Amir Qaseem, MD, PhD, MHA; Timothy J. Wilt, MD, MPH; Robert M. McLean, MD; Mary Ann Forciea, MD; for the Clinical Guidelines Committee of the American College of Physicians *
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 All ACP clinical practice guidelines are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.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.
Financial Support: Financial support for the development of this guideline comes exclusively from the ACP operating budget.
Disclosures: Dr. McLean reports personal fees from Takeda Pharmaceuticals outside the submitted work and membership in the American College of Physicians Clinical Guidelines Committee and the American College of Rheumatology Quality of Care Committee. Dr. Barry reports grants, personal fees, and nonfinancial support from Healthwise outside the submitted work. Dr. Boyd reports other support from UpToDate outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-2367. All financial and intellectual disclosures of interest were declared and potential conflicts were discussed and managed. Dr. Manaker participated in the discussion for this guideline but was recused from voting on the recommendations because of an active indirect financial conflict. Dr. Kansagara participated in the discussion for this guideline but was recused from voting on the recommendations because of an inactive direct financial conflict. A record of disclosures of interest and management of conflicts of interest is kept for each Clinical Guidelines Committee meeting and conference call and can be viewed at www.acponline.org/clinical_information/guidelines/guidelines/conflicts_cgc.htm.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
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. Qaseem: American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106.
Dr. Wilt: Minneapolis VA Medical Center, VA Medical Center 111-0, Minneapolis, MN 55417.
Dr. McLean: Yale School of Medicine, 46 Prince Street, Suite 302, New Haven, CT 06519.
Dr. Forciea: Penn Health System, 3615 Chestnut Street, Philadelphia, PA 19104.
Author Contributions: Conception and design: A. Qaseem, R. McLean, M.J. Barry.
Analysis and interpretation of the data: A. Qaseem, T. Wilt, R. McLean, M.A. Forciea, C. Boyd, R.P. Harris, L.L. Humphrey, S. Vijan.
Drafting of the article: A. Qaseem, R. McLean, M.A. Forciea, T.D. Denberg.
Critical revision of the article for important intellectual content: A. Qaseem, T. Wilt, R. McLean, M.A. Forciea, T.D. Denberg, M.J. Barry, C. Boyd, R.D. Chow, R.P. Harris, L.L. Humphrey, S. Vijan.
Final approval of the article: A. Qaseem, T. Wilt, R. McLean, M.A. Forciea, T.D. Denberg, M.J. Barry, C. Boyd, R.D. Chow, N. Fitterman, R.P. Harris, L.L. Humphrey, S. Vijan.
Statistical expertise: A. Qaseem, T. Wilt.
Administrative, technical, or logistic support: A. Qaseem, T.D. Denberg.
Collection and assembly of data: R.P. Harris.
The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on noninvasive treatment of low back pain.
Using the ACP grading system, the committee based these recommendations on a systematic review of randomized, controlled trials and systematic reviews published through April 2015 on noninvasive pharmacologic and nonpharmacologic treatments for low back pain. Updated searches were performed through November 2016. Clinical outcomes evaluated included reduction or elimination of low back pain, improvement in back-specific and overall function, improvement in health-related quality of life, reduction in work disability and return to work, global improvement, number of back pain episodes or time between episodes, patient satisfaction, and adverse effects.
The target audience for this guideline includes all clinicians, and the target patient population includes adults with acute, subacute, or chronic low back pain.
Given that most patients with acute or subacute low back pain improve over time regardless of treatment, clinicians and patients should select nonpharmacologic treatment with superficial heat (moderate-quality evidence), massage, acupuncture, or spinal manipulation (low-quality evidence). If pharmacologic treatment is desired, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants (moderate-quality evidence). (Grade: strong recommendation)
For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation (low-quality evidence). (Grade: strong recommendation)
In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy. Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. (Grade: weak recommendation, moderate-quality evidence)
Table. The American College of Physicians Guideline Grading System*
Appendix Table 1. Pharmacologic and Nonpharmacologic Treatments for Acute or Subacute Low Back Pain
Appendix Table 2. Pharmacologic and Nonpharmacologic Treatments for Chronic Low Back Pain
Appendix Table 2. Continued
Appendix Table 3. Pharmacologic and Nonpharmacologic Treatments for Radicular Low Back Pain
Appendix Table 4. Adverse Events for Treatments for Acute, Chronic, and Radicular Low Back Pain
Summary of the American College of Physicians guideline on noninvasive treatments for acute, subacute, or chronic low back pain.
COX-2 = cyclooxygenase-2; LLLT = low-level laser therapy; NSAID = nonsteroidal anti-inflammatory drug; SMR = skeletal muscle relaxant.
The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.
Alain Braillon M.D., Ph.D
University Hospital, CEDEX
February 16, 2017
Acupuncture and low-back pain: an international bazar
The American College of Physicians (ACP) guideline on non-invasive treatments for low back pain recommending “complementary and alternative medicine therapies” (massage, acupuncture, or spinal manipulation)” while mentioning the “low-quality evidence” deserves comment.(1)First, the correct term is “Complementary and Alternative Practices” (CAP): medicine should be based on evidence. Adding “therapies” to practices which enduringly failed to show evidence of relevant effects creates an oxymoron.(2) For low back pain, endpoints are a decrease in pharmacological treatment, an increase in the odds of being at work, improved functional limitations or quality of life …Second, the recommendation ignored several old robust trials published in core clinical journals showing effectiveness of Cognitive Behavioral Therapies.(e.g. 3,4) The trial cited as reference 121 was prolonged, confirming improvements in pain and functional limitations at 26 weeks.(5)Third, in England, the National Institute for Health and Care Excellence specifically recommended acupuncture NOT be used for managing low back pain as evidence is lacking.(https://www.nice.org.uk/guidance/ng59) In Australia, Friends of Science in Medicine warned “There is already enough evidence to confidently conclude that acupuncture doesn’t work. It is merely a theatrical placebo based on pre-scientific myths”(www.scienceinmedicine.org.au/images/pdf/acupuncturereview.pdf) and showed advertising claims are grossly misleading lay people.(http://www.scienceinmedicine.org.au/images/pdf/ukasaletter.pdf)Patients need explanations and reassurance to promote autonomy, not to be given faith in weird practices. Several skills in the doctor-patient encounter are pivotal (take time, remove barriers, let the patient explain…), CAP cannot replace them, they only strengthen medical arrogance. Voltaire at his time (1694-1778) stated "The art of medicine consists in amusing the patient while nature cures the disease." In 2017 AD, why amusing patients with weird practices from BC and non-existing meridians? Last, acupuncture was excluded from the Imperial Medical Institute by a decree of the Emperor of China in 1822, being regarded as superstitious and irrational.1 Qaseem A, Wilt TJ1, McLean RM et al. Noninvasive treatments for acute, subacute, and chronic low back pain: A clinical practice guideline from the American College of Physicians. Ann Intern Med 2017. Online Feb 14. doi: 10.7326/M16-2367.2 Braillon A. Placebo and chronic low back pain: Too much in way of expectations, too little in terms of data. Pain 2017;158:535-536. 3 Cherkin DC, Sherman KJ, Balderson BH et al. Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: A randomized clinical trial. JAMA 2016;315:1240-9. 4 Lamb SE, Mistry D, Lall R et al. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet 2010;375:916-235 Cherkin DC, Sherman KJ, Balderson BH et al. Two-year follow-up of a randomized clinical trialof mindfulness-based stress reduction vs cognitive behavioral therapy or usual care for chronic low back pain. JAMA 2017:317:642-3.
Patient Advocate / Independent Scholar
February 22, 2017
Comment on ACP low back pain guideline
The College of Physician’s guideline for noninvasive treatments of low back pain (1) is logical and makes total sense, but I have a number of comments. I believe that the authors should have mentioned the cardiovascular (CV) risk factors associated with NSAIDs.(2-4) In the same vein, on page 11, the paper reads, “COX-2–selective NSAIDs…are associated with lower risk for adverse effects than nonselective NSAIDs.” This statement is not necessarily true and adverse events are dependent upon many elements including the specific NSAID and risk factor.(4) Rofecoxib is one example of a COX-2 selective NSAID with intolerable side effects that was pulled from the market.(5)The paper states under “Harms of Pharmacological Therapies,” that the harms were obtained from the reviews and admittedly there were no NSAID CV adverse events in the articles, but the authors raise potential harms of opioids under “Recommendation 3,” including addiction, abuse and overdose, and those adverse effects are also absent in the reviews. It’s important to be consistent and thus the CV risk factor for NSAIDs should have been added, along with a suggestion that clinicians evaluate their patient’s cardiovascular health prior to prescribing non-steroidal anti-inflammatories. Furthermore, I have posited that the onset of pain may trigger the unconscious animal brain to believe there is a direct threat to survival.(6) In nature, injured animals get eaten. Under Recommendation 1, the authors suggest the clinician provides social support through educating the patient about the positive prognosis, course of healing and staying active—all while using patient-centered care. This is excellent advice and may help to disarm any potential threat in the patient’s mind, conscious or unconscious. However, I wish the guideline had recommended consistent social support until the patient has recovered. There are a couple of reasons for this with the most important being to help prevent short-term low back pain from turning into long-term chronic pain. Individuals that catastrophize and/or are afraid to move their bodies may be vulnerable to this negative conversion and consistent support may help prevent it.(7-10) In addition, psycho-social elements can worsen one’s pain (11) and staying in touch with the patient may mitigate these negative influences. Although some clinicians may not be accustomed to providing social support, my experience as a patient advocate has taught me that most people just need reassurance that everything is going to be fine, and that they are not alone in their recovery from back pain.Mark CollenFounder, PainExhibit.orgEditorial Board Member, Journal of Pain & Palliative Care PharmacotherapyThe author declares no conflicts of interest.References(1) Qaseem A, Wilt TJ, McLean RM, Forciea MA. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of PhysiciansNoninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain. Ann Intern Med. 2017. [Epub ahead of print](2) McGettigan P, Henry D. Use of non-steroidal anti-inflammatory drugs that elevate cardiovascular risk: an examination of sales and essential medicines lists in low-, middle-, and high-income countries. PLoS Med. 2013;10:e1001388.(3) Bello AE, Holt RJ. Cardiovascular risk with non-steroidal anti-inflammatory drugs: clinical implications. Drug Saf. 2014;37:897-902.(4) Harirforoosh S, Asghar W, Jamali F. Adverse effects of nonsteroidal antiinflammatory drugs: an update of gastrointestinal, cardiovascular and renal complications. J Pharm Pharm Sci. 2014;16:821-847.(5) Berenson A, Gardiner H, Meier B, Pollack A. Despite warnings, drug giant took long path to Vioxx recall. New York Times. November 14, 2004. Available at: http://www.nytimes.com/2004/11/14/business/despite-warnings-drug-giant-took-long-path-to-vioxx-recall.html? Accessed February 21, 2017.(6) Collen M. Pain and treatment from a human primate perspective. J Pain Palliat Care Pharmacother. 2014;28:152-157.(7) Quartana PJ, Campbell CM, Edwards RR. Pain catastrophizing: a critical review. Expert Rev Neurother. 2009;9:745-758.(8) Smeets RJ, Vlaeyen JW, Kester AD, Knottnerus JA. Reduction of pain catastrophizing mediates the outcome of both physical and cognitive-behavioral treatment in chronic low back pain. J Pain. 2006;7:261-271.(9) O’Sullivan P. Diagnosis and classification of chronic low back pain disorders: maladaptive movement and motor control impairments as underlying mechanism. Man Ther. 2005;10:242-255.(10) Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007;30:77-94.(11) Hoogendoorn WE, van Poppel MN, Bongers PM, Koes BW, Bouter LM. Systematic review of psychosocial factors at work and private life as risk factors for back pain. Spine. 2000;25:2114-2125.
IVAN VUCINA MD
CLINICA LAS CONDES/U. DE CHILE
February 17, 2017
ABOUT GUIDELINE LOW BACK PAIN
Don't you believe that low back pain will have different treatments according to the cause can go since a muscular problem until osteoporotic fracture of the spine.
Donald R. Murphy, DC, FCC, Michael J. Schneider, DC, PhD, Christopher G. Bise, PT, MS, DPT, Brian Justice, DC
Alpert Medical School of Brown University
February 23, 2017
Low Back Pain Guideline: What is the Next Step?
Congratulations to the ACP on a job well done in synthesizing the literature on noninvasive treatments for low back pain (LBP). Several treatment approaches are identified for which evidence suggests effectiveness. As Atlas points out in his editorial (1), the next question becomes “what does the clinician do with this information?” We would like provide input from a clinical, operational and translational viewpoint. How does the primary care practitioner (PCP) use the information from the guideline when seeing a patient with LBP? Do they refer the patient for all recommended treatments? Do they refer the patient for each treatment one at a time until they land on one that helps? Do they provide a list of recommended treatments and allow the patient to choose? None of these are efficient options, in our view. We think this illustrates the need in spine care for a designated professional who is specially trained, skilled and experienced in evidence-based clinical reasoning to determine the best course of action for each individual patient. A professional who can, based on the unique clinical features in each patient, provide differential diagnosis, manage the majority without the need for referral and, when necessary, provide guidance regarding other noninvasive or invasive options. As the guideline points out, medications are not recommended as a first-line approach, so this professional need not be a medical physician. This role can be played by specially-trained chiropractors and physical therapists. We refer to this professional as the Primary Spine Practitioner (PSP) (2). An appropriately trained PSP can provide a clear, evidence-based explanation of the problem (the most important factor in patient satisfaction (3)) as well as evidence-based management that is tailored to each patient’s individual needs (2). The PSP can go beyond the general recommendations of a guideline to individualized care for each patient in a way that most PCPs are not well trained to do (4). PSP services have been implemented in several environments. Preliminary data suggest that these services are efficient and provide good outcomes and patient satisfaction at low cost (5). Provider satisfaction, particularly for the PCP, is high. A formal training and certification program for PSPs has been developed at the University of Pittsburgh. We anticipate that wide implementation of PSP services, particularly within an integrated spine care pathway (5), will be of great benefit to PCPs and, most important, to patients and the health care system. 1. Atlas SJ. Management of Low Back Pain: Getting From Evidence-Based Recommendations to High-Value Care. Annals of internal medicine. 2017. doi: 10.7326/M17-0293. PubMed PMID: 28192792.2. Murphy DR, Justice BD, Paskowski IC, Perle SM, Schneider MJ. The Establishment of a Primary Spine Care Practitioner and its Benefits to Health Care Reform in the United States. Chiropractic & manual therapies. 2011;19(1):17. PubMed PMID: 21777444.3. Verbeek J, Sengers M, Riemens L, Haafkens J. Patient expectations of treatment for back pain: a systematic review of qualitative and quantitative studies. Spine. 2004;29(20):2309-17.4. Goff I, Wise EM, Coady D, Walker D. Musculoskeletal training: are GP trainees exposed to the right case mix for independent practice? Clinical rheumatology. 2014. doi: 10.1007/s10067-014-2767-z. PubMed PMID: 25190366.5. Paskowski I, Schneider M, Stevans J, Ventura JM, Justice BD. A hospital-based standardized spine care pathway: report of a multidisciplinary, evidence-based process. Journal of manipulative and physiological therapeutics. 2011;34(2):98-106. PubMed PMID: 21334541.The authors declare no conflictsDonald R. Murphy, DC, FRCCMedical Director of Spine ProgramCare New England Health SystemClinical Assistant Professor, Department of Family MedicineAlpert Medical School of Brown University600 Pawtucket AvenuePawtucket, RI 02860 USADRMurphy@KentRI.orgMichael J. Schneider, DC, PhDAssociate Professor, Department of Physical TherapyUniversity of PittsburghBridgeside Point 1100 Technology Drive, Suite 210Pittsburgh, PA 15219-3130 USAmjs5@pitt.eduChristopher G. Bise PT, MS, DPT, OCSAssistant Professor, Department of Physical TherapyUniversity of PittsburghSchool of Health and Rehabilitation ScienceBridgeside Point 1100 Technology Drive, Suite 210Pittsburgh, PA 15219-3130 USAcbise@pitt.eduBrian Justice, DCMedical Director Pathway Development and Spine Care Excellus BlueCross BlueShield165 Court Street, Rochester, NY email@example.com
Donald M. Marcus, M.D.
Baylor College of Medicine
March 1, 2017
The Guideline (1) appropriately emphasizes the importance of nonpharmacologic therapies for back pain, which are underutilized, but the recommendation of a multiplicity of therapies supported by low to moderate evidence is confusing, Moreover, I disagree with the claim of moderate-quality of evidence for acupuncture. Placebos are very effective for relief of pain, and a number of sham procedures have been used as controls for traditional acupuncture. The preponderance of evidence from high-quality controlled trials is that there is there is no clinically relevant difference between sham and traditional acupuncture for relief of pain of knee osteoarthritis or back pain (2). The Guideline is based in part on the systematic review of Chou et al. (3), which states that five trials that were consistent with the efficacy of acupuncture could not be included in the review. However, two of those trial, references 66 and 67, found no specific efficacy for acupuncture beyond the sham procedure, as did two other trials that were not included in review, references 10 and 12 in (2). The control in the latter large trial was toothpicks in a plastic tube. The recommendation of acupuncture in the Guideline was cited by several medical websites that aggregate news and by the media, which may mislead healthcare providers and the public. Endorsing a placebo therapy violates professionalism standards requiring use of the best evidence in guiding practice, and in enabling patients to make informed decisions about therapy. The lack of rigor in evaluating acupuncture raises concerns about other therapies listed in Recommendation 2. The lack of truly effective pharmacologic or nonpharmacologic treatments for chronic low back pain is widely acknowledged. The compilation of many weakly effective, disparate therapies in the Guideline will do little to assist healthcare providers in making informed decisions, or for other purposes, including informing insurance coverage, quality of care evaluations, and medicolegal liability standards (4). References(1) Qaseem A, Wilt TJ, McLean RM, Forciea MA. Noninvasive treatments for acute, subacute and chronic low back pain: A clinical practice guideline from the American College of Physicians. Ann Intern Med 2017 doi:10.7326/M16-2367.(2) Marcus DM. Is acupuncture for pain a placebo treatment? An examination of the evidence. The Rheumatologist 2010; 4: 1, 28-35.(3) Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, et al. Nonpharmacologic theerrapies for low back pain: A systematic review for an American College of Physicians clinical practice guideline. Ann Int Med 2017: 166 doi10.7326/M16-2459.(4) Greenfield S. Clinical practice guidelines. Expanded use and misuse. JAMA 2017; 317: 594-5.
Lisa H Le, Robert G Badgett
University of Kansas School of Medicine-Wichita
March 6, 2017
Reassessment of benefit from tramadol
We are concerned about the Guideline’s recommendation of tramadol to be secondary line pharmacotherapy of chronic back pain. We acknowledge that the Guideline labels this recommendation as ‘weak’ and supported by ‘moderate’ evidence; however, we suggest tramadol should not be a recommendation at all as the underlying evidence rests on unregistered and short duration trials. We updated the Cochrane meta-analysis that the guideline’s recommendation is based on.(1) We completed the search for newer trials with a mix of methods. We subgrouped the trials based on whether they were registered prior to execution. Results are online at https://openMetaAnalysis.github.io/tramadol. Our findings suggest several biases. While there are insufficient trials to test for publication bias with a funnel plot, we found significant differences in results between registered and unregistered trials with benefit confined to unregistered trials. Unregistered trials may lead to inflated results due to both publication bias and selective reporting bias.(2,3) Two of the four unregistered trials reported selecting patients after an open-label run-in phase - which may also inflate results.(4) In addition, the short duration of these trials (the longest lasting 13 weeks) does not seem relevant to the treatment of a chronic disease. Finally, heterogeneity of overall results was substantial at 90%. Focusing on the subgroup of registered trials, we found no benefit from tramadol with 17% heterogeneity. Although the Guidelines describe the registered trial by Lee as showing benefit, this study is problematic.(5) According to the registration archives at ClinicalTrials.gov, the trial was registered after completion. The primary outcome according to ClinicalTrials.gov was “difference in pain intensity as measured on the Visual Analog Scale”. If this is interpreted as the mean change, that result is insignificant. If this interpreted as proportion responding, the authors omitted the randomized patients who dropped out. When we recalculate with an intention to treat analysis, the results are insignificant. We encourage others to use the data from this review to help evolve the assessment of tramadol for chronic therapy of back pain. References:1.Chaparro LE, Furlan AD, Deshpande A, Mailis-Gagnon A, Atlas S, Turk DC. Opioids compared to placebo or other treatments for chronic low-back pain. Cochrane Database Syst Rev. 2013 Aug 27;(8):CD004959. PMID: 239830112.Kaplan RM, Irvin VL. Likelihood of Null Effects of Large NHLBI Clinical Trials Has Increased over Time. PLoS One. 2015 Aug 5;10(8):e0132382. PMID: 262448683.Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004 May 26;291(20):2457-65. PMID: 151618964.Prasad V, Berger VW. Hard-Wired Bias: How Even Double-Blind, Randomized Controlled Trials Can Be Skewed From the Start. Mayo Clin Proc. 2015 Sep;90(9):1171-5. PMID: 262777025.Lee JH, Lee CS; Ultracet ER Study Group.. A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablet for the treatment of chronic low back pain. Clin Ther. 2013 Nov;35(11):1830-40. PMID: 24183364.
Amir Qaseem, MD, PhD, Scott Manaker, MD, PhD, Sandeep Vijan, MD
Ann Arbor VA, Univ of Pennsylvania, ACP
April 4, 2017
IN RESPONSE: We disagree with the comment from Dr. Braillon and Dr. Marcus questioning the efficacy of acupuncture. Although not all trials showed benefit (1), acupuncture versus sham needles showed a small beneficial effect on pain, with no evidence of an effect on function in acute low back pain and improvement in both pain an function in chronic low back pain; similar findings were shown even when compared to NSAIDs. However, we agree with the commenters that sustained benefit has not been demonstrated with acupuncture. We agree with Dr. Braillon regarding evidence of benefit with the use of cognitive behavioral therapy, and we recommend CBT in our guideline. We concur with Mr. Collen that there is both observational and meta-analytic evidence that suggests that NSAIDs may increase CV risk; however, as our review process is focused specifically on the setting of low back pain, we did not conduct independent evidence searches for the side effects of medications outside of the trials. This is an admitted limitation of our process and one that we will need to consider in future reviews. Mr. Collen also notes that psychosocial support is essential to throughout the recovery process and it likely might be the case, but the evidence review did not identify any such studies to support the recommendations.Dr. Vucina notes that low back pain has heterogeneous causes, and that treatment may vary. We agree this is likely, but rarely addressed by current trials; further, there is no agreement on clear methods to define the source of low back pain, as symptoms and imaging findings are rarely determinative. Dr. Murphy and colleagues advocate for “Primary Spine Practitioners (PSP)” to manage back pain. While we concur that the array of treatment options and the lack of head-to-head comparisons of these options makes choices difficult for physicians and patients, we would also comment that low back pain is so ubiquitous that training enough PSPs to care for back pain would be an undertaking of massive proportion. Ideally the options laid out in our guideline (2), along with the fact that most back pain is self-limited, would suffice for many patients, and rare referral would occur for more refractory cases.We appreciate the updated review conducted by Drs. Le and Badgett. Given their findings, we would agree that tramadol would likely not have been recommended as a treatment option for chronic low back pain. Sandeep Vijan, MD, MSAnn Arbor VA HSR&D CCMR, Ann Arbor, MI Scott Manaker, MD, PhDHospital of the University of Pennsylvania, Philadelphia, PA 19104Amir Qaseem, MD, PhD, MHAAmerican College of Physicians, Philadelphia, PennsylvaniaReferences1. Chou R, Deyo R, Friedly J, et al. Systemic pharmacologic therapies for low back pain: A systematic review for an American College of Physicians clinical practice guideline. Annals of Internal Medicine. 2017.2. Qaseem A, Wilt TJ, McLean RM, Forciea M, for the Clinical Guidelines Committee of the American College of P. Noninvasive treatments for acute, subacute, and chronic low back pain: A clinical practice guideline from the American College of Physicians. Annals of Internal Medicine. 2017.
Jeremy D. Whyman MD, Rosanne M. Leipzig MD, PhD
Brookdale Dept. of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai
April 24, 2017
We were pleased to see the ACP guideline on noninvasive treatments for low back pain in the April 4th, 2017 issue, however we were surprised there were no caveats on treatment of older adults nor discussion of the age of patients in the evidentiary trials.The stakes of improperly treated back pain may be high in older adults. Each year back pain is experienced by nearly 17 million people 65 years and older. Age > 75 years and osteoporosis are ‘red flags’ that can indicate a serious underlying pathology such as a vertebral fracture. Older adults with chronic low back pain have more difficulty performing everyday tasks and more depressive symptoms. They are also at greater risk of adverse effects from some of the first line medications recommended in the guideline.The use of NSAIDs in the elderly increases the risk of acute GI bleeds by a factor of 4. Although Proton Pump Inhibitors (PPIs) reduce this risk, PPIs are associated with increased bone loss, pneumonia and Clostridium Difficile in this population. Skeletal muscle relaxants are a ‘drug to avoid’ in the elderly (American Geriatrics Society 2015 Updated Beers Criteria) and have been associated with increased ED visits and hospitalization. Our challenge as clinicians caring for these adults is to alleviate their pain without causing more harm, including greater functional decline. In the future, we hope that ACP will consider a focus in their guidelines that helps clinicians address the complexity of low back pain in aging adults. Jeremy D. Whyman, MDPalliative Medicine and Geriatrics FellowBrookdale Dept. of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai Rosanne M. Leipzig MD, PhD Gerald and May Ellen Ritter ProfessorVice Chair, EducationBrookdale Dept. of Geriatrics and Palliative MedicineIcahn School of Medicine at Mount SinaiEnthoven WTM Geuze J, Scheele J et al. Prevalence and “Red Flags” regarding specific causes of back pain in older adults presenting in general practice. Physical Therapy 2016:96(3):305-312.Weiner DK, Haggerty CL., et al. How does low back pain impact physical function in independent, well-functioning older adults? Evidence from the Health ABC Cohort and implications for the future. Pain Med. 2003 Dec;4(4):311-20.Pilotto, Alberto, Franceschi, Marilisa, et al. The risk of upper gastrointestinal bleeding in elderly users of aspirin and other non-steroidal antiinflammatory drugs: The role of gastroprotective drugs. Aging Clinical and Experimental Research December 2003, Volume 15, Issue 6, pp 494–499.Kapadia A, Wynn Daisy, Salzman B, Potential Adverse Effects of Proton Pump Inhibitors in the Elderly. Clinical Geriatrics, July/August 2010.Alvarez, Carlos A., et al. Association of skeletal muscle relaxers and antihistamines on mortality, hospitalizations, and emergency department visits in elderly patients: a nationwide retrospective cohort study. BMC Geriatrics 2015.
Massage Therapy Graduate, Canada
May 16, 2017
Previous acupuncture recommendations are now being reconsidered by many prominent institutions. The NICE guideline for NHS patients in the U.K. now recommends against the use of acupuncture for low-back pain, following a high-quality review that critically examined the existing evidence regarding the use of acupuncture and found it to be no more effective than a placebo. The Toronto Hospital for Sick Children has also recently removed references on their website that suggested the efficacy of acupuncture in managing specific chronic pain conditions. The WHO has done the same, no longer suggesting that acupuncture is effective for low-back pain and sciatica. A review by the Friends of Science in Medicine association describing a lack of evidence of a therapeutic effect has been endorsed by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.As someone about to enter a field that is frequently associated with, or considered a part of, complementary healthcare, I know first-hand how misguided and overblown the claims and hopes of acupuncture’s efficacy can be. Such claims are generally based on small and probably unmeaningful effects taken selectively from the total evidence. I have often seen my own mentors and peers pushing for the use of acupuncture for many chronic and serious conditions for which there is no basis of evidence at all of acupuncture’s efficacy, including systemic, neurological, and developmental conditions. When questioned, they will usually refer to authorities perceived as “legitimate”, including the ACP, to say that claims of acupuncture “working” are backed by experts. We see a similar situation (as touched on in one of the comments above), with advertisers and media using the guise of “expert-backed” legitimization to recommend acupuncture in misleading ways, often to an audience of vulnerable people who could be making better-informed and more effective treatment and management choices for their conditions. Many of these entities specifically mention the ACP as lending credence to their claims, sometimes somewhat out of context.I hope that you will reconsider your recommendation of a practice that is simply not supported by the majority of the research evidence that exists to date. Patients with complex conditions, including low-back pain, deserve accurate and realistic information regarding their treatment options, especially from such trusted and reputable sources as the ACP.This comment is condensed from a longer open letter to the ACP that can be accessed, with further sourcing, via the reference below.MacGregor, A. (14 May 2017). Acupuncture for back pain: an open letter by a Canadian therapist. Retrieved from http://edzardernst.com/2017/05/acupuncture-for-back-pain-an-open-letter-by-a-canadian-therapist/
Daniel Pomerantz MD MPH FACP
Albert Einstein College of Medicine
June 5, 2017
Treatment failure is a treatment issue, not a patient issue
The guideline is generally useful and helpful; however, I wish the third recommendation had been phrase just a little differently.The language we use to talk about whether and how our treatment has, or has not, helped our patient can shape our thinking. Many authors have written about how the language we use can change the way we think. No one has written more trenchantly about this issue than George Orwell in his novel, 1984, and in his essay, 'Politics and the English Language.' The third recommendation from Qaseem, et al reads: Recommendation 3: In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy. Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. (Grade: weak recommendation, moderate-quality evidence). Right in the middle is the phrase, "in patients who have failed the aforementioned treatments." This phrase confuses the subject and predicate. The treatment has failed to help the patient. We should not blame the patient for "failing" to improve, but rather accept our responsibility for recommending, with good reason, a treatment which was intended to be helpful, but which has failed to improve our patient's condition. Our desire to linguistically offload responsibility to the patient is understandable, but pernicious, especially when we are considering whether to prescribe opioids for chronic pain. While the evidence for benefit is weak, there are some patients who do well with them, provided that we prescribe opioids responsibly, and continue to provide other forms of treatment and support for chronic back pain. If we label our patients as "failures," will we be less likely to consider prescribing opioids for them? I suspect that this habit of thinking of the patient having failed the treatment makes us less willing to consider opioids, even when other evidence might suggest a benefit. We should accept responsibility for our treatment failures, by clearly and consistently labeling the treatment, rather than the patient, as the failure.
Qaseem A, Wilt TJ, McLean RM, Forciea MA, for the Clinical Guidelines Committee of the American College of Physicians. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. ;166:514–530. doi: 10.7326/M16-2367
Download citation file:
Published: Ann Intern Med. 2017;166(7):514-530.
Published at www.annals.org on 14 February 2017
Back Pain, Guidelines, High Value Care, Neurology, Neuropathy.
Results provided by:
Copyright © 2019 American College of Physicians. All Rights Reserved.
Print ISSN: 0003-4819 | Online ISSN: 1539-3704
Conditions of Use