Back Pain Technologies Beyond the Buzz Hassan Moinzadeh

Back Pain Technologies: Beyond the Buzz Hassan Moinzadeh, MD, Ph. D, Paradigm Medical Director © Paradigm Outcomes, Proprietary

Normal Pain Perception 2 © Paradigm Outcomes, Proprietary

What Happens to the Sensory Receptors? Vibration Pressure Nociceptor Vibration Touch Temperature Pressure 3 © Paradigm Outcomes, Proprietary

Wind-Up Pain • caused by constant bombardment of the second order neurons in the Dorsal Horn of the Spinal Cord • sprouting of Wide Dynamic Range (WDR) neurons • induction of glutamate dependent Nmethyl-D-aspartate (NMDA) receptors • Opioid tolerance 4 © Paradigm Outcomes, Proprietary

What is Pain? Pain is a sensation 5 © Paradigm Outcomes, Proprietary

Pain: A Complex, Subjective Experience 6 © Paradigm Outcomes, Proprietary

Pain is an experience unique to each individual. It is impacted not only by the actual physiological processes of pain perception and the relay mechanisms to the brain, but also by autonomic control, neuromodulation, cognitive meaning making and affective states. Pain Perception ■ Nociception ■ influenced not only by the pain’s intensity, but also by its meaning to the patient ■ Somatosensory system ■ Pain neurological interpretation ■ linked with the patient’s social, cultural and psychological background & history ■ Neuromodulation ■ Cognitive interpretation ■ Emotional influences and responses 7 © Paradigm Outcomes, Proprietary

Low Back Pain Low back pain is a symptom, not a specific disease. Insert your own picture Low back pain is usually described as discomfort in the lumbosacral region of the back that may or may not radiate to the legs, hips, and buttocks. http: //www. mdguidelines. com/low-back-pain/definition 8 © Paradigm Outcomes, Proprietary

Back Pain Statistics Back pain is the most common disability condition for working-age Americans. ■ Low back pain is the most common type of pain according to the National Institute of Health statistics ■ Back pain is the leading cause of disability in Americans under 45 years old ■ More than 26 million Americans between the ages of 20 and 64 experience frequent back pain ■ Adults with low back pain are often in worse physical and mental health than people who do not have low back pain ■ Adults reporting low back pain: – Three times as likely to be in fair or poor health – More than four times as likely to experience serious psychological distress All data from American Academy of Pain Medicine Facts and Figures on Pain factsheet 9 © Paradigm Outcomes, Proprietary

Why is Back Pain so Hard to Treat? The interface between injured worker, provider, and various approaches designed to “fix” the problem often create additional challenges and may lead an acute injury to proceed to chronic pain. ■ Complexity of low back anatomy and function ■ Common asymptomatic incidental imaging findings ■ Acute and chronic back pain differ ■ Importance of the psychosocial aspects of pain reporting ■ Absence of simple “pain generator” ■ Modern medicine responds more readily to symptoms than to actual spine function ■ Tendency of injured workers to prefer passive versus active treatments ■ Quick-fix focus of pain management (drugs, interventions, surgeries) (Magnetic Resonance Imaging of the Lumbar Spine in People without Back Pain, Maureen C. Jensen, et. Al. NEJM volume 331: 6973, July 14, 1994, number 2) 10 © Paradigm Outcomes, Proprietary

Anatomy and Physiology of Back Pain Looking at the bones Assessing back pain 11 © Paradigm Outcomes, Proprietary

Most Back Pain is Not From a Herniated Disc Just because there’s pathology on an MRI does not mean that’s the cause of a person’s pain complaints. 12 © Paradigm Outcomes, Proprietary

The Muscles Strength, flexibility and coordination matter … and muscles can hurt. 13 © Paradigm Outcomes, Proprietary

Back Function Matters Flexibility is a key indicator. 14 © Paradigm Outcomes, Proprietary

Assessing Back Pain What tests do and do not tell us. ■ Imaging ■ Physiologic testing – X-ray – EMG – CT – Blood work – MRI – Discogram ■ Physical examination – Physical and functional examination ■ Concept of false positives – Behavioral assessment – MRI of a bulging disc – Facet arthropathy – Bone spurs 15 © Paradigm Outcomes, Proprietary

Common Misdiagnoses Careful application of objective assessment is vital. ■ Discogenic pain ■ Radiculopathy ■ Sacroiliac Joint Syndrome ■ Piriformis Syndrome The Evidence Drives Diagnosis 16 © Paradigm Outcomes, Proprietary

When Low Back Pain Becomes Something More The biopsychosocial nature of low back pain. ■ Imaging and anatomy does not tell the whole picture ■ Pain behavior and Visual Analog Scale (VAS) are not a measure of spine pathology ■ Fear avoidance and its effect on function ■ The pain emotional experience ■ How should these cases be approached? 17 © Paradigm Outcomes, Proprietary

Factors Impacting Pain Psychosocial factors including personal, familial, and cultural experiences influence how pain is felt and processed. ■ How you interpret pain messages and tolerate pain can be affected by your: – Emotional and psychological state – Memories of past pain experiences – Upbringing – Attitude – Expectations – Beliefs and values – Age – Sex – Social and cultural influences 18 © Paradigm Outcomes, Proprietary

Causation 19 © Paradigm Outcomes, Proprietary

LBP Causation A specific work-related back complaint should not infer causation of everything spinal. ■ What is the diagnosis? ■ Do not confuse the incidental spinal imaging finding with the non-axial cause of pain. ■ Determination of causation typically involves mechanism of injury, temporal relationship, and dose effect. 20 © Paradigm Outcomes, Proprietary

LBP Causation Using ODG as a guide Bradford-Hill criteria: 1. Temporal Relationship: Exposure always precedes the outcome; this is the only absolutely essential criterion. 2. Strength: The stronger the association, the more likely it is causal, but a small association does not mean that there is not a causal effect. 3. Dose-Response Relationship: An increasing amount of exposure increases the risk. This is strong evidence for a causal relationship, but the absence of a dose-response relationship does not rule out a causal relationship, for example, if a threshold exists above which a relationship may develop. 4. Consistency: The association is consistent when results are replicated in studies in different settings using different methods. This strengthens the likelihood of an effect. 5. Plausibility: The association agrees with currently accepted understanding of pathological processes. A plausible mechanism between cause and effect is helpful, but Hill noted that knowledge of the mechanism is limited by current knowledge. 6. Consideration of Alternate Explanations: It is always necessary to consider multiple hypotheses before making conclusions about causal relationships. 7. Experiment: The condition can be altered by an appropriate experimental regimen. The hypothesis can be tested. 8. Coherence: The association should be compatible with existing theory and knowledge, but the lack of laboratory evidence cannot nullify the epidemiological affect on associations. (Hill, 1965) 21 © Paradigm Outcomes, Proprietary

LBP Causation Continued ■ ODG Causality Likelihood. Based on the raw data, Causality Likelihood indicates the benchmark percentage of total lost workdays, both occupational and non-occupational, that are occupational in nature. It can be used statistically to estimate what percentage of costs for this condition is represented by workers' comp. This indicator should not be used in an industrial injury setting to imply a likelihood of causation. See Preface for more information. ■ Intervertebral disc disorders, Causality Likelihood: Under 5% ■ Displacement of thoracic or lumbar intervertebral disc without myelopathy, Causality Likelihood: Under 5% ■ Spinal stenosis, other than cervical, Causality Likelihood: Under 5% ■ Lumbago, Causality Likelihood: Under 5% ■ Sciatica, Causality Likelihood: Under 5% ■ Thoracic or lumbosacral neuritis or radiculitis, unspecified, Causality Likelihood: Under 5% ■ Backache, unspecified, Causality Likelihood: Under 5% ■ Other symptoms referable to back, Causality Likelihood: 7% ■ Lumbar sprains and strains, Causality Likelihood: Over 80% 22 © Paradigm Outcomes, Proprietary

Causation The bigger picture ■ Careful vetting of past history ■ Comorbid conditions ■ Separate the symptoms from the MRI findings – Diabetes and related conditions – Generalized pain conditions ■ Limit the scope of causation. Example, minor twisting injury may be a strain, but it is not responsible for a spinal anatomy problem, whether or not the stain ever recovers – Arthritis – Smoking – Obesity – Addiction ■ Careful of the difference between exacerbation and aggravation – Psychiatric – Hepatitis C ■ Apportionment 23 © Paradigm Outcomes, Proprietary

Red Flags a Claim is Going Sideways Management strategies may need to change to address what’s happening with the claim! ■ Front line intel – Referral to a pain management specialist – Surgery being mentioned – Specific diagnoses: CRPS – Specific physicians – Poor response to approved procedure ■ Claims data analysis – Not RTW – Escalating pharmacy including opioids – Procedures/surgeries despite not meeting indications – Multiple ineffective interventional procedures 24 © Paradigm Outcomes, Proprietary

Pain Treatments The intervention must be indicated for this diagnosis and actually be effective. 25 © Paradigm Outcomes, Proprietary

Effectiveness: Restoration of Function Disturbance of function, not pain, is what ultimately causes disability ■ Restoration of function: the concept ■ Rehabilitation should be the goal of all pain management interventions = return to optimal function ■ What is function? (World Health Organization, International Classification of Function) ■ Studies repeatedly show that when you uncouple pain and function, function can dramatically improve ■ Objective measures ■ Measurement that is not subjective, not dependent on effort ■ Blood pressure, temperature, pulse, range of motion, calf measurement, reflexes, strength, gait ■ Functional measures examples (ODG 2012) ■ Work Functions and/or Activities of Daily Living, Self Report of Disability (e. g. , walking, driving, keyboard or lifting tolerance, Oswestry, pain scales, return-to-work, etc. ) ■ Physical Impairments (e. g. , joint ROM, muscle flexibility, strength, or endurance deficits) ■ Approach to Self-Care and Education (e. g. , reduced reliance on other treatments, modalities, or medications, such as reduced use of painkillers) ■ Decreased need for healthcare intervention 26 © Paradigm Outcomes, Proprietary

Commonly Use Pain Treatments What is their role? ■ Interventional pain procedures ■ Exercise – Challenges to making it effective – The latest on ESI – HEP one month post PT, Adherence to duration per session was more probable than adherence to frequency per week; self-efficacy was a big problem – The blatant failures : discogram, IDET – SCS, ITP ■ Surgery ■ Medications – “Spinal fusions serve as case study for debate over when certain surgeries are necessary” “My hunch is that as many as half of the spine fusions in the U. S. are unnecessary, ”-Deyo quote The Washington Post October 27, 2013 – Sad truth – NNT – Pharma commercial interests – Opioids: “No Safe Threshold: Opioid Overdoses Can Occur at Both High and Low Dose Regimens” (Back Letter 11/2015) – There are specific criteria – Bad reason for surgery: Get better quicker, nothing else worked ■ Neuropathic paid meds 27 © Paradigm Outcomes, Proprietary

Psychosocial Factors and Chronic Pain Disability conviction, maladaptive coping strategies, fear avoidance, depression, dependency, and catastrophizing can increase the risk of an injury turning into chronic pain. Beliefs Attitudes and Expectations • Meaning of symptoms within the context of the individual and society • Patient’s level of control over the pain • Pain’s impact on daily life now, and worries about the future. Coping Maladaptive behaviors/emotions • Fear of engaging in rehab efforts after onset of pain • Hypervigilance—Preoccupation and selective attention to bodily symptoms • Physical deconditioning may exacerbate pain and maintain disability Fear Avoidance Fear of causing pain or causing harm • Pain-related anxiety and fear may actually exacerbate the pain • Increased autonomic activation and threat response 28 © Paradigm Outcomes, Proprietary

Fear of Pain is More Disabling Than Pain Itself Waddell (1993): There is greater disability and work loss associated with avoiding activities and movement because of a fear of increasing pain. • Decreased mobility and loss of range of motion • Increased physiological arousal and prolonged muscle spasms • Cardiovascular deconditioning leads to increased disability conviction. 29 © Paradigm Outcomes, Proprietary

Psychological Factors and Chronic Pain Dependency: Tend to be more depressed, functionally impaired and in worse pain. • The future depends on others, including surgeons, spouses, employers, attorneys, carriers. • The worst that can happen is true. This is horrible. It is killing me. There’s no way I can stand it. I’m damaged for the rest of my life. I am condemned to suffer. Suffering and Catastrophizing 30 © Paradigm Outcomes, Proprietary

Best Predictors of Acute Injury Progressing to Chronic Pain 1. Maladaptive Attitudes and Beliefs 2. Lack of Social Support 3. Heightened Emotional Reactivity 4. Job Dissatisfaction 5. Substance Abuse 6. Compensation Status 7. Prevalence of Pain Behaviors 8. Psychiatric diagnosis • N. B. —Severity of injury and physical demands of the job are not accurate predictors. 11/24/2020 31 © Paradigm Outcomes, Proprietary

Medications These are the medications typically prescribed for back pain. ■ NSAIDS ■ Muscle relaxants ■ Neuropathic pain medications ■ SSRIs ■ Opioids ■ Topicals ■ Over the counter ■ Miscellaneous 32 © Paradigm Outcomes, Proprietary

Opiate Medications and Psychosocial Factors Although opiates work remarkably well in the acute phase of injury, their effectiveness in the treatment of chronic pain conditions is more complicated. Pain patients have increased disease conviction, somatic preoccupation, and externalized locus of control leading to increased opioid seeking behaviors. Opioid Risk Tool • Low, Medium, or High Risk • Personal or family history of substance abuse, age, history of adolescent sexual abuse, certain psych. dx Psychological Dependency • Pseudoaddiction— fear of uncontrolled pain • True addiction— Compulsive use of a substance resulting in physical, psychological, or social harm to the user. 33 Side Effects • Neuro-behavioral issues—may worsen depression, and exacerbate anxiety and irritability • Cognitive impairment/sedation • Opioid-induced Hyperalgesia © Paradigm Outcomes, Proprietary

Interventional Technologies Very careful selection is needed before choosing one of these technologies. ■ Trigger point injections ■ “Minimally invasive” procedures ■ Spinal cord stimulators Ripped from the Headlines – “Epidural Steroid Injections Are Associated With Less Improvement in Patients With Lumbar Spinal Stenosis” -SPINE – “Spinal Fusion For Degenerative Disc Disease: An Operation in Search of an Indication” -The Back Letter – “…could not find evidence of any other benefits of total disc replacement, and the studies provided no insights on the long-term risks associated with it. ” -Cochrane Review ■ Intrathecal pain pumps ■ Surgery 34 © Paradigm Outcomes, Proprietary

The Best Outcome: Restore Function Diet, exercise, meditation, stress management: Less interventions and medications, more self-care! ■ Therapeutic exercise – Physical therapy – Pool therapy ■ Cognitive Behavioral Therapy and other psychotherapeutic modalities ■ Medical Case Management to clarify diagnoses, establish good lines of communication with providers, injured worker, and carrier, and identify EBM best options for treatment ■ Adjunctive treatments ■ Lifestyle changes ■ Pain management/FRP/opioid detox ■ Attitude changes 35 © Paradigm Outcomes, Proprietary

Adjunctive Interventions When do they work and for whom? ■ Passive modalities – Massage – Acupuncture – Heat and cold modalities ■ Durable Medical Equipment – Electrical stimulation – Back braces – Mattresses – Assistive devices (canes, walkers) Acupuncture image from Wonderlane via Flickr Creative Commons 36 © Paradigm Outcomes, Proprietary

Case Management Tips: Treatment in Context © Paradigm Outcomes, Proprietary

Challenges for the Insurer ■ Often put in the position of certifying sequential single services – Trial and error ■ Outcomes of popular treatments often not game changing Avoid This Trap! – Lack of measurement ■ Behavioral factors get ignored in medical treatment offers – Why factors influence a doctor decision to prescribe opioids 1 “Because nothing else worked” is a poor criteria to justify an intervention. ■ Doctors , injured workers often do not fully engage in the effective conservative interventions – Immediate gratification ■ Injured workers often agree to invasive treatments that are statistically not likely to help them 1 What Factors Affect Physicians' Decisions to Prescribe Opioids for Chronic Noncancer Pain Patients? Turk, Dennis C. Ph. D. , et al, Clinical Journal of Pain: December 1997 - Volume 13 - Issue 4 - pp 330 -336 38 © Paradigm Outcomes, Proprietary

Addressing Provider Challenges Considerations Overemphasis on subjective complaint and imaging Tactics Measurement, concordance, peer-to-peer, case management Many mainstay treatments are not steeped in deep Accountability to EBM, clarify selection criteria evidence • Commonly used does not mean effective • Surgical “cures” have been disappointing, when not applied selectively Rush to market for procedures and medications • FDA approval does not validate effectiveness • Lack of careful selection Vetting new technology, UR, peer-to-peer Providers often offer boutique service • No time or resource to week through the behaviors • Take IW history at face value Guide toward pain management instead of pain medicine 39 © Paradigm Outcomes, Proprietary

Addressing Injured Worker Challenges Considerations Tactics Lack of medical sophistication • Blind trust • Assumption of beneficence • Lack of knowledge Education, second opinion, case management Human nature can play a counter-adaptive role Cognitive behavioral techniques, education, coaching • Fantasy of a quick and total fix • Dislike of exercise and other active involvement • Disbelieve of the psychosocial aspects of pain Individual personality traits affect individual approach • Coping ability • Anger/entitlement • Secondary gain Cognitive behavioral techniques 40 © Paradigm Outcomes, Proprietary

Systematic Management Techniques to Stop a Runaway Case Coordinated Intervention Physician and Nurse 41 © Paradigm Outcomes, Proprietary

Conclusions and Advice Challenge ■ LBP is a group of problems with location of perceived pain in common ■ Avoid providers who try to over-explain the symptoms ■ The overwhelming number of cases are self- limited and non-surgical ■ Promote early self-care and (HEP) activity limitation ■ Non-medical healthcare factors promote interventional and surgical care that is not needed ■ Avoid known aggressively interventional providers ■ Build trust in order to help educate IWs as healthcare consumers ■ IWs often have low health literacy ■ Recognize psychosocial factors early, especially sense of injustice, catastrophizing, and fear avoidance ■ Psychosocial factors are the greatest risks for chronic pain (and poor outcome) ■ Providers often do not take psychosocial factors into account in treatment plan ■ Assure PS factors are incorporated in treatment ■ Identify meaningful objective measures with the IW (education) ■ Objective outcome measures not part of most care 42 © Paradigm Outcomes, Proprietary