Roger Chou, MD; Richard Deyo, MD, MPH; Janna Friedly, MD; Andrea Skelly, PhD, MPH; Robin Hashimoto, PhD; Melissa Weimer, DO, MCR; Rochelle Fu, PhD; Tracy Dana, MLS; Paul Kraegel, MSW; Jessica Griffin, MS; Sara Grusing, BA; Erika D. Brodt, BS
Disclaimer: The authors of this manuscript are responsible for its content. A representative from the Agency for Healthcare Research and Quality (AHRQ) served as a Contracting Officer's Technical Representative and provided technical assistance during the conduct of the full evidence report and provided comments on draft versions of the full evidence report. The AHRQ did not directly participate in the literature search, determination of study eligibility criteria, data analysis or interpretation, or preparation, review, or approval of the manuscript for publication. Statements in the report should not be construed as endorsement by AHRQ or the U.S. Department of Health and Human Services. The AHRQ retains a license to display, reproduce, and distribute the data and the report from which this manuscript was derived under the terms of the agency's contract with the author.
Grant Support: By contract HHSA290201200014I from AHRQ, U.S. Department of Health and Human Services.
Disclosures: Dr. Chou reports grants from AHRQ and funds for manuscript preparation from ACP during the conduct of this study. Dr. Deyo reports grants from AHRQ during the conduct of the study; grants from the National Institutes of Health (NIH), AHRQ, Centers for Disease Control and Prevention, and Patient-Centered Outcomes Research Institute (PCORI) outside the submitted work; personal fees from UpToDate and other support from Kaiser Permanente outside the submitted work; and a financial gift from NuVasive as part of a lifetime achievement award from the International Society for Study of the Lumbar Spine. Dr. Friedly reports grants from AHRQ during the conduct of the study and grants from PCORI and NIH outside the submitted work. Dr. Skelly reports grants from AHRQ during the conduct of the study and other support from the Washington State Health Technology Assessment (HTA) Program and AOSpine North America outside the submitted work. Dr. Hashimoto reports grants from AHRQ during the conduct of the study, other support from the Washington State HTA Program, and personal fees from Amgen, which were received after the submitted work was prepared. Dr. Weimer, Ms. Dana, Ms. Grusing, and Ms. Brodt report grants from AHRQ during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-2459.
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.
Reproducible Research Statement:Study protocol: Available at www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014014735. Statistical code: Not applicable. Data set: See the and full report at www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2178.
Requests for Single Reprints: Roger Chou, MD, 3181 Southwest Sam Jackson Park Road, Mail Code: BICC, Portland, OR 97239; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Chou and Fu, Ms. Dana, Ms. Griffin, and Ms. Grusing: 3181 Southwest Sam Jackson Park Road, Mail Code: BICC, Portland, OR 97239.
Dr. Deyo: 3181 Southwest Sam Jackson Park Road, Mail Code: FM, Portland, OR 97239.
Dr. Friedly: 325 Ninth Avenue, Box 359612, Seattle, WA 98104.
Drs. Skelly and Hashimoto and Ms. Brodt: 705 South 9th Street, Suite 203, Tacoma, WA 98405.
Dr. Weimer: 3181 Southwest Sam Jackson Park Road, Mail Code: L-475, Portland, OR 97239.
Mr. Kraegel: University of Washington, Department of Pharmacy, Box 357630, Seattle, WA 98195.
Author Contributions: Conception and design: R. Chou, J. Friedly, M. Weimer.
Analysis and interpretation of the data: R. Chou, R. Deyo, J. Friedly, A. Skelly, R. Hashimoto, M. Weimer, R. Fu, T. Dana, J. Griffin, E. Brodt.
Drafting of the article: R. Chou, A. Skelly, R. Hashimoto, M. Weimer, R. Fu, J. Griffin, S. Grusing, E. Brodt.
Critical revision for important intellectual content: R. Chou, R. Deyo, J. Friedly, M. Weimer, J. Griffin.
Final approval of the article: R. Chou, R. Deyo, J. Friedly, A. Skelly, R. Hashimoto, M. Weimer, R. Fu, T. Dana, P. Kraegel, J. Griffin, S. Grusing, E. Brodt.
Statistical expertise: R. Chou, R. Fu.
Obtaining of funding: R. Chou.
Administrative, technical, or logistic support: T. Dana, P. Kraegel, J. Griffin, S. Grusing, E. Brodt.
Collection and assembly of data: R. Chou, R. Deyo, A. Skelly, R. Hashimoto, M. Weimer, T. Dana, P. Kraegel, J. Griffin, S. Grusing, E. Brodt.
A 2007 American College of Physicians guideline addressed nonpharmacologic treatment options for low back pain. New evidence is now available.
To systematically review the current evidence on nonpharmacologic therapies for acute or chronic nonradicular or radicular low back pain.
Ovid MEDLINE (January 2008 through February 2016), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and reference lists.
Randomized trials of 9 nonpharmacologic options versus sham treatment, wait list, or usual care, or of 1 nonpharmacologic option versus another.
One investigator abstracted data, and a second checked abstractions for accuracy; 2 investigators independently assessed study quality.
The number of trials evaluating nonpharmacologic therapies ranged from 2 (tai chi) to 121 (exercise). New evidence indicates that tai chi (strength of evidence [SOE], low) and mindfulness-based stress reduction (SOE, moderate) are effective for chronic low back pain and strengthens previous findings regarding the effectiveness of yoga (SOE, moderate). Evidence continues to support the effectiveness of exercise, psychological therapies, multidisciplinary rehabilitation, spinal manipulation, massage, and acupuncture for chronic low back pain (SOE, low to moderate). Limited evidence shows that acupuncture is modestly effective for acute low back pain (SOE, low). The magnitude of pain benefits was small to moderate and generally short term; effects on function generally were smaller than effects on pain.
Qualitatively synthesized new trials with prior meta-analyses, restricted to English-language studies; heterogeneity in treatment techniques; and inability to exclude placebo effects.
Several nonpharmacologic therapies for primarily chronic low back pain are associated with small to moderate, usually short-term effects on pain; findings include new evidence on mind–body interventions.
Agency for Healthcare Research and Quality. (PROSPERO: CRD42014014735)
Table 1. Definitions for Magnitude of Effects, Based on Mean Between-Group Differences
Literature search and selection.
ACP = American College of Physicians; AHRQ = Agency for Healthcare Research and Quality; APS = American Pain Society; KQ = key question; RCT = randomized, controlled trial; SR = systematic review.
* Cochrane databases include the Cochrane Register of Controlled Trials and the Cochrane Database of Systematic Reviews.
† Other sources include prior reports, reference lists of relevant articles, systematic reviews, and others.
‡ Publications may be included or excluded for several interventions.
Table 2. Nonpharmacologic Treatments Versus Sham, No Treatment, or Usual Care for Chronic Low Back Pain
Table 3. Nonpharmacologic Treatments Versus Sham, No Treatment, or Usual Care for Acute Low Back Pain
Table 4. Nonpharmacologic Treatments for Radicular Low Back Pain
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John C Licciardone, DO, MS, MBA, Robert J Gatchel, PhD, ABPP
University of North Texas Health Science Center (Licciardone), University of Texas at Arlington (Gatchel)
February 27, 2017
Spinal Manipulation for Patients with Chronic Low Back Pain
We read with interest the review by Chou and colleagues1 for the American College of Physicians (ACP) Clinical Practice Guideline for low back pain. We were quite disappointed that the OSTEOPATHIC Trial was excluded, as it assessed spinal manipulation in adult patients with non-specific chronic low back pain during 12 weeks of follow-up.2 Our trial results were not reported until 2013 and did not appear in systematic reviews published through the search end-date.1(Supplement Table 1) However, it is unclear why the trial was not identified in searches conducted by the authors through November 2016.1(Supplement Table 2) The exclusion of the OSTEOPATHIC Trial is important for two reasons. First, with 455 patients randomized to either active or sham treatment arms, the study is larger than any other spinal manipulation trial included in Supplement Table 2. Second, our trial initially reported a medium effect size (RR, 1.41; 95% CI, 1.13-1.76) in achieving substantial improvement (50% reduction) in pain with spinal manipulation. Identifying such risk estimates for successful pain outcomes was one of the objectives of the authors’ review. Indeed, the NIH Task Force on research standards for chronic low back pain now advocates using responder analysis, such as performed in our trial, to identify the percentage of patients achieving clinically important change.3 Interestingly, the authors cited a secondary report from our trial4 in their Discussion to note that the magnitude of treatment effects may vary according to baseline severity of pain or functional deficits. During the search period, we used other analytical methods recommended by the NIH Task Force (e.g., composite outcome measures and cumulative distribution functions) to assess spinal manipulation, including subgroup results according to baseline severity. An important finding was that spinal manipulation was associated with a large effect size (RR, 2.36; 95% CI, 1.31-4.24) in achieving recovery from chronic low back pain at 12 weeks, as defined by the composite measure of pain intensity ≤10mm/100mm and Roland-Morris Disability score ≤2/24.5 Cumulative distribution functions demonstrated better response in patients with moderate to severe baseline levels of pain and functional deficits. Readers need to be aware that our trial results indicate that spinal manipulation may be more effective in treating chronic low back pain than reported by Chou and colleagues (and, by extension, in the new ACP Guideline). Possible explanations for our positive findings include using physicians to provide spinal manipulation and adopting analytical approaches recommended by the NIH Task Force.References1. Chou R, Deyo R, Friedly J, et al. Nonpharmacologic therapies for low back pain: a systematic review for an American College of Physicians clinical practice guideline. Ann Intern Med. 2017.2. Licciardone JC, Minotti DE, Gatchel RJ, Kearns CM, Singh KP. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med. 2013;11(2):122-129.3. Deyo RA, Dworkin SF, Amtmann D, et al. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014;15(6):569-585.4. Licciardone JC, Kearns CM, Minotti DE. Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: results from the OSTEOPATHIC Trial. Man Ther. 2013;18(6):533-540.5. Licciardone JC, Gatchel RJ, Aryal S. Recovery from chronic low back pain after osteopathic manipulative treatment: a randomized controlled trial. J Am Osteopath Assoc. 2016;116(3):144-155.
Oregon Health & Science University
June 23, 2017
The OSTEOPATHIC Trial (1) was identified in searches and excluded because it evaluated a multicomponent osteopathic intervention that included manipulation as well as a massage-like component (“soft tissue stretching, kneading, and pressure), myofascial stretching and release, positional treatment of myofascial tender points, and muscle energy techniques; the techniques were aimed at the back as well as the the iliac and pubic regions. According to the methods for our review (2), we excluded comparisons involving multicomponent therapy that did not meet our definition for multidisciplinary rehabilitation (a coordinated program with both physical and biopsychosocial treatment components provided by professionals from at least two different specialties) and did not compare the effects of multicomponent therapy versus individual components for assessing, because it is not possible to determine the incremental benefits of multicomponent therapy over its individual components. The OSTEOPATHIC trial was relevant for evaluating effects of baseline pain on treatment benefits, since the factor of primary interest was the severity of baseline pain rather than the specific intervention being studied, and few other trials evaluated this association. In addition to mean improvements, the proportion of patients experiencing clinically relevant improvement was an outcome evaluated in our review. However, as noted in the review, few trials reported such outcomes. Therefore, it is difficult to gauge how the OSTEOPATHIC trial findings highlighted by Licciardone and colleague compare to the studies in our review. However, the median difference reported in the OSTEOPATHIC Trial for improvement in pain scores between the osteopathic intervention and sham (9 points on a 0 to 100 pain scale) is in line with differences reported in trials of (single component) manipulation, meeting the criteria for “small” effects as defined in our methods. The OSTEOPATHIC Trial found little difference between the osteopathic intervention and sham in median scores on the Roland Morris Disability Questionnaire, a measure of back-specific function.References:1. Licciardone JC, Minotti DE, Gatchel RJ, Kearns CM, Singh KP. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med 2013;11:122-9.2. 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.effectiveheatlchare.ahrq.gov/reports/final.cfm (accessed June 23, 2017).
Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, et al. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. ;166:493–505. doi: 10.7326/M16-2459
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Published: Ann Intern Med. 2017;166(7):493-505.
Published at www.annals.org on 14 February 2017
Back Pain, Neurology, Neuropathy, Rheumatology.
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