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*
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 All ACP clinical practice guidelines are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.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, firstname.lastname@example.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
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).
Clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain (strong recommendation, moderate-quality evidence).
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).
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).
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).
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.
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.
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 3. Definitions for Estimating Magnitude of Effects
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 6. Level of Evidence and Summary Grades for Noninvasive Interventions in Patients with Chronic or Subacute Low Back Pain
Initial evaluation of low back pain (LBP
Management of low back pain (LBP
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Video News Release - New Guidelines for Diagnosing and Treating Low Back Pain
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.
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.
Oregon Health & Science University
December 5, 2007
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
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.
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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.
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.
Douglas K. Owens, MD, MS Veterans Affairs Palo Alto Health Care System, Palo Alto, and Stanford University, Stanford, California References
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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.
Stanley J Antolak
Center for Urologic and Pelvic Pain
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.
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
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
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 email@example.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 firstname.lastname@example.org
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.
Chou R, Qaseem A, Snow V, Casey D, Cross JT, Shekelle P, 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. doi: 10.7326/0003-4819-147-7-200710020-00006
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Published: Ann Intern Med. 2007;147(7):478-491.
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