CHRONIC PAIN MANAGEMENT & SPINAL CORD STIMULATOR. Agenda. The Case Manager Is the Key. What is Pain? PAIN PAIN

Transcription

1 CHRONIC PAIN MANAGEMENT & SPINAL CORD STIMULATOR Agenda Outline importance of the case manager in managing pain patients Pain as a major health issue in the United States Osama Malak, MD, M.Sc, FIPP Assistant Professor, Ohio University Director, Comprehensive Pain Care Center SCS as an advanced treatment for pain The Case Manager Is the Key To educating patients on best therapy options To ensuring proper care coordination for patient success To helping place patients on the path to improved functionality and return to work To assisting adjustors in case closure What is Pain? Pain is an unpleasant sensory and or emotional experience associated with actual or potential tissue damage, or described in terms of such damage. (IASP) PAIN PAIN Most common reason individuals seek health care, 9 in 10 American regularly suffer from pain Chronic pain is the most common cause of long-term disability and almost 1/3 of American will experience chronic pain As population ages the number of people who will need treatment for chronic pain will increase tremendously 1999 survey 1 in 4 individuals with pain receive appropriate therapy The adverse consequence of inadequate pain management are considerable, Yet, recent studies and reports suggest that many types of pain are under treated Brookoff D. Chronic Pain, June 2001 Chronic Pain in America Survey,

2 Afferent and Efferent Function of Peripheral Nociceptors Afferent Nociceptive Pathways Julius D, Basbaum AI. Nature. 2001;413: Afferent Nociceptive Pathways. Pain management: pathophysiology of pain and pain assessment. Available at: pain_mgmt/module01/index.htm. Accessed: August 8, Physiological Pain High threshold Well-localized and transient Stimulus-response relationship Warning/protective system Carried by A and C fibers Acute Pain is a Warning Symptom of an Underlying Problem 2

3 Pain Intensity What Is Chronic Pain? Acute Tissue Injury May Lead to Chronic Pain Stimulus (acute tissue injury) Chronic pain is pain that Lasts past the expected time of healing Has no physiological value or warning function for the body May spread and increase in intensity May become stronger than the initial pain from the injury Neurotransmitter Glutamate, aspartate Release Substance P, Calcitonin gene-related peptide Electrophysiological Excitatory Responses postsynaptic potential Intracellular Calcium Nitric oxide Stress synthase Responses Protein kinase C Structural Responses Neuropsychological Responses Cholecystokinin, Enkephalin Neuropeptide Y Vasoactive intestinal peptide Dynorphin Galanin Sensitization Wind-up C-fos?Bcl-2 C-jun?Bax Sprouting Remodeling?Apoptosis/ cell death Allodynia, impairment Perception Stimulationproduced analgesia Aversion Chronic pain syndrome Avoidance Disability Suffering Quality of life (s) (min) (h) (days) (months) (years) Time in Seconds (logarithmic scale) Carr DB, Goudas LC. Lancet. 1999;353: Central Sensitization C-Nociceptive primary afferent Glutamate N M D A Positive Feedback Loop Sustained glutaminate activation of NMDA receptor leads to progressive increase in the sensitivity of NMDA receptor to glutamate. Post synaptic neuron becomes more hypersensitive to all of its inputs including those from pain-related primary afferents as well as inputs from non-pain related sensitve mechanoreceptive afferents. The Results: Allodynia, hyperalgesia, and spontaneous pain Sensitization Clinical Pathologic Pain : Hyperalgesia Allodynia Injury Normal Pain Response Hyperalgesia heightened sense of pain to noxious stimuli Allodynia pain resulting from normally painless stimuli Inflammatory or Neuropathic Hyperalgesia Allodynia Spontaneous Pain does not have any protective function Stimulus Intensity Gottschalk A, Smith DS. Am Fam Physician. 2001;

4 Adverse Consequences Physical: Impair ability to carry out ADL, decrease QOL and cause significant suffering Psychological: Anxiety, fear, anger or depression Financial: Individuals absenteeism, underemployment and unemployment Health care cost and disability compensation DEPRESSION CHRONIC PAIN LIMITED or LOST ABILITIES STRESS Butler RJ, J Health Econ Chronic Pain is Very Expensive Chronic Pain is the most expensive health care problem in the US today at $240 billion annually 40 Million physician visits per year 515 Million lost work days per year The Average Chronic Pain Patient: Suffered seven years Undergone three major surgeries Incurred medical bills of $50,000 - $100,000 How Low-Back Pain Impacts the Economy and Healthcare $100 B TOTAL SPENT Low-back pain costs the U.S. economy over $100 billion annually. Back Pain Costs Americans billions a year (Boyle) Third most expensive disorder, after heart disease and cancer (University of Wisconsin) Accounts for 2.5% of the nation s total health-care bill (Boyle) Second most common reason for visits to the doctor s office, outnumbered by upper-respiratory infections (In Project Briefs) One of the most common reasons for missed work (In Project Briefs) Accounts for more than 6 million cases annually (University of Wisconsin) One-half of all working Americans admit to having back pain symptoms each year (Vallfors) Failed Back Surgery Syndrome Also known as postlaminectomy syndrome General term to describe condition of patients who have not had a successful result with spine surgery Surgery fails to remove the pain Pain is diffuse, dull, and achy in the back and sharp, burning, and stabbing in the legs 4

5 Complexities in Managing FBSS Costs to Disability and Workers Compensation 1,285,000 SPINAL SURGERIES 5 200,000 LUMBAR SPINE SURGERIES 6,7 FBSS 40,000-80,000 PATIENTS 6,7 (20%-40%) Between 20 and 40 percent of patients were diagnosed with FBSS resulting from lumbar spine surgeries in Back pain is the most common reason for filing workers compensation claims. 3 From an economic perspective, the average cost of a workers compensation claim for low back pain was $8,300, which was more than twice the average cost ($4,075) for all compensable claims combined. 4 Complexities in Managing FBSS LIKELIHOOD OF RETURNING TO WORK 8 100% 80% 60% 40% 20% 50% 25% 6 MONTHS 1 YEAR OUT OF WORK After receiving treatment for low back pain, patients are less likely to return to work the longer they have been out. Unmanaged Pain: Economic Costs Emergency Room Visits Diagnostic Merry-Go-Round Hospitalizations, Multiple Surgeries Rehabilitation Therapies Pharmaceuticals Loss of Productivity 0% Chronic Pain Patients Philosophy of Care Multifaceted problem Loss of employment or income, depression, fear, anxiety, sleep disorders, marital and family dysfunction Physicians are often as dissatisfied as the patients Search for the pain generator is frequently unsuccessful Unrealistic expectations Secondary gain issues An approach is needed Acute Pain - Chronic Pain Medical Behavioral Management Modification Interventional Management 5

6 Pain An unpleasant sensory or emotional experience Two types of pain Acute Pain Short term Associated with actual or potential tissue damage Chronic pain Nociceptive Neuropathic Nociceptive Pain Somatic pain arises from Bones and joints Muscles Skin Connective tissue Aching or throbbing Localized Visceral pain arises from Visceral organs, such as the GI tract and pancreas Tumor involvement Obstructive Neuropathic Pain Abnormal processing of sensory input by the peripheral nervous system (PNS) or CNS Centrally generated pain Peripherally generated pain Mixed Pain Many patients have a combination of both nociceptive and neuropathic pain Disease or trauma has damaged nerve cells and other tissues Causality of Neuropathic Pain When nerves becomes damaged or injured, they stop working properly. They may send the wrong signal to the brain. Injured nerves might tell the brain that your foot is experiencing burning pain even when you aren t stepping on something hot. Character and Quality of Neuropathic Pain Burning Tingling Sharp, shooting Throbbing Numbness Painful to light touch Itching 6

7 Types of Neuropathic Pain Multimodal Approach Neuropathic chronic pain patterns (may be mixed with aching pain) Failed Back Surgery Syndrome (FBSS) Complex Regional Pain Syndrome I (CRPS I) Complex Regional Pain Syndrome II (CRPS II) Postherpetic Neuralgia Phantom Limb Pain Ascending input Spinothalamic tract Pain Descending modulation Dorsal horn Opioids 2-Agonists Centrally acting analgesics Anti-inflammatory agents Local anesthetics Opioids 2-Agonists Dorsal root ganglion Local anesthetics Peripheral Trauma nociceptors Local anesthetics Anti-inflammatory agents, ice Gottschalk A, Smith DS. Am Fam Physician. 2001;63: Old Chronic Pain Treatment Continuum Treatment Considerations Rest Physical medicine Non-opioid analgesics Injections Opioid analgesics Psychological evaluation Surgery or implantable devices Neuroablation Is Opioid Therapy Effective?9 Short-term efficacy RCTs and observational studies demonstrate improvement in pain No evidence to support dosing >180 mg morphine equivalent per day Long-term efficacy No RCTs for longer than 8 months Overall evidence is weak Most studies look at VAS; no evidence of improved function Are Opioids Safe Therapy? Side effects Dysphoria, constipation, urinary retention, somnolence, cognitive changes Immune and hormonal function Testosterone, estrogen, cortisol suppression, decreased libido, infertility 10 Addiction Social, psychological, physical, and financial consequences 7

8 Opioid Summary The literature suggests that chronic opioids do not provide a functional benefit or even adequate reductions in VAS for most patients High dose opioids have little value in chronic long-term use Who Should We Refer to Interventional Pain? Injury to the spine or specific body part Pain persisting past expected time Treating doctor stalled in progress and treatment ideas Motivated and legitimate patient Why Interventional? Interventional Therapy Diagnostic Anatomical source of the pain Placebo effect Failed block Theraputic Immediate relief of pain Break pain cycle Long term relief Trigger Points Injections Epidural Steroid Injection Selective Nerve or Nerve Root Block Discogram and IDET Facet Block and RFA Definition of Neuromodulation Neuromodulation is the electrical or chemical modulation of the central nervous system (CNS) to reduce chronic pain or improve neurologic function Neuromodulation Devices Electrical stimulators and drug pumps Allow the delivery of very small, precise doses of electricity or drugs directly to targeted nerve sites 8

9 CNS Pain Management Gate Control Theory (Melzack) Gate Control Theory (Melzack) Sensory impulses are greater than pain impulses A gate in the spinal cord closes, preventing the pain signal from reaching the brain C FIBER INHIBITORY INTERNEURON Sensory C FIBER INHIBITORY INTERNEURON Gate AaAb FIBERS PROJECTION NEURON Pain AaAb FIBERS PROJECTION NEURON Gate Control Theory and SCS An SCS system implanted near the dorsal columns stimulates pain-inhibiting nerve fibers, which masks painful sensations with tingling sensations (paresthesia) Sensory SCS Gate C FIBER INHIBITORY INTERNEURON Indicated Use Statement for SCS Indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with: failed back surgery syndrome, and intractable low back and leg pain Pain AaAb FIBERS PROJECTION NEURON Spinal Cord Stimulation (SCS) Use of an implanted medical device to deliver electrical pulses to the dorsal spinal cord. SCS Is Not TENS SCS should not be confused with TENS. TENS is an external device that reduces pain by applying low-voltage energy through electrode pads over the skin. 9

10 SCS and Pain SCS devices are FDA-approved/cleared as an aid in the management of chronic, intractable pain of the arms, legs, and trunk of the body Used for over 40 years for chronic pain conditions Intractable neuropathic pain Patient Selection Criteria Pain is neuropathic in origin Patient has undergone a successful trial and has demonstrated a willingness to participate in the treatment protocol Pain is in the arms, legs, and trunk of the body Conservative therapies have not provided long-term pain relief Patient is willing, motivated, and able to operate the device Patient is a suitable candidate for surgery and free of active general infections No contraindications present (demand-type cardiac pacemakers) Multidisciplinary screening Components of SCS Devices Leads Power source Programmer Charging system, if applicable Leads Leads come in a variety of lengths Spacing between the contacts varies and will influence the shape of the electrical field Leads are placed in the epidural space Placed either percutaneous through a needle or surgically Lead Family 2010 Tim Deer, MD. All rights reserved. 10

11 Percutaneous Leads Catheter style Placed via special needle Less invasive Have cylindrical electrodes Provide circumferential stimulation Photo courtesy of Claudio Feler, MD Surgical Leads Paddle style Placed via incision (laminectomy) More invasive implantation Very stable Have plate electrodes Provide unidirectional stimulation Photo courtesy of Claudio Feler, MD Primary Cell Power Source Finite battery life Replacement depends on usage Ideal for patients that require or prefer the simplicity of a non-rechargeable battery Primary Cell Power Rechargeable Power Source Functions like the primary cell battery, but it has more battery power Frequency of recharging depends on how often the stimulator is used and at what settings Ideal for patients with moderate to high power requirements who can manage a recharge schedule 62 Programming Options Rapid Programmer system with MultiSteering technology simplifies the programming of multifocal pain to help deliver optimal therapy. Patient Programmer a handheld, portable device that lets patients adjust how the therapy feels. Recharging System Transfers energy from external charging unit to the battery System plugs into standard electrical outlet Frequency of recharging depends on amount of time stimulation is used and power required 11

12 Matching Device to Patient Matching the device to patient What is the cause of the patient s pain? Where is the patient s pain pattern? Does the patient have any unusual anatomy? What are the power requirements? One of the purposes of the trial Procedure Usually performed in two stages Temporary evaluation period Permanent implant Temporary Evaluation Period A temporary evaluation period provides an opportunity to measure the effectiveness of SCS without making a longterm commitment Gauge patient response Provide an adjustment period Fine-tune therapy parameters Improve therapy cost-effectiveness Temporary Evaluation Period The goal is at least a 50% reduction in pain without intolerable side effects 12 Patient-specific goals may include less pain reduction but improved quality of life Purpose of Psychological Assessment13 Exposes psychological factors that can influence the outcome of surgery Used to determine how well a presurgical assessment could predict a surgical outcome Facilitates patient selection for specific pain therapies Provides clues to evaluate the patient s response to a temporary evaluation or treatment Temporary Evaluation Period Patient and family receive extensive pretrial education Outpatient/office procedure to place leads Leads are connected to a trial stimulator with settings created to cover painful areas Allows the patient and the physician to determine if SCS will provide pain relief 12

13 Nerve Fibers Nerve Root Fibers Dorsal Root Lumbar Axial Fibers Dorsal Nerve Dorsal Root Ganglion How Are Device Factors Evaluated? Temporary SCS trial Ventral Root Nerve Root Ventral Nerve Spinal Nerve Neurostimulation Temporary Evaluation Assessment Criteria Pain control Did the trial relieve the patient s pain and by what percentage? Activities Did the trial improves the patient s ability to participate in normal activities and to what degree? Sleep Was the patient able to sleep comfortably during the trial? Medication Did the need for pain medications change during the trial? Patients who experience a positive response to the temporary evaluation may be candidates for long-term neurostimulation therapy. Temporary Evaluation Outcomes Determine the number of leads and contacts for permanent implant match the device to the patient Determine device type Primary cell IPG Rechargeable IPG Monitor patient expectations 13

14 After Temporary Evaluation Period Patient, family, and physician discuss the temporary evaluation and determine if the patient should move forward with the permanent implant The physician and patient will decide what is the best type of system for the patient s pain pattern Permanent Implant The leads and IPG will be implanted during a minor surgical procedure Implantation Procedure Implantation procedure performed by a physician in a hospital or ambulatory surgery center On average, the procedure takes 1-2 hours from start to finish May be an outpatient procedure or, in some cases, may require a stay in the hospital Getting Their Lives Back Patients should gradually return to activities of daily living Some changes in stimulation are common as activity increases Adjustments can be made through the programming system Patients and physicians have a life-long relationship Rethinking the Chronic Pain Treatment Continuum Cost-Effectiveness Analysis of Neurostimulation Therapy For Chronic Pain22 Evaluated 104 patients with FBSS 60 implanted after successful trial; 44 control patients Actual mean cumulative costs 5-year follow-up SCS group $29,123 15% RTW Control group $38,029 0% RTW * Canadian dollars RTW = return to work 14

15 SUCCESS RATE Cost-Effectiveness of Neurostimulation SCS is cost-effective, as several experts have shown: Bell et al. 21 showed that SCS pays for itself within 2.1 years with patients who have clinically effective SCS for failed back surgery syndrome. Neurostimulation vs. Repeat Surgery Based on a study by North 14, neurostimulation is more effective than repeat surgery as a treatment for persistent radicular pain after lumbosacral spine surgery. Success* at mean 3- year follow-up 14 Neurostimulation Re-operation * Success is defined as at least 50% pain relief; and would undergo treatment again for same result Importance of Timing With SCS in thetreatment of FBSS The sooner an SCS system is implanted after a failed back surgery, the more effective SCS may be. 85% 68% The success rate of neurostimulation decreases from 85% if delayed by <2 years to about 9% if delayed by >15 years % 35% 11% 9% < >15 SCS Studies Reduction in pain Author No. Patients Follow-Up Results Kumar years 74% had 50% relief North 19 3 years 47% had 50% relief Barolat 41 1 year 50%-65% had good/excel. relief Van Buyten years 68% had good/excel. relief Alò months (2.5 years) Mean pain scores declined from 8.2 at baseline to 4.8 Cameron 747 up to 59 mos. 62% had 50% relief or significant reduction in pain scores TIME UNTIL INTERVENTION (YEARS) SCS Studies Reduction in medication Author No. Patients Follow-Up Results SCS Studies Improvement in daily activities Author No. Patients Follow-Up Results North 19 3 years 50% reduced their med use Van Buyten years as a group reduced the medication use by >50% Cameron 766 up to 84 mos. 45% reduced their med use Taylor 681 n/a 53% no longer needed Analgesics Barolat 41 1 year As a group, significant improvements in function and mobility North 19 3 years As a group, improvements in a range of activities 15

16 SCS Studies Return to work Author No. Patients Follow-Up Results Van Buyten years 31% returned to work Taylor 1133 n/a 40% returned to work Dario 23 3 years 35% returned to work The Take-Home You are the key to educating patients about therapy options. You are the key to helping place patients on the path to improved functionality and return to work. You are the key to providing the best opportunities for case closure. The Take-Home A team approach using the case manager, physicians, and other medical personnel can be very successful. In selected patients, implantable devices provide the best outcomes when compared to other options. You are the quarterback for ensuring optimal communication among all parties. Questions? Thank you for your time! References 1. National Institute of Arthritis and Musculoskeletal Skin Diseases website. News and Events Page. Available at: Accessed May 10, Martin BI, Deyo RA, Mirza SK, et al. Expenditures and health status among adults with back and neck problems. JAMA. 2008;299: Guo HR, Tanaka S, Halperin WE, Cameron LL. Back Pain Prevalence in US Industry and Estimates of Lost Workdays. AM J Public Health. 1999; 89: Pai S, Sundaram LJ. Low Back Pain: An Economic Assessment in the United States. Orthop Clin N Am. 2004;35: HCUP Nationwide Inpatient Sample (NIS): All U.S. Inpatient Spine Surgeries. Healthcare Cost and Utilization Project (HCUP) Agency for Healthcare Research and Quality (AHRQ), Rockville, MD Stojanovic MP. Stimulation Methods for Neuropathic Pain Control. Curr Pain Headache Rep. 2001;5: Barolat G, Oakley JC, Law JD, North RB, Ketcik B, Sharan A. Epidural Spinal Cord Stimulation with a Multiple Electrode Paddle Lead is Effective in Treating Intractable Low Back Pain. Neuromodulation. 2001;4: Katz JN. Lumbar Disc Disorders and Low-Back Pain: Socioeconomic Factors and Consequences. J Bone Joint Surg. 2006;88A(suppl. 2): Ballantyne JC, Mao J. Opioid Therapy for Chronic Pain. N Engl J Med, 2003;349: Lee C, et al. Low Serum Cortisol Associated with Oopioid Use: Case Report and Review of the Literature. Endocrinologist 2002;12: Krames E, Poree L, Deer T, Levy R. Implementing the SAFE Principles for the Development of Pain Medicine Therapeutic Algorithms That Include Neuromodulation Techniques. Neuromodulation. 2009;12: Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year experience. Neurosurgery. 2006; 58: Block AR, et al. The Use of Presurgical Psychological Screening to Predict the Outcome of Spine Sugery.Spine J. 2001;1(4): North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal Cord Stimulation versus Repeated Lumbosacral Spine Surgery for Chronic Pain: A Randomized, Controlled Trail. Neurosurgery. 2005; 56:98-106; discussion Kumar K, et al. Spinal Cord Stimulation vs. Conventional Medical Management: A Prospective, Randomized, Controlled, Multicenter Study of Patients with Failed Back Surgery Syndrome. Neuromodulation 2005;8:

17 References 16. Van Buyten JP, Van Zundert J, Vueghs P, Vanduffel L. Efficacy of Spinal Cord Stimulation: 10 Years of Experience in a Pain Centre in Belgium. Eur J Pain. 2001;5: Cameron T. Safety and Efficacy of Spinal Cord Stimulation for the Treatment of Chronic Pain: A 20-Year Literature Review. J Neurosurg Spine. 2004;100(3): Alò K, Yland M, Charnov J, Redko V. Multiple program spinal cord stimulation in the treatment of chronic pain: follow-up of multiple program SCS. Neuromodulation. 1999;2(4): Taylor RS, Van Buyten JP, Buchser E. Spinal Cord Stimulation for Chronic ack and Leg Pain and Failed Back Surgery Syndrome: A Systematic Review and Analysis of Prognostic Factors. Spine. 2005;30: Dario A, Fortini G, Bertollo D, Bacuzzi A, Grizzetti C, Cuffari S. Treatment of Failed Back Surgery Syndrome. Neuromodulation. 2001;4: Bell GK, Kidd D, North RB. Cost Effectiveness Analysis of Spinal Cord Stimulation in Treatment of Failed Back Surgery Syndrome. J Pain Symptom Manage. 1997;13: Kumar K, Malik S, Demeria D. Treatment of Chronic Pain with Spinal Cord Stimulation versus Alternative Therapies: Cost-Effective Analysis. Neurosurgery. 2002;51: