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Clinical Guidelines |2 October 2007

Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society Free

Roger Chou, MD; Amir Qaseem, MD, PhD, MHA; Vincenza Snow, MD; Donald Casey, MD, MPH, MBA; J. Thomas Cross Jr, MD, MPH; Paul Shekelle, MD, PhD; Douglas K. Owens, MD, MS; 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*

Roger Chou, MD

From Oregon Health & Science University, Portland, Oregon; the American College of Physicians, Philadelphia, Pennsylvania; Atlantic Health, Morristown, New Jersey; Medstudy, Colorado Springs, Colorado; and Veterans Affairs Health Care System and RAND, Santa Monica, Veterans Affairs Palo Alto Health Care System, Palo Alto, and Stanford University, Stanford, California.

Amir Qaseem, MD, PhD, MHA

From Oregon Health & Science University, Portland, Oregon; the American College of Physicians, Philadelphia, Pennsylvania; Atlantic Health, Morristown, New Jersey; Medstudy, Colorado Springs, Colorado; and Veterans Affairs Health Care System and RAND, Santa Monica, Veterans Affairs Palo Alto Health Care System, Palo Alto, and Stanford University, Stanford, California.

Vincenza Snow, MD

From Oregon Health & Science University, Portland, Oregon; the American College of Physicians, Philadelphia, Pennsylvania; Atlantic Health, Morristown, New Jersey; Medstudy, Colorado Springs, Colorado; and Veterans Affairs Health Care System and RAND, Santa Monica, Veterans Affairs Palo Alto Health Care System, Palo Alto, and Stanford University, Stanford, California.

Donald Casey, MD, MPH, MBA

From Oregon Health & Science University, Portland, Oregon; the American College of Physicians, Philadelphia, Pennsylvania; Atlantic Health, Morristown, New Jersey; Medstudy, Colorado Springs, Colorado; and Veterans Affairs Health Care System and RAND, Santa Monica, Veterans Affairs Palo Alto Health Care System, Palo Alto, and Stanford University, Stanford, California.

J. Thomas Cross Jr, MD, MPH

From Oregon Health & Science University, Portland, Oregon; the American College of Physicians, Philadelphia, Pennsylvania; Atlantic Health, Morristown, New Jersey; Medstudy, Colorado Springs, Colorado; and Veterans Affairs Health Care System and RAND, Santa Monica, Veterans Affairs Palo Alto Health Care System, Palo Alto, and Stanford University, Stanford, California.

Paul Shekelle, MD, PhD

From Oregon Health & Science University, Portland, Oregon; the American College of Physicians, Philadelphia, Pennsylvania; Atlantic Health, Morristown, New Jersey; Medstudy, Colorado Springs, Colorado; and Veterans Affairs Health Care System and RAND, Santa Monica, Veterans Affairs Palo Alto Health Care System, Palo Alto, and Stanford University, Stanford, California.

Douglas K. Owens, MD, MS

From Oregon Health & Science University, Portland, Oregon; the American College of Physicians, Philadelphia, Pennsylvania; Atlantic Health, Morristown, New Jersey; Medstudy, Colorado Springs, Colorado; and Veterans Affairs Health Care System and RAND, Santa Monica, Veterans Affairs Palo Alto Health Care System, Palo Alto, and Stanford University, Stanford, California.

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*

Article, Author, and Disclosure Information

From Oregon Health & Science University, Portland, Oregon; the American College of Physicians, Philadelphia, Pennsylvania; Atlantic Health, Morristown, New Jersey; Medstudy, Colorado Springs, Colorado; and Veterans Affairs Health Care System and RAND, Santa Monica, Veterans Affairs Palo Alto Health Care System, Palo Alto, and Stanford University, Stanford, California.
Clinical Efficacy Assessment Subcommittee of the American College of Physicians: Douglas K. Owens, MD, MS (Chair)†; Donald E. Casey Jr., MD, MPH, MBA‡; J. Thomas Cross Jr., MD, MPH‡; Paul Dallas, MD; Nancy C. Dolan, MD; Mary Ann Forciea, MD; Lakshmi Halasyamani, MD; Robert H. Hopkins Jr., MD; and Paul Shekelle, MD, PhD‡. Co-chairs and members of the American College of Physicians/American Pain Society Low Back Pain Guidelines Panel: John D. Loeser, MD (Co-chair); Douglas K. Owens, MD, MS (Co-chair); Richard W. Rosenquist, MD (Co-chair); Paul M. Arnstein, RN, PhD, APRN-BC; Steven Julius Atlas, MD, MPH; Jamie Baisden, MD; Claire Bombardier, MD; Eugene J. Carragee, MD; John Anthony Carrino, MD, MPH; Donald E. Casey Jr., MD, MPH, MBA; Daniel Cherkin, PhD; Penney Cowan; J. Thomas Cross Jr., MD, MPH; Anthony Delitto, PhD, MHS; Robert J. Gatchel, Ph.D, ABPP; Lee Steven Glass, MD, JD; Martin Grabois, MD; Timothy R. Lubenow, MD; Kathryn Mueller, MD, MPH; Donald R. Murphy, DC, DACAN; Marco Pappagallo, MD; Kenneth G. Saag, MD, MSc; Paul G. Shekelle, MD, PhD; Steven P. Stanos, DO; and Eric Martin Wall, MD, MPH. Participants from the Veterans Affairs/Department of Defense Evidence-Based Practice Workgroup: Carla L. Cassidy, ANP, MSN; COL Leo L. Bennett, MC, MD, MPH; John Dooley, MD; LCDR Leslie Rassner, MD; Robert Ruff, MD, PhD; and Suzanne Ruff, MHCC. †Also a co-chair of the American College of Physicians/American Pain Society Low Back Pain Guidelines Panel. ‡Also members of the American College of Physicians/American Pain Society Low Back Pain Guidelines Panel.
Note: Clinical practice guidelines are “guides” only and may not apply to all patients and all clinical situations. Thus, they are not intended to override clinicians' judgment. All ACP clinical practice guidelines are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.
Disclaimer: The authors of this article are responsible for its contents, including any clinical or treatment recommendations. The views and opinions expressed are those of Veterans Affairs/Department of Defense Evidence-Based Practice Workgroup members and do not necessarily reflect official Veterans Health Affairs or Department of Defense positions.
Acknowledgments: The authors thank Laurie Hoyt Huffman for reviewing the manuscript and providing helpful suggestions, Jayne Schablaske and Michelle Pappas for administrative assistance in preparing the manuscript, Andrew Hamilton for conducting the literature searches, and Oded Susskind for assistance in developing the algorithm.
Grant Support: Financial support for the development of this guideline comes exclusively from the ACP and APS operating budgets.
Potential Financial Conflicts of Interest: Honoraria: R. Chou (Bayer Healthcare Pharmaceuticals). Grants received: V. Snow (Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality, Novo Nordisk, Pfizer Inc., Merck & Co. Inc., Bristol-Myers Squibb, Atlantic Philanthropics, Sanofi-Pasteur).
Requests for Single Reprints: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, aqaseem@acponline.org.
Current Author Addresses: Dr. Chou: 3181 SW Sam Jackson Park Road, Mailcode BICC, Portland, OR 97239.
Drs. Qaseem and Snow: American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106.
Dr. Casey: 475 South Street, PO Box 1905, Morristown, NJ 07962.
Dr. Cross: 1761 South 8th Street, Suite H, Colorado Springs, CO 80906.
Dr. Shekelle: 1776 Main Street, Santa Monica, CA 90401.
Dr. Owens: 117 Encina Commons, Stanford, CA 94305

Abstract

Recommendation 1:

Clinicians should conduct a focused history and physical examination to help place patients with low back pain into 1 of 3 broad categories: nonspecific low back pain, back pain potentially associated with radiculopathy or spinal stenosis, or 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).

Recommendation 2:

Clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain (strong recommendation, moderate-quality evidence).

Recommendation 3:

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 (strong recommendation, moderate-quality evidence).

Recommendation 4:

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) (strong recommendation, moderate-quality evidence).

Recommendation 5:

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 self-care options (strong recommendation, moderate-quality evidence).

Recommendation 6:

For patients with low back pain, 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 (strong recommendation, moderate-quality evidence). For most patients, first-line medication options are acetaminophen or nonsteroidal anti-inflammatory drugs.

Recommendation 7:

For patients who do not improve with self-care options, clinicians should consider the addition of nonpharmacologic therapy with proven benefits—for acute low back pain, spinal manipulation; for chronic or subacute low back pain, intensive interdisciplinary rehabilitation, exercise therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive-behavioral therapy, or progressive relaxation (weak recommendation, moderate-quality evidence).

* This paper, written by Roger Chou, MD; Amir Qaseem, MD, PhD, MHA; Vincenza Snow, MD; Donald Casey, MD, MPH, MBA; J. Thomas Cross Jr., MD, MPH; Paul Shekelle, MD, PhD; and Douglas K. Owens, MD, MS, was developed for the American College of Physicians' Clinical Efficacy Assessment Subcommittee and the American College of Physicians/American Pain Society Low Back Pain Guidelines Panel. For members of these groups, see end of text. Approved by the American College of Physicians Board of Regents on 14 July 2007. Approved by the American Pain Society Board Executive Committee on 18 July 2007.

Low back pain is the fifth most common reason for all physician visits in the United States (1, 2). Approximately one quarter of U.S. adults reported having low back pain lasting at least 1 whole day in the past 3 months (2), and 7.6% reported at least 1 episode of severe acute low back pain (see Glossary) within a 1-year period (3). Low back pain is also very costly: Total incremental direct health care costs attributable to low back pain in the U.S. were estimated at $26.3 billion in 1998 (4). In addition, indirect costs related to days lost from work are substantial, with approximately 2% of the U.S. work force compensated for back injuries each year (5).

Many patients have self-limited episodes of acute low back pain and do not seek medical care (3). Among those who do seek medical care, pain, disability, and return to work typically improve rapidly in the first month (6). However, up to one third of patients report persistent back pain of at least moderate intensity 1 year after an acute episode, and 1 in 5 report substantial limitations in activity (7). Approximately 5% of the people with back pain disability account for 75% of the costs associated with low back pain (8).

Many options are available for evaluation and management of low back pain. However, there has been little consensus, either within or between specialties, on appropriate clinical evaluation (9) and management (10) of low back pain. Numerous studies show unexplained, large variations in use of diagnostic tests and treatments (11, 12). Despite wide variations in practice, patients seem to experience broadly similar outcomes, although costs of care can differ substantially among and within specialties (13, 14).

The purpose of this guideline is to present the available evidence for evaluation and management of acute and chronic low back pain (see Glossary) in primary care settings. The target audience for this guideline is all clinicians caring for patients with low (lumbar) back pain of any duration, either with or without leg pain. The target patient population is adults with acute and chronic low back pain not associated with major trauma. Children or adolescents with low back pain; pregnant women; and patients with low back pain from sources outside the back (nonspinal low back pain), fibromyalgia or other myofascial pain syndromes, and thoracic or cervical back pain are not included. These recommendations are based on a systematic evidence review summarized in 2 background papers by Chou and colleagues in this issue (15, 16) from an evidence report by the American Pain Society (17). The evidence report (17) discusses the evidence for the evaluation, and the 2 background papers (15, 16) summarize the evidence for management.

Methods

The literature search for this guideline included studies from MEDLINE (1966 through November 2006), the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, and EMBASE. The literature search included all English-language articles reporting on randomized, controlled trials of nonpregnant adults (age >18 years) with low back pain (alone or with leg pain) of any duration that evaluated a target medication and reported at least 1 of the following outcomes: back-specific function, generic health status, pain, work disability, or patient satisfaction. The American College of Physicians (ACP) and the American Pain Society (APS) convened a multidisciplinary panel of experts to develop the key questions and scope used to guide the evidence report, review its results, and formulate recommendations. The background papers by Chou and colleagues (15, 16) provide details about the methods used for the systematic evidence review.

This guideline grades its recommendations by using the ACP's clinical practice guidelines grading system, adapted from the classification developed by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) work group (Appendix Table 1) (18). The evidence in this guideline was first evaluated by the ACP/APS panel by using a system adopted from the U.S. Preventive Services Task Force for grading strength of evidence, estimating magnitude of benefits, and assigning summary ratings (Appendix Tables 2, 3, and 4) (19). The evidence was independently reviewed by the ACP's Clinical Efficacy Assessment Subcommittee. The ratings for individual low back pain interventions discussed in this guideline are summarized in Appendix Table 5 for acute low back pain (<4 weeks' duration) and in Appendix Table 6 for chronic/subacute low back pain (>4 weeks' duration). This guideline considered interventions to have “proven” benefits only when they were supported by at least fair-quality evidence and were associated with at least moderate benefits (or small benefits but no significant harms, costs, or burdens). Figures 1 and 2 present an accompanying algorithm.

Appendix Table 1. The American College of Physicians Clinical Practice Guidelines Grading System

Appendix Table 1. The American College of Physicians Clinical Practice Guidelines Grading System

Appendix Table 2. Methods for Grading the Strength of the Overall Evidence for an Intervention

Appendix Table 2. Methods for Grading the Strength of the Overall Evidence for an Intervention

Appendix Table 3. Definitions for Estimating Magnitude of Effects

Appendix Table 3. Definitions for Estimating Magnitude of Effects

Appendix Table 4. Recommendations and Summary Ratings

Appendix Table 4. Recommendations and Summary Ratings

Appendix Table 5. Level of Evidence and Summary Grades for Noninvasive Interventions in Patients with Acute Low Back Pain

Appendix Table 5. Level of Evidence and Summary Grades for Noninvasive Interventions in Patients with Acute Low Back Pain

Appendix Table 6. Level of Evidence and Summary Grades for Noninvasive Interventions in Patients with Chronic or Subacute Low Back Pain

Appendix Table 6. Level of Evidence and Summary Grades for Noninvasive Interventions in Patients with Chronic or Subacute Low Back Pain

Figure 1.

Initial evaluation of low back pain (LBP

Figure 2.

Management of low back pain (LBP

Recommendations: Evaluation of Low Back Pain

Recommendation 1: Clinicians should conduct a focused history and physical examination to help place patients with low back pain into 1 of 3 broad categories: nonspecific low back pain, back pain potentially associated with radiculopathy or spinal stenosis, or 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).

More than 85% of patients who present to primary care have low back pain that cannot reliably be attributed to a specific disease or spinal abnormality (nonspecific low back pain [see Glossary]) (20). Attempts to identify specific anatomical sources of low back pain in such patients have not been validated in rigorous studies, and classification schemes frequently conflict with one another (21). Moreover, no evidence suggests that labeling most patients with low back pain by using specific anatomical diagnoses improves outcomes. In a minority of patients presenting for initial evaluation in a primary care setting, low back pain is caused by a specific disorder, such as cancer (approximately 0.7% of cases), compression fracture (4%), or spinal infection (0.01%) (22). Estimates for prevalence of ankylosing spondylitis in primary care patients range from 0.3% (22) to 5% (23). Spinal stenosis (see Glossary) and symptomatic herniated disc (see Glossary) are present in about 3% and 4% of patients, respectively. The cauda equina syndrome (see Glossary) is most commonly associated with massive midline disc herniation but is rare, with an estimated prevalence of 0.04% among patients with low back pain (24).

A practical approach to assessment is to do a focused history and physical examination to determine the likelihood of specific underlying conditions and measure the presence and level of neurologic involvement (24, 25). Such an approach facilitates classification of patients into 1 of 3 broad categories: nonspecific low back pain, back pain potentially associated with radiculopathy (see Glossary) or spinal stenosis (suggested by the presence of sciatica [see Glossary] or pseudoclaudication), and back pain potentially associated with another specific spinal cause. The latter category includes the small proportion of patients with serious or progressive neurologic deficits or underlying conditions requiring prompt evaluation (such as tumor, infection, or the cauda equina syndrome), as well as patients with other conditions that may respond to specific treatments (such as ankylosing spondylitis or vertebral compression fracture).

Diagnostic triage into 1 of these 3 categories helps guide subsequent decision making. Clinicians should inquire about the location of pain, frequency of symptoms, and duration of pain, as well as any history of previous symptoms, treatment, and response to treatment. The possibility of low back pain due to problems outside the back, such as pancreatitis, nephrolithiasis, or aortic aneurysm, or systemic illnesses, such as endocarditis or viral syndromes, should be considered. All patients should be evaluated for the presence of rapidly progressive or severe neurologic deficits, including motor deficits at more than 1 level, fecal incontinence, and bladder dysfunction. The most frequent finding in the cauda equina syndrome is urinary retention (90% sensitivity) (24). In patients without urinary retention, the probability of the cauda equina syndrome is approximately 1 in 10 000.

Clinicians should also ask about risk factors for cancer and infection. In a large, prospective study from a primary care setting, a 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), and age older than 50 years (positive likelihood ratio, 2.7) were each associated with a higher likelihood for cancer (26). The posttest probability of cancer in patients presenting with back pain 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% (26). Features predicting the presence of vertebral infection have not been well studied but may include fever, intravenous drug use, or recent infection (22). Clinicians should also consider risk factors for vertebral compression fracture, such as older age, history of osteoporosis, and steroid use, and ankylosing spondylitis, such as younger age, morning stiffness, improvement with exercise (see Glossary), alternating buttock pain, and awakening due to back pain during the second part of the night only (27), as specific treatments are available for these conditions. Clinicians should be aware that criteria for diagnosing early ankylosing spondylitis (before the development of radiographic abnormalities) are evolving (28).

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 (29, 30). More than 90% of symptomatic lumbar disc herniations (back and leg pain due to a prolapsed lumbar disc compressing a nerve root) occur at the L4/L5 and L5/S1 levels. A focused examination that includes straight-leg-raise testing (see Glossary) 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. A positive result on the straight-leg-raise test (defined as reproduction of the patient's sciatica between 30 and 70 degrees of leg elevation) (24) has a relatively high sensitivity (91% [95% CI, 82% to 94%]) but modest specificity (26% [CI, 16% to 38%]) for diagnosing herniated disc (31). By contrast, the crossed straight-leg-raise test is more specific (88% [CI, 86% to 90%]) but less sensitive (29% [CI, 24% to 34%]).

Evidence on the utility of history and examination for identifying lumbar spinal stenosis is sparse (32). High-quality studies showed a trade-off between sensitivities and specificities, resulting in modest or poor positive likelihood ratios (1.2 for pseudoclaudication and 2.2 for radiating leg pain) (32). Changing symptoms on downhill treadmill testing are associated with the highest positive likelihood ratio (3.1). The usefulness of pain relieved by sitting for predicting presence of spinal stenosis ranges from poor to high (32). Age older than 65 years was associated with a positive likelihood ratio of 2.5 and a negative likelihood ratio of 0.33 in 1 lower-quality study (33). Other findings have only been evaluated in lower-quality studies or are poorly predictive for lumbar spinal stenosis.

Psychosocial factors and emotional distress should be assessed because they are stronger predictors of low back pain outcomes than either physical examination findings or severity and duration of pain (6, 34, 35). Assessment of psychosocial factors identifies patients who may have delayed recovery and could help target interventions, as 1 trial in a referral setting found intensive multidisciplinary rehabilitation more effective than usual care in patients with acute or subacute low back pain identified as having risk factors for chronic back pain disability (36). Direct evidence on effective primary care interventions for identifying and treating such factors in patients with acute low back pain is lacking (37, 38), although this is an area of active research. Evidence is currently insufficient to recommend optimal methods for assessing psychosocial factors and emotional distress. However, psychosocial factors that may predict poorer low back pain outcomes include presence of depression, passive coping strategies, job dissatisfaction, higher disability levels, disputed compensation claims, or somatization (34, 35, 39).

Evidence is also insufficient to guide appropriate intervals or methods (such as office visit vs. telephone follow-up) for reassessment of history, physical examination, or psychosocial factors. However, patients with acute low back pain generally experience substantial improvement in the first month after initial presentation (6, 40), suggesting that a reasonable approach is to reevaluate patients with persistent, unimproved symptoms after 1 month. In patients with severe pain or functional deficits, older patients, or patients with signs of radiculopathy or spinal stenosis (see recommendation 4), earlier or more frequent reevaluation may also be appropriate.

Recommendation 2: Clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain (strong recommendation, moderate-quality evidence).

There is no evidence that routine plain radiography in patients with nonspecific low back pain is associated with a greater improvement in patient outcomes than selective imaging (41–43). In addition, exposure to unnecessary ionizing radiation should be avoided. This issue is of particular concern in young women because the amount of gonadal radiation from obtaining a single plain radiograph (2 views) of the lumbar spine is equivalent to being exposed to a daily chest radiograph for more than 1 year (44). Routine advanced imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) is also not associated with improved patient outcomes (45) and identifies many radiographic abnormalities that are poorly correlated with symptoms (22) but could lead to additional, possibly unnecessary interventions (46, 47).

Plain radiography is recommended for initial evaluation of possible vertebral compression fracture in selected higher-risk patients, such as those with a history of osteoporosis or steroid use (22). Evidence to guide optimal imaging strategies is not available for low back pain that persists for more than 1 to 2 months despite standard therapies 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). Thermography and electrophysiologic testing are not recommended for evaluation of nonspecific low back pain.

Recommendation 3: 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 (strong recommendation, moderate-quality evidence).

Prompt work-up with MRI or CT is recommended in patients who have severe or progressive neurologic deficits or are suspected of having a serious underlying condition (such as vertebral infection, the cauda equina syndrome, or cancer with impending spinal cord compression) because delayed diagnosis and treatment are associated with poorer outcomes (48–50). Magnetic resonance imaging is generally preferred over CT if available because it does not use ionizing radiation and provides better visualization of soft tissue, vertebral marrow, and the spinal canal (22). There is insufficient evidence to guide precise recommendations on diagnostic strategies in patients who have risk factors for cancer but no signs of spinal cord compression. Several strategies have been proposed for such patients (22, 51), but none have been prospectively evaluated. Proposed strategies generally recommend plain radiography or measurement of erythrocyte sedimentation rate (a rate ≥20 mm/h is associated with 78% sensitivity and 67% specificity for cancer [29]), with MRI reserved for patients with abnormalities on initial testing (22, 51). An alternative strategy is to directly perform MRI in patients with a history of cancer, the strongest predictor of vertebral cancer (51). For patients older than 50 years of age without other risk factors for cancer, delaying imaging while offering standard treatments and reevaluating within 1 month may also be a reasonable option (52).

Recommendation 4: Clinicians should evaluate patients with persistent low back pain and signs or symptoms of 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).

The natural history of lumbar disc herniation with radiculopathy in most patients is for improvement within the first 4 weeks with noninvasive management (53, 54). There is no compelling evidence that routine imaging affects treatment decisions or improves outcomes (55). For prolapsed lumbar disc with persistent radicular symptoms despite noninvasive therapy, discectomy or epidural steroids are potential treatment options (56–60). Surgery is also a treatment option for persistent symptoms associated with spinal stenosis (61–64).

Magnetic resonance imaging (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 (22). 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 (such as electrophysiologic testing) are beyond the scope of this guideline, but decisions should be based on the clinical correlation between symptoms and radiographic findings, severity of symptoms, patient preferences, surgical risks (including the patient's comorbid conditions), and costs and will generally require specialist input.

Recommendations: Treatment of Low Back Pain

Recommendation 5: 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 self-care options (strong recommendation, moderate-quality evidence).

Clinicians should inform all patients of the generally favorable prognosis of acute low back pain with or without sciatica, including a high likelihood for substantial improvement in the first month (6, 40). Clinicians should explain that early, routine imaging and other tests usually cannot identify a precise cause, do not improve patient outcomes, and incur additional expenses. Clinicians should also review indications for reassessment and diagnostic testing (see recommendations 1 and 4). General advice on self-management for nonspecific low back pain should include recommendations to remain active, which is more effective than resting in bed for patients with acute or subacute low back pain (65, 66). If patients require periods of bed rest to relieve severe symptoms, they should be encouraged to return to normal activities as soon as possible. Self-care education books (see Glossary) based on evidence-based guidelines, such as The Back Book(67), are recommended because they are an inexpensive and efficient method for supplementing clinician-provided back information and advice and are similar or only slightly inferior in effectiveness to such costlier interventions as supervised exercise therapy, acupuncture (see Glossary), massage (see Glossary), and spinal manipulation (see Glossary) (65, 66, 68–70). Other methods for providing self-care education, such as e-mail discussion groups, layperson-led groups, videos, and group classes, are not as well studied.

Factors to consider when giving advice about activity limitations to workers with low back pain are the patient's age and general health and the physical demands of required job tasks. However, evidence is insufficient to guide specific recommendations about the utility of modified work for facilitating return to work (71). For worker's compensation claims, clinicians should refer to specific regulations for their area of practice, as rules vary substantially from state to state. Brief individualized educational interventions (defined as a detailed clinical examination and advice, typically lasting several hours over 1 to 2 sessions) (see Glossary) can reduce sick leave in workers with subacute low back pain (72–74).

Application of heat by heating pads or heated blankets is a self-care option (see Glossary) for short-term relief of acute low back pain (75). In patients with chronic low back pain, firm mattresses are less likely than a medium-firm mattress to lead to improvement (76). There is insufficient evidence to recommend lumbar supports (77) or the application of cold packs (75) as self-care options.

Although evidence is insufficient to guide specific self-management recommendations for patients with acute radiculopathy or spinal stenosis, some trials enrolled mixed populations of patients with and without sciatica, suggesting that applying principles similar to those used for nonspecific low back pain is a reasonable approach (see also recommendation 4).

Recommendation 6: For patients with low back pain, 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 (strong recommendation, moderate-quality evidence). For most patients, first-line medication options are acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs).

Medications in several classes have been shown to have moderate, primarily short-term benefits for patients with low back pain. Each class of medication is associated with unique trade-offs involving benefits, risks, and costs. For example, acetaminophen is a slightly weaker analgesic than NSAIDs (<10 points on a 100-point visual analogue pain scale) (78–82) but is a reasonable first-line option for treatment of acute or chronic low back pain because of a more favorable safety profile and low cost (79, 82–84). However, acetaminophen is associated with asymptomatic elevations of aminotransferase levels at dosages of 4 g/d (the upper limit of U.S. Food and Drug Administration–[FDA] approved dosing) even in healthy adults, although the clinical significance of these findings are uncertain (85). Nonselective NSAIDs are more effective for pain relief than is acetaminophen (80), but they are associated with well-known gastrointestinal and renovascular risks (83). In addition, there is an association between exposure to cyclooxygenase-2–selective or most nonselective NSAIDs and increased risk for myocardial infarction (86). Clinicians should therefore assess cardiovascular and gastrointestinal risk factors before prescribing NSAIDs and recommend the lowest effective doses for the shortest periods necessary. Clinicians should also remain alert for new evidence about which NSAIDs are safest and consider strategies for minimizing adverse events in higher-risk patients who are prescribed NSAIDs (such as co-administration with a proton-pump inhibitor) (87). There is insufficient evidence to recommend for or against analgesic doses of aspirin in patients with low back pain (88).

Opioid analgesics or tramadol are an option when used judiciously in patients with acute or chronic low back pain who have severe, disabling pain that is not controlled (or is unlikely to be controlled) with acetaminophen and NSAIDs. Because of substantial risks, including aberrant drug-related behaviors with long-term use in patients vulnerable or potentially vulnerable to abuse or addiction, potential benefits and harms of opioid analgesics should be carefully weighed before starting therapy (89–91). Failure to respond to a time-limited course of opioids should lead to reassessment and consideration of alternative therapies or referral for further evaluation (92–94). Evidence is insufficient to recommend one opioid over another (95).

The Glossary term skeletal muscle relaxants refers to a diverse group of medications, some with unclear mechanisms of action, grouped together because they carry FDA-approved indications for treatment of musculoskeletal conditions or spasticity. Although the antispasticity drug tizanidine has been well studied for low back pain, there is little evidence for the efficacy of baclofen or dantrolene, the other FDA-approved drugs for the treatment of spasticity (96). Other medications in the skeletal muscle relaxant class are an option for short-term relief of acute low back pain, but all are associated with central nervous system adverse effects (primarily sedation). There is no compelling evidence that skeletal muscle relaxants differ in efficacy or safety (96, 97). Because skeletal muscle relaxants are not pharmacologically related, however, risk–benefit profiles could in theory vary substantially. For example, carisoprodol is metabolized to meprobamate (a medication associated with risks for abuse and overdose), dantrolene carries a black box warning for potentially fatal hepatotoxicity, and both tizanidine and chlorzoxazone are associated with hepatotoxicity that is generally reversible and usually not serious.

Tricyclic antidepressants are an option for pain relief in patients with chronic low back pain and no contraindications to this class of medications (98, 99). Antidepressants in the selective serotonin reuptake inhibitor class and trazodone have not been shown to be effective for low back pain, and serotonin–norepineprhine reuptake inhibitors (duloxetine and venlafaxine) have not yet been evaluated for low back pain. Clinicians should bear in mind, however, that depression is common in patients with chronic low back pain and should be assessed and treated appropriately (100).

Gabapentin is associated with small, short-term benefits in patients with radiculopathy (101, 102) and has not been directly compared with other medications or treatments. There is insufficient evidence to recommend for or against other antiepileptic drugs for back pain with or without radiculopathy. For acute or chronic low back pain, benzodiazepines seem similarly effective to skeletal muscle relaxants for short-term pain relief (96) but are also associated with risks for abuse, addiction, and tolerance. Neither benzodiazepines nor gabapentin are FDA-approved for treatment of low back pain (with or without radiculopathy). If a benzodiazepine is used, a time-limited course of therapy is recommended.

Herbal therapies, such as devil's claw, willow bark, and capsicum, seem to be safe options for acute exacerbations of chronic low back pain, but benefits range from small to moderate. In addition, many of the published trials were led by the same investigator, which could limit applicability of findings to other settings (103).

Systemic corticosteroids are not recommended for treatment of low back pain with or without sciatica, because they have not been shown to be more effective than placebo (104–107).

Most medication trials evaluated patients with nonspecific low back pain or mixed populations with and without sciatica. There is little evidence to guide specific recommendations for medications (other than gabapentin) for patients with sciatica or spinal stenosis. Evidence is also limited on the benefits and risks associated with long-term use of medications for low back pain. Therefore, extended courses of medications should generally be reserved for patients clearly showing continued benefits from therapy without major adverse events.

Recommendation 7: For patients who do not improve with self-care options, clinicians should consider the addition of nonpharmacologic therapy with proven benefits—for acute low back pain, spinal manipulation; for chronic or subacute low back pain, intensive interdisciplinary rehabilitation, exercise therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive-behavioral therapy, or progressive relaxation (weak recommendation, moderate-quality evidence).

For acute low back pain (duration <4 weeks), spinal manipulation administered by providers with appropriate training is associated with small to moderate short-term benefits (108). Supervised exercise therapy and home exercise regimens are not effective for acute low back pain (109), and the optimal time to start exercise therapy after the onset of symptoms is unclear. Other guidelines suggest starting exercise after 2 to 6 weeks, but these recommendations seem to be based on poor-quality evidence (25, 110). Other nonpharmacologic treatments have not been proven to be effective for acute low back pain.

For subacute (duration >4 to 8 weeks) low back pain, intensive interdisciplinary rehabilitation (defined as an intervention that includes a physician consultation coordinated with a psychological, physical therapy, social, or vocational intervention) (see Glossary) is moderately effective (111), and functional restoration (see Glossary) with a cognitive-behavioral component reduces work absenteeism due to low back pain in occupational settings (112). There is little evidence on effectiveness of other treatments specifically for subacute low back pain (113). However, many trials enrolled mixed populations of patients with chronic and subacute symptoms, suggesting that results may reasonably be applied to both situations.

For chronic low back pain, moderately effective nonpharmacologic therapies include acupuncture (114, 115), exercise therapy (109), massage therapy (116), Viniyoga-style yoga (see Glossary) (70), cognitive-behavioral therapy or progressive relaxation (see Glossary) (117, 118), spinal manipulation (108), and intensive interdisciplinary rehabilitation (119), although the level of supporting evidence for different therapies varies from fair to good (Appendix Table 6). In meta-regression analyses, exercise programs that incorporate individual tailoring, supervision, stretching, and strengthening are associated with the best outcomes (109). The evidence is insufficient to conclude that benefits of manipulation vary according to the profession of the manipulator (chiropractor vs. other clinician trained in manipulation) or according to presence or absence of radiating pain (108). With the exception of continuous or intermittent traction (see Glossary), which has not been shown to be effective in patients with sciatica (120–122), few trials have evaluated the effectiveness of treatments specifically in patients with radicular pain (122) or symptoms of spinal stenosis. In addition, there is insufficient evidence to recommend any specific treatment as first-line therapy. Patient expectations of benefit from a treatment should be considered in choosing interventions because they seem to influence outcomes (123). Some interventions (such as intensive interdisciplinary rehabilitation) may not be available in all settings, and costs for similarly effective interventions can vary substantially. There is insufficient evidence to recommend the use of decision tools or other methods for tailoring therapy in primary care, although initial data are promising (124–126).

Transcutaneous electrical nerve stimulation (see Glossary) and intermittent or continuous traction (in patients with or without sciatica) have not been proven effective for chronic low back pain (Appendix Table 6). Acupressure (see Glossary), neuroreflexotherapy (see Glossary), and spa therapy (see Glossary) have not been studied in the United States, and percutaneous electrical nerve stimulation (see Glossary) is not widely available. There is insufficient evidence to recommend interferential therapy (see Glossary), low-level laser therapy (see Glossary), shortwave diathermy (see Glossary), or ultrasonography. Evidence is inconsistent on back schools (see Glossary), which have primarily been evaluated in occupational settings, with some trials showing small, short-term benefits (127).

It may be appropriate to consider consultation with a back specialist when patients with nonspecific low back pain do not respond to standard noninvasive therapies. However, there is insufficient evidence to guide specific recommendations on the timing of or indications for referral, and expertise in management of low back pain varies substantially among clinicians from different disciplines (including primary care providers). In general, decisions about consultation should be individualized and based on assessments of patient symptoms and response to interventions, the experience and training of the primary care clinician, and the availability of specialists with relevant expertise. In considering referral for possible surgery or other invasive interventions, other published guidelines suggest referring patients with nonspecific low back pain after a minimum of 3 months (25) to 2 years (128) of failed nonsurgical interventions. Although specific suggestions about timing of referral are somewhat arbitrary, one factor to consider is that trials of surgery for nonspecific low back pain included only patients with at least 1 year of symptoms (129–131). Other recommendations for invasive interventions are addressed in a separate guideline from the APS (17).

Glossary

General

Acute low back pain: Low back pain present for fewer than 4 weeks, sometimes grouped with subacute low back pain as symptoms present for fewer than 3 months.

Cauda equina syndrome: Compression on nerve roots from the lower cord segments, usually due to a massive, centrally herniated disc, which can result in urinary retention or incontinence from loss of sphincter function, bilateral motor weakness of the lower extremities, and saddle anesthesia.

Chronic low back pain: Low back pain present for more than 3 months.

Herniated disc: Herniation of the nucleus pulposus of an intervertebral disc through its fibrous outer covering, which can result in compression of adjacent nerve roots or other structures.

Neurogenic claudication: Symptoms of leg pain (and occasionally weakness) on walking or standing, relieved by sitting or spinal flexion, associated with spinal stenosis.

Nonspecific low back pain: Pain occurring primarily in the back with no signs of a serious underlying condition (such as cancer, infection, or cauda equina syndrome), spinal stenosis or radiculopathy, or another specific spinal cause (such as vertebral compression fracture or ankylosing spondylitis). Degenerative changes on lumbar imaging are usually considered nonspecific, as they correlate poorly with symptoms.

Radiculopathy: Dysfunction of a nerve root associated with pain, sensory impairment, weakness, or diminished deep tendon reflexes in a nerve root distribution.

Sciatica: Pain radiating down the leg below the knee in the distribution of the sciatic nerve, suggesting nerve root compromise due to mechanical pressure or inflammation. Sciatica is the most common symptom of lumbar radiculopathy.

Spinal stenosis: Narrowing of the spinal canal that may result in bony constriction of the cauda equina and the emerging nerve roots.

Straight-leg-raise test: A procedure in which the hip is flexed with the knee extended in order to passively stretch the sciatic nerve and elicit symptoms suggesting nerve root tension. A positive test is usually considered reproduction of the patient’s sciatica when the leg is raised between 30 and 70 degrees. Reproduction of the patient’s sciatica when the unaffected leg is lifted is referred to as a positive “crossed” straight-leg-raise test.

Interventions

Acupressure: An intervention consisting of manipulation with the fingers instead of needles at specific acupuncture points.

Acupuncture: An intervention consisting of the insertion of needles at specific acupuncture points.

Back school: An intervention consisting of education and a skills program, including exercise therapy, in which all lessons are given to groups of patients and supervised by a paramedical therapist or medical specialist.

Brief individualized educational interventions: Individualized assessment and education about low back pain problems without supervised exercise therapy or other specific interventions. As we defined them, brief educational interventions differ from back schools because they do not involve group education or supervised exercise.

Exercise: A supervised exercise program or formal home exercise regimen, ranging from programs aimed at general physical fitness or aerobic exercise to programs aimed at muscle strengthening, flexibility, stretching, or different combinations of these elements.

Functional restoration (also called physical conditioning, work hardening, or work conditioning): An intervention that involves simulated or actual work tests in a supervised environment in order to enhance job performance skills and improve strength, endurance, flexibility, and cardiovascular fitness in injured workers.

Interdisciplinary rehabilitation (also called multidisciplinary therapy): An intervention that combines and coordinates physical, vocational, and behavioral components and is provided by multiple health care professionals with different clinical backgrounds. The intensity and content of interdisciplinary therapy varies widely.

Interferential therapy: The superficial application of a medium-frequency alternating current modulated to produce low frequencies up to 150 Hz. It is thought to increase blood flow to tissues and provide pain relief and is considered more comfortable for patients than transcutaneous electrical nerve stimulation.

Low-level laser therapy: The superficial application of lasers at wavelengths between 632 and 904 nm to the skin in order to apply electromagnetic energy to soft tissue. Optimal treatment parameters (wavelength, dosage, dose-intensity, and type of laser) are uncertain.

Massage: Soft tissue manipulation using the hands or a mechanical device through a variety of specific methods. The pressure and intensity used in different massage techniques vary widely.

Neuroreflexotherapy: A technique from Spain characterized by the temporary implantation of staples superficially into the skin over trigger points in the back and referred tender points in the ear. Neuroreflexotherapy is believed to stimulate different zones of the skin than acupuncture.

Percutaneous electrical nerve stimulation (PENS): An intervention that involves inserting acupuncture-like needles and applying low-level electrical stimulation. It differs from electroacupuncture in that the insertion points target dermatomal levels for local pathology, rather than acupuncture points. However, there is some uncertainty over whether PENS should be considered a novel therapy or a form of electroacupuncture.

Progressive relaxation: A technique which involves the deliberate tensing and relaxation of muscles, in order to facilitate the recognition and release of muscle tension.

Self-care options: Interventions that can be readily implemented by patients without seeing a clinician or that can be implemented on the basis of advice provided at a routine clinic visit.

Self-care education book: Reading material (books, booklets, or leaflets) that provide education and self-care advice for patients with low back pain. Although the specific content varies, self-care books are generally based on principles from published clinical practice guidelines and encourage a return to normal activity, adoption of a fitness program, and appropriate lifestyle modification, and they provide advice on coping strategies and managing flares.

Shortwave diathermy: Therapeutic elevation of the temperature of deep tissues by application of short-wave electromagnetic radiation with a frequency range from 10-100 MHz.

Spa therapy: An intervention involving several interventions, including mineral water bathing, usually with heated water, typically while staying at a spa resort.

Spinal manipulation: Manual therapy in which loads are applied to the spine by using short- or long-lever methods and high-velocity thrusts are applied to a spinal joint beyond its restricted range of movement. Spinal mobilization, or low-velocity, passive movements within or at the limit of joint range, is often used in conjunction with spinal manipulation.

Traction: An intervention involving drawing or pulling in order to stretch the lumbar spine. Various methods are used, usually involving a harness around the lower rib cage and the iliac crest, with the pulling action done by using free weights and a pulley, motorized equipment, inversion techniques, or an overhead harness.

Transcutaneous electrical nerve stimulation (TENS): Use of a small, battery-operated device to provide continuous electrical impulses via surface electrodes, with the goal of providing symptomatic relief by modifying pain perception.

Yoga: An intervention distinguished from traditional exercise therapy by the use of specific body positions, breathing techniques, and an emphasis on mental focus. Many styles of yoga are practiced, each emphasizing different postures and techniques.

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Appendix Table 1. The American College of Physicians Clinical Practice Guidelines Grading System

Appendix Table 1. The American College of Physicians Clinical Practice Guidelines Grading System

Appendix Table 2. Methods for Grading the Strength of the Overall Evidence for an Intervention

Appendix Table 2. Methods for Grading the Strength of the Overall Evidence for an Intervention

Appendix Table 3. Definitions for Estimating Magnitude of Effects

Appendix Table 3. Definitions for Estimating Magnitude of Effects

Appendix Table 4. Recommendations and Summary Ratings

Appendix Table 4. Recommendations and Summary Ratings

Appendix Table 5. Level of Evidence and Summary Grades for Noninvasive Interventions in Patients with Acute Low Back Pain

Appendix Table 5. Level of Evidence and Summary Grades for Noninvasive Interventions in Patients with Acute Low Back Pain

Appendix Table 6. Level of Evidence and Summary Grades for Noninvasive Interventions in Patients with Chronic or Subacute Low Back Pain

Appendix Table 6. Level of Evidence and Summary Grades for Noninvasive Interventions in Patients with Chronic or Subacute Low Back Pain

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Video News Release - New Guidelines for Diagnosing and Treating Low Back Pain (2:27)

The ACP releases guidelines for physicians on diagnosing and treating low back pain in their patients.

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6 Comments

Jan M Bjordal

Bergen University College, University of Bergen, Norway

November 7, 2007

Failing evidence behind first-line medication recommendations

The overviews of non-pharmacological(1) and pharmacological treatments(2) form the basis for the treatment recommendations 6 and 7 in this guideline (3) for low back pain management. We have previously pointed out in rapid responses to the journal website that the overview method is methodologically inferior to systematic reviews, and that the real power of the scientific evidence is not transparently available for critical appraisal in overviews. Overviews also tend to be biased in favour of those interventions where systematic reviews -however poor- have been included in the overview. In this guideline (3), clinicians are strongly advised to (always) "consider the use of medications" and "first- line options are acetaminophen or non-steroidal anti-inflammatory drugs". Non-pharmacological treatments are given "weak recommendations", but only for "patients who do not improve". Superficial heat packs, low level laser therapy (LLLT) and transcutaneous electrical nerve stimulation (TENS) are not even on the "weak recommendation" list. The implication of these recommendations is that drugs are the only available treatment options with moderate quality evidence, and seemingly loads of trials to scientifically support this notion. The scientific facts can, however, be interpreted quite differently.

For NSAIDs, the main source for the overview conclusion is in fact a withdrawn Cochrane review which found a negative standardized mean difference between NSAID and placebo in three trials (4). After corrections for data extraction errors (dipyrone group data mistakenly included instead of diclofenac group data(5) ) in the Cochrane review, we found a non-significant relative risk for improvement from 6 trials. For acetaminophen, there are no placebo-controlled trials of low back pain. But indirect evidence from systematic reviews of other chronic conditions such as osteoarthritis of the knee joint, shows that acetaminophen is largely ineffective (6). These recommendations fail to include their own overview findings:(1) "For acute low back pain, the only therapy with good evidence of efficacy is superficial heat." Indeed, the only published comparison between acetaminophen and superficial heat, showed superficial heat to be superior to first-line recommended acetaminophen(7). Another recent study confirms the positive effect of superficial heat both in terms of significant pain relief and by halving the need for NSAIDs as rescue medication(8). We expect the authors to correct this non-inclusion error of superficial heat in the recommendations.

A commonly used methodological option by the overview method is to include evidence from trials published after the deadline of the included systematic reviews(9), anticipating that these reviews are scientifically sound. Even if doing this, only a single NSAID trial with an effect of 11 mm [95% CI: 4 to 18] versus placebo was found in acute low back pain(10). On the other hand, a well-conducted TENS-trial found a pain reduction of 32 mm [95% CI: 25 to 40] compared to placebo-TENS on a 100 mm VAS-scale (11). One of the largest problems with the overview method, is that the included systematic reviews have different protocols and inclusion criteria. For instance, the Cochrane NSAID-review included trials with oral and injected drug administration, mixed populations of sciatica and non-specific low back pain, and acute and chronic conditions. Sub-group analyses were only performed for acute and chronic conditions. On the other hand, the Cochrane TENS.-review (12) failed to find all studies (13) and excluded trials with acute(11) and subacute conditions (14, 15), middle or upper back involvement (16) or arthritic conditions(17). Most of the non-included trials reported positive findings. One of the two included trials in the Cochrane TENS-review reported a negative result, but this trial included patients with sciatica(18) where the overview found both medication and other therapies to be largely ineffective. Our own analysis, showed a significant effect of five TENS-trials with a magnitude of 15 mm [95%CI: 5 to 25] over placebo on a 100 mm VAS-scale in non-specific low back pain. If the NSAID Cochrane review had excluded the trials with mixed samples and injecting administration routes too, there would not be sufficient evidence to conclude anything. So, by and large, the overview method induces comparisons between heterogeneous patient samples and different treatment administrations, which makes the readers non-the-wiser.

We find it rather paradoxical that first-line recommendations of acetaminophen rest on no evidence from controlled trials, while, according to our analysis, there is moderate evidence of no significant effect of NSAIDs if the evidence is limited to only to include systematic reviews in the medication overview. For LLLT where no systematic reviews were included in the overview, even 5 positive LLLT-trials out of 6 in total, was not enough to gain a "fair" grading of evidence or far less merit a "weak" recommendation in chronic non-specific low back pain. Even if we do not make the two justified corrections in trial data in the analysis of the Cochrane NSAID-review (dipyrone trial data replaced with diclofenac data(5), and mixed trial data replaced with only back pain data without sciatica(19)), the NSAIDs recommendations for acute non-specific low back pain are based on 0 out of 6 included trials showing significant effects of NSAIDs. On this background the 6th recommendation that "clinicians should consider the use of medications with proven benefit" is far from bullet-proof with the obvious lack of evidence for the two first-line recommended medications acetaminophen and NSAIDs.

It seems clear to us that the overview method of synthesizing evidence has been overdue for replacement for a long time. In light of the current material, we can see that all conclusions regarding acetaminophen and NSAIDs in fact rest on unacceptably volatile interpretations based on a handful of trials. A different, but seemingly valid, interpretation of these trial data lead to the conclusion that some of the non- pharmacological therapies are at least as effective as drug therapies in both acute and chronic non-specific low back pain.

For low back pain, it is timely to ask if these methodological flaws have lead to unjustified favourisation of drug therapies compared to physical interventions in non-specific low back pain management. It is due time to reconsider the validity of the currently used overview method for synthesizing scientific evidence for low back pain treatment, the inclusion of withdrawn and outdated systematic reviews, and the probably misleading treatment guidelines.

REFERENCES

1. Chou, R. and L.H. Huffman, Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med, 2007. 147(7): 492-504.

2. Chou, R. and L.H. Huffman, Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med, 2007. 147(7): 505-14.

3. Chou, R., A. Qaseem, V. Snow, D. Casey, J.T. Cross, Jr., P. Shekelle, 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(7): 478-91.

4. van Tulder, M.W., R.J. Scholten, B.W. Koes and R.A. Deyo, WITHDRAWN: Non-steroidal anti-inflammatory drugs for low-back pain. Cochrane Database Syst Rev, 2007(3): CD000396.

5. Babej-Dolle, R., S. Freytag, J. Eckmeyer, G. Zerle, S. Schinzel, G. Schmeider, et al., Parenteral dipyrone versus diclofenac and placebo in patients with acute lumbago or sciatic pain: randomized observer-blind multicenter study. Int J Clin Pharmacol Ther, 1994. 32(4): 204-9.

6. Bjordal, J.M., A. Klovning, A.E. Ljunggren and L. Slordal, Short-term efficacy of pharmacotherapeutic interventions in osteoarthritic knee pain: A meta-analysis of randomised placebo-controlled trials. Eur J Pain, 2007. 11(2): 125-38.

7. Nadler, S.F., D.J. Steiner, G.N. Erasala, D.A. Hengehold, R.T. Hinkle, M. Beth Goodale, et al., Continuous low-level heat wrap therapy provides more efficacy than Ibuprofen and acetaminophen for acute low back pain. Spine, 2002. 27(10): 1012-7.

8. Kettenmann, B., C. Wille, E. Lurie-Luke, D. Walter and G. Kobal, Impact of continuous low level heatwrap therapy in acute low back pain patients: subjective and objective measurements. Clin J Pain, 2007. 23(8): 663-8.

9. Airaksinen, O., J.I. Brox, C. Cedraschi, J. Hildebrandt, J. Klaber- Moffett, F. Kovacs, et al., Chapter 4 European guidelines for the management of chronic nonspecific low back pain. Eur Spine J, 2006. 15(Supplement 2): s192-s300.

10. Dreiser, R.L., M. Marty, E. Ionescu, M. Gold and J.H. Liu, Relief of acute low back pain with diclofenac-K 12.5 mg tablets: a flexible dose, ibuprofen 200 mg and placebo-controlled clinical trial. Int J Clin Pharmacol Ther, 2003. 41(9): 375-85.

11. Bertalanffy, A., A. Kober, P. Bertalanffy, B. Gustorff, O. Gore, S. Adel, et al., Transcutaneous electrical nerve stimulation reduces acute low back pain during emergency transport. Acad Emerg Med, 2005. 12(7): 607 -11.

12. Khadilkar, A., S. Milne, L. Brosseau, V. Robinson, M. Saginur, B. Shea, et al., Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain. Cochrane Database Syst Rev, 2005(3): CD003008.

13. Topuz, O., E. Ozfidan, M. Ozgen and F. Ardic, Efficacy of Transcutaneous Electrical Stimulation and Percutaneous Neuromodulation Therapy in chronic low back pain. Journal of Back and Musculoskeletal Rehabilitation, 2004. 17: 127-33.

14. Glaser, J.A., M.A. Baltz, P.J. Nietert and C.V. Bensen, Electrical muscle stimulation as an adjunct to exercise therapy in the treatment of nonacute low back pain: a randomized trial. J Pain, 2001. 2(5): 295-300.

15. Herman, E., R. Williams, P. Stratford, A. Fargas-Babjak and M. Trott, A randomized controlled trial of transcutaneous electrical nerve stimulation (CODETRON) to determine its benefits in a rehabilitation program for acute occupational low back pain. Spine, 1994. 19(5): 561-8.

16. Moore, S.R. and J. Shurman, Combined neuromuscular electrical stimulation and transcutaneous electrical nerve stimulation for treatment of chronic back pain: a double-blind, repeated measures comparison. Arch Phys Med Rehabil, 1997. 78(1): 55-60.

17. Gemignani, G., I. Olivieri, G. Ruju and G. Pasero, Transcutaneous electrical nerve stimulation in ankylosing spondylitis: a double-blind study. Arthritis Rheum 1991. 34(6): 788-789.

18. Deyo, R.A., N.E. Walsh, D.C. Martin, L.S. Schoenfeld and S. Ramamurthy, A controlled trial of transcutaneous electrical nerve stimulation (tens) and exercise for chronic low back pain. New Engl J Med, 1990. 322(23): 1627-34.

19. Jacobs, J.H. and M.F. Grayson, Trial of an anti-inflammatory agent (indomethacin) in low back pain with and without radicular involvement. Br Med J, 1968. 3(5611): 158-60.

Conflict of Interest:

None declared

Roger Chou

Oregon Health & Science University

December 5, 2007

In Response

In response:

We thank the authors of the letters for their comments on our low back pain guideline (1) and evidence reviews (2, 3). Dr. Bjordal notes some methodologic concerns with our reviews. To clarify, we performed a systematic review of a broad range of low back pain topics, and when prior systematic reviews were available and of sufficient quality, we included them. The idea that new systematic reviews of the primary literature should always be conducted when developing clinical practice guidelines is both unsupported by any empirical evidence and if implemented could be a poor use of scientific resources (4). Guideline panels need relevant, current, high-quality reviews of the evidence; if existing reviews fulfill those criteria then it is wasteful to ignore them and conduct new reviews. We included systematic reviews published in or after the year 2000 and identified higher-quality reviews using a validated quality rating instrument (5, 6). Although systematic reviews should be updated, there is no compelling reason to ignore higher-quality Cochrane reviews (7) that met our criteria for inclusion and were "withdrawn" only because they did not meet an updating deadline, not because of methodological deficiencies or the publication of contradictory trials (8).

Dr. Bjordal suggests that we graded evidence for acetaminophen too positively. In his letter, Dr. Bjordal describes one trial as evaluating acute low back pain when it actually evaluated chronic low back pain (9). Otherwise, our descriptions of the evidence are similar (Appendix Tables 10 and 11 (2)). We agree that our evidence ratings for acetaminophen were generous given some inconsistency among trials of acute low back pain, and lack of direct evidence and small benefits for chronic low back pain. We re-rated evidence for acetaminophen for acute low back pain fair quality with moderate benefits, and for chronic low back pain fair quality with small benefits (see Correction). Because of acetaminophen's favorable safety profile compared to other pharmacologic therapies, these changes do not change our recommendation to consider it as a first-line option for pharmacologic therapy (1).

For NSAIDs, skeletal muscle relaxants, and benzodiazepines, Dr. Bjordal's focus on single outcomes from placebo-controlled trials reported in Cochrane reviews ignores much of the available evidence. Our assessments are based on both placebo and active-controlled trials, non- Cochrane systematic reviews, data on various outcomes related to pain, function, and global efficacy, and indirect evidence from patients with other pain conditions (Appendix Tables 10 and 11 (2)). We also evaluated consistency between trials and across higher-quality systematic reviews (10). In addition, post-hoc analyses, such as those presented by Dr. Bjordal, can be misleading and should be interpreted cautiously. For example, excluding trials based on small differences in quality scores is problematic given unpredictable associations between summary quality rating scores and estimates of effects (11). We did not report data on mean improvement in pain scores from a Cochrane review of NSAIDs because of substantial, unexplained heterogeneity (p<0.0001) (7).

As Dr. Bjordal surmised, we inverted relative risks (1/relative risk) for "˜no pain relief' with skeletal muscle relaxants and benzodiazepines (as reported in a Cochrane review (12)) to present results for a positive outcome (achieving pain relief) (2). However, this transformation was incorrect, as relative risks (unlike odds ratios) are not a symmetric statistic. We will correct the article to show original results as reported in the Cochrane review (see Corrections). This correction does not change any conclusions, but we thank Dr. Bjordal for noting this error.

We disagree with Dr. Bjordal's assertion that there is enough evidence to establish efficacy of low-level laser therapy (LLLT) and transcutaneous electrical nerve stimulation (TENS). In the case of LLLT, there is substantial diversity across trials in doses and types of laser, some inconsistency among higher-quality trials, and the possibility of publication bias. Our conclusion of insufficient evidence is similar to a recently published Cochrane review (13). For TENS, the highest quality placebo-controlled trial found no benefit in chronic low back pain (14). In addition, it is inappropriate to pool studies of disparate populations and therapies (TENS and neuromuscular stimulation), as proposed by Dr. Bjordal, and two of the trials proposed for pooling found no benefits on pain or function with TENS versus placebo (15, 16).

We disagree with Dr. Ernst that our conclusions regarding rare risk of serious adverse events with spinal manipulation are misleading or downplay the risk of cerebrovascular events (3). Our review deals with low back pain and treatment with lumbar spinal manipulation. There are no reports of cerebrovascular events following lumbar spine manipulation or in patients being treated for low back pain (17, 18). Cervical manipulation is not a subject of our review or practice guideline.

Dr. Bjordal suggests that recommendations for therapy favor pharmacologic over non-pharmacologic options (1). In fact, we recommend either type of therapy as options (Figure 1, Box 9 (1)), and strength of evidence and magnitude of benefits were graded similarly for several pharmacologic and non-pharmacologic therapies (Appendix Tables 5 and 6). However, recommendation 7 on non-pharmacologic therapies in general was graded "weak" because of relatively weak evidence for some suggested options (Appendix Tables 10 and 11 (3)), higher costs compared to first- line pharmacologic therapies, and less convenience (most non-pharmacologic options involving multiple provider visits). It would be appropriate to select a non-pharmacologic over pharmacologic therapy in patients who express such a preference, but the trade-offs should be discussed (19). Superficial heat is already recommended as a self-care option (Figure 2, Interventions box (1)).

Roger Chou, MD Oregon Health & Science University, Portland, Oregon

Paul Shekelle, MD, PhD Veterans Affairs Health Care System and RAND, Santa Monica, California

Amir Qaseem, MD, PhD, MHA The American College of Physicians, Philadelphia, Pennsylvania

Douglas K. Owens, MD, MS Veterans Affairs Palo Alto Health Care System, Palo Alto, and Stanford University, Stanford, California

References

1. 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;147:478 -491.

2. Chou R, Huffman LH. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Annals of Internal Medicine. 2007;147:505-514.

3. Chou R, Huffman LH. Non-pharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians Clinical Practice Guideline. Annals of Internal Medicine. 2007;147:492-504.

4. Silagy CA, Stead LF, Lancaster T. Use of systematic reviews in clinical practice guidelines: case study of smoking cessation. BMJ. 2001;323:833-836.

5. Jadad AR, McQuay HJ. Meta-analyses to evaluate analgesic interventions: a systematic qualitative review of their methodology. Journal of Clinical Epidemiology. 1996;49:235-243.

6. Oxman AD, Guyatt GH. Validation of an index of the quality of review articles. Journal of Clinical Epidemiology. 1991;44(11):1271-1278.

7. van Tulder MW, Schotten RJPM, Koes BW, Deyo RA. Non-steroidal anti -inflammatory drugs for low-back pain Cochrane Database of Systematic Reviews. 2000(2).

8. Shojania KG, Sampson M, Ansari MT, Ji J, Doucette S, Moher D. How quickly do systematic reviews go out of date? a survival analysis. Ann Intern Med. 2007;147:224-233.

9. Hickey RF, Hickey RF. Chronic low back pain: a comparison of diflunisal with paracetamol. New Zealand Medical Journal. 1982;95(707):312 -4.

10. GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ. 2004;328:1490-1494.

11. Juni P, Witschi A, Bloch R, Egger M. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA. 1999;282:1054-1060.

12. van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM. Muscle relaxants for non-specific low-back pain Cochrane Database of Systematic Reviews. 2003(4).

13. Yousefi-Nooraie R, Schonstein E, Heidari K, et al. Low level laser therapy for nonspecific low-back pain. Cochrane Database of Systematic Reviews. 2007;2.

14. Deyo RA, Walsh NE, Martin DC, Schoenfeld LS, Ramamurthy S. A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain. New England Journal of Medicine. 1990;322:1627-34.

15. Herman E, Williams R, Stratford P, Fargas-Babkak A, Trott M. A randomized controlled trial of transcutaneous electrical nerve stimulation (CODETRON) to determine its benefits in a rehabilitation program for acute occupational low back pain. Spine. 1994;19(5):561-568. 16. Moore SR, Shurman J. Combined neuromuscular electrical stimulation and transcutaneous electrical nerve stimulation for treatment of chronic back pain: a double-blind, repeated measures comparison. Arch Phys Med Rehabil. 1997;78:55-60.

17. Ernst E. Cerebrovascular complications associated with spinal manipulation. Physical Therapy Reviews. 2004;9(1):5-15.

18. Ernst E. Adverse effects of spinal manipulation: a systematic review. Journal of the Royal Society of Medicine. 2007;100:330-338.

19. Schunemann HJ, Jaeschke R, Cook DJ, et al. An official ATS statement: Grading the quality of evidence and strength of recommendations in ATS guidelines and recommendations. Am J Respir Crit Care Med. 2006;174:605-614.

Conflict of Interest:

None declared

Roger Chou

Oregon Health & Science University

December 5, 2007

Correction

Correction

We write to provide corrections to the recent joint guideline by the American College of Physicians and the American Pain Society on diagnosis and treatment of low back pain (1) and supporting evidence reviews (2, 3). In the original print version of the guideline, the target populations were described incorrectly (1). The word "not" was inadvertently dropped from a sentence that described populations that were excluded from the guideline. Children or adolescents with low back pain; pregnant women; patients with low back pain from sources outside the back (nonspinal low back pain), fibromyalgia or other myofascial pain syndromes, and thoracic or cervical back pain are not covered by the guideline. The online version of guideline has already been corrected.

In response to a letter to the editor (4) we re-reviewed the evidence on acetaminophen and believe we originally graded the evidence too positively in the guideline and evidence review (1, 2). However, our guideline recommendations remain the same. Acetaminophen for acute low back pain should be rated "˜fair' rather than "˜good' quality. Acetaminophen for chronic low back pain should be rated "˜fair' rather than "˜good' quality and magnitude of benefit "˜small' rather than "˜moderate' (Appendix Tables 5 and 6 in the guideline (1) and Appendix Tables 10 and 11 in the evidence review (2)). The Abstract/Data Synthesis section of the evidence review should read: "We found good evidence that NSAIDs, skeletal muscle relaxants (for acute low back pain), and tricyclic antidepressants (for chronic low back pain) are effective for pain relief"¦We also found fair evidence that acetaminophen, opioids, tramadol, benzodiazepines, and gabapentin (for radiculopathy) are effective for pain relief (2)." The Abstract/Conclusions section should read: "Medications with good evidence of short-term effectiveness for low back pain are NSAIDs, skeletal muscle relaxants (for acute low back pain), and tricyclic antidepressants (for chronic low back pain)." Similar changes should be applied to the Discussion section. As noted, these changes do not affect Recommendation 6 suggesting acetaminophen as an option for first-line pharmacologic therapy (1). This recommendation is based in large part on the safety profile of acetaminophen, when taken in appropriate dosages in patients without a contraindication.

Reference 62 in the evidence review on medications for low back pain is incorrect and should refer to a different trial by the same first author (5).

In the evidence review on medications, we inverted (calculated 1/relative risk) results for "not achieving pain relief" as reported in a Cochrane review (6) in order to report the likelihood of achieving pain relief. This conversion was incorrect because relative risk is not a symmetric statistic. The evidence review (2) will be corrected to state results as originally reported in the Cochrane review: for skeletal muscle relaxants, relative risks for not achieving pain relief 0.80 [CI, 0.71 to 0.89] at 2-4 days and 0.67 [0.13 to 3.44] at 5-7 days and relative risks for not achieving global efficacy 0.49 [CI, 0.25 to 0.95] at 2-4 days and 0.68 [CI, 0.41 to 1.13] at 5-7 days; and for benzodiazepines, relative risks for not achieving pain relief 0.71 [CI, 0.54 to 0.93] and for not achieving global efficacy 0.63 [CI, 0.42 to 0.97] at 8-14 days (6). Similarly, in the evidence review on non-pharmacologic therapies (3), results for a systematic review by Kool et al (7) on exercise therapy should state a relative risk of 0.73 [CI, 0.56 to 0.95] for not returning to work after 1 year . None of these corrections affect conclusions of the evidence reviews or guidelines.

All corrections have been applied to the online version of the articles.

Roger Chou, MD Oregon Health & Science University, Portland, Oregon

Paul Shekelle, MD, PhD Veterans Affairs Health Care System and RAND, Santa Monica, California

Amir Qaseem, MD, PhD, MHA The American College of Physicians, Philadelphia, Pennsylvania

Douglas K. Owens, MD, MS Veterans Affairs Palo Alto Health Care System, Palo Alto, and Stanford University, Stanford, California References

1. 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;147:478 -491.

2. Chou R, Huffman LH. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Annals of Internal Medicine. 2007;147:505-514.

3. Chou R, Huffman LH. Non-pharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians Clinical Practice Guideline. Annals of Internal Medicine. 2007;147:492-504.

4. Bjordal JM, Lopes-Martin RAB, Klovning A, Roland PH, Slordal L. Overviews are methodically inferior to systematic reviews and contribute to myths of effective drugs. Annals Online. 17 Oct 2007.

5. Berry H, Bloom B, Hamilton EBD, Swinson DR. Naproxen sodium, diflunisal, and placebo int he treatment of chronic back pain. Ann Rheum Dis. 1982;41:129-132.

6. van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM. Muscle relaxants for non-specific low-back pain Cochrane Database of Systematic Reviews. 2003(4).

7. Kool J, de Bie R, Oesch P, Knusel O, van den Brandt P, Bachmann S. Exercise reduces sick leave in patients with non-acute non-specific low back pain: a meta-analysis. Journal of Rehabilitation Medicine. 2004;36(2):49-62.

Conflict of Interest:

None declared

Stanley J Antolak

Center for Urologic and Pelvic Pain

December 5, 2007

Middle cluneal neuropathy: a neglected cause of low back pain.

In a series of three articles regarding low back pain, 1,2,3 the authors overlook the role of the middle cluneal nerves as a cause of serious, debilitating back pain. Modern textbooks of neurology, anatomy, and neurosurgery do not discuss these nerves. This prevents young physicians and surgeons from awareness of this frequent cause of low back pain. In the three articles cited, there are 428 references, none of which identify middle cluneal neuropathy as a basis of acute and chronic pelvic pain. Lack of awareness causes the sufferers to undergo unnecessary conventional evaluations and surgical interventions.

Back pain due to these nerves was first associated with a movable, presacral nodule that is called a "back mouse" or episacroiliac lipoma.4 All persons with middle cluneal neuropathy do not have such palpable nodules. Approximately 30% of persons will have a palpable nodule at the sacral region. One-half of these are tender.

In a practice limited to pelvic pain there is a similar frequency of occurrence of these nodules. The back pain complaints can be reproduced by pressure medial to the nodule. Pain may remain local or may extend to the inguinal and suprapubic regions, the genitalia, perineum, anus, legs, and feet.

Examination is best performed with the patient standing and flexed about 20 degrees. Indeed, most patients will agree that this position, used while brushing their teeth or washing dishes, aggravates their pains.

We have performed subcutaneous perineural blocks using local anesthetics. Pain of several years duration can be relieved immediately but this rarely provides long term pain control. Surgical excision of a portion of the nerve is effective.5 Radiofrequency ablation and cryotherapy should be considered.

Our plea is that old literature on this process be reviewed and that all physicians treating back pain become acquainted with middle cluneal neuropathy. It is unconscionable to perform three discectomies and a spinal fusion on a man over 14 years with never any pain relief. Bilateral back mice were identified and the nerves infiltrated with local anesthetic providing immediate, complete pain relief.

Conflict of Interest:

None declared

Philip P Tygiel

Tygiel Physical Therapy

May 10, 2008

Early Physical Therapy intervention necessary for low back pain.

Response to ACP-APS Guidelines

To The Editor Annals of Internal Medicine

We applaud the American College of Physicians (ACP) and the American Pain Society (APS) for attempting to establish guidelines for the management of low back pain, and we concur with the recommendations regarding diagnostic testing, patient education and pharmacological interventions.1 However, the recommendations for non-pharmacologic treatment for acute low back pain are a cause for concern. Recommending heat as the only therapy which demonstrated effectiveness is misguided. A thorough review of the literature, especially with regard to physical therapy intervention, supports an active, classification-based approach to acute low back pain. In fact, an argument can be made that reliance upon heat alone, as an initial care strategy for low back pain without other early physical therapy intervention, can actually promote unfavorable outcomes and an increased incidence of chronic low back pain. Following the ACP/APS recommendations as currently published will probably do more harm than good.

We agree that it is very important to educate patients about the expected course of low back pain and to encourage physical activity, but that is not enough to reduce the likelihood of chronicity. Studies have clearly demonstrated that for acute low back pain, as for all acute musculoskeletal injuries, early physical therapy intervention, to modulate pain, restore normal mobility with manipulation/mobilization and improve biomechanical function with specific exercise routines, reduces the chance of developing chronic pain from 15% to 2%.2,3 Additionally, comparisons of having low back patients treated with classification based physical therapy, as compared to a practice guideline approach similar to that being recommended 4 , show superior outcomes for the classification based therapy group.5

A study by Linton, et al.,, of the Department of Occupational Medicine at the Orebro Medical Center in Sweden has demonstrated that early active physical therapy intervention for patients suffering their first episode of acute musculoskeletal pain significantly decreased the incidence of chronic pain.2

In this study, injured workers complaining of acute musculoskeletal pain were either seen by a physical therapist within the first few days after injury or had to wait a week or more to be seen. Both groups were seen by a general practitioner to rule out aggressive disease or problems that might require medical treatment. Patients in the early intervention group saw a physical therapist within the first three days following their injury. The control group might be sent for physical therapy, but would often have to wait between three weeks to three months for their appointment. The physical therapists performed a functional examination followed by education and treatment if needed. The physical therapists reinforced healthy behaviors, specifically the maintenance of daily activities and the practice of specified "training" activities. Specific advice was provided as to how the patient might help him or herself to improve and which activities should be maintained during the recovery. If the therapist deemed it necessary, individual treatments were administered for up to 12 weeks.

At follow-up, 12 months later, investigators looked at patient outcomes, particularly with regard to time off of work and development of chronic pain. Chronic cases were defined as those individuals sick listed for more than 200 days during the following year. The results demonstrate that early active physical therapy significantly reduces the incidence of the development of chronic pain and the amount of lost work time for patients suffering acute musculo-skeletal injury. The results can be summarized as follows:

"¢ Of those people who were suffering their first episode of musculoskeletal pain who had early physical therapy intervention only 2% went on to develop chronic pain. Of those who did not get early intervention, 15% became chronic pain patients.

"¢ 32% of the early activation group lost no workdays as compared to only 23% of the control group.

"¢ Only 26% of the early activation group lost 11-30 days while 33% of the control group missed that much work.

"¢ 17% of the early activation group lost more than 30 days. Almost twice that many, 31% of the control group were off work for more than 30 days.

The physical therapy a patient needs following acute onset of low back pain varies depending on the patient's presenting signs and symptoms. A classification system on which to base treatment was proposed by DeLitto, et al., in 1995.6 The treatment-based classification has been expounded upon and refined since. 7,8 It recognizes four classifications of patient presentation that help to guide appropriate treatment. Using this system a patient can be placed into one of four treatment approaches that they are most likely to respond well to. These four classifications are Manipulation, Stabilization, Specific Exercise or Traction. The Specific Exercise group is further subdivided by type of exercise. It was also recognized that some patients may start under one classification but then progress into another. For instance a patient who initially demonstrates immobility, and therefore requires manipulation, might later require specific exercises either to maintain that mobility in a specific direction or to stabilize the trunk and spine to prevent what caused the end range immobility in the first place.

Fritz, et al., demonstrated that there were better short-term outcomes for patients with acute work related low back pain when they were treated using a classification based approach to physical therapy instead of an approach based on recommendations from the AHCPR clinical practice guidelines which does not take a patient's pathokinesiological signs and symptoms into account. Fritz, et al., have also demonstrated improved outcomes in patients in an occupational setting when the treatment of manipulation is applied in concordance with the treatment-based classification.5

Brennan, et al., examined the patient care for low back pain in subjects that demonstrated concordance (i.e. matched or not matched) of care with the classification categories. The authors found the matched treatment groups had a clinically significant improvement in outcomes compared to the subjects not treated with appropriate classification treatments in short term and long term outcomes (Oswestry scores). 8

Spengler, et al.,, reported that just 10% of the total number of people who suffer back injuries account for 79% of the total incurred costs and that the most chronic cases, just 1.2%, account for 27%. 9 Direct medical expenses are only a small part of the total cost of back pain. To an even larger extent were the costs of temporary disability payments and permanent disability awards. 10

Failure to refer first episode musculoskeletal pain patients for physical therapy in the first few days following injury results in an eight fold increase in the number of patients going on to have chronic pain, and a 50% increase in patients who lose more than 10 workdays. The cost of caring for and reimbursing these patients is tremendous. The cost of early active physical therapy is minimal by comparison. Many acute patients will require only 1-3 visits for education and an exercise program. Some will require more visits and a few; approximately 15%, will need extensive treatment.

In the industrial setting the reduction in temporary disability payments to cover the lost days and permanent disability awards for chronic pain far outweighs the cost of early intervention. Even for the non-industrial injuries though, the savings in money, pain and suffering far outweigh the cost of early physical therapy intervention.

Following clinical practice guidelines for low back pain that do not call for early classification based physical therapy intervention is a violation of the very first rule of medicine, Primum non nocere, "above all do no harm". Early intervention can reduce the incidence of chronicity from 15% to 2%. Conversely, failure to institute early physical therapy results in 13 out of every 100 patients who injure their backs developing chronic pain that could have been avoided. That is a level of potential harm that is unacceptable. We therefore encourage the ACP and APS to revise their guidelines for treating low back pain and to include recommendations for early referral to a physical therapist, with expertise in orthopedic manual physical therapy, for classification based diagnosis and treatment. The best evidence available shows that to be the best and only proven way to reduce the incidence of chronicity.

Philip Paul Tygiel PT, MTC Britt Smith PT, DPT, OCS, FAAOMPT Eric Robertson PT, DPT Mark Shropshire PT, MSPT, OCS Tim Thorsen PT, MTC Members, American Academy of Orthopedic Mauual Physical Therapy (AAOMPT)

May 8, 2008

References:

1 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. Oct 2 2007;147(7):478-491.

2 Linton, SJ, Helsing, A, and Anderson, D, A controlled study of effects of an early intervention on acute musculoskeletal pain problems. Pain. 54 (1993): 353-359.

3 Pinnington, Mark A,, Miller ,Julia; Stanley, Ian .An evaluation of prompt access to physiotherapy in the management of low back pain in primary care. Family Practice Vol. 21, No. 4(2004) : 372-80

4 Bigos S, Boyer O,, et al.,. Acute Low Back Pain in Adults. AHCPR Publication 95-0642. 1994

5 Fritz, JM; Delitto, A; Ehhard, RE. Comparison of Classification- based Physical Therapy with Therapy Based on Clinical Practiced Guidelinesfor Patients with Acute Low back pain; A Randomized Clinical Trial. SPINE Vol.28(13),2003

6 Delitto A, Erhard RE, Bowling RW. A treatment based classification approach to low back syndrome: identifying and staging patients for conservative treatment. Phys Ther. 1995;75:470-85

7 Fritz JM. Cleland JA, Childs JD. Sub-grouping patients with low back pain: Evolution of a classification approach to physical therapy. JOSPT 2007 Vol 23(6).290-302.

8 Brennan GP,. Fritz, JM,, et al.,. Identifying Subgroups of Patients With Acute/Subacute "Nonspecific" Low Back Pain Results of a Randomized Clinical Trial. SPINE Volume 31, Number 6, pp 623"“631 Â©2006

9 Spengler, D., Bigos, SJ, Martin, NZ, Zeh, J., Fisher, L and Nachenson, A. Back injuries in industry: a retrospective study. Overview and cost analysis. Spine. II (1986) 241-245.

10 Leavitt SS, Johnson TL, Beyer JD. The process of recovery, Part 1. Med. Surg. 40:7-14,1971

Contact Information:

Philip Paul Tygiel, PT, MTC Tygiel Physical Therapy 6606 East Carondelet Drive Tucson, AZ 85710 Phone: 520 296 8513 fax: 520 296 0075 Email: TygielPT@aol.com

Britt Smith, PT, DPT, OCS, FAAOMPT 2497 Power Road, No. 10 Grand Junction CO 81503-2795 Brittsmith1@msn.com

EricRobertson,PT,DPT Assistant Professor Department of Physical Therapy Medical College of Georgia, Augusta, GA ekrdpt@gmail.com

Mark Shropshire PT, MSPT, OCS Motion Synergy Physical Therapy LLC 345 E. Wisconsin Ave. Suite 5 Appleton, WI 54911-4802 www.motionsynergy.com

Tim P. Thorsen P.T., M.T.C. 586 Shepard Street Rhinelander, WI 54501 tthorsen@spinesport.com

Conflict of Interest:

None declared

Amir Qaseem

American College of Physicians

August 28, 2008

Re: Early Physical Therapy intervention necessary for low back pain

We thank Dr Tygiel and colleagues for their comments on our guideline on LBP. There is a lack of strong or moderate evidence that shows that exercise therapy within the first 4 weeks improves outcomes. The meta-analysis by Hayden et al as well as other systematic reviews/meta-analyses show that exercise therapy for acute LBP (<4 weeks) is associated with minimal or no benefits. There is no high-quality evidence that early referral to PT improves outcomes in patients with acute (<4 weeks) LBP. The Linton study was relatively small, enrolled persons with neck or back pain, and does not specify duration of symptoms ("not sick-listed within the last 3 months"). Furthermore, the intervention is not just PT, it is early primary care evaluation plus PT and thus it is impossible to differentiate which one was the effective component of the intervention. Also results of this study have never been duplicated. The Pinnington study also does not specify duration of symptoms (first presentation for LBP "within 6 months") and is an uncontrolled observational study. Our guideline does not only recommend heat for acute LBP. We also recommend staying active, spinal manipulation, and first-line analgesics (acetaminophen and NSAIDs). As far as utilizing a prediction rule to see if someone is more likely to respond to a particular type of exercise therapy and/or manipulation and then targeting that therapy, a recent study was unable to independently duplicate the work of DeLitto et al (Hancock Eur Spine J 2008;17:936-43). Also, in our discussion, we do state that methods for targeting these therapies are in development and look promising but need further validation.

Conflict of Interest:

None declared

Not Available

Citations

©

2007 American College of Physicians

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