Evidence-Based Evaluation of Patients with Low Back Pain

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Transcript Evidence-Based Evaluation of Patients with Low Back Pain

Welcome to Low Back Pain: Evaluation, Management, and Prognosis

Welcome and Overview

Bill McCarberg Founder Chronic Pain Management Program Kaiser Permanente San Diego, California Adjunct Assistant Clinical Professor University of California School of Medicine San Diego, California

Evidence-Based Evaluation of Patients With Low Back Pain

Learning Objective

 Discuss the differential diagnosis for low back pain (LBP) and the importance of clinical red and yellow flags in evaluation of LBP

Low Back Pain Guidelines

 In 2007, the American College of Physicians (ACP) and American Pain Society (APS) issued comprehensive joint clinical practice guidelines for diagnosis and treatment of LBP

Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Guideline #1

 Clinicians should conduct a focused history and physical examination to help place patients with LBP into 1 of 3 broad categories  Nonspecific LBP  Back pain potentially associated with radiculopathy or spinal stenosis  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  Strong recommendation  Moderate-quality evidence

Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Focused History and Physical Examination

  Determine presence and level of neurological involvement 1,2 Classify patients into 3 broad categories    Nonspecific LBP potentially associated with radiculopathy Spinal stenosis Back pain potentially associated with another specific spinal cause  Patients with serious or progressive neurologic deficits or underlying conditions requiring prompt evaluation    Tumor Infection Cauda equina syndrome  Patients with other conditions that may respond to specific treatments   Ankylosing spondylitis Vertebral compression fracture

1. Deyo RA, et al. JAMA. 1992;268(6):760-765. 2. Bigos SJ, et al. Acute Low Back Problems in Adults. Clinical Practice Guideline, No. 14; 1994.

Evaluation of Back Pain

 Site  Length of illness     Spread Quality Intensity Frequency  Duration  Time of onset  Mode of onset  Precipitating factors  Aggravating factors  Relieving factors  Associated features

McGuirk BE, et al. In: Ballantyne J, Fishman S and Bonica JJ, eds. Bonica's Management of Pain. 2010:1094-1105.

Epidemiology of Low Back Pain

 90% of American adults experience an episode of back pain during their lifetime  Of patients who have acute back pain  90% to 95% have a non –life-threatening condition  Although up to 85% cannot be given an exact diagnosis, nearly all recover within 4 to 6 weeks  For 5% to 10% of patients, acute back pain is a manifestation of more serious pathology  Vascular catastrophes, malignancy, spinal cord compressive syndromes, and infectious disease processes

Winters ME, et al. Med Clin North Am. 2006;90(3):505-523.

What Is Seen in Primary Care Practice?

 In minority of patients presenting for initial evaluation in primary care setting, LBP is caused by 1    Cancer (approximately 0.7% of cases) Compression fracture (4%) Spinal infection (0.01%)  Estimates for prevalence of ankylosing spondylitis in primary care patients range from 0.3%1 to 5% 2  Spinal stenosis and symptomatic herniated disc are present in about 3% and 4% of patients, respectively  Cauda equina syndrome most commonly associated with massive midline disc herniation, but rare  Estimated prevalence of 0.04% 3

1. Jarvik JG, et al. Ann Intern Med. 2002;137(7):586-597. 2. Underwood MR, et al. Br J Rheumatol. 1995;34(11):1074-1077.

3. Deyo RA, et al. JAMA. 1992;268(6):760-765.

Cost of Low Back Pain

 LBP is one of top 10 reasons patients seek care from family physicians 1    Prevalence of LBP has varied from 7.6% to 37%  Peak prevalence between 45 and 60 years of age 2  Also reported by adolescents and by adults of all ages 80% of adults seek care at some time for acute LBP 3   One-third of US disability costs are due to low back disorders 3 Direct costs of diagnosing and treating LBP in United States estimated in 1991 to be $25 * billion annually 4  Indirect costs, including lost earnings, are even higher 4 Proper diagnosis and appropriate treatment of LBP saves healthcare resources, relieves suffering

*40 billon in 2008 using Consumer Price Index to compute the relative value of money.

1. AAFP. Facts About Family Practice; 1996. 2. Borenstein DG. Curr Opin Rheumatol. 1997;9(2):144-150. 3. Kuritzky L, et al. Prim Care Rep 1995;1:29-38. 4. Frymoyer JW, et al. Orthop Clin North Am. 1991;22(2):263-271.

Etiology of Low Back Pain

 Nonspecific LBP  Back pain potentially associated with radiculopathy or spinal stenosis  Back pain potentially associated with another specific spinal cause

Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Structural Sources of Low Back Pain

 Muscles of the back 1,2  Interspinous ligaments 2-4  Zygapophyseal joints 5-7  Sacroiliac joint(s) 8  Intervertebral discs 9-12  Mechanical 12 or chemical irritation of dura mater 13

1. Kellgren JH. Clin Sci. 1938;3:175-190. 2. Bogduk N. Med J Aust. 1980;2(10):537-541. 3. Kellgren JH. Clin Sci. 1939;4:35-46. 4. Feinstein B, et al. J Bone Joint Surg Am. 1954;36-A(5):981-997. 5. Mooney V, et al. Clin Orthop Relat Res. 1976(115):149-156. 6. McCall IW, et al. Spine (Phila Pa 1976). 1979;4(5):441-446. 7. Fukui S, et al. Clin J Pain. 1997;13(4):303-307.

8. Fortin JD, et al. Spine (Phila Pa 1976). 1994;19(13):1475-1482. 9. Wilberg G. Acta Orthop Scand. 1947;19:211-221. 10. Falconer MA, et al. J Neurol Neurosurg Psychiatry. 1948;11(1):13-26.

11. Kuslich SD, et al. Orthop Clin North Am. 1991;22(2):181-187. 12. O'Neill CW, et al. Spine (Phila Pa 1976). 2002;27(24):2776-2781. 13. El-Mahdi MA, et al. Neurochirurgia (Stuttg). 1981;24(4):137-141.

Causes of Low Back Pain

 Possible sources of back pain have been demonstrated; causes have been more elusive  Refuted: conditions traditionally considered to be possible causes are actually not causes  Eg, spondylolysis, spondylolisthesis, degenerative changes (spondylosis)  Accepted: tumors and infections  Untested: muscle sprain, ligament sprain, segmental dysfunction, and trigger points  Known source, unknown cause: sacroiliac joints, zygapophyseal joints, internal disc disruption

McGuirk BE, et al. In: Ballantyne J, Fishman S and Bonica JJ, eds. Bonica's Management of Pain. 2010:1105-1122.

Diagnostic Triage Guides Subsequent Decision-Making

 Inquire about  Location of pain  Frequency of symptoms  Duration of pain  History of previous symptoms, treatment, and response to treatment  Consider possibility of LBP due to problems outside the back  Pancreatitis  Nephrolithiasis  Aortic aneurysm  Systemic illnesses (eg, endocarditis or viral syndromes)

Differential Diagnosis for Acute Low Back Pain

Disease or Condition Back strain Acute disc herniation Osteoarthritis or spinal stenosis Spondylolisthesis Ankylosing spondylitis Infection Malignancy Patient Age (Years) 20-40 Location of Pain Low back, buttock, posterior thigh 30-50 30-50 Any age 15-40 >50 Quality of Pain Ache, spasm Aggravating or Relieving Factors Increased with activity or bending Signs Local tenderness, limited spinal motion Low back to lower leg Low back to lower leg; often bilateral Back, posterior thigh Sacroiliac joints, lumbar spine Affected bone(s) Sharp, shooting, or burning pain; paresthesia in leg Ache, shooting pain, “pins and needles” sensation Ache Ache Sharp pain, ache Dull ache, throbbing pain; slowly progressive Decreased with standing; increased with bending or sitting Increased with walking, especially up an incline; decreased with sitting Increased with activity or bending Morning stiffness Varies Increased with recumbency or cough Positive straight leg raise test, weakness, asymmetric reflexes Mild decrease in extension of spine; may have weakness or asymmetric reflexes Exaggeration of the lumbar curve, palpable “step off” (defect between spinous processes), tight hamstrings Decreased back motion, tenderness over sacroiliac joints Fever, percussive tenderness; may have neurologic abnormalities or decreased motion May have localized tenderness, neurologic signs, or fever Adapted from: Patel AT, et al. Am Fam Physician. 2000;61(6):1779-1786.

Guideline #2

 Clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific LBP  Strong recommendation  Moderate-quality evidence

Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Plain X-Rays for Low Back Pain

 There is no evidence that routine plain radiography in patients with nonspecific LBP is associated with a greater improvement in patient outcomes than selective imaging 1-3  Exposure to unnecessary ionizing radiation should be avoided, particularly in young women (amount of gonadal radiation from obtaining a single plain radiograph [2 views] of the lumbar spine is equivalent to daily chest radiograph for more than 1 year) 4  Routine advanced imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) is not associated with improved patient outcomes, 5 identifies radiographic abnormalities poorly correlated with symptoms, 6 and could lead to additional, possibly unnecessary interventions 7,8

1. Deyo RA, et al. Arch Intern Med. 1987;147(1):141-145. 2. Kendrick D, et al. BMJ. 2001;322(7283):400-405. 3. Kerry S, et al. Br J Gen Pract. 2002;52(479):469-474. 4. Jarvik JG. Neuroimaging Clin N Am. 2003;13(2):293-305. 5. Gilbert FJ, et al. Radiology. 2004;231(2):343-351. 6. Jarvik JG, et al. Ann Intern Med. 2002;137(7):586-597. 7. Jarvik JG, et al. JAMA. 2003;289(21):2810-2818. 8. Lurie JD, et al. Spine (Phila Pa 1976). 2003;28(6):616-620.

Plain X-Rays for Low Back Pain

(cont.)

 Plain radiography is recommended for initial evaluation of possible vertebral compression fracture in select high-risk patients, such as those with a history of osteoporosis or steroid use 1  Evidence to guide optimal imaging strategies is not available for LBP that persists for more than 1 to 2 months if there are no symptoms suggesting radiculopathy or spinal stenosis, although plain radiography may be a reasonable initial option (see recommendation 4 for imaging recommendations in patients with symptoms suggesting radiculopathy or spinal stenosis) 2  Thermography and electrophysiologic testing are not recommended for evaluation of nonspecific LBP

1. Jarvik JG, et al. Ann Intern Med. 2002;137(7):586-597.

2. Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Guideline #3

 Clinicians should perform diagnostic imaging and testing for patients with LBP when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination  Strong recommendation  Moderate-quality evidence

Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

CT or MRI Diagnostic Imaging

 Prompt work-up with MRI or CT is recommended if severe or progressive neurologic deficits or suspected serious underlying condition; delayed diagnosis and treatment associated with poorer outcomes 1-3  MRI is generally preferred over CT if available; does not use ionizing radiation, provides better visualization of soft tissue, vertebral marrow, and the spinal canal 4

1. Loblaw DA, et al. J Clin Oncol. 2005;23(9):2028-2037. 2. Todd NV. Br J Neurosurg. 2005;19(4):301-306. 3. Tsiodras S, et al. Clin Orthop Relat Res. 2006;444:38-50. 4. Jarvik JG, et al. Ann Intern Med. 2002;137(7):586-597.

CT or MRI Diagnostic Imaging

(cont.)

 There is insufficient evidence to guide diagnostic strategies in patients who have risk factors for cancer but no signs of spinal cord compression  Proposed strategies generally recommend plain radiography or measurement of erythrocyte sedimentation rate 3 , with MRI reserved for patients with abnormalities on initial testing 1,2  Alternative strategy is to directly perform MRI in patients with a history of cancer, the strongest predictor of vertebral cancer; 2 for patients older than 50 without other risk factors for cancer, delaying imaging while offering standard treatments and reevaluating within 1 month may also be a reasonable option 4

1. Jarvik JG, et al. Ann Intern Med. 2002;137(7):586-597. 2. Joines JD, et al. J Gen Intern Med. 2001;16(1):14-23. 3. van den Hoogen HM, et al. Spine (Phila Pa 1976). 1995;20(3):318-327. 4. Suarez-Almazor ME, et al. JAMA. 1997;277(22):1782-1786.

Guideline #4

 Clinicians should evaluate patients with persistent LBP and signs or symptoms or radiculopathy or spinal stenosis with MRI (preferred) or CT only if they are potential candidates for surgery or epidural steroid injection (for suspected radiculopathy)  Strong recommendation  Moderate-quality evidence

Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Imaging for Low Back Pain

 The natural history of lumbar disc herniation with radiculopathy in most patients is for improvement within the first 4 weeks with noninvasive management 1,2  There is no compelling evidence that routine imaging effects treatment decisions or improves outcomes 3  For prolapsed lumbar disc with persistent radicular symptoms despite noninvasive therapy, discectomy or epidural steroids are potential treatment options 4-8  Surgery is also a treatment option for persistent symptoms associated with spinal stenosis 9-12

1. Vroomen PC, et al. Br J Gen Pract. 2002;52(475):119-123. 2. Weber H. Spine (Phila Pa 1976). 1983;8(2):131-140. 3. Modic MT, et al. Radiology. 2005;237(2):597-604. 4. Gibson JN, et al. Cochrane Database Syst Rev. 2000(3):CD001350. 5. Gibson JN, et al. Cochrane Database Syst Rev. 2005(4):CD001352. 6. Nelemans PJ, et al. Spine (Phila Pa 1976). 2001;26(5):501-515. 7. Peul WC, et al. N Engl J Med. 2007;356(22):2245-2256. 8. Weinstein JN, et al. JAMA. 2006;296(20):2451-2459. 9. Amundsen T, et al. Spine (Phila Pa 1976). 2000;25(11):1424-1435. 10. Atlas SJ, et al. Spine (Phila Pa 1976). 2005;30(8):936-943. 11. Weinstein JN, et al. N Engl J Med. 2007;356(22):2257-2270. 12. Malmivaara A, et al. Spine (Phila Pa 1976). 2007;32(1):1-8.

MRI for Low Back Pain

 MRI (preferred if available) or CT is recommended for evaluating patients with persistent back and leg pain who are potential candidates for invasive interventions  Plain radiography cannot visualize discs or accurately evaluate the degree of spinal stenosis 1  However, clinicians should be aware that findings on MRI or CT (such as bulging disc without nerve root impingement) are often nonspecific  Recommendations for specific invasive interventions, interpretation of radiographic findings, and additional work-up beyond scope of guideline, but decisions should be based on clinical correlation between symptoms and radiographic findings, severity of symptoms, patient preferences, surgical risks, and costs and will generally require specialist input 2

1. Jarvik JG, et al. Ann Intern Med. 2002;137(7):586-597.

2. Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Critical Clinical Indicators of Pathology

 In patients with back and leg pain, a typical history for sciatica (back and leg pain in a typical lumbar nerve root distribution) has a fairly high sensitivity, but uncertain specificity for herniated disc 1,2  >90% of symptomatic lumbar disc herniations (back and leg pain due to a prolapsed lumbar disc compressing a nerve root) occur at L4/L5 and L5/S1 levels 3

1. van den Hoogen HM, et al. Spine (Phila Pa 1976). 1995;20(3):318-327. 2. Vroomen PC, et al. J Neurol. 1999;246(10):899-906. 3. Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Critical Clinical Indicators of Pathology (cont.)

 A focused examination that includes straight-leg-raise testing and a neurologic examination that includes evaluation of knee strength and reflexes (L4 nerve root), great toe and foot dorsiflexion strength (L5 nerve root), foot plantarflexion and ankle reflexes (S1 nerve root), and distribution of sensory symptoms should be done to assess the presence and severity of nerve root dysfunction

Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Critical Clinical Indicators of Pathology (cont.)

 A positive result on straight-leg-raise test (defined as reproduction of the patient’s sciatica between 30 and 70 degrees of leg elevation) has a relatively high sensitivity (91% [95% CI, 82% to 94%]) , but modest specificity (26% [CI, 16% to 38%]) for diagnosing herniated disc  Crossed straight-leg-raise test is more specific (88% [CI, 86% to 90%]) , but less sensitive (29% [CI, 24% to 34%])

Deville WL, et al. Spine (Phila Pa 1976). 2000;25(9):1140-1147.

Critical Clinical Indicators of Pathology (cont.)

 All patients should be evaluated for  Presence of rapidly progressive or severe neurologic deficits  Motor deficits at more than 1 level, fecal incontinence, and bladder dysfunction  Most frequent finding in cauda equina syndrome is urinary retention (90% sensitivity)  Without urinary retention, probability is approximately 1 in 10,000

Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Deyo RA, et al. JAMA. 1992;268(6):760-765.

Yellow Flags

 Identify psychosocial problems in acute phase  Slow progress to recovery may be due to undetected, or unrevealed psychosocial factors  Pertain to patient's beliefs and behaviors concerning physical activity and domestic, social, and vocational responsibilities  Example: patient believes physical activity might harm back, make pain worse, so avoids activities  Most destructive is aversion to work  Belief that work caused pain, work aggravates pain, work is too heavy, and work should not be done

McGuirk BE, et al. In: Ballantyne J, Fishman S and Bonica JJ, eds. Bonica's Management of Pain. 2010:1094-1105.

Psychosocial Factors of Low Back Pain

 Stronger predictors of LBP outcomes than either physical findings or severity/duration of pain 1-3  Assessment of psychosocial factors identifies patients who may have delayed recovery and could help target interventions  1 trial in referral setting found intensive multidisciplinary rehabilitation more effective than usual care in patients with acute or subacute LBP identified as having risk factors for chronic back pain disability 4  Direct evidence on effective primary care interventions for identifying and treating such factors in patients with acute LBP is lacking 5,6  Evidence is currently insufficient to recommend optimal methods for assessing psychosocial factors and emotional distress 7  However, psychosocial factors that may predict poorer LBP outcomes include presence of depression, passive coping strategies, job dissatisfaction, higher disability levels, disputed compensation claims, or somatization 8-10

1. Pengel LH, et al. BMJ. 2003;327(7410):323. 2. Fayad F, et al. Ann Readapt Med Phys. 2004;47(4):179-189. 3. Pincus T, et al. Spine (Phila Pa 1976). 2002;27(5):E109-120. 4. Gatchel RJ, et al. J Occup Rehabil. 2003;13(1):1-9. 5. Hay EM, et al. Lancet. 2005;365(9476):2024-2030. 6. Jellema P, et al. BMJ. 2005;331(7508):84.

7. Chou R, et al. Ann Intern Med. 2007;147(7):478-491. 8. Steenstra IA, et al. Occup Environ Med. 2005;62(12):851-860. 9. Deyo RA, et al. Spine (Phila Pa 1976). 2006;31(23):2724-2727. 10. Carey TS, et al. Spine (Phila Pa 1976). 1996;21(3):339-344.

Red Flags of Lower Back Pain

History  Gradual onset of back pain  Age <20 years or >50 years  Thoracic back pain  Pain lasting longer than 6 weeks    History of trauma   Fever/chills/night sweats  Unintentional weight loss  Pain worse with recumbency  Pain worse at night  Unrelenting pain despite supratherapeutic doses of analgesics  History of malignancy  History of immunosuppression  Recent procedure causing bacteremia  History of intravenous drug use     Physical Examination   Fever Hypotension Extreme hypertension Pale, ashen appearance Pulsatile abdominal mass Pulse amplitude differentials Spinous process tenderness Focal neurologic signs Acute urinary retention

Winters ME, et al. Med Clin North Am. 2006;90(3):505-523.

Risk for Chronicity

 Vertebral infection  Intravenous drug use, recent infection  Vertebral compression fracture  Older age, history of osteoporosis, and steroid use  Musculoskeletal  Inactivity  In general  Emotional distress

Cancer-Related Risk Factors

 Large, prospective study from a primary care setting  History of cancer (positive likelihood ratio, 14.7)  Unexplained weight loss (positive likelihood ratio, 2.7)  Failure to improve after 1 month (positive likelihood ratio, 3.0)  Age >50 years (positive likelihood ratio, 2.7)  Posttest probability of cancer increases from approximately 0.7% to 9% in patients with a history of cancer (not including nonmelanoma skin cancer)  In patients with any 1 of the other 3 risk factors, the likelihood of cancer only increases to approximately 1.2%

Deyo RA, et al. J Gen Intern Med. 1988;3(3):230-238.

Non-Cancer-Related Risk Factors

 Features predicting vertebral infection not well studied, but may include fever, intravenous drug use, or recent infection 1  Consider risk factors for vertebral compression fracture, such as older age, history of osteoporosis, and steroid use; and for ankylosing spondylitis, such as younger age, morning stiffness, improvement with exercise, alternating buttock pain, and awakening due to back pain during the second part of the night only 2  Clinicians should be aware that criteria for diagnosing early ankylosing spondylitis (before the development of radiographic abnormalities) are evolving 3

1. Jarvik JG, et al. Ann Intern Med. 2002;137(7):586-597. 2. Rudwaleit M, et al. Arthritis Rheum. 2006;54(2):569-578. 3. Rudwaleit M, et al. Arthritis Rheum. 2005;52(4):1000-1008.

Racial/Cultural Aspects of Assessment

 To communicate effectively with all patients  Always use simple words, not medical jargon  Determine what the patient/caregiver already knows or believes about his/her health situation  Encourage questions by asking, “What questions do you have?” (allows for an open ended response), instead of “Do you have any questions?” (allows for a “no” response, ending the conversation)  Use the “teach-back” method to confirm the level of understanding: Ask patients/family members to restate what was just communicated in the appointment or meeting

Zacharoff KL. Cross-Cultural Pain Management: Effective Treatment of Pain in the Hispanic Population; 2009.

Culturally Competent Care

 Ensure that patients/consumers receive effective, understandable, and respectful care that is provided in a manner compatible with their cultural health beliefs and practices and preferred language  Implement strategies to recruit, retain, and promote at all levels of the organization a diverse staff and leadership that are representative of the demographic characteristics of the service area  Ensure that staff, at all levels and across all disciplines, receives ongoing education and training in CLAS delivery

USDHHS OMH. National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health Care; 2001.

Avoiding Racial and Cultural Bias per Knox H. Todd, MD, MPH

 Make pain assessment mandatory  Give a nonopioid analgesic at triage  Track reasons for unscheduled returns  Audit for ethnic bias  Consider which pain scales should be used  Use multilingual laminated cards

Todd KH. Medical Ethics Advisor. 1999.

Pearls for Practice

 Categorize patients into 1 of 3 broad groups: nonspecific low back pain, back pain potentially associated with radiculopathy or spinal stenosis, or back pain potentially associated with another specific spinal cause  Evaluate psychosocial risk factors to predict the risk for chronic, disabling low back pain  Provide patients with evidence-based information on expected course of low back pain, effective self-care options, and recommend that they be physically active

Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Questions?

Please pass your question card to a staff member.

Treatment of Low Back Pain: Pharmacologic and Nonpharmacologic Options

Roger Chou, MD, FACP Associate Professor of Medicine, Department of Medicine Department of Medical Informatics and Clinical Epidemiology Oregon Health & Science University

Disclosure: Roger Chou, MD, FACP

 Dr. Chou has disclosed that he has no actual or potential conflict of interest in regard to this activity  His presentation will include off-label discussion of anticonvulsants, benzodiazepines, and tricyclic antidepressants for the treatment of low back pain (LBP)

Learning Objective

 Integrate evidence-based pharmacologic and nonpharmacologic therapies into a comprehensive treatment plan for chronic LBP

Low Back Pain Burden

 LBP is the fifth most common reason for US office visits, and the second most common symptomatic reason 1-2  $90.7 billion dollars in total healthcare expenditures in 1998 3  LBP is the most common cause for activity limitations in persons under the age of 45 4

1. Hart LG, et al. Spine (Phila Pa 1976). 1995;20(1):11-19. 2. Deyo RA, et al. Spine (Phila Pa 1976). 2006;31(23):2724-2727.

3. Luo X, et al. Spine (Phila Pa 1976). 2004;29(1):79-86.

4. Von Korff M, et al. Spine (Phila Pa 1976). 1996;21(24):2833-2837.

Increasing Rates of Back Surgery

Trends in Rates of Discectomy/Laminectomy and Fusion in 1992-2003 Weinstein JN, et al. Spine (Phila Pa 1976). 2006;31(23):2707-2714.

Increasing Rates of Back Injections

Lumbosacral Injection Rates by Year: Age- and Sex-Adjusted per 100,000 2055.2

553.4

79.7

SI=sacroiliac.

Friedly J, et al. Spine (Phila Pa 1976). 2007;32(16):1754-1760.

263.9

212.3

Increasing Costs

Martin BI, et al. JAMA. 2008;299(6):656-664.

Year

Rising Prevalence of Chronic LBP

Prevalence of Chronic Low Back Pain in North Carolina, 1992 and 2006 Characteristic Total Sex Male Female Age (Years) 21-34 35-44 45-54 55-64

65 Race/Ethnicity Non-Hispanic White Non-Hispanic Black Hispanic Other % Prevalence (95% CI) 1992: 3.9% 1992 (n=8067) 3.9 (3.4-4.4) 2006 (n=9924) 10.2 (9.3-11.0) 2006: 10.2% % Increase 162 2.9 (2.2-3.6) 4.8 (4.0-5.6) 1.4 (0.8-2.0) 4.8 (3.3-6.3) 4.2 (3.0-5.5) 6.3 (4.2-8.3) 5.9 (4.5-7.3) 4.1 (3.5-4.7) 3.0 (2.0-4.0) ** 4.1 (1.4-6.8) 8.0 (6.8-9.2) 12.2 (10.9-13.5) 4.3 (3.0-5.6) 9.2 (7.2-11.2) 13.5 (11.4-15.7) 15.4 (12.8-17.9) 12.3 (10.2-14.4) 10.5 (9.4-11.5) 9.8 (8.2-11.4) 6.3 (3.8-8.9) 9.1 (6.0-12.0) 176 154 201 92 219 146 109 155 226 120 PRR (2.5-97.5% CI)* 2.62 (2.21-3.13) 2.76 (2.11-3.75) 2.54 (2.13-3.08) 3.01 (1.95-5.17) 1.92 (1.35-2.86) 3.19 (2.29-4.59) 2.46 (1.73-3.50) 2.09 (1.62-2.84) 2.55 (2.13-3.05) 3.26 (2.32-4.96) 2.20 (1.16-6.99) CI=confidence interval. PRR=prevalence rate ratio.

*The PRRs and CI were estimated via bootstrapping; 97.5% CIs were reported rather than to assume normality.

**Unable to estimate owing to scall cell count (n<5).

Freburger JK, et al. Arch Intern Med. 2009;169(3):251-258.

Practice Patterns

 Spine surgery rates in the US are the highest in the world  Rates in the US 5 times higher than in the UK  20-fold variation in fusion: 4.6 per 1000 in Idaho Falls to 0.2 per 1000 in Bangor, Maine  Interventional therapies are also widely used  Intradiscal electrothermal therapy estimated at 7000-10,000 annually  20-fold variation in epidural steroid injections: 104 per 1000 in Palm Springs to 5.6 per 1000 in Honolulu

Deyo RA, et al. Clin Orthop Relat Res. 2006;443:139-146.

Weinstein JN, et al. Spine (Phila Pa 1976). 2006;31(23):2707-2714.

“7 Back Pain Breakthroughs: Are you hurting? Here’s help.”

Reader’s Digest

July 2007 

End Back Pain Agony

(Michael J. Weiss)

Weiss MJ. Reader's Digest. July, 2007.

Reader’s Digest “Cures” for Low Back Pain

 “Cures” based on anecdotal evidence, not yet approved, and/or only in animal studies  Infrared belt: $2335  “Magic Spinal Wand”  Percutaneous automatic discectomy  Flexible fusion  Stem cells  Site-directed bone growth  New bed  Based on an unpublished observational study funded by a sleep products trade group

Weiss MJ. Reader's Digest. July, 2007.

Low Back Pain Guidelines Project

Overview and Timeline

 Began 2004; primary care guidelines published October 2007  Address both acute and chronic LBP, and nonspecific LBP and LBP with radiculopathy or spinal stenosis  Guideline for interventional therapies/surgery published May 2009  Partnership between the American Pain Society and the American College of Physicians (ACP)  Funded by the American Pain Society  Multidisciplinary panel with 25 members; over 15 specialties/organizations represented  Series of 3 face-to-face meetings to develop guidelines  Consensus achieved for all recommendations

Recommendation Grid

ACP Methods

Quality of Evidence High Moderate Low Insufficient Strength of Recommendation Benefits Do or Do Not Clearly Outweigh Risks Strong Strong Strong Benefits and Risks and Burdens Finely Balanced Weak Weak Weak I Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Basic Principles of Selecting Therapy for Low Back Pain

 For most LBP, labeling with a specific etiology doesn’t help inform therapy choices  Most patients with acute LBP will improve regardless of which therapy is chosen  For chronic LBP, therapies are moderately effective at best  Use interventions with proven efficacy  Noninvasive approaches to most LBP  Consider psychosocial factors

Recommendation

Treatment of Low Back Pain

 Provide patients with evidence-based information about their expected course, advise patients to remain active, and provide information about effective self-care options  Strong recommendation  Moderate-quality evidence

Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Advice and Self-Care for Low Back Pain

 Inform patients of generally favorable prognosis of acute LBP with or without sciatica  Discuss need for re-evaluation if not improved  Advise to remain active  Consider self-care education books  Superficial heat moderately effective for acute LBP  No evidence to support use of lumbar supports  Firm mattresses inferior to medium-firm mattresses (1 RCT)

RCT=randomized controlled trial.

Recommendation

Treatment of Low Back Pain

 Consider the use of medications with proven benefits in conjunction with back care information and self care … for most patients, first-line medication options are acetaminophen or NSAIDs  Strong recommendation  Moderate-quality evidence

NSAIDs=nonsteroidal anti-inflammatory drugs.

Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Pharmacologic Interventions

Drug Acetaminophen Skeletal muscle relaxants NSAIDs Tricyclic antidepressants Net Benefit Small to moderate Moderate (for acute LBP only) Moderate Small to moderate (for chronic LBP only) Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Chou R, et al. Ann Intern Med. 2007;147(7):505-514.

This information includes a use that has not been approved by the US FDA.

Level of Evidence Fair Good Good Good

Pharmacologic Interventions (cont.)

Drug Opioids and tramadol Benzodiazepines Antiepileptic medications Systemic steroids Net Benefit Moderate Moderate Small (for radiculopathy only) No benefit Level of Evidence Fair Fair Fair Good Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Chou R, et al. Ann Intern Med. 2007;147(7):505-514.

This information includes a use that has not been approved by the US FDA.

Recommendation Treatment of Low Back Pain

 For patients who do not improve with self-care options, consider the addition of nonpharmacologic therapy with proven benefits  For chronic or subacute LBP, options include  Intensive interdisciplinary rehabilitation  Exercise therapy  Acupuncture  Massage therapy  Spinal manipulation  Yoga  Cognitive-behavioral therapy  Progressive relaxation Weak recommendation Moderate-quality evidence

Chou R, et al. Ann Intern Med. 2007;147(7):478-491.

Noninvasive Interventions for Chronic or Subacute LBP

Intervention Behavioral therapy Exercise therapy Spinal manipulation Acupuncture Net Benefit Moderate Moderate Moderate Moderate Level of Evidence Good Good Good Fair Chou R, et al. Ann Intern Med. 2007;147(7):492-504.

Noninvasive Interventions for Chronic or Subacute LBP (cont.)

Intervention Massage Yoga Back schools Traction Interferential therapy, lumbar supports, short-wave diathermy, TENS, ultrasound TENS=transcutaneous electrical nerve stimulation.

Chou R, et al. Ann Intern Med. 2007;147(7):492-504.

Net Benefit Moderate Moderate Small No benefit Unclear Level of Evidence Fair Fair (for Viniyoga) Fair Fair Poor

Recommendation

Interventional Therapies for Nonradicular Low Back Pain

 In patients with persistent nonradicular LBP, facet joint corticosteroid injection, prolotherapy, and intradiscal corticosteroid injection are not recommended  Strong recommendation  Moderate-quality evidence  There is insufficient evidence to adequately evaluate benefits of other interventional therapies for nonradicular LBP

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1066-1077.

Interventional Therapies for Nonradicular Low Back Pain

 Interventional therapies not proven to be effective in placebo-controlled, randomized trials  No trials (SI joint injection), trials showing no benefit (facet joint injection), inconsistent results (IDET, RFDN), or poor-quality evidence (trigger point injections)  Promising results from nonrandomized studies not replicated in randomized trials  IDET  Facet joint steroid injection  Not clear if interventions are ineffective, or if patients were not accurately selected

IDET=intradiscal electrothermal therapy. RFDN=radiofrequency denervation.

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1066-1077.

Placebo-Controlled Trials of RFDN for Presumed Facet Joint Pain

Study Gallagher, 1994 Leclaire, 2001 Nath, 2008 Tekin, 2007 van Kleef, 1999 van Wijk, 2005 Sample Size 41 70 Selection Uncontrolled block Uncontrolled block 40 60 30 81 Quality Poor quality No major issues Controlled block Baseline differences (1.6 points for pain) Clinical criteria Uncontrolled block Uncontrolled block Poor quality No major issues Technical issues?

Benefits Can’t tell No 1.5 points for leg pain, NS for back pain <1 point for pain, 0.5 points for function 1-2 point for pain and function No NS=not significant.

Placebo-Controlled Trials of RFDN for Presumed Facet Joint Pain

Study Gallagher, 1994 Leclaire, 2001 Nath, 2008 Tekin, 2007 van Kleef, 1999 van Wijk, 2005 Sample Size 41 70 Selection Uncontrolled block Uncontrolled block 40 60 30 81 Quality Poor quality No major issues Controlled block Baseline differences (1.6 points for pain) Clinical criteria Uncontrolled block Uncontrolled block Poor quality No major issues Technical issues?

Benefits Can’t tell No 1.5 points for leg pain, NS for back pain <1 point for pain, 0.5 points for function 1-2 point for pain and function No

Placebo-Controlled Trials of RFDN for Presumed Facet Joint Pain

(cont.) Study Leclaire, 2001 Nath, 2008 van Kleef, 1999 Sample Size 70 Selection Uncontrolled block Quality No major issues 40 30 Controlled block Baseline differences (1.6 points for pain) Uncontrolled block No major issues Benefits No 1.5 points for leg pain, NS for back pain 1-2 point for pain and function

Recommendation

Surgery for Nonradicular Low Back Pain

 In patients with nonradicular LBP, common degenerative spinal changes, and persistent and disabling symptoms … discuss risks and benefits of surgery as an option  Weak recommendation  High-quality evidence

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1066-1077.

Surgery for Nonradicular Low Back Pain With Degenerative Changes

 Benefits vary depending on comparator  Benefits of fusion vs standard nonsurgical therapy less than 15 points on a 100-point pain or function scale (1 RCT)  No difference vs intensive interdisciplinary rehabilitation (3 RCTs)  All enrollees failed >1 year of nonsurgical management and are not at higher risk for poor surgical outcomes  Fewer than half experience optimal outcomes (relief of pain, return to work, decreased analgesic use)  No evidence that instrumentation improves outcomes  Shared decision-making approach recommended

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1066-1077.

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1094-1109.

Recommendation

Interventional Therapies for Radicular LBP

 In patients with persistent radiculopathy due to herniated lumbar disc … discuss risks and benefits of epidural steroid injection as an option  Weak recommendation  Moderate-quality evidence

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1066-1077.

Interventional Therapies for Radiculopathy/Prolapsed Disc

 Epidural steroid injection  Short-term benefits in some higher-quality trials, but data are inconsistent (could be related to comparator used in trials)  No long-term benefits  No route clearly superior  Limited evidence of no benefit for spinal stenosis  Shared decision-making approach recommended

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1066-1077.

Recommendation

Surgery for Radicular Low Back Pain and Spinal Stenosis

 In patients with persistent radiculopathy due to herniated lumbar disc or persistent and disabling leg pain due to spinal stenosis … discuss risks and benefits of surgery as an option  Strong recommendation  High-quality evidence

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1066-1077.

Surgery for Herniated Disc With Radiculopathy

 Discectomy associated with more rapid improvement in symptoms than nonsurgical therapy  Patients improved either with or without surgery  No progressive neurologic deficits without immediate surgery  Long-term (after 1-2 years) outcomes similar in some trials  Most trials evaluated standard open discectomy or microdiscectomy  Shared decision-making approach recommended

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1066-1077.

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1094-1109.

Surgery for Spinal Stenosis

 Decompressive laminectomy associated with superior outcomes vs nonsurgical therapy  Mild improvement with nonsurgical therapy  No severe neurologic deficits without immediate surgery  Benefits may diminish with long-term (>2 years) follow-up  Shared decision-making approach recommended

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1066-1077.

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1094-1109.

Conclusions

 The quality of evidence for different LBP therapies varies  A number of therapies appear similarly and moderately effective for LBP  Guidelines can provide clinicians with a useful framework for choosing therapies  Factors that influence choices from recommended therapies include patient preferences, availability, and costs  Shared decision-making can help make decisions consistent with patient values and preferences

Questions?

Please pass your question card to a staff member.

Current Understanding of the Prevention of Chronicity of Low Back Pain

Bill McCarberg, MD Founder, Chronic Pain Management Program Kaiser Permanente San Diego Adjunct Assistant Clinical Professor, University of California, San Diego

Disclosure: Bill McCarberg, MD

Type Speakers Bureau Company Abbott Laboratories; Cephalon, Inc.; Eli Lilly and Company; Endo Pharmaceuticals; Forest Pharmaceuticals; King Pharmaceuticals; Ligand Pharmaceuticals, Inc.; Merck & Co., Inc.; Mylan Pharmaceuticals, Inc.; Pfizer, Inc.; PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Purdue Pharma LP

 Dr. McCarberg’s presentation will not include discussion of off-label, experimental, and/or investigational uses of drugs or devices

Learning Objective

 Evaluate early interventions for acute back pain in patients considered at high risk for transition to chronic low back pain (CLBP)

Disability from Back Pain

 The minority of cases which involve disability account for a disproportionate percentage of overall healthcare costs  The most cost-effective approach is to more aggressively pursue secondary prevention efforts on subacute patients before chronic disability is fully established 1  Acute: <3 weeks  Subacute: >3 weeks but <3 months  Chronic: >3 months, or more than 6 episodes in 12 months

1. Waddell G, et al. Occup Med (Lond). 2001;51(2):124-135.

Adverse Prognostic Indicators

 Yellow flags are psychosocial indicators suggesting increased risk of progression to long-term distress, disability, and pain  Can be applied more broadly to assess likelihood of development of persistent problems from acute pain presentation  Yellow flags can relate to the patient’s attitudes and beliefs, emotions, behaviors, family, and workplace

Kendall NA. Baillieres Best Pract Res Clin Rheumatol. 1999;13(3):545-554.

Risk Factors for Chronic Low Back Pain: Yellow Flags

          Belief that pain and activity are harmful “Sickness behavior” such as extended rest Bodily preoccupation and catastrophic thinking Low or negative mood, anxiety, social withdrawal Personal problems (eg, marital, financial, etc) History of substance abuse Problems/dissatisfaction with work (“blue flags”) Overprotective family/lack of support History of disability and other claims Inappropriate expectations of treatment  Low expectation of active participation The presence of yellow flags highlights the need to address specific psychosocial factors as part of a multimodal management approach

Additional Risk Factors for Chronicity

 Previous history of low back pain  Age  Nerve root involvement  Poor physical fitness  Self-rated health poor  Heavy manual labor, inability for light duty upon return to work (“black flags”)  Ongoing medico-legal actions  Obesity *  Smoking *

*No evidence for efficacy of smoking cessation or nonoperative weight loss as interventions for CLBP.

Wai EK, et al. Spine J. 2008;8(1):195-202.

Interventional Therapies Do Not Prevent Chronicity

Level of Evidence and Summary Grades for Interdisciplinary Rehabilitation, Injections, Other Interventional Therapies, and Surgery for Patients With Nonradicular LBP Intervention Interdisciplinary rehabilitation Prolotherapy Intradiscal steroid injection Fusion surgery Facet joint steroid injection Botulinum toxin injection Local injections Epidural steroid injection Medial branch block (therapeutic) Sacroiliac joint steroid injection Condition Nonspecific LBP Nonspecific LBP Presumed discogenic pain Nonradicular LBP with common dengerative changes Presumed facet joint pain Nonspecific LBP Nonspecific LBP Nonspecific LBP Presumed facet joint pain Presumed sacroiliac joint pain Level of Evidence Good Good Good Fair Fair Poor Poor Poor Poor Poor Net Benefit Moderate No benefit No benefit Moderate vs standard nonsurgical therapy, no difference vs intensive rehabilitation No benefit Unable to estimate Unable to estimate Unable to estimate Unable to estimate Unable to estimate Grade D I I I B D D B I I

 Additionally, regardless of the comparator intervention, there is no convincing evidence that epidural steroids are associated with long-term benefits or reduced rates of subsequent surgery

Chou R, et al. Spine (Phila Pa 1976). 2009;34(10):1066-1077.

The Fear-Avoidance Model of Chronic Pain

Injury Disuse Disability Depression Avoidance Escape Pain Anxiety Hypervigilance Fear of Pain Threat Perception Pain Experience Catastrophizing Low Fear Recovery Confrontation Negative Affectivity Threatening Illness Information Leeuw M, et al. J Behav Med. 2007;30(1):77-94.

Vlaeyen JW, et al. Pain. 2000;85(3):317-332.

Assessment of Fear-Avoidance Behaviors

 Pain Catastrophizing Scale (PCS) 1  13 items  Fear of Pain Questionnaire (FPQ) 2  30 items  Fear-Avoidance Beliefs Questionnaire (FABQ) 3  16 items  Coping Strategies Questionnaire (CSQ) 4  42 items

1. Sullivan MJL, et al. Psychological Assessment. 1995;7(4):524-532.

2. McNeil DW, et al. J Behav Med. 1998;21(4):389-410.

3. Waddell G, et al. Pain. 1993;52(2):157-168.

4. Rosenstiel AK, et al. Pain. 1983;17(1):33-44.

Reducing Catastrophizing

 Numerous interventions appear effective  Cognitive-behavioral therapies 1-4  Physiotherapy and other activity based interventions 5  Intensive patient education and exposure interventions 6, 7  Limited understanding of the mechanisms by which changes in catastrophizing occur

1. Linton SJ, et al. Pain. 2001;90(1-2):83-90.

2. Basler HD, et al. Patient Educ Couns. 1997;31(2):113-124.

3. Vlaeyen JW, et al. Pain Res Manag. 2002;7(3):144-153.

4. Hoffman BM, et al. Health Psychol. 2007;26(1):1-9.

5. Smeets RJ, et al. J Pain. 2006;7(4):261-271.

6. Moseley GL, et al. Clin J Pain. 2004;20(5):324-330.

7. Leeuw M, et al. Pain. 2008;138(1):192-207.

Comprehensive Interventions With High-Risk Patients Show Promise

 High-risk patients identified with SCID  Intensive interdisciplinary team intervention  4 major components: psychology, physical therapy, occupational therapy, and case management  Physical therapy sessions: both individual and group exercise classes  Biofeedback/pain management sessions  Group didactic sessions  Case manager/occupational therapy sessions  Interventions spaced over a 3-week period

SCID=Structured Clinical Interview for DSM-IV Disorders.

Gatchel RJ, et al. J Occup Rehabil. 2003;13(1):1-9.

Early Intensive Intervention Effectiveness

Outcome Measure Long-Term Outcome Results at 12-Month Follow-Up % return to work at follow-up* Average number of healthcare visits regardless of reason** Average number of healthcare visits related to LBP** Average number of disability days due to back pain** HR-I (n=22) 91% 25.6

17.0

38.2

HR-NI (n=48) 69% 28.8

27.3

102.4

LR (n=54) 87% 12.4

9.3

20.8

p-Value .027

.004

.004

.001

Average of self-rated most “intense pain” at 12-month follow-up (0-100 scale)** Average of self-rated pain over last 3 months (0-100 scale)** % currently taking narcotic analgesics* % currently taking psychotropic medication 46.4

26.8

27.3% 4.5% 67.3

43.1

43.8% 16.7% 44.8

25.7

18.5% 1.9% .001

.001

.020

.019

*Chi-square analysis. **ANOVA.

HR-I=high-risk intervention group. HR-NI=high-risk nonintervention group. LR=low-risk group.

Gatchel RJ, et al. J Occup Rehabil. 2003;13(1):1-9.

Most Recent Preventing Chronicity Study (April 2009)

 First-onset, subacute LBP patients  Behavioral medicine intervention (n=34)  Four 1-hour individual treatment sessions included  Education about back function and pain  Systematic graduated increases in physical exercise to quota with feedback  Planning and contracting activities of daily living  Self-management and problem-solving training to cope with pain  Contingent reinforcement of active functioning and nonreinforcement of pain behaviors  Vocational counseling, as needed  Compared to “attention control” group (n=33)

Slater MA, et al. Arch Phys Med Rehabil. 2009;90(4):545-552.

Most Recent Preventing Chronicity Study (April 2009) (cont.)

 Chi square analysis comparing proportions recovered at 6 months after pain onset for behavioral medicine and attention control participants found rates 54% vs 23% for those completing all 4 sessions and 6-month follow-up (p=.02)  Conclusions: early intervention using a behavioral medicine rehabilitation approach may enhance recovery and reduce chronic pain and disability in patients with first-onset, subacute LBP

Slater MA, et al. Arch Phys Med Rehabil. 2009;90(4):545-552.

Key Impact Factors in Back Disability Prevention

Spread of Rankings for Impact Provided by Key Stakeholders (N=33) at the End of a Consensus Process (Round 3) 1. Provider Reassurance 2. Recovery Expectation 3. Fears 4. Knowledge 5. Appropriate Care 6. Disability Management 7. Self-Management 8. Case Management 9. Temporary Duties 10. Alternative Care 11. Back Supports } p=.055

} p=.045

} p<.001

} p<.001

0 2 Guzman J, et al. Spine (Phila Pa 1976). 2007;32(7):807-815.

4 6 Rankings by Panel 8 10 12

Provider Reassurance

 Tell patients your plan and your expectations  Set reasonable expectations with patient buy-in  Reassure severity of acute pain does not correlate with outcome or duration  Follow up regularly to check response to treatment  Reassess for further diagnostic of therapeutic options

Summary

 Psychosocial aspects of pain and pain perception significantly influence patient outcomes  Assessing for yellow flags and identifying patients at high risk of chronicity early in pain process (subacute) yields best chance for intervention and possible prevention  Multiple psychosocial and physical interventions appear promising; aggressive/ intensive intervention seems most important  Nurture the therapeutic relationship with shared expectations and goals of treatment

Questions?

Question and Answer Session

Thank You for Attending Low Back Pain: Evaluation, Management, and Prognosis