
Apm Data on 212 out of 242 with HF10 Therapy
N=212
65% reduction in pain
86% responder rate
Incredible progress
in Neuromodulation
for the for the pain
patient in 2016
“More than half of all patients with chronic painful conditions experience sustained and significant levels of pain reduction following
SCS treatment. Although only limited evidence exists for burst stimulation, there is now Level I evidence for both dorsal root
ganglion SCS and high-frequency SCS that demonstrates compelling results compared with traditional therapies. The body of
evidence built on traditional SCS research may be redundant, with newer iterations of SCS therapies such as dorsal root ganglion SCS,
high-frequency SCS, and burst SCS. A number of variables have been identified that can affect SCS efficacy: implanter experience,
appropriate patient selection, etiologies of patient pain, existence of comorbidities, including psychiatric illness, smoking status,
and delay to SCS implant following pain onset. Overall, scientific literature demonstrates SCS to be a safe, effective, and drug-free
treatment option for many chronic pain etiologies.
Verrills P, Sinclair C, Barnard A. A review of spinal cord stimulation systems for chronic pain. J Pain Res. 2016 Jul 1;9:481-92. doi:
10.2147/JPR.S108884. eCollection 2016. Review
Failed Back
• HF10 Therapy: Trial Phase
– Typical T8 and T9 placement
• HF10 Therapy Trial Results
– 100% improvement in back pain during the trial
– 90% improvement in pain after implantation
– off of all daily medications for 5 months
– recently seen in follow up
Primary afferent nociceptors convey
noxious information to projection
neurons within the dorsal horn.
Therapeutic Targets
A subset of these projection neurons
transmits information to the
somatosensory cortex via the
thalamus, providing information about
the location and intensity of the
painful stimulus.
Other projection neurons engage the
cingulate and insular cortices via
connections in the brainstem
(parabrachial nucleus) and amygdala,
contributing to the affective
component of the pain experience.
This ascending information also
accesses neurons of the rostral ventral
medulla and midbrain periaqueductal
gray to engage descending feedback
systems that regulate the output from
the spinal cord.
Origins of Burst Stimulation
• Burst is a naturally occurring signaling modality in
human physiology. For example, the “lateral pain
system” fires in a tonic manner, but the “medial
pain system” fires in burst1.
• First applied to SCS by Dirk De Ridder MD, PhD,
Antwerpen Belgium.
• Published Experience.
–
–
–
De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. (2013) Burst Spinal Cord Stimulation for Limb and
Back Pain. World Neurosurg. 2013 Jan 12. pii: S1878-8750.
De Ridder, D., Vanneste, S., Plazier, M., van der Loo, E., and Menovsky, T. (2010). Burst Spinal Cord Stimulation:
Toward Paresthesia-Free Pain Suppression. Neurosurgery, 66(5): 986-990.
De Ridder, D., Vanneste, S., van der Loo, E., Plazier, M., Menovsky, T., and van de Heyning P. (2010). Burst
Stimulation of the Auditory Cortex: A New Form of Neurostimulation for Noise-Like Tinnitus Suppression.
JNeurosurg, 112: 1289-1294.
1. Lopez-Garcia, J. A. and King, A. E. (1994), Membrane Properties of Physiologically Classified Rat Dorsal Horn Neurons In Vitro: Correlation with
Cutaneous Sensory Afferent Input. European Journal of Neuroscience, 6: 998–1007.
94
CONFIDENTI
Burst Stimulation
Pain stimuli are processed in parallel by two pathways:
 Lateral discriminatory pathway.
 WDR neurons firing in tonic -> PH (lam. 1, 4-6) -> Thalamus (VPL, VPM) -> 1 & 2 SSC.
 Fires tonically2.
 Medial affective/attentional pathway.
 Nociceptive specific neurons firing in bursts -> PH (lam. 1) -> Thalamus (MDvc, VMpo)
-> Anterior Cingulate, Anterior Insula, Amygdala.
 Fires in bursts2.
1. De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. (2013) Burst Spinal
Cord Stimulation for Limb and Back Pain. World Neurosurg. 2013 Jan 12. pii: S18788750.
2. J. A. Lopez-Garcia, A. E. King: Membrane Properties of Physiologically Classified Rat
Dorsal Horn Neurons In Vitro: Correlation with Cutaneous Sensory Afferent Input.
European Journal of Neuroscience. Volume 6, Issue 6, pages 998–1007, June 1994