Disclosure Statement of Financial Interest. Evidence Based Evaluation and. Learning Objectives. What is Low Back Pain?

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1 Disclosure Statement of Financial Interest Evidence Based Evaluation and Management of Low Back Pain June 28, 2013 St. Charles Medical Center Summer Boslaugh and Alison Little DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. Alison Little, MD, MPH, Center for Evidence based Policy, Oregon Health & Science University Summer Boslaugh, MBA/MHA Oregon Health Care Quality Corporation Learning Objectives Understand current care Consistently apply the State of Oregon Evidencebased Clinical Guidelines for Evaluation and Management of Low Back Pain Order imaging for back pain appropriately Instruct and support patients in self management of acute low back pain Refer appropriately for consultation and/or treatment of low back pain What is Low Back Pain? Aching, burning, stabbing, sharp or dull, well defined or vague Following activity or trauma, but often unrelated to any specific activity At least 80% of individuals experience a significant episode in their lifetime Definition access from the North American Spine Society: Problem Statement Low Back Pain Utilization Report (March 2013) Clinical effectiveness research indicates new onset low back pain: Is usually self limited Requires little medical intervention However there is evidence of significant overuse of services Low Back Pain: Utilization of Health Care Services in Oregon. Oregon Health Care Quality Corporation. Oregon Health Care Quality Corporation, Web. March corp.org/wp content/uploads/2013/03/lbp Baseline

2 Percent of Uncomplicated Episodes with within 90 Days by Image Type Percent Appropriate Low Back Pain by Payer Type (HEDIS Measure, first 28 days) Low Back Pain: Utilization of Health Care Services in Oregon. Oregon Health Care Quality Corporation. Oregon Health Care Quality Corporation, Web. March corp.org/wp content/uploads/2013/03/lbp Baseline Low Back Pain: Utilization of Health Care Services in Oregon. Oregon Health Care Quality Corporation. Oregon Health Care Quality Corporation, Web. March corp.org/wp content/uploads/2013/03/lbp Baseline Percent of Episodes with Plain Film X Rays in first 90 days by Payer Type Percent of Episodes with Emergency Department Visits in first 90 days by Payer Type Percent of Episodes with a Narcotics Prescription by Payer Type Percent of Episodes with a Skeletal Muscle Relaxant Prescription by Payer Type

3 Percent of Episodes with Complementary Care by Payer Type 2010 Distribution of Estimated Costs for Newly Diagnosed Low Back Pain Episodes 2010 Estimated Cost per Patient with Acute Low Back Pain by Geographic Region State of Oregon Evidence based Clinical Guidelines Project Oregon s Action Plan for Health (2010) includes a strategy to identify and develop 10 sets of Oregon based best practice guidelines and standards that can be uniformly applied across public and private health care to drive down costs and reduce unnecessary care. In November 2011, the first guideline, Evaluation and Management of Low Back Pain, was published. Access the guidelines online: Based Evaluation and Management of Low Back Pain Developed by a collaborative group of public and private partners to provide upto date, evidence based guidance on the evaluation and management of low back pain Evaluation and Management of Low Back Pain Guideline Development Process: Search for existing guidelines in 17 databases 13 possible guidelines identified, 10 sufficiently broad for further evaluation Quality of guidelines assessed (two reviewers) Five good or fair quality Final selection based on quality and scope (addressed acute, subacute, chronic, wide variety of interventions, graphic representation)

4 Evaluation and Management of Low Back Pain Case Presentation Guideline Development Process: Base guideline: Chou, R., Qaseem, A., Snow, V. et al for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians and the American College of Physicians/ American Pain Society Low Back Pain Guidelines Panel. (2007).Diagnosis and treatment of low back pain: A joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med, 147(7), specialties invited to peer review, 7 responded, minor changes made Posted for public comment, 7 commenters, minor changes made Final guideline approved by HERC October 2011 Sarah, 38 year old woman with a history of more than 4 years of back pain Pain described as dull, aching in lumbar area without radiation No neurologic symptoms Otherwise healthy, with PMH positive only for appendectomy and hypothryroidism (on replacement) Case Presentation Prior evaluation 3 years ago included CT of L/S spine which showed herniated disc at L5 S1 Prior treatments included corsets, chiropractic manipulation, acupuncture Currently taking naproxen 220 mg BID Case Presentation Physical exam Normal neurologic exam Decreased spinal flexion Plain radiography Narrowed L5 S1 disc space Case Presentation Sarah is diagnosed with non specific LBP Provided with information on a mild stretching and strengthening home exercise program After 1 month, she reported that her pain was 95% better and occurred only occasionally. Spinal flexion was slightly increased. E&M LBP Recommendation 1 Focused History & Physical Clinicians should conduct a focused history and physical examination, including a neurological exam, to help place patients with low back pain into 1 of 3 broad categories: 1.Nonspecific low back pain 2.Back pain potentially associated with radiculopathy or spinal stenosis 3.Back pain potentially associated with another specific spinal cause. The history should include assessment of psychosocial risk factors, which predict risk for chronic disabling back pain. Appropriate referrals for management of potentially serious conditions (see Table B) could be considered at this time.

5 E&M LBP Recommendation 2/ Advanced LBP Recommendation 1 No Routine Clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain. E&M LBP Recommendation 2/ Advanced LBP Recommendation 1 No Routine No evidence that routine plain radiography in nonspecific LBP is associated with greater improvement than selective imaging Unnecessary radiation exposure (L/S spine films equivalent to over 300 CXRs) Routine advanced imaging not associated with improved outcomes, identifies incidental findings E&M LBP Recommendation 3/ Advanced LBP Recommendation 2 Indications for Clinicians should perform diagnostic imaging and testing for patients with low back pain when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination. Possible cause Cancer Key features on history or physical exam History of cancer with new onset LBP Unexplained weight loss Failure to improve after 1 month Age > 50 years Multiple risk factors for cancer Lumbosacral plain radiograph Lumbosacral plain radiograph or ESR Possible cause Spinal column infection Key features on history or physical exam Fever IV drug use Recent infection ESR and/or CRP Possible cause Cauda equina syndrome Key features on history or physical exam Urinary retention Motor deficits at multiple levels Fecal incontinence Saddle anaesthesia

6 Possible cause Vertebral compression fracture Key features on history or physical exam History of osteoporosis Use of corticosteroids Older age Lumbosacral plain radiograph Possible cause Ankylosing spondylitis Key features on history or physical exam Morning stiffness Improvement with exercise Alternating buttock pain Awakening due to back pain in the second part of the night Younger age Anteriorposterior pelvis plain radiography ESR and/or CRP, HLA B27 Possible cause Nerve compression/ disorders (e.g. herniated disc with radiculopathy) Key features on history or physical exam Back pain with leg pain in L4, L5 or Sa nerve root distribution Positive straight leg raise or crossed straight legraise test Radiculopathic symptoms present > 1 month Severe/progressive neurologic deficits, progressive motor weakness Consider EMG/NCV Possible cause Spinal stenosis Key features on history or physical exam Radiating leg pain Older age Pain usually relieved with sitting (Pseudoclaudication a weak predictor) Spinal stenosis symptoms present > 1 month Consider EMG/NCV E&M LBP Recommendation 4/ Advanced LBP Recommendation 3 Advanced Clinicians should evaluate patients with persistent low back pain and signs or symptoms of radiculopathy or spinal stenosis with magnetic resonance imaging (preferred) or computed tomography only if they are potential candidates for surgery or epidural steroid injection (for suspected radiculopathy). Oregon Health Policy and Research. Available at: Based E&M LBP Recommendation 4/ Advanced LBP Recommendation 3 Advanced Best Practice Advice from American College of Physicians (2011) The ACP has found strong evidence that routine imaging for low back pain by using radiography or advanced imaging methods is not associated with a clinically meaningful effect on patient outcomes. Unnecessary imaging exposes patients to preventable harms, may lead to additional unnecessary interventions, and results in unnecessary costs. Diagnostic imaging should be performed only in selected, higher risk patients who have severe or progressive neurologic deficits or are suspected of having a serious or specific underlying condition. Advanced imaging with or CT should be reserved for patients with a suspected serious underlying condition or neurologic deficits, or who are candidates for invasive interventions. Oregon Health Policy and Research. Available at: Based

7 Recommendation 5 Patient Education Clinicians should provide patients with evidence based information on low back pain with regard to their expected course, advise patients to remain active, and provide information about effective selfcare options. Recommendation 5 Patient Education Quality Corp consumer booklet Get Vertical: And Don t Take Back Pain Lying Down! available from Partner for Quality Care Livingston, C., King, V., Little, A., Pettinari, C., Thielke, A., & Gordon, C. (2011). State of Oregon Evidence based Clinical Guidelines Project. Evaluation and management of low back pain: A clinical practice guideline based on the joint practice guideline of the American College of Physicians and the American Pain Society (Diagnosis and treatment of low back pain). Salem: Office for Oregon Health Policy and Research. Available at: Based Livingston, C., King, V., Little, A., Pettinari, C., Thielke, A., & Gordon, C. (2011). State of Oregon Evidence based Clinical Guidelines Project. Evaluation and management of low back pain: A clinical practice guideline based on the joint practice guideline of the American College of Physicians and the American Pain Society (Diagnosis and treatment of low back pain). Salem: Office for Oregon Health Policy and Research. Available at: Based Recommendation 5 Patient Education When you first get low back pain, what 3 things can you do on your own that will help the most? 1.To feel better sooner, stay active! (lying down to rest your back can slow down your recovery) 2.Use hot packs or a heating pad 3.Take non prescription medicine for pain(acetaminophen, aspirin, ibuprofen, or naproxen) Recommendation 6 Pharmacologic Therapy Clinicians should consider the use of medications with proven benefits in conjunction with back care information and self care. Clinicians should assess severity of baseline pain and functional deficits, potential benefits, risks, and relative lack of long term efficacy and safety data before initiating therapy. For most patients, first line medication options are acetaminophen or non steroidal anti inflammatory drugs Access the booklet online: Partner for Quality Care: Recommendation 6 Pharmacologic Therapy Acetaminophen slightly less effective but safe NSAIDs slightly more effective but known GI/renal/CV adverse events Opioids/tramadol optional for severe pain, but risks of diversion/abuse substantial failure to respond indicates need for re assessment Recommendation 6 Pharmacologic Therapy Sales of opioid pain relievers nationally quadrupled between 1999 and Enough were prescribed in 2010 to medicate every American adult with 5 mg of hydrocodone Q 4 hours for a month. In 2010, Oregon had the second highest rate of narcotic abuse in the US CDC Report: Vital Signs: Overdoses of Prescription Opioid Pain Relievers:

8 Recommendation 6 Pharmacologic Therapy In 2007, the number of druginduced deaths in Oregon (564) exceeded the number of deaths from motor vehicle accidents (490) or firearms (387) Recommendation 6 Pharmacologic Therapy Skeletal muscle relaxants optional for shortterm treatment, significant CNS adverse events Benzodiazepines have similar efficacy but more risk for abuse/diversion Tricyclic antidepressants optional for chronic LBP Insufficient evidence for antiepileptic drugs Some evidence of efficacy for herbal therapies (devil s claw, willow bark, capsicum) Corticosteroids not recommended (no more effective than placebo) Oregon Drug Control Update: _oregon.pdf Recommendation 7 Non pharmacologic therapy For patients who do not improve with selfcare options, clinicians should consider the addition of non pharmacologic therapy with proven benefits Acute low back pain spinal manipulation Chronic or subacute low back pain intensive interdisciplinary rehabilitation, exercise therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive behavioral therapy, or progressive relaxation. Interventions (Addresses Recommendations 5 7) = Interventions supported by grade B evidence (at least fair quality evidence of moderate benefit, or small benefit but no significant harms, costs, or burdens). No intervention was supported by grade A evidence (good quality evidence of substantial benefit) = Carries greater risk of harms than other agents in table **Associated with significant risks related to potential for abuse, addiction and tolerance. This evidence evaluates effectiveness of these agents with relatively short term use. Chronic use of these agents may result in significant harms. Extracted and modified from Chou R, Qaseem A, Snow V, et al: Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007; 147: Case Study How did Sarah s care comport with the guideline recommendations? Adheres to the guideline: History and physical with neurologic exam NSAIDs Exercise program Prior use of chiropractic/ acupuncture Does not adhere to the Guideline L/S plain radiography Prior use of corset Guideline for Percutaneous Interventions for Low Back Pain Recommendation 1 Epidural Steroid Injection for persistent radiculopathy due to herniated lumbar disc In patients with persistent radiculopathy due to herniated lumbar disc, it is recommended that clinicians discuss risks and benefits of epidural steroid injection as an option. It is recommended that shared decision making regarding epidural steroid injection include a specific discussion about inconsistent evidence showing moderate shortterm benefits, and lack of long term benefits. There is insufficient evidence to adequately evaluate benefits and harms of epidural steroid injection for spinal stenosis. Livingston, C., Little, A., King, V., Pettinari, C., Thielke, A., Pensa, M., Vandegriff, S., & Gordon, C. (2012). State of Oregon Evidencebased Clinical Guidelines Project. Percutaneous interventions for low back pain: A clinical practice guideline based on the 2009 American Pain Society Guideline (Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain). Salem: Office for Oregon Health Policy and Research. Available at: Based

9 Guideline for Percutaneous Interventions for Low Back Pain ESI for persistent radiculopathy 2 herniated lumbar disc Evidence on effectiveness mixed for radiculopathy due to herniated disc Some trials found moderate short term (6 weeks) benefit compared to placebo injection, others did not Epidural saline or local placebo generally had poorer results than soft tissue placebo Guideline for Percutaneous Interventions for Low Back Pain ESI for persistent radiculopathy 2 herniated lumbar disc No evidence of long term benefit or reduction in surgery Serious complications possible Recent epidemic of fungal infections due to contaminated steroid used for ESI (745 cases/58 deaths as of June 3, 2013) Insufficient evidence regarding number of injections No apparent benefit for spinal stenosis, but evidence limited Livingston, C., Little, A., King, V., Pettinari, C., Thielke, A., Pensa, M., Vandegriff, S., & Gordon, C. (2012). State of Oregon Evidencebased Clinical Guidelines Project. Percutaneous interventions for low back pain: A clinical practice guideline based on the 2009 American Pain Society Guideline (Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain). Salem: Office for Oregon Health Policy and Research. Available at: Based Livingston, C., Little, A., King, V., Pettinari, C., Thielke, A., Pensa, M., Vandegriff, S., & Gordon, C. (2012). State of Oregon Evidencebased Clinical Guidelines Project. Percutaneous interventions for low back pain: A clinical practice guideline based on the 2009 American Pain Society Guideline (Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain). Salem: Office for Oregon Health Policy and Research. Available at: Based Guideline for Percutaneous Interventions for Low Back Pain Recommendation 2 Facet Joint Injection, Prolotherapy, Intradiscal Corticosteroid Injection In patients with persistent nonradicular low back pain, facet joint corticosteroid injection, prolotherapy, and intradiscal corticosteroid injection are not recommended. RCTs find no benefit compared to sham therapy Guidelines for Percutaneous Interventions for Low Back Pain Recommendation 3 Other Interventional Procedures There is insufficient evidence to adequately evaluate benefits of: Local injections Botulinum toxin injection Epidural steroid injection (for non radicular back pain) Intradiscal electrothermal therapy (IDET) Therapeutic medial branch block Radiofrequency denervation Sacroiliac joint steroid injection Coblation nucleoplasty Percutaneous intradiscal radiofrequency thermocoagulation Livingston, C., Little, A., King, V., Pettinari, C., Thielke, A., Pensa, M., Vandegriff, S., & Gordon, C. (2012). State of Oregon Evidencebased Clinical Guidelines Project. Percutaneous interventions for low back pain: A clinical practice guideline based on the 2009 American Pain Society Guideline (Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain). Salem: Office for Oregon Health Policy and Research. Available at: Based Livingston, C., Little, A., King, V., Pettinari, C., Thielke, A., Pensa, M., Vandegriff, S., & Gordon, C. (2012). State of Oregon Evidencebased Clinical Guidelines Project. Percutaneous interventions for low back pain: A clinical practice guideline based on the 2009 American Pain Society Guideline (Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain). Salem: Office for Oregon Health Policy and Research. Available at: Based Data Summary Higher than expected plain film x ray imaging, 19% across all payers High prescribing rate of opiates, 16% across payers Differences between payers in treatment: Medicare has higher rates of plain film x ray Medicaid has higher ED use Commercial has higher narcotic prescribing Guideline Summary Low back pain is one of the most common conditions seen in primary care Most cases are self resolving and require no evaluation beyond history and physical Patient education including advice to stay active is effective Several classes of medications are effective, with differential risks Several non pharmacologic interventions are effective for chronic non specific LBP

10 Guideline Summary Contact Us Epidural steroid injections have moderate short term effectiveness for radiculopathy, but possibility of harms Facet Joint and Intradiscal CS Injection, Prolotherapy not effective Insufficient evidence to evaluate most other percutaneous interventions for LBP Alison Little, MD, MPH Center for Evidence Based Policy Oregon Health and Science University (503) Summer Boslaugh, MBA/MHA Oregon Health Care Quality Corporation (503) corp.org Thank you! Questions? Handouts: Guidelines Low Back Pain: Utilization of Health Care Services in Oregon, Oregon Health Care Quality Corporation Report Consumer Booklet Evaluations

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