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Comparative Effectiveness Review Number 169
Noninvasive Treatments for Low Back Pain
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Comparative Effectiveness ReviewNumber 169
Noninvasive Treatments for Low Back Pain
Prepared for:
Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov
Contract No. 290-2012-00014-I
Prepared by:
Pacific Northwest Evidence-based Practice Center Portland, OR
Investigators:
Roger Chou, M.D., FACP Richard Deyo, M.D., M.P.H. Janna Friedly, M.D. Andrea Skelly, Ph.D., M.P.H. Robin Hashimoto, Ph.D. Melissa Weimer, D.O., M.C.R. Rochelle Fu, Ph.D. Tracy Dana, M.L.S. Paul Kraegel, M.S.W. Jessica Griffin, M.S. Sara Grusing, B.A. Erika Brodt, B.S.
AHRQ Publication No. 16-EHC004-EF February 2016
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This report is based on research conducted by the Pacific Northwest Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00014-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders.
AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.
This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report.
Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected].
Suggested citation: Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt E. Noninvasive Treatments for Low Back Pain. Comparative Effectiveness Review No. 169. (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No. 290-2012-00014-I.) AHRQ Publication No. 16-EHC004-EF. Rockville, MD: Agency for Healthcare Research and Quality; February 2016. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
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PrefaceThe Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. These reviews provide comprehensive, science-based information on common, costly medical conditions, and new health care technologies and strategies.
Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. In the context of developing recommendations for practice, systematic reviews can help clarify whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about AHRQ EPC systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm.
AHRQ expects that these systematic reviews will be helpful to health plans, providers, purchasers, government programs, and the health care system as a whole. Transparency and stakeholder input are essential to the Effective Health Care Program. Please visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an email list to learn about new program products and opportunities for input.
If you have comments on this systematic review, they may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, or by email to [email protected].
Richard G. Kronick, Ph.D. Director Agency for Healthcare Research and Quality
Stephanie Chang, M.D., M.P.H. Director Evidence-based Practice Center Program Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality
Arlene S. Bierman, M.D., M.S. Director Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality
Suchitra Iyer, Ph.D. Task Order Officer Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality
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Investigator AffiliationsRoger Chou, M.D., FACP Department of Medical Informatics & Clinical Epidemiology Oregon Health & Science University
Richard Deyo, M.D., M.P.H. Department of Family Medicine Oregon Health & Science University
Janna Friedly, M.D. Physical Medicine and Rehabilitation University of Washington
Andrea Skelly, Ph.D., M.P.H. Spectrum Research
Robin Hashimoto, Ph.D. Spectrum Research
Melissa Weimer, D.O., M.C.R. Department of Medicine Oregon Health & Science University
Rochelle Fu, Ph.D. Department of Public Health & Preventive Medicine Oregon Health & Science University
Tracy Dana, M.L.S. Department of Medical Informatics & Clinical Epidemiology Oregon Health & Science University
Paul Kraegel, M.S.W Department of Pharmacy University of Washington
Jessica Griffin, M.S. Department of Medical Informatics & Clinical Epidemiology Oregon Health & Science University
Sara Grusing, B.A. Department of Medical Informatics & Clinical Epidemiology Oregon Health & Science University
Erika Brodt, B.S. Spectrum Research
Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project: Leah Williams, B.S., for editorial support; our Task Order Officer, Suchitra Iyer, Ph.D., for her support and guidance in developing this report; and our Associate Editor, Timothy Carey, M.D., M.P.H., for his review of this report.
Key Informants In designing the study questions, the EPC consulted several Key Informants who represent the end-users of research. The EPC sought the Key Informant input on the priority areas for research and synthesis. Key Informants are not involved in the analysis of the evidence or the writing of the report. Therefore, in the end, study questions, design, methodological approaches, and/or conclusions do not necessarily represent the views of individual Key Informants.
Key Informants must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their role as end-users, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any conflicts of interest.
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The list of Key Informants who provided input to this report follows:
Thiru Annaswamy, M.D. Department of Physical Medicine & Rehabili-tation University of Texas Southwestern Medical Center Dallas, TX
Gert Bronfort, D.C., Ph.D. Neck and Back Research Program Northwestern Health Sciences University Bloomington, MN
Richard Deyo, M.D., M.P.H. Department of Family MedicineOregon Health & Science University Portland, OR
Julie M. Fritz, Ph.D., P.T., A.T.C. Research College of Health University of Utah Salt Lake City, UT
Scott Haldeman, M.D., Ph.D., D.C. Neurology University of California at Irvine Santa Ana, CA
Michael Jabbour, M.S., LAc New York State Acupuncture Coalition Forest Hills, NY
Peter Marshall, M.D. Minneapolis VA Medical Center Minneapolis, MN
Technical Expert PanelIn designing the study questions and methodology at the outset of this report, the EPC consulted several technical and content experts. Broad expertise and perspectives were sought. Divergent and conflicted opinions are common and perceived as healthy scientific discourse that results in a thoughtful, relevant systematic review. Therefore, in the end, study questions, design, methodologic approaches, and/or conclusions do not necessarily represent the views of individual technical and content experts.
Technical Experts must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential conflicts of interest identified.
The list of Technical Experts who provided input to this report follows:
Daniel Cherkin, M.S., Ph.D.* Group Health Research Institute Seattle, WA
Julie M. Fritz, Ph.D., P.T., A.T.C. Research College of Health University of Utah Salt Lake City, UT
Lee Glass, M.D.* Washington Department of Labor and Industries Olympia, WA
Christine Goertz, D.C., Ph.D.* Patient-Centered Outcomes Research Institute Washington, DC
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Rowland G. Hazard, M.D., FACP* Professor of Orthopedics and Medicine Giesel School of Medicine at Dartmouth Lebanon, NH
W. Michael Hooten, M.D. Mayo Clinic Rochester, MN
Partap S. Khalsa, D.C., Ph.D.* National Center for Complementary and Integrative Health National Institutes of Health Bethesda, MD
Kurt Kroenke, M.D., M.A.C.P. Indiana University Center for Health Services and Outcomes Research Indianapolis, IN Robert McLean, M.D. Hospital of Saint Raphael New Haven, CT
Gavril Pasternak, M.D., Ph.D.* Memorial Sloan Kettering Cancer Center New York, NY
Judith Turner, Ph.D.* University of Washington Seattle, WA
Timothy Wilt, M.D., M.P.H.* VA Medical Center Minneapolis, MN
*Provided comments on draft report.
Peer ReviewersPrior to publication of the final evidence report, EPCs sought input from independent Peer Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the scientific literature presented in this report do not necessarily represent the views of individual reviewers.
Peer Reviewers must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential nonfinancial conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential nonfinancial conflicts of interest identified.
The list of Peer Reviewers follows:
Steven Atlas, M.D. Massachusetts General Hospital Boston, MA
John Mayer, D.C., Ph.D. University of South Florida Tampa, FL
Kathryn Mueller, M.D., M.P.H. Environmental and Occupational Health Colorado School of Public Health Aurora, CO
Karen Sherman, Ph.D., M.P.H. Group Health Research Institute Seattle, WA
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Noninvasive Treatments for Low Back Pain
Structured AbstractObjectives. Low back pain is common, and many pharmacological and nonpharmacological therapies are available. This review examines the evidence on the comparative benefits and harms of noninvasive treatments for low back pain.
Data sources. A prior systematic review (searches through October 2008), electronic databases (Ovid MEDLINE® and the Cochrane Libraries, January 2008 to April 2015), reference lists, and clinical trials registries.
Review methods. Using predefined criteria, we selected systematic reviews of randomized trials of pharmacological treatments (acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], opioids, skeletal muscle relaxants, benzodiazepines, antidepressants, antiseizure medications, and systemic corticosteroids) and nonpharmacological treatments (psychological therapies, multidisciplinary rehabilitation, spinal manipulation, acupuncture, massage, exercise and related therapies, and various physical modalities) for nonradicular or radicular low back pain that addressed effectiveness or harms versus placebo, no treatment, usual care, a sham therapy, an inactive therapy, or another active therapy. We also included randomized trials that were not in systematic reviews. The quality of included studies was assessed, data were extracted, and results were summarized qualitatively based on the totality of the evidence.
Results. Of the 2,545 citations identified at the title and abstract level, a total of 156 publications were included. Most trials enrolled patients with pain symptoms of at least moderate intensity (e.g., >5 on a 0- to 10-point numeric rating scale for pain). Across interventions, pain intensity was the most commonly reported outcome, followed by back-specific function. When present, observed benefits for pain were generally in the small (5 to 10 points on a 0- to 100-point visual analog scale or 0.5 to 1.0 points on a 0- to 10-point numeric rating scale) to moderate (10 to 20 points) range. Effects on function were generally smaller than effects on pain; in some cases, there were positive effects on pain but no effects on function, and fewer studies measured function than pain. Benefits were mostly measured at short-term followup. For acute low back pain, evidence suggested that NSAIDs (strength of evidence [SOE]: low to moderate), skeletal muscle relaxants (SOE: moderate), opioids (SOE: low), exercise (SOE: low), and superficial heat (SOE: moderate) are more effective than placebo, no intervention, or usual care, and that acetaminophen (SOE: low) and systemic corticosteroids (SOE: low) are no more effective than placebo. For chronic low back pain, effective therapies versus placebo, sham, no treatment, usual care, or wait list are NSAIDs, opioids, tramadol, duloxetine, multidisciplinary rehabilitation, acupuncture, and exercise (SOE: moderate) and benzodiazepines, psychological therapies, massage, yoga, tai chi, and low-level laser therapy (SOE: low); spinal manipulation was as effective as other active interventions (SOE: moderate). Few trials evaluated the effectiveness of treatments for radicular low back pain, but the available evidence found that benzodiazepines, corticosteroids, traction, and spinal manipulation were not effective or were associated with small effects (SOE: low). Relatively few trials directly compared the effectiveness of different medications or different nonpharmacological therapies, or compared pharmacological versus nonpharmacological therapies, and they generally found no clear differences in effects.
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Pharmacological therapies were associated with increased risk of adverse events versus placebo (SOE: low to moderate). Trials were not designed or powered to detect serious harms from pharmacological therapies. Although rates appeared to be low and there was not an increased risk of serious harms versus placebo, this does not rule out significant risk from some treatments. For nonpharmacological therapies, assessment of harms was suboptimal, but serious harms appeared to be rare (SOE: low).
Conclusions. A number of pharmacological and nonpharmacological noninvasive treatments for low back pain are associated with small to moderate, primarily short-term effects on pain versus placebo, sham, wait list, or no treatment. Effects on function were generally smaller than effects on pain. More research is needed to understand optimal selection of treatments, effective combinations and sequencing of treatments, effectiveness of treatments for radicular low back pain, and effectiveness on outcomes other than pain and function.
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ContentsExecutive Summary ........................................................................................................................... ES-1Introduction ................................................................................................................................ 1 Background ............................................................................................................................................. 1 Nature and Burden of Low Back Pain ............................................................................................... 1 Interventions For Low Back Pain ...................................................................................................... 1 Rationale For Evidence Review ......................................................................................................... 2 Scope of Review and Key Questions ................................................................................................... 2 PICOTS ................................................................................................................................................. 3 Analytic Framework ............................................................................................................................ 5Methods ....................................................................................................................................... 6 Topic Refinement and Review Protocol .............................................................................................. 6 Literature Search Strategy ..................................................................................................................... 6 Study Selection ....................................................................................................................................... 7 Population and Condition of Interest ............................................................................................... 7 Interventions and Comparisons ........................................................................................................ 7 Outcomes, Timing, and Setting ......................................................................................................... 8 Study Designs ....................................................................................................................................... 8 Data Extraction and Data Management ............................................................................................. 9 Assessing Methodological Quality of Individual Studies ................................................................. 9 Assessing Applicability ........................................................................................................................ 10 Evidence Synthesis and Rating the Body of Evidence ..................................................................... 12 Grading the Strength of Evidence for Each Key Question ............................................................. 12 Peer Review and Public Commentary............................................................................................... 13Results ........................................................................................................................................ 14 Results of Literature Searches ............................................................................................................. 16 Key Question 1. What are the comparative benefits and harms of different pharmacological
therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Includes NSAIDs, acetaminophen, opioids, muscle relaxants, antiseizure medications, antidepressants, corticosteroids, and topical/patch-delivered medications ................................. 16
Acetaminophen.................................................................................................................................. 16 NSAIDs ............................................................................................................................................... 18 Opioids, Tramadol, and Tapentadol................................................................................................ 22 Skeletal Muscle Relaxants ................................................................................................................. 28 Benzodiazepines ................................................................................................................................ 31 Antidepressants.................................................................................................................................. 33 Antiseizure Medications ................................................................................................................... 36 Corticosteroids................................................................................................................................... 41 Topical Medications .......................................................................................................................... 43
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Key Question 2. What are the comparative benefits and harms of different nonpharmacological noninvasive therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Includes but is not limited to multidisciplinary rehabilitation, exercise (various types), physical modalities (ultrasound, transcutaneous electrical nerve stimulation, electrical muscle stimulation, interferential therapy, heat [various forms], and ice), traction tables/devices, back supports/bracing, spinal manipulation, various psychological therapies, acupuncture, massage therapy (various types), yoga, magnets, and low-level lasers. ................ 43
Exercise and Related Interventions: Exercise ................................................................................ 44 Exercise and Related Interventions: Pilates .................................................................................... 54 Exercise and Related Interventions: Tai Chi .................................................................................. 55 Exercise and Related Interventions: Yoga ...................................................................................... 57 Psychological Therapies .................................................................................................................... 60 Multidisciplinary Rehabilitation ..................................................................................................... 66 Acupuncture ....................................................................................................................................... 71 Massage ............................................................................................................................................... 76 Spinal Manipulation .......................................................................................................................... 80 Physical Modalities: Ultrasound ...................................................................................................... 87 Physical Modalities: Transcutaneous Electrical Nerve Stimulation ........................................... 91 Physical Modalities: Electrical Muscle Stimulation ...................................................................... 93 Physical Modalities: Percutaneous Electrical Nerve Stimulation ............................................... 95 Physical Modalities: Interferential Therapy ................................................................................... 98 Physical Modalities: Superficial Heat or Cold ............................................................................. 100 Low-Level Laser Therapy ............................................................................................................... 103 Short-Wave Diathermy ................................................................................................................... 107 Lumbar Supports ............................................................................................................................. 108 Traction ............................................................................................................................................. 111 Taping ................................................................................................................................................ 114Discussion ................................................................................................................................ 204 Key Findings and Strength of Evidence .......................................................................................... 204 Findings in Relationship to What Is Already Known ................................................................... 207 Applicability ........................................................................................................................................ 210 Implications for Clinical and Policy Decisionmaking .................................................................. 211 Limitations of the Review Process ................................................................................................... 212 Limitations of the Evidence Base ..................................................................................................... 213 Research Gaps..................................................................................................................................... 214Conclusions ............................................................................................................................. 242References ................................................................................................................................ 243Abbreviations .......................................................................................................................... 273TablesTable A. Pharmacological therapies versus placebo for acute low back pain ............................... ES-8Table B. Pharmacological therapies versus active comparators for acute low back pain ............ ES-8Table C. Pharmacological therapies versus placebo for chronic low back pain ........................... ES-9Table D. Pharmacological therapies versus active comparators for chronic low back pain ....... ES-9Table E. Pharmacological therapies versus placebo for radicular low back pain ....................... ES-10
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Table F. Nonpharmacological treatments versus sham, no treatment, or usual care for acute or subacute low back pain.................................................................................................................. ES-11
Table G. Nonpharmacological treatments versus sham, no treatment, or usual care for chronic low back pain ......................................................................................................................................... ES-11
Table H. Nonpharmacological treatments versus active comparators for chronic low back pain .................................................................................................................................................. ES-13
Table I. Summary of evidence ........................................................................................................... ES-15Table 1. Summary of systematic reviews of pharmacological treatments for low back pain ....... 117Table 2. Characteristics and conclusions of included acetaminophen trials .................................. 121Table 3. Characteristics and conclusions of included NSAID trials ................................................ 122Table 4. Characteristics and conclusions of included opioid trials .................................................. 124Table 5. Characteristics and conclusions of included skeletal muscle relaxant trials .................... 126Table 6. Characteristics and conclusions of included benzodiapine trials...................................... 127Table 7. Characteristics and conclusions of included antidepressant trials .................................... 128Table 8. Characteristics and conclusions of included antiseizure trials .......................................... 132Table 9. Characteristics and conclusions of included corticosteroid trials ..................................... 136Table 10. Summary of systematic reviews of nonpharmacological treatments for low
back pain ............................................................................................................................................. 138Table 11. Characteristics and conclusions of included exercise trials ............................................. 148Table 12. Characteristics and conclusions of included tai chi trials ................................................ 162Table 13. Characteristics and conclusions of included yoga trials ................................................... 164Table 14. Characteristics and conclusions of included psychological therapy trials ..................... 166Table 15. Characteristics and conclusions of included multidisciplinary rehabilitation trials .... 170Table 16. Characteristics and conclusions of included acupuncture trials ..................................... 172Table 17. Characteristics and conclusion s of included massage trials ............................................ 174Table 18. Characteristics and conclusions of included spinal manipulation trials ........................ 176Table 19. Characteristics and conclusions of included ultrasound trials ........................................ 180Table 20. Characteristics and conclusions of included transcutaneous electrical nerve stimulation
(TENS) trials ....................................................................................................................................... 183Table 21. Characteristics and conclusions of included electrical muscle stimulation trials ......... 185Table 22. Characteristics and conclusions of included percutaneous electrical nerve
stimulation (PENS) trials .................................................................................................................. 189Table 23. Characteristics and conclusions of included interferential therapy trials ...................... 191Table 24. Characteristics and conclusions of included superficial heat or cold trials ................... 192Table 25. Characteristics and conclusions of included low-level laser therapy trials .................... 194Table 26. Characteristics and conclusions of included diathermy trials ......................................... 197Table 27. Characteristics and conclusions of included lumbar supports trials .............................. 198Table 28. Characteristics and conclusions of included traction trials ............................................. 200Table 29. Characteristics and conclusions of included taping trials ................................................ 201Table 30. Summary of evidence ............................................................................................................ 213Table 31. Pharmacological therapies versus placebo for acute low back pain ................................ 235Table 32. Pharmacological therapies versus active comparators for acute low back pain ............ 235Table 33. Nonpharmacological treatments versus sham, no treatment, or usual care for acute or
subacute low back pain...................................................................................................................... 235
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Table 34. Nonpharmacological treatments versus active comparators for acute or subacute low back pain ............................................................................................................................................. 236
Table 35. Pharmacological therapies versus placebo for chronic low back pain ............................ 237Table 36. Pharmacological therapies versus active comparators for chronic low back pain ........ 237Table 37. Nonpharmacological treatments versus sham, no treatment, or usual care for chronic
low back pain ...................................................................................................................................... 238Table 38. Nonpharmacological treatments versus active comparators for chronic low back
pain ...................................................................................................................................................... 240Table 39. Pharmacological therapies versus placebo for radicular low back pain ......................... 241Table 40. Nonpharmacological treatments versus sham, no treatment, or usual care for radicular
low back pain ...................................................................................................................................... 241Table 41. Nonpharmacological treatments versus active comparators for radicular low back
pain ...................................................................................................................................................... 241FiguresFigure A. Analytic framework ............................................................................................................ ES-3Figure 1. Analytic framework ................................................................................................................... 5Figure 2. Literature flow diagram ........................................................................................................... 14Appendixes Appendix A. Search StrategiesAppendix B. Inclusion and Exclusion CriteriaAppendix C. Included StudiesAppendix D. Excluded StudiesAppendix E. Data AbstractionAppendix F. Quality AssessmentAppendix G. Outcome MeasuresAppendix H. Strength of EvidenceAppendix I. Abbreviations Used in the Appendixes
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Executive Summary
Background
Nature and Burden of Low Back PainLow back pain is one of the most frequently encountered conditions in clinical practice. Up
to 84 percent of adults have low back pain at some time in their lives, and over one-quarter of U.S. adults report recent (in the last 3 months) low back pain.1,2 Low back pain can have major adverse impacts on quality of life and function. Low back pain is also costly: total U.S. health care expenditures for low back pain in 1998 were estimated at $90 billion.3 Since that time, costs of low back pain care have risen at a rate higher than observed for overall health expenditures.4 In addition to high direct costs, low back pain is one of the most common reasons for missed work or reduced productivity while at work, resulting in high indirect costs.5
The prognosis for acute low back pain (generally defined as an episode lasting less than 4 weeks) is generally favorable. Most patients experience a rapid improvement in (and often a complete resolution of) pain and disability, and are able to return to work.6 In those with persistent symptoms, continued improvement is often seen in the subacute phase between 4 and 12 weeks, although at a slower rate than observed at first. In a minority of patients, low back pain lasts longer than 12 weeks, at which point it is considered chronic; levels of pain and disability often remain relatively constant thereafter.7 Recently, a National Institutes of Health Research Task Force defined chronic low back pain as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months.8 Patients with chronic back pain account for the bulk of the burdens and costs of low back pain.9,10 Predictors of chronicity are primarily related to psychosocial factors, such as presence of psychological comorbidities, maladaptive coping strategies (e.g., fear avoidance [avoiding activities because of fears that they will further damage the back] or catastrophizing [anticipating the worst possible outcomes from low back pain]), presence of nonorganic signs (symptoms without a distinct anatomical or physiological basis),11 high baseline functional impairment, and low general health status.7 Back pain is frequently associated with presence of depression and anxiety.
Attributing symptoms of low back pain to a specific disease or spinal pathology is a challenge.12 Spinal imaging abnormalities, such as degenerative disc disease, facet joint arthropathy, and bulging or herniated intervertebral discs, are extremely common in patients with or without low back pain, particularly in older adults, and such findings are poor predictors for the presence or severity of low back pain.13 Radiculopathy from nerve root impingement (often due to a herniated intervertebral disc) and radiculopathy from spinal stenosis (narrowing of the spinal canal) are each present in about 4 to 5 percent of patients with low back pain and can cause neurological symptoms, such as lower extremity pain, paresthesias, and weakness; the natural history and response to treatment for these conditions may differ from back pain without neurologic involvement.14
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Interventions for Low Back PainMultiple treatment options for acute and chronic low back pain are available. Broadly, these
can be classified as pharmacological treatments,15 noninvasive nonpharmacological treatments,16 injection therapies,17 and surgical treatments.18 This report focuses on the comparative benefits and harms of pharmacological and noninvasive nonpharmacological treatments; each of these categories encompasses a number of different therapies. Pharmacological treatments include nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, opioids, muscle relaxants, antiseizure medications, antidepressants, and corticosteroids; nonpharmacological treatments include exercise and related interventions (e.g., yoga), complementary and alternative therapies (e.g., spinal manipulation, acupuncture, and massage), psychological therapies (e.g., cognitive-behavioral therapy, relaxation techniques, and multidisciplinary rehabilitation), and physical modalities (e.g., traction, ultrasound, transcutaneous electrical nerve stimulation [TENS], low-level laser therapy, interferential therapy, superficial heat or cold, back supports, and magnets).
Scope of Review and Key QuestionsThe provisional Key Questions; populations, interventions, comparators, outcomes, timing,
settings, and study designs (PICOTS); and analytic framework for this topic (Figure A) were posted on the Agency for Healthcare Research and Quality (AHRQ) Web site for public comment from December 17, 2013, through January 17, 2014.
Key Question 1. What are the comparative benefits and harms of different pharmacological therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Includes NSAIDs, acetaminophen, opioids, muscle relaxants, antiseizure medications, antidepressants, corticosteroids, and topical/patch-delivered medications.
Key Question 2. What are the comparative benefits and harms of different nonpharmacological noninvasive therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Includes but is not limited to multidisciplinary rehabilitation, exercise (various types), physical modalities (ultrasound, transcutaneous electrical nerve stimulation, electrical muscle stimulation, interferential therapy, heat [various forms], and ice), traction tables/devices, back supports/bracing, spinal manipulation, various psychological therapies, acupuncture, massage therapy (various types), yoga, magnets, and low-level lasers.
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Figure A. Analytic framework
*Patient characteristics include clinical, demographic, and psychosocial risk factors associated with low back pain outcomes.
†Intermediate outcomes (e.g., inflammation) are typically not measured.
KQ = Key Question.
MethodsThis Comparative Effectiveness Review follows the methods suggested in the AHRQ
“Methods Guide for Effectiveness and Comparative Effectiveness Reviews” (hereafter, “AHRQ Methods Guide”).19 Our methods are summarized in this section; for additional details, see the review protocol posted on the AHRQ Effective Health Care Program Web site (www.effectivehealthcare.ahrq.gov).
Literature Search and SelectionA research librarian conducted searches in Ovid MEDLINE®, the Cochrane Central Register
of Controlled Trials, and the Cochrane Database of Systematic Reviews through August 2014. We restricted search start dates to January 2008 because searches in a prior American Pain Society/American College of Physicians (APS/ACP) review were conducted through October 2008; the APS/ACP review was used to identify studies published prior to 2008.20 For interventions not addressed in the APS/ACP review, we searched the same databases without a search date start restriction. We also hand searched the reference lists of relevant studies and searched for unpublished studies in ClinicalTrials.gov. Scientific information packets were solicited from drug and device manufacturers, and a notice published in the Federal Register invited interested parties to submit relevant published and unpublished studies. We conducted an update search in April 2015 using the same search strategy as in the original search.
We developed criteria for inclusion and exclusion of studies based on the Key Questions and PICOTS. Abstracts were reviewed by two investigators, and all citations deemed potentially
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appropriate for inclusion by at least one of the reviewers were retrieved. Two investigators then independently reviewed all full-text articles for final inclusion. Discrepancies were resolved by discussion and consensus.
Population and condition of interest. This report focuses on adults with low back pain of any duration (categorized as acute [
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comparison, and results), methods of quality assessment, quality ratings for included studies, methods for synthesis, and results. For primary studies not included in systematic reviews, we abstracted the following data: study design, year, setting, country, sample size, eligibility criteria, population and clinical characteristics, intervention characteristics, and results. Information relevant for assessing applicability was also abstracted, including the characteristics of the population, interventions, and care settings; the use of run-in or washout periods; and the number of patients enrolled relative to the number assessed for eligibility. All study data were verified for accuracy and completeness by a second team member.
Risk-of-Bias Assessment of Individual StudiesTwo investigators independently assessed quality (risk of bias) of systematic reviews and
primary studies not included in systematic reviews using predefined criteria, with disagreements resolved by consensus. Randomized trials were evaluated using criteria and methods developed by the Cochrane Back Review Group,24 and cohort studies were evaluated using criteria developed by the U.S. Preventive Services Task Force.25 Systematic reviews were assessed using the AMSTAR quality rating instrument.22 These criteria and methods were used in conjunction with the approach recommended in the AHRQ Methods Guide.21 Studies were rated as good, fair, or poor. We re-reviewed the quality ratings of studies included in the prior APS/ACP review to ensure consistency in quality assessment.23
For primary studies included in systematic reviews, we relied on the quality ratings or risk-of-bias assessments performed in the systematic reviews as long as they used a standardized method for assessing quality (e.g., Cochrane Back Review Group, Cochrane Risk of Bias tool, PEDro [Physiotherapy Evidence Database] tool). If we were uncertain about the methods used to assess risk of bias or quality, we assessed the quality of individual studies ourselves, using the methods described previously.
We did not exclude studies rated poor quality a priori, but they were considered the least reliable when synthesizing the evidence, particularly when discrepancies among studies were present.
Data SynthesisWe synthesized data qualitatively, based on the totality of evidence (i.e., evidence included
in the prior APS/ACP review plus new evidence). We synthesized results for continuous as well as dichotomous outcomes. We reported binary outcomes based on the proportion of patients achieving successful pain reduction, improvement in function, or some composite overall measure of success as defined in the trials, which varied in how they categorized successful outcomes.
In addition, we reported meta-analysis from systematic reviews that reported pooled estimates from studies that were judged to be homogeneous enough to provide a meaningful combined estimate and used appropriate pooling methods (e.g., random-effects model in the presence of statistical heterogeneity). When statistical heterogeneity was present, we examined the type of inconsistency present and evaluated subgroup and sensitivity analyses based on
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study characteristics, intervention factors, and patient factors. We did not conduct updated meta-analysis with new studies. Rather, we qualitatively examined whether results of new studies were consistent with pooled or qualitative findings from prior systematic reviews. When we included more than one systematic review for a particular intervention and comparison, we evaluated the consistency of results among reviews.
We assessed the strength of evidence (i.e., evidence in prior reviews as well as new evidence) for each Key Question and outcome using the approach described in the AHRQ Methods Guide19 based on the overall quality of each body of evidence.
ResultsDatabase searches resulted in 2,545 potentially relevant articles. After dual review of
abstracts and titles, 1,310 articles were selected for full-text dual review; 156 publications were determined to meet inclusion criteria and were included in this review.
Most trials were conducted in patients with nonradicular low back pain or mixed populations with primarily nonradicular low back pain. Some trials enrolled mixed populations of patients with acute and subacute symptoms, with few trials restricted to patients with subacute low back pain. Therefore, acute and subacute low back pain were grouped together when summarizing findings. Pain was the most commonly reported outcome in the trials, followed by function, with evidence on other efficacy outcomes generally too limited to reach reliable conclusions. In addition, most trials focused on short-term outcomes, frequently with followup limited to the active treatment period. Assessment and reporting of harms were suboptimal, particularly for the nonpharmacological therapies. Summarizing evidence on nonpharmacological therapies was also complicated by variability in the techniques used; in the number, length, and intensity of sessions; and in the duration of treatment. Common methodological shortcomings included failure to report randomization or allocation concealment methods, unblinded or unclearly blinded design, and high or unclear attrition.
Key Question 1. Pharmacological TherapiesFor acute or subacute low back pain, NSAIDs, opioids (buprenorphine patch), and skeletal
muscle relaxants were associated with small effects on pain versus placebo, and NSAIDs were associated with small effects on function (Table A). Acetaminophen and systemic corticosteroids were associated with no beneficial effects versus placebo. Head-to-head comparisons were limited but indicated no clear differences between acetaminophen versus NSAIDs or between different NSAIDs (Table B).
For chronic low back pain, NSAIDs and tramadol were associated with moderate effects on pain versus placebo, and opioids, duloxetine, and benzodiazepines were associated with small effects (Table C). Effects on function were small for NSAIDs, opioids, tramadol, and duloxetine. Tricyclic antidepressants were not associated with beneficial effects, and there was insufficient evidence to determine effects of gabapentin or pregabalin. Head-to-head comparisons were limited but showed no clear differences between different NSAIDs, different long-acting opioids, or long-acting versus short-acting opioids. Evidence was too inconsistent to determine effects of opioids versus NSAIDs (Table D).
-
ES-7
Evidence on effects of pharmacological therapies for radiculopathy was extremely limited (Table E). There were no differences in pain or function between systemic corticosteroids versus placebo, and evidence was insufficient to determine effects of gabapentin or pregabalin.
Pharmacological therapies were associated with an increased risk of adverse events versus placebo. However, serious harms were rare in clinical trials, with no clear increase in risk based on clinical trials. In particular, trials of opioids were not designed to assess for serious harms, such as overdose, abuse, and addiction. Such harms have been reported in observational studies of opioids for chronic pain, although such studies did not meet inclusion criteria because they were not restricted to patients with low back pain.26
Key Question 2. Nonpharmacological Noninvasive TherapiesEvidence on the effectiveness of nonpharmacological therapies for acute low back pain was
limited. There was limited evidence that spinal manipulation, heat, massage, and low-level laser therapy are associated with some beneficial effects versus a sham therapy, no intervention, or usual care (Table F). Effects on pain or function were moderate for exercise, massage, and heat, and otherwise small.
For chronic low back pain, a number of nonpharmacological therapies appear to be effective for improving pain or function (Table G). These include exercise, yoga, and tai chi; various psychological therapies; multidisciplinary rehabilitation; acupuncture; spinal manipulation (vs. an inert treatment); and low-level laser therapy. Effects were small to moderate in magnitude. Other physical modalities were not associated with beneficial effects, or evidence was insufficient to estimate effects. Based on head-to-head comparisons, multidisciplinary rehabilitation was associated with small to moderate beneficial effects on pain and function versus standard physical therapy, and spinal manipulation and massage were associated with small beneficial effects versus other active interventions (Table H). There was no strong evidence of differences in effectiveness among different exercise, massage, spinal manipulation, or acupuncture techniques, or among different types of psychological therapies.
Assessment and reporting of harms for nonpharmacological therapies were suboptimal but indicated no serious harms. Reported harms were generally related to superficial symptoms at the application site or a temporary increase in pain.
-
ES-8
Tabl
e A
. Pha
rmac
olog
ical
ther
apie
s ve
rsus
pla
cebo
for a
cute
low
bac
k pa
in
Dru
gPa
in: M
agni
tude
of
Effe
ctPa
in: E
vide
nce
Pain
: SO
EFu
nctio
n:
Mag
nitu
de o
f Effe
ctFu
nctio
n:
Evid
ence
Func
tion:
SO
EA
ceta
min
ophe
nN
o ef
fect
1 R
CT
Low
No
effe
ct1
RC
TLo
wN
SA
IDs
Sm
all (
pain
inte
nsity
); no
ef
fect
(pai
n re
lief)
1 S
R (4
RC
Ts)
Mod
erat
eS
mal
l2
RC
TsLo
w
Opi
oids
(bup
reno
rphi
ne
patc
h)S
mal
l2
RC
TsLo
wN
o ev
iden
ce--
--
Ske
leta
l mus
cle
rela
xant
sP
ain
relie
f: R
R, 1
.72
(95%
CI,
1.32
to 2
.22)
at 5
–7 d
ays
1 S
R (3
RC
Ts) +
1
RC
TM
oder
ate
No
evid
ence
----
Ben
zodi
azep
ines
Una
ble
to e
stim
ate
2 R
CTs
Insu
ffici
ent
Una
ble
to e
stim
ate
2 R
CTs
Insu
ffici
ent
Ant
isei
zure
med
icat
ions
No
evid
ence
----
No
evid
ence
----
Sys
tem
ic c
ortic
oste
roid
sN
o ef
fect
2 R
CTs
Low
No
effe
ct2
RC
TsLo
wC
I =
con
fide
nce
inte
rval
; NS
AID
= n
onst
eroi
dal a
nti-
infl
amm
ator
y dr
ug; R
CT
= r
ando
miz
ed c
ontr
olle
d tr
ial;
RR
= r
elat
ive
risk
; SO
E =
str
engt
h of
evi
denc
e; S
R =
sys
tem
atic
re
view
.
Tabl
e B
. Pha
rmac
olog
ical
ther
apie
s ve
rsus
act
ive
com
para
tors
for a
cute
low
bac
k pa
in
Dru
gPa
in: M
agni
tude
of
Effe
ctPa
in: E
vide
nce
Pain
: SO
EFu
nctio
n:
Mag
nitu
de o
f Effe
ctFu
nctio
n:
Evid
ence
Func
tion:
SO
EA
ceta
min
ophe
n vs
. NS
AID
Una
ble
to e
stim
ate
1 R
CT
Insu
ffici
ent
Una
ble
to e
stim
ate
1 R
CT
Insu
ffici
ent
NS
AID
vs.
NS
AID
No
diffe
renc
e6
RC
TsM
oder
ate
----
--O
pioi
d vs
. NS
AID
Una
ble
to e
stim
ate
(inco
nsis
tent
)3
RC
TsIn
suffi
cien
tN
o di
ffere
nce
1 R
CT
Insu
ffici
ent
Long
-act
ing
opio
id v
s. lo
ng-a
ctin
g op
ioid
No
clea
r diff
eren
ce4
RC
TsM
oder
ate
No
clea
r diff
eren
ce4
RC
TsM
oder
ate
Long
-act
ing
opio
id v
s. s
hort-
actin
g op
ioid
No
clea
r diff
eren
ce*
6 R
CTs
Low
----
--
Ben
zodi
azep
ine
(dia
zepa
m) v
s.
skel
etal
mus
cle
rela
xant
No
diffe
renc
e1
RC
TLo
w--
----
Ske
leta
l mus
cle
rela
xant
vs.
ske
leta
l m
uscl
e re
laxa
ntN
o cl
ear d
iffer
ence
1 S
R (2
RC
Ts)
Low
----
--
CI =
con
fiden
ce in
terv
al; N
SA
ID =
non
ster
oida
l ant
i-infl
amm
ator
y dr
ug; R
CT
= ra
ndom
ized
con
trolle
d tri
al; R
R =
rela
tive
risk;
SO
E =
stre
ngth
of e
vide
nce;
SR
=
syst
emat
ic re
view
; SS
RI =
sel
ectiv
e se
roto
nin
reup
take
inhi
bito
r.
-
ES-9
Tabl
e C
. Pha
rmac
olog
ical
ther
apie
s ve
rsus
pla
cebo
for c
hron
ic lo
w b
ack
pain
Dru
gPa
in: M
agni
tude
of
Effe
ctPa
in: E
vide
nce
Pain
: SO
EFu
nctio
n:
Mag
nitu
de o
f Effe
ctFu
nctio
n: E
vide
nce
Func
tion:
SO
EA
ceta
min
ophe
nN
o ev
iden
ce--
--N
o ev
iden
ce--
--N
SA
IDs
Mod
erat
e1
SR
(4 R
CTs
)M
oder
ate
Sm
all
1 S
R (2
RC
Ts)
Low
Opi
oids
Sm
all
1 S
R (6
RC
Ts)
Mod
erat
eS
mal
l1
SR
(4 R
CTs
)M
oder
ate
Ske
leta
l mus
cle
rela
xant
sU
nabl
e to
est
imat
e3
RC
TsIn
suffi
cien
t--
----
Tram
adol
Mod
erat
e1
SR
(5 R
CTs
) + 2
R
CTs
Mod
erat
eS
mal
l1
SR
(5 R
CTs
) + 2
R
CTs
Mod
erat
e
Ben
zodi
azep
ines
: te
traze
pam
Failu
re to
impr
ove
at
10–1
4 da
ys: R
R, 0
.71
(95%
CI,
0.54
to 0
.93)
1 S
R (2
RC
Ts)
Low
----
--
Tric
yclic
ant
idep
ress
ants
No
effe
ct1
SR
(4 R
CTs
)M
oder
ate
No
effe
ct1
SR
(2 R
CTs
)Lo
wA
ntid
epre
ssan
ts: S
SR
IN
o ef
fect
1 S
R (3
RC
Ts)
Mod
erat
e--
----
Ant
idep
ress
ants
: dul
oxet
ine
Sm
all
3 R
CTs
Mod
erat
eS
mal
l3
RC
TsM
oder
ate
Gab
apen
tin/p
rega
balin
Una
ble
to e
stim
ate
2 R
CTs
Insu
ffici
ent
Una
ble
to e
stim
ate
2 R
CTs
Insu
ffici
ent
CI =
con
fiden
ce in
terv
al; N
SA
ID =
non
ster
oida
l ant
i-infl
amm
ator
y dr
ug; R
CT
= ra
ndom
ized
con
trolle
d tri
al; R
R =
rela
tive
risk;
SO
E =
stre
ngth
of e
vide
nce;
SR
=
syst
emat
ic re
view
; SS
RI =
sel
ectiv
e se
roto
nin
reup
take
inhi
bito
r.
-
Tabl
e D
. Pha
rmac
olog
ical
ther
apie
s ve
rsus
act
ive
com
para
tors
for c
hron
ic lo
w b
ack
pain
Dru
g Pa
in: M
agni
tude
of
Effe
ct
Pain
: Ev
iden
ce
Pain
: SO
E
Func
tion:
M
agni
tude
of
Effe
ct
Func
tion:
Ev
iden
ce
Func
tion:
SO
E A
ceta
min
ophe
n vs
. N
SA
ID
Una
ble
to
estim
ate
1 R
CT
Insu
ffici
ent
Una
ble
to
estim
ate
1 R
CT
Insu
ffici
ent
NS
AID
vs.
NS
AID
N
o di
ffere
nce
6 R
CTs
M
oder
ate
--
--
--
Opi
oid
vs. N
SA
ID
Una
ble
to
estim
ate
(inco
nsis
tent
) 3
RC
Ts
Insu
ffici
ent
No
diffe
renc
e 1
RC
T In
suffi
cien
t
Long
-act
ing
opio
id v
s.
long
-act
ing
opio
id
No
clea
r di
ffere
nce
4 R
CTs
M
oder
ate
No
clea
r di
ffere
nce
4 R
CTs
M
oder
ate
Long
-act
ing
opio
id v
s.
shor
t-act
ing
opio
id
No
clea
r di
ffere
nce*
6
RC
Ts
Low
--
--
--
Ben
zodi
azep
ine
(dia
zepa
m) v
s. s
kele
tal
mus
cle
rela
xant
N
o di
ffere
nce
1 R
CT
Low
--
--
--
Ske
leta
l mus
cle
rela
xant
vs
. ske
leta
l mus
cle
rela
xant
No
clea
r di
ffere
nce
1 S
R (2
R
CTs
) Lo
w
--
--
--
*Alth
ough
som
e R
CTs
foun
d lo
ng-a
ctin
g op
ioid
s to
be a
ssoc
iate
d w
ith g
reat
er p
ain
relie
f tha
n sh
ort-a
ctin
g op
ioid
s, pa
tient
sra
ndom
ized
to lo
ng-a
ctin
g op
ioid
s als
o re
ceiv
ed h
ighe
r dos
es o
f opi
oids
. N
SAID
= n
onst
eroi
dal a
nti-i
nfla
mm
ator
y dr
ug; R
CT
= ra
ndom
ized
con
trolle
d tri
al; S
OE
= st
reng
th o
f evi
denc
e; S
R =
syst
emat
ic
revi
ew.
ES-10
-
ES-11
Tabl
e E.
Pha
rmac
olog
ical
ther
apie
s ve
rsus
pla
cebo
for r
adic
ular
low
bac
k pa
in
Dru
gPa
in: M
agni
tude
of E
ffect
Pain
: Evi
denc
ePa
in: S
OE
Func
tion:
M
agni
tude
of E
ffect
Func
tion:
Ev
iden
ceFu
nctio
n:
SOE
NS
AID
sS
mal
l1
SR
(2 R
CTs
)Lo
w--
----
Ben
zodi
azep
ines
: dia
zepa
mR
R, 0
.5 (9
5% C
I, 0.
3 to
0.8
)1
RC
TLo
wN
o ef
fect
1 R
CT
Low
Sys
tem
ic c
ortic
oste
roid
sN
o ef
fect
5 R
CTs
Mod
erat
eN
o ef
fect
5 R
CTs
Mod
erat
eG
abap
entin
/pre
gaba
linU
nabl
e to
est
imat
e5
RC
TsIn
suffi
cien
tU
nabl
e to
est
imat
e5
RC
TsIn
suffi
cien
tC
I =
con
fide
nce
inte
rval
; NS
AID
= n
onst
eroi
dal a
nti-
infl
amm
ator
y dr
ug; R
CT
= r
ando
miz
ed c
ontr
olle
d tr
ial;
RR
= r
elat
ive
risk
; SO
E =
str
engt
h of
evi
denc
e; S
R =
sys
tem
atic
re
view
.
Tabl
e F.
Non
phar
mac
olog
ical
trea
tmen
ts v
ersu
s sh
am, n
o tr
eatm
ent,
or u
sual
car
e fo
r acu
te o
r sub
acut
e lo
w b
ack
pain
Inte
rven
tion
Pain
: M
agni
tude
of E
ffect
Pain
: Evi
denc
ePa
in: S
OE
Func
tion:
M
agni
tude
of E
ffect
Func
tion:
Ev
iden
ceFu
nctio
n:
SOE
Exe
rcis
e vs
. usu
al c
are
Mod
erat
e1
SR
(3 R
CTs
) + 3
R
CTs
Low
Mod
erat
e1
SR
(3 R
CTs
) +
3 R
CTs
Low
Acu
punc
ture
vs.
sha
mS
mal
l2
RC
TsLo
wN
o ef
fect
5 R
CTs
Low
Mas
sage
vs.
sha
mM
oder
ate
1 S
R (2
RC
Ts)
Low
Mod
erat
e1
SR
(2 R
CTs
)Lo
wM
assa
ge v
s. u
sual
car
eS
mal
l to
no e
ffect
2 R
CTs
Low
Sm
all t
o no
effe
ct2
RC
TsLo
wS
pina
l man
ipul
atio
n vs
. sha
mS
mal
l2
RC
TsLo
wN
o ef
fect
1 S
R (3
RC
Ts)
Low
Hea
t wra
p vs
. pla
cebo
Mod
erat
e1
SR
(2 R
CTs
) + 2
R
CTs
Mod
erat
eM
oder
ate
1 S
R (2
RC
Ts)
Mod
erat
e
Low
-leve
l las
er th
erap
y pl
us N
SA
ID v
s.
sham
plu
s N
SA
IDM
oder
ate
1 R
CT
Low
Sm
all
1 R
CT
Low
Lum
bar s
uppo
rts v
s. n
o lu
mba
r sup
ports
or
inac
tive
treat
men
tU
nabl
e to
det
erm
ine
5 R
CTs
Insu
ffici
ent
Una
ble
to d
eter
min
e5
RC
TsIn
suffi
cien
t
NS
AID
= n
onst
eroi
dal a
nti-
infl
amm
ator
y dr
ug; R
CT
= r
ando
miz
ed c
ontr
olle
d tr
ial;
SO
E =
str
engt
h of
evi
denc
e; S
R =
sys
tem
atic
rev
iew
.
-
ES-12
Tabl
e G
. Non
phar
mac
olog
ical
trea
tmen
ts v
ersu
s sh
am, n
o tr
eatm
ent,
or u
sual
car
e fo
r chr
onic
low
bac
k pa
in
Inte
rven
tion
Pain
: Mag
nitu
de o
f Ef
fect
Pain
: Evi
denc
ePa
in: S
OE
Func
tion:
M
agni
tude
of E
ffect
Func
tion:
Ev
iden
ceFu
nctio
n:
SOE
Exe
rcis
e vs
. usu
al c
are
Sm
all
1 S
R (1
9 R
CTs
) +
1 S
RM
oder
ate
Sm
all
1 S
R (1
7 R
CTs
) +
1 S
RM
oder
ate
Mot
or c
ontro
l exe
rcis
es v
s. m
inim
al
inte
rven
tion
Mod
erat
e (s
hort
to
long
term
)1
SR
(2 R
CTs
)Lo
wS
mal
l (sh
ort t
o lo
ng
term
)1
SR
(3 R
CTs
)Lo
w
Tai c
hi v
s. w
ait l
ist o
r no
tai c
hiM
oder
ate
2 R
CTs
Low
Sm
all
1 R
CT
Low
Yoga
vs.
usu
al c
are
Mod
erat
e1
RC
TLo
wM
oder
ate
1 R
CT
Low
Yoga
vs.
edu
catio
nS
mal
l (sh
ort t
erm
) an
d no
effe
ct (l
ong
term
)
5 R
CTs
(sho
rt te
rm) +
4 R
CTs
(lo
ng te
rm)
Low
Sm
all (
shor
t ter
m)
and
no e
ffect
(lon
g te
rm)
5 R
CTs
(sho
rt te
rm) +
4 R
CTs
(lo
ng te
rm)
Low
Pro
gres
sive
rela
xatio
n vs
. wai
t-lis
t con
trol
Mod
erat
e1
SR
(3 R
CTs
)Lo
wM
oder
ate
1 S
R (3
RC
Ts)
Low
EM
G b
iofe
edba
ck v
s. w
ait l
ist o
r pla
cebo
Mod
erat
e1
SR
(3 R
CTs
)Lo
wN
o ef
fect
1 S
R (3
RC
Ts)
Low
Ope
rant
ther
apy
vs. w
ait-l
ist c
ontro
lS
mal
l1
SR
(3 R
CTs
)Lo
wN
o ef
fect
1 S
R (2
RC
Ts)
Low
Cog
nitiv
e-be
havi
oral
ther
apy
vs. w
ait-l
ist
cont
rol
Mod
erat
e1
SR
(5 R
CTs
)Lo
wN
o ef
fect
1 S
R (4
RC
Ts)
Low
Mul
tidis
cipl
inar
y re
habi
litat
ion
vs. n
o m
ultid
isci
plin
ary
reha
bilit
atio
nM
oder
ate
1 S
R (3
RC
Ts)
Low
Sm
all
1 S
R (3
RC
Ts)
Low
Mul
tidis
cipl
inar
y re
habi
litat
ion
vs. u
sual
ca
reM
oder
ate
(sho
rt te
rm),
smal
l (lo
ng
term
), fa
vors
re
habi
litat
ion
1 S
R (9
RC
Ts)
(sho
rt te
rm) +
1
SR
(7 R
CTs
) (lo
ng
term
)
Mod
erat
eS
mal
l (sh
ort a
nd
long
term
)1
SR
(9 R
CTs
) (s
hort
term
) +
1 S
R (7
RC
Ts)
(long
term
)
Mod
erat
e
Acu
punc
ture
vs.
sha
m a
cupu
nctu
reM
oder
ate
1 S
R (4
RC
Ts) +
4
RC
TsLo
wN
o ef
fect
1 S
R (4
RC
Ts) +
4
RC
TsLo
w
Acu
punc
ture
vs.
no
acup
unct
ure
Mod
erat
e1
SR
(4 R
CTs
)M
oder
ate
Mod
erat
e1
SR
(3 R
CTs
)M
oder
ate
Spi
nal m
anip
ulat
ion
vs. s
ham
man
ipul
atio
nN
o ef
fect
1 S
R (3
RC
Ts) +
1
RC
TLo
wU
nabl
e to
est
imat
e1
RC
T--
Spi
nal m
anip
ulat
ion
vs. i
nert
treat
men
tS
mal
l7
RC
TsLo
w--
----
Mas
sage
vs.
usu
al c
are
No
effe
ct1
RC
TLo
wU
nabl
e to
est
imat
e2
RC
TsIn
suffi
cien
tU
ltras
ound
vs.
sha
m u
ltras
ound
No
effe
ct1
SR
(3 R
CTs
)Lo
wU
nabl
e to
est
imat
e5
RC
TsIn
suffi
cien
tU
ltras
ound
vs.
no
ultra
soun
dN
o ef
fect
1 S
R (2
RC
Ts)
Low
No
effe
ct1
SR
(2 R
CTs
)Lo
wTE
NS
vs.
sha
m T
EN
SN
o ef
fect
1 S
R (4
RC
Ts)
Low
No
effe
ct1
SR
(2 R
CTs
)Lo
wP
EN
S v
s. s
ham
PE
NS
Una
ble
to e
stim
ate
2 R
CTs
Insu
ffici
ent
Una
ble
to e
stim
ate
2 R
CTs
Insu
ffici
ent
-
ES-13
Ele
ctric
al m
uscl
e st
imul
atio
n vs
. sha
m, n
o st
imul
atio
n, o
r usu
al c
are
No
evid
ence
----
No
evid
ence
----
Low
-leve
l las
er th
erap
y vs
. sha
m la
ser
Sm
all
3 R
CTs
Low
Sm
all
3 R
CTs
Low
Lum
bar s
uppo
rts v
s. n
o lu
mba
r sup
ports
Una
ble
to e
stim
ate
2 R
CTs
Insu
ffici
ent
Una
ble
to e
stim
ate
2 R
CTs
Insu
ffici
ent
Trac
tion
vs. p
lace
bo, s
ham
, or n
o tra
ctio
nU
nabl
e to
est
imat
e1
SR
(13
RC
Ts)
Insu
ffici
ent
Una
ble
to e
stim
ate
1 S
R (1
3 R
CTs
)In
suffi
cien
tK
ines
io ta
ping
® v
s. s
ham
tapi
ngN
o ef
fect
2 R
CTs
Low
No
effe
cts
2 R
CTs
Low
EM
G =
ele
ctro
myo
grap
hy; P
EN
S =
per
cuta
neou
s el
ectr
ical
ner
ve s
tim
ulat
ion;
RC
T =
ran
dom
ized
con
trol
led
tria
l; S
OE
= s
tren
gth
of e
vide
nce;
SR
=
syst
emat
ic r
evie
w; T
EN
S =
tran
scut
aneo
us e
lect
rica
l ner
ve s
tim
ulat
ion.
Tabl
e H
. Non
phar
mac
olog
ical
trea
tmen
ts v
ersu
s ac
tive
com
para
tors
for c
hron
ic lo
w b
ack
pain
Inte
rven
tion
Pain
: Mag
nitu
de o
f Ef
fect
Pain
: Evi
denc
ePa
in: S
OE
Func
tion:
M
agni
tude
of E
ffect
Func
tion:
Ev
iden
ceFu
nctio
n:
SOE
MC
E v
s. g
ener
al e
xerc
ise
(sho
rt te
rm)
Sm
all,
favo
rs M
CE
for
shor
t ter
m1
SR
(6 R
CTs
)Lo
wS
mal
l, fa
vors
MC
E1
SR
(6 R
CTs
)Lo
w
MC
E v
s. g
ener
al e
xerc
ise
(inte
rmed
iate
term
)S
mal
l, fa
vors
MC
E fo
r in
term
edia
te te
rm1
SR
(3 R
CTs
)Lo
w--
----
MC
E v
s. g
ener
al e
xerc
ise
(long
te
rm)
Sm
all,
favo
rs M
CE
for
long
term
1 S
R (4
RC
Ts)
Low
Sm
all,
favo
rs M
CE
1 S
R (3
RC
Ts)
Low
MC
E v
s. m
ultim
odal
phy
sica
l th
erap
y (in
term
edia
te te
rm)
Mod
erat
e, fa
vors
MC
E1
SR
(4 R
CTs
)Lo
wM
oder
ate,
favo
rs
MC
E1
SR
(3 R
CTs
)Lo
w
MC
E +
exe
rcis
e vs
. exe
rcis
e al
one
No
clea
r diff
eren
ce2
RC
TsLo
w--
----
Pila
tes
vs. u
sual
car
e +
phys
ical
ac
tivity
No
effe
ct to
sm
all
effe
ct, f
avor
s P
ilate
s7
RC
TsLo
wN
o cl
ear d
iffer
ence
7 R
CTs
Low
Pila
tes
vs. o
ther
exe
rcis
eN
o cl
ear d
iffer
ence
3 R
CTs
Low
No
clea
r diff
eren
ce3
RC
TsLo
wTa
i chi
vs.
oth
er e
xerc
ise
Mod
erat
e, fa
vors
tai
chi
1 R
CT
Low
----
--
Yoga
vs.
exe
rcis
eS
mal
l, fa
vors
yog
a1
SR
(5 R
CTs
)Lo
w--
----
Psy
chol
ogic
al th
erap
ies
vs.
exer
cise
or p
hysi
cal t
hera
pyN
o cl
ear d
iffer
ence
1 S
R (6
RC
Ts)
Low
----
--
Psy
chol
ogic
al th
erap
ies
vs.
psyc
holo
gica
l the
rapi
esN
o cl
ear d
iffer
ence
10 R
CTs
Mod
erat
eN
o cl
ear d
iffer
ence
10 R
CTs
Mod
erat
e
Mul
tidis
cipl
inar
y re
habi
litat
ion
vs.
phys
ical
ther
apy
(sho
rt te
rm)
Sm
all,
favo
rs
mul
tidis
cipl
inar
y re
habi
litat
ion
1 S
R (1
2 R
CTs
)M
oder
ate
Sm
all,
favo
rs
mul
tidis
cipl
inar
y re
habi
litat
ion
1 S
R (1
3 R
CTs
)M
oder
ate
-
ES-14
Mul
tidis
cipl
inar
y re
habi
litat
ion
vs.
phys
ical
ther
apy
(long
term
)M
oder
ate,
favo
rs
mul
tidis
cipl
inar
y re
habi
litat
ion
1 S
R (9
RC
Ts)
Mod
erat
eM
oder
ate,
favo
rs
mul
tidis
cipl
inar
y re
habi
litat
ion
1 S
R (1
0 R
CTs
)M
oder
ate
Spi
nal m
anip
ulat
ion
vs. o
ther
act
ive
inte
rven
tions
(exe
rcis
e, u
sual
car
e,
med
icat
ions
, mas
sage
)
No
clea
r diff
eren
ce1
SR
(6 R
CTs
)M
oder
ate
No
clea
r diff
eren
ce1
SR
(6 R
CTs
)M
oder
ate
Acu
punc
ture
vs.
med
icat
ions
Sm
all,
favo
rs
acup
unct
ure
1 S
R (3
RC
Ts)
Low
Sm
all,
favo
rs
acup
unct
ure
1 S
R (3
RC
Ts)
Low
MC
E =
mot
or c
ontr
ol e
xerc
ise;
RC
T =
ran
dom
ized
con
trol
led
tria
l; S
OE
= s
tren
gth
of e
vide
nce;
SR
= s
yste
mat
ic r
evie
w.
-
ES-15
Discussion
Key Findings and Strength of EvidenceThe key findings of this review are described in the summary-of-evidence table (Table I).
-
ES-16
Tabl
e I.
Sum
mar
y of
evi
denc
e
Key
Que
stio
nIn
terv
entio
nO
utco
me
Stre
ngth
of
Evi
denc
eC
oncl
usio
nK
ey Q
uest
ion
1.
Pha
rmac
olog
ical
th
erap
ies
Ace
tam
inop
hen
Ace
tam
inop
hen
vs.
plac
ebo,
acu
te L
BP
: Pai
n an
d fu
nctio
n
Low
One
goo
d-qu
ality
tria
l fou
nd n
o di
ffere
nce
betw
een
acet
amin
ophe
n vs
. pla
cebo
in p
ain
inte
nsity
or f
unct
ion
thro
ugh
3 w
eeks
.
Ace
tam
inop
hen
vs. N
SA
ID,
acut
e LB
P: P
ain
and
glob
al
impr
ovem
ent
Insu
ffici
ent
A sy
stem
atic
revi
ew fo
und
no d
iffer
ence
bet
wee
n ac
etam
inop
hen
vs.
NS
AID
s in
pai
n in
tens
ity (3
tria
ls; p
oole
d S
MD
, 0.2
1; 9
5% C
I, −0
.02
to 0
.43)
or l
ikel
ihoo
d of
exp
erie
ncin
g gl
obal
impr
ovem
ent (
3 tri
als;
R
R, 0
.81;
95%
CI,
0.58
to 1
.14)
at ≤
3 w
eeks
, alth
ough
est
imat
es
favo
red
NS
AID
s.A
ceta
min
ophe
n vs
. pla
cebo
, ch
roni
c LB
PIn
suffi
cien
tN
o st
udy
eval
uate
d ac
etam
inop
hen
vs. p
lace
bo.
Ace
tam
inop
hen
vs. N
SA
ID,
chro
nic
LBP
Insu
ffici
ent
Ther
e w
as in
suffi
cien
t evi
denc
e fro
m 1
tria
l to
dete
rmin
e ef
fect
s of
ac
etam
inop
hen
vs. N
SA
IDs.
Ace
tam
inop
hen
vs. o
ther
in
terv
entio
ns, a
cute
LB
PIn
suffi
cien
tTh
ere
was
insu
ffici
ent e
vide
nce
from
4 tr
ials
to d
eter
min
e ef
fect
s of
ac
etam
inop
hen
vs. o
ther
inte
rven
tions
.A
ceta
min
ophe
n vs
. pla
cebo
: A
dver
se e
vent
s (s
erio
us
adve
rse
even
ts)
Mod
erat
eO
ne tr
ial f
ound
no
diffe
renc
e be
twee
n sc
hedu
led
acet
amin
ophe
n, a
s-ne
eded
ace
tam
inop
hen,
or p
lace
bo in
risk
of s
erio
us a
dver
se e
vent
s (~
1% in
eac
h gr
oup)
.A
ceta
min
ophe
n vs
. N
SA
IDs:
Adv
erse
eve
nts
Mod
erat
eA
syst
emat
ic re
view
foun
d th
at a
ceta
min
ophe
n w
as a
ssoc
iate
d w
ith
low
er ri
sk o
f sid
e ef
fect
s vs
. NS
AID
s.A
ceta
min
ophe
n vs
pl
aceb
o, N
SA
ID, o
r oth
er
inte
rven
tion,
radi
cula
r LB
P
Insu
ffici
ent
No
stud
y ev
alua
ted
acet
amin
ophe
n fo
r rad
icul
ar lo
w b
ack
pain
.
-
ES-17
Key
Que
stio
n 1.
P
harm
acol
ogic
al
ther
apie
s
NS
AID
sN
SA
IDs
vs. p
lace
bo, a
cute
LB
P: P
ain
and
func
tion
Mod
erat
e fo
r pa
in, l
ow fo
r fu
nctio
n
A sy
stem
atic
revi
ew fo
und
NS
AID
s to
be
asso
ciat