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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 • • • • • • • • • • 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? • New rules on toxicology-They need education perhaps from our lab! • http://dwd.wisconsin.gov/wc/medical/pdf/CHRONIC%20OPIOID%20CLINICAL%20MANAGEMEN T%20GUIDELINES%20.pdf • • • • • • • • • • • 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 • • • • • • • 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 • Provides excellent discrimination between high risk and low risk patients (Passik, et al, 2008). • Exhibited a high degree of sensitivity and specificity for determining which individuals are at risk for opioid abuse (Webster & Webster, 2005). • 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