THE PAIN DECADE AND THE PUBLIC HEALTH Rollin M. Gallagher, MD, MPH Clinical Professor, Departments of Anesthesiology and Psychiatry University of Pennsylvania School of Medicine Director of Pain Management, Philadelphia VA Medical Center National Pain Management Coordinating Committee, Veteran Affairs Health System Editor in Chief, Pain Medicine Board of Directors: American Academy of Pain Medicine and National Pain Foundation Immediate Past President, American Board of Pain Medicine Rollin M. Gallagher, MD, MPH Clinical Professor, Departments of Anesthesiology and Psychiatry University of Pennsylvania School of Medicine Director of Pain Management, Philadelphia VA Medical Center National Pain Management Coordinating Committee, Veteran Affairs Health System Editor in Chief, Pain Medicine Board of Directors: American Academy of Pain Medicine and National Pain Foundation Immediate Past President, American Board of Pain Medicine

The Pain Decade and the Public Health History –Conceptualization – Lippe, Saper, Ashburn et al, 1999 –Matriculation – SB 3163 –Enrollment – October 28, 2000 –Life span – History –Conceptualization – Lippe, Saper, Ashburn et al, 1999 –Matriculation – SB 3163 –Enrollment – October 28, 2000 –Life span –

Pain is a more terrible lord of mankind than even death itself. Albert S. Schweitzer, 1931 On the Edge of the Primeval Forest. New York: Macmillan, 1931:652 Albert S. Schweitzer, 1931 On the Edge of the Primeval Forest. New York: Macmillan, 1931:652

Pain Medicine History Epochs –Antiquity to 19 th Century Pain a symptom treated by purgation Dichotomy of pain – Descartes and Byron –Physical pain –Mental pain Epochs –Antiquity to 19 th Century Pain a symptom treated by purgation Dichotomy of pain – Descartes and Byron –Physical pain –Mental pain

Pain Medicine History Epochs –Late 19 th Century to 1980s: Age of medical science and technology Spine surgery and back pain disability Psychogenic pain, compensation neurosis and behavioral medicine John Bonica and IASP Gate Theory of Pain (Wall and Melzack) Hospice and the treatment of suffering Epochs –Late 19 th Century to 1980s: Age of medical science and technology Spine surgery and back pain disability Psychogenic pain, compensation neurosis and behavioral medicine John Bonica and IASP Gate Theory of Pain (Wall and Melzack) Hospice and the treatment of suffering

Pain Medicine History Epochs –Late 20 th Century to 2007 Rise of epidemiology –Failed spine surgery syndrome –Geographic variation in surgical rates –National variation in opioid analgesia –The myth of psychogenic pain and psychiatric co-morbidity –Pain diseases versus chronic pain –Multi-factorial bio-psycho-social causation Epochs –Late 20 th Century to 2007 Rise of epidemiology –Failed spine surgery syndrome –Geographic variation in surgical rates –National variation in opioid analgesia –The myth of psychogenic pain and psychiatric co-morbidity –Pain diseases versus chronic pain –Multi-factorial bio-psycho-social causation

Neuropathic low back pain DIAGNOSIS There Are Many Painful Diseases and Pain Diseases *Complex regional pain syndrome. Nociceptive pain Caused by activity in neural pathways in response to potentially tissue-damaging stimuli Neuropathic pain Initiated or caused by a primary lesion or dysfunction in the nervous system Postoperative pain Mechanical low back pain Sickle cell crisis Arthritis Peripheral neuropathy Postherpetic neuralgia Diabetic neuropathy Sports/Exercise injuries Central post- stroke pain Trigeminal neuralgia Inflammatory / Immunological Mediation CANCER PAIN, LBP, CHRONIC FACIAL PAIN (mixed pain states) SENSITIZATION CRPS* Phantom tooth pain

Phenomenological Model of Pain Disease: Post Herpetic Neuralgia Exposure to Varicella Virus Chicken Pox with Infection, with invasion of dorsal root ganglion & spinal nerves in childhood Shingles Activation of virus and disease of acute herpes zoster Precipitating Factors: Acute illness, Stress, Age, Immuno- Suppression, Cancer. Risk factors for chronic pain: Severity and duration of acute rash, Pain severity, Anxiety severity. * Predisposing Condition Post- herpetic Neuralgia Successful Pain Control * Factors reducing risk for PHN: Early anti-viral treatment, Early amitriptylene, Good pain control. Factors enhancing good outcome: Access to appropriate pain treatment Access to rehabilitation. BPSOUTCOMESBPSOUTCOMES Initial exposure

Mismanaged chronic pain is often a personal catastrophe! ….and is a huge public health problem. Quality of life –Physical functioning –Ability to perform activities of daily living (ADLs) –Work Social consequences –Marital/family relations –Intimacy/sexual activity –Social role and friendships Quality of life –Physical functioning –Ability to perform activities of daily living (ADLs) –Work Social consequences –Marital/family relations –Intimacy/sexual activity –Social role and friendships Psychological morbidity –Fear, anger, suffering –Sleep disturbances –Loss of self-esteem Medical comorbidites & consequences –Accidents –Medication effects –Immune function –Clinical depression Psychological morbidity –Fear, anger, suffering –Sleep disturbances –Loss of self-esteem Medical comorbidites & consequences –Accidents –Medication effects –Immune function –Clinical depression Societal consequences - Health care costs - Disability - Lost workdays - Business failures - Higher taxes Established effects (by research) of chronic pain Pain causes these problems. These problems reduce the effectiveness of pain treatment. They must be managed to obtain good treatment outcomes

Depression and Pain Comorbidity Response Remission Symptoms Syndrome Recovery ContinuationAcute Relapse Gallagher & Verma, Prog Pain Res Man 2004, Adapted from Kupfer DJ. J Clin Psychiatry. ; 1991;52(suppl): Dohrenwend BP, et al. Pain. 1999;83(2): Raphael et al Pain 2004 Treatment Phases Normalcy Maintenance RelapseRecurrence Progression to disorder Pain Pain, A condition or symptom that causes or activates depression

Pain Medicine History Epochs –Late 20 th Century to 2007 Rise of Neuroscience and Biotechnology –Gate theory –Molecular biology and neurotransmitters –Psychopharmacology –Neuropharmacology –Neuromodulation –disease Epochs –Late 20 th Century to 2007 Rise of Neuroscience and Biotechnology –Gate theory –Molecular biology and neurotransmitters –Psychopharmacology –Neuropharmacology –Neuromodulation –disease

Pain in our wounded warriors ( ) 686,306 OIF-OEF veterans 229,015 using VA services (33.4%) 43 % have musculoskeletal diseases (all cause pain by definition) - back pain most common 37% have mental health disorders Kang et al. Paper presented at War-Related Illness and Injury Study Center, ,306 OIF-OEF veterans 229,015 using VA services (33.4%) 43 % have musculoskeletal diseases (all cause pain by definition) - back pain most common 37% have mental health disorders Kang et al. Paper presented at War-Related Illness and Injury Study Center, 2007.

The Polytrauma Challenge 65% of OEF/OIF combat injuries are caused by improvised explosive devices (IEDs), landmines, shrapnel, and other blast phenomena. –multiple visible injuries (tissue wounds) –hidden injuries [bone and soft tissue damage, including nerves] – 60% with symptoms of traumatic brain injury (TBI) : hearing, vision, cognition, emotional control –Over 95% have chronic pain 65% of OEF/OIF combat injuries are caused by improvised explosive devices (IEDs), landmines, shrapnel, and other blast phenomena. –multiple visible injuries (tissue wounds) –hidden injuries [bone and soft tissue damage, including nerves] – 60% with symptoms of traumatic brain injury (TBI) : hearing, vision, cognition, emotional control –Over 95% have chronic pain

C fiber Abeta fiber Nerve injury Phenotypical Changes Spinal cord Damage Neuro- plasticity Central sensitization Alteration of modulatory systems Ectopic discharge Ectopic discharge Adapted from Woolf & Mannion, Lancet 1999 Attal & Bouhassira, Acta Neurol Scand 1999 ANS activation <<< Stress <<< Pain <<< BRAIN PROCESSING +++ Limb trauma

567 severe single extremity trauma patients at 7 years Predictors of poor outcome before injury include: Alcohol abuse 1 month before injury Older age, lower education, low self efficacy (Gallagher Pain 1989) Predictors of poor outcome at 3 months post-injury: Acute pain intensity, anxiety, depression and sleep disturbance Does early intervention make a difference? Castillo et al. Pain 124 (2006):

Opioid protective effect Patients treated with opioids for pain at three months post-discharge were protected against chronic pain.. despite the fact that these patients had higher pain intensity levels and were thus at higher risk for chronic pain lending support to the theory that…..early aggressive pain treatment may protect patients from central sensitization and chronic pain. Patients treated with opioids for pain at three months post-discharge were protected against chronic pain.. despite the fact that these patients had higher pain intensity levels and were thus at higher risk for chronic pain lending support to the theory that…..early aggressive pain treatment may protect patients from central sensitization and chronic pain.

Early, Continuous, and Restorative Pain Management in Injured Soldiers: The Challenge Ahead Rollin M. Gallagher, MD, MPH Rosemary Polomano, PhD, RN Pain Medicine 2006;7(4): John Farrar, MD, PhD David Oslin, MD Wensheng Guo, PhD Chester Buckenmaier, MD Geselle McKnight, CRNP Alexander Stojadinovic, MD Rollin M. Gallagher, MD, MPH Rosemary Polomano, PhD, RN Pain Medicine 2006;7(4): John Farrar, MD, PhD David Oslin, MD Wensheng Guo, PhD Chester Buckenmaier, MD Geselle McKnight, CRNP Alexander Stojadinovic, MD

THE END: CPRS Pain Cycle Pathology: -Muscle atrophy, weakness; -Bone demineralization; -Depression Less active Kinesophobia Decreased motivation Increased isolation Role loss Disability Pathophysiology of Maintenance: -Radiculopathy -Neuroma traction -Myofascial sensitization -Brain pathology (loss, reorganization) Psychopathology of maintenance: -Encoded anxiety dysregulation - PTSD -Emotional allodynia -Mood disorder Neurogenic Inflammation: - Glial activation - Pro-inflammatory cytokines - blood-nerve barrier dysruption Acute injury and pain Peripheral Sensitization: Na+ channels Lower threshold Central sensitization

PNS NA channels Lidocaine Patch 5% Carbamazepine Oxycarbazine Tricyclics Topiramate Spinal cord BRAIN Modulation by Norepinephrine Serotonin Endogenous opiates Tricyclics, SSRIs, SNRIs (Venlafaxine, Duloxetine), Tramadol, Opiates Voltage gated Ca channels (L & PQ presynaptic): Gabapentin, Pregabalin Mechanism Targets For Neuropathic Pain Pharmacotherapy 2 agonists Tizanidine Clonidine (Adapted from Beydoun 2001) Anti-inflammatory NSAID, Cox 2 NMDA antagonists: Ketamine, Dextromethorphan

Pain Medicine History Epochs –Late 20 th Century to 2007 Emergence of the specialty of Pain Medicine Evolving organizational models of care –Sequential care model –Multidisciplinary pain center model –Managed care model –Pain medicine and primary care community rehabilitation model Epochs –Late 20 th Century to 2007 Emergence of the specialty of Pain Medicine Evolving organizational models of care –Sequential care model –Multidisciplinary pain center model –Managed care model –Pain medicine and primary care community rehabilitation model

The tertiary, sequential care model INJURY/SYMPTOM Emergency Services Primary Care Specialty Office #1 Specialty Office #2 Specialty Office #3 TREATMENT FAILURES Specialty Office #4 ALTERNATIVE TREATMENTS TIME (6) (5) Gallagher RM. Med Clin N Am 83(5): , CHASING THE SYMPTOM THROUGH A REDUCTIONISTIC, BIOMEDICAL MODEL

The multi-disciplinary, biobehavioral pain center model INJURY/SYMPTOM Emergency Services Primary Care Specialty Offices, Alternative Care Treatment Failure Treatment Success Multidisciplinary Pain Center: MD, PT, OT, Behav Med, Voc Rehab time 1 1

The managed primary care model INJURY/SYMPTOM Primary Care Office Emergency Services Specialty Offices Treatment Failures time JOB LOSS INSURANCE LOSS 11 2 (3) 3 (4) Gallagher RM. Med Clin N Am 83(5): , DOES NOT WORK FOR PATIENTS OR POPULATIONS JUST SAY NO!!

Cost vs. Quality ResourceResourceResourceResource Quality of care (outcomes) Excess care Best practice (From W. Brose, MD)

The pain medicine and primary care community rehabilitation model A systems model for pain management that is based on three core principles: 1) empowerment by education of and support for primary care provider, patient and community 2) outcomes focus: evidence based, quality improvement approach 3) shared responsibility for outcomes amongst, patient, providers, health care system, and payers 4) Easy access for early intervention 5) Evidence-based rational polypharmacy imbedded in goal-oriented, stepped, selectively multi-modal treatment (e.g., PT, behavioral, social) ** ** Gallagher RM. Rational polypharmacy in integrated pain treatment. Am J Phys Med & Reh 2005(S);84(3):S64-76 A systems model for pain management that is based on three core principles: 1) empowerment by education of and support for primary care provider, patient and community 2) outcomes focus: evidence based, quality improvement approach 3) shared responsibility for outcomes amongst, patient, providers, health care system, and payers 4) Easy access for early intervention 5) Evidence-based rational polypharmacy imbedded in goal-oriented, stepped, selectively multi-modal treatment (e.g., PT, behavioral, social) ** ** Gallagher RM. Rational polypharmacy in integrated pain treatment. Am J Phys Med & Reh 2005(S);84(3):S64-76

Pain medicine and primary care community rehabilitation model INJURY/SYMPTOM Emergency Services PrimaryCare: ClinicalAlgorithms Recurrent or persistent pain impairing function Integrated Pain Medicine Eval & Services: Med. trials, PT, Blocks, Behavioral mgmt. Sub-specialty Eval. & mgmt. Treatment Failure Multidisc- iplinary Pain Center (4) Community Support & Services (PT, OT, Voc, behavioral, pharmacy) Gallagher RM. Med Clin N Am 83(5): ,

Nociceptive pain Neuropathic pain Pain condition + depression Secondary sleep disturbance Secondary depression Primary D. NSAIDs, Cox-IIs, opioids, lidocaine p.? doxepin cr.? Persists after adequate analgesia Evaluate risks Antihistamine, zolpidem, etc. Trazodone Low-dose TCA Lidocaine patch; gabapentin & other AED (Ca+ & Na+ channels); alpha 2 agonists (tizanidine, clonidine); opioids Titrate TCAs (Na+ channels and SNRI) : desipramine, nortriptyline, SSRI trial Evaluate risks SNRIs: venlafaxine, duloxetine Algorithm for Medication Selection in Chronic Pain With and Without Comorbid Depression Adapted from Gallagher RM, Verma S. Semin Clin Neurosurgery This information concerns uses that have not been approved by the US FDA. Evaluate risks

The Opioid Renewal Clinic: A structured approach to managing opioids for pain in primary care Wiedemer N, et al Pain Medicine 2007 Bair M, Pain Medicine 2007 Aberrant Behavior Categories over one year

OUR CONUNDRUM Growing societal awareness of: 1. the prevalence of inadequately treated chronic pain 2. its impact on society 3. the need for access to effective pain treatment vs Growing societal awareness of: 1. The rapidly increasing rate of use of opioid prescriptions 2. The increasing rate of prescription drug abuse 3. The increasing rate of prescription drug abuse deaths Growing societal awareness of: 1. the prevalence of inadequately treated chronic pain 2. its impact on society 3. the need for access to effective pain treatment vs Growing societal awareness of: 1. The rapidly increasing rate of use of opioid prescriptions 2. The increasing rate of prescription drug abuse 3. The increasing rate of prescription drug abuse deaths

Balanced Pain Policy Initiative Center for Practical Bioethics Kansas City, MO American Academy of Pain Medicine American Pain Society American Society of Addiction Medicine DEA FSMB National Association of Attorneys General Wisconsin Pain Policy Center Wisconsin Department of Regulation & Licensing American Academy of Pain Medicine American Pain Society American Society of Addiction Medicine DEA FSMB National Association of Attorneys General Wisconsin Pain Policy Center Wisconsin Department of Regulation & Licensing

Physicians Charged with Opioid Analgesic Prescribing Offenses Goldenbaum, Donald M., Ph.D.; Christopher, Myra; Gallagher, Rollin M., M.D., M.P.H.; Fishman, Scott, M.D; Payne, Richard, M.D.; Joranson, David, MSSW; Edmondson, Drew, J.D.; McKee, Judith, J.D.; Thexton, Arthur, J.D., M.A. Author Affiliations: Center for Practical Bioethics (Goldenbaum and Christopher) AAPM: Philadelphia V.A. Medical Center/University of Pennsylvania (Gallagher) AAPM: U. California, Davis (Fishman) Duke University Divinity School (Payne) U. Wisconsin (Joranson) Attorney General, State of Oklahoma (Edmondson) National Association of Attorneys General (McKee) Wisconsin Department of Regulation & Licensing (Thexton). Goldenbaum, Donald M., Ph.D.; Christopher, Myra; Gallagher, Rollin M., M.D., M.P.H.; Fishman, Scott, M.D; Payne, Richard, M.D.; Joranson, David, MSSW; Edmondson, Drew, J.D.; McKee, Judith, J.D.; Thexton, Arthur, J.D., M.A. Author Affiliations: Center for Practical Bioethics (Goldenbaum and Christopher) AAPM: Philadelphia V.A. Medical Center/University of Pennsylvania (Gallagher) AAPM: U. California, Davis (Fishman) Duke University Divinity School (Payne) U. Wisconsin (Joranson) Attorney General, State of Oklahoma (Edmondson) National Association of Attorneys General (McKee) Wisconsin Department of Regulation & Licensing (Thexton).

PRINCIPLES OF TREATMENT: Summary Primary prevention: avoid injuries and diseases Secondary prevention: When injuries or diseases occur, prevent or minimize nociception or neural activation of pain pathways, improve coping and adaptation, and restore and maintain function Risk management Tertiary prevention manage perpetuating factors, control pain and restore function and quality of life Primary prevention: avoid injuries and diseases Secondary prevention: When injuries or diseases occur, prevent or minimize nociception or neural activation of pain pathways, improve coping and adaptation, and restore and maintain function Risk management Tertiary prevention manage perpetuating factors, control pain and restore function and quality of life

Decade of Pain Control and Research Goals: To Promote Pain Medicine –Research –Education –Clinical Practice –Advocacy & Policy Development How are we doing after 6 years? A snapshot Goals: To Promote Pain Medicine –Research –Education –Clinical Practice –Advocacy & Policy Development How are we doing after 6 years? A snapshot

Growth in the Number of Published Articles on Pain over the Past 30 years. (Source: June 10, 2003, Pub Med search with keyword pain ) Fishman S, Gallagher RM, Carr D, Sullivan: Pain Med 2004

Growth in the Number of Published Articles on Nociception over the Past 30 years. (Source: June 10, 2003, Plumbed search with keyword nociception) Fishman S, Gallagher RM, Carr D, Sullivan: Pain Med 2004

Growth in the Number of Published Articles related to pain over the past 3.5 years. (Source: August 2, 2004, Plumbed search with keywords: pain, neuropathic, nociception) No. Published Articles Search Term (5 years)(3.5 years)% increase Pain59,749 72,018> 21% Neuropathic 1,527 2,481> 62% Nociception 831 1,220> 47%

Journal proliferation Concomitantly rapid rise in numbers of journals devoted to pain –2 new academic journals started in 2000 indexed recently by the National Library of Medicine for MEDLINE, Index Medicus and Pub Med. - Pain Medicine indexed 2003; Imp F Increased to six issues yearly in 2005 Increased to eight issues in 2007 Increase to twelve issues in Journal of Pain indexed in 2004 –Neuromodulation, likely to follow. –Growth of review pain journals (Pain Practice, Pain Physician, J Opioid) –Multiple special supplements to other specialty society journals (Family Practice, Neurology, Psychiatry, JAMA, Internal Medicine, Neurosurgery) –Multiple sponsored articles and throw away journals Concomitantly rapid rise in numbers of journals devoted to pain –2 new academic journals started in 2000 indexed recently by the National Library of Medicine for MEDLINE, Index Medicus and Pub Med. - Pain Medicine indexed 2003; Imp F Increased to six issues yearly in 2005 Increased to eight issues in 2007 Increase to twelve issues in Journal of Pain indexed in 2004 –Neuromodulation, likely to follow. –Growth of review pain journals (Pain Practice, Pain Physician, J Opioid) –Multiple special supplements to other specialty society journals (Family Practice, Neurology, Psychiatry, JAMA, Internal Medicine, Neurosurgery) –Multiple sponsored articles and throw away journals

NIH Research Initiatives Pain is much more prominent in RFAs from several institutes. Challenge: Capps-Rogers 2007: HR 2994 The National Pain Care Policy Act 2007 National Cancer Institute: Challenge: Will pain and palliative care become a pre-requisite in evaluating CA clinical trials? Pain is much more prominent in RFAs from several institutes. Challenge: Capps-Rogers 2007: HR 2994 The National Pain Care Policy Act 2007 National Cancer Institute: Challenge: Will pain and palliative care become a pre-requisite in evaluating CA clinical trials?

VA-military Initiatives Senator Akaka (D-HI) introduces bill to enhance VA and military pain care and research –Promoting Improvements in Treatment of Veterans Suffering from Chronic and Acute Pain –Provide research funding for studies of pain in military and in VA –October 15, 2007 Senator Akaka (D-HI) introduces bill to enhance VA and military pain care and research –Promoting Improvements in Treatment of Veterans Suffering from Chronic and Acute Pain –Provide research funding for studies of pain in military and in VA –October 15, 2007

COMMUNITY HEALTH SYSTEM VETERANS HEALTH SYSTEM COMMUNITY SUPPORT SYSTEM MILITARY HOSPITAL, USA MILITARY BASE CLINIC, USA Transition to Community Care: Pain Medicine and Mental Health Services

SOCIETAL INTEREST Non-profit advocacy organizations: –American Chronic Pain Association –National Pain Foundation: –American Pain Foundation: Non-profit advocacy organizations: –American Chronic Pain Association –National Pain Foundation: –American Pain Foundation:

The future? Pain Medicine as a Specialty –Standardize training –Create qualified teachers of all doctors Medical schools Residencies Pain Fellowships –Promote important research Societal Awareness for Advocacy and Policy Change Organization of health care – Performance-based medicine – Pain Medicine and Primary Care Community Rehabilitation Model – Integrated medical record – Risk management Pain Medicine as a Specialty –Standardize training –Create qualified teachers of all doctors Medical schools Residencies Pain Fellowships –Promote important research Societal Awareness for Advocacy and Policy Change Organization of health care – Performance-based medicine – Pain Medicine and Primary Care Community Rehabilitation Model – Integrated medical record – Risk management