Report of the NIH Task Force on Research Standards for Chronic Low Back Pain

Note from PTJ's Editor in Chief: Both investigators and readers get frustrated reading research on low back pain because of different definitions of “chronic” and different outcome measures. Lack of consensus on study methods makes it difficult to determine if contradictory findings are based on different methods or different interventions; lack of consensus also prevents synthesis across studies. Dr. Partap Khalsa, Deputy Director, National Center for Complementary and Integrative Health, announced the release of Research Standards for Chronic Low Pain, and the hope is that future investigations will adopt them and reduce variability in research reporting. The task force on research standards was an international, multidisciplinary team including Anthony Delitto, PT, PhD, FAPTA. Its findings have been published in leading pain journals. PTJ is among the first professional journals to share the report with its readers. Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients' lives. Such cLBP is often termed non-specific and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. Therefore, NIH Pain Consortium charged a Research Task Force (RTF) to draft standards for research on cLBP. The resulting multidisciplinary panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimum dataset to describe research participants (drawing heavily on the PROMIS methodology); reporting “responder analyses” in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved the recommendations, which investigators should incorporate into NIH grant proposals. The RTF believes that these recommendations will advance the field, help to resolve controversies, and facilitate future research addressing the genomic, neurologic, and other mechanistic substrates of chronic low back pain. We expect that the RTF recommendations will become a dynamic document and undergo continual improvement. Perspective: A task force was convened by the NIH Pain Consortium with the goal of developing research standards for chronic low back pain. The results included recommendations for definitions, a minimum dataset, reporting outcomes, and future research. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes.

[1]  M. Bushnell,et al.  How neuroimaging studies have challenged us to rethink: is chronic pain a disease? , 2009, The journal of pain : official journal of the American Pain Society.

[2]  G. Huston The Hospital Anxiety and Depression Scale. , 1987, The Journal of rheumatology.

[3]  D. Cella,et al.  Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients. , 2011, Journal of clinical epidemiology.

[4]  Stéphane Lehéricy,et al.  Clinical and research diagnostic criteria for Alzheimer's disease. , 2012, Neuroimaging clinics of North America.

[5]  P. Shekelle,et al.  Will this patient develop persistent disabling low back pain? , 2010, JAMA.

[6]  N. Bogduk On the definitions and physiology of back pain, referred pain, and radicular pain , 2009, PAIN®.

[7]  I. Abraham,et al.  Lack of evidence-based research for idiopathic low back pain: the importance of a specific diagnosis. , 2002, Archives of internal medicine.

[8]  S. Shortreed,et al.  Comparison of back pain prognostic risk stratification item sets. , 2014, The journal of pain : official journal of the American Pain Society.

[9]  D. Newell,et al.  Relationship between STarT Back Screening Tool and prognosis for low back pain patients receiving spinal manipulative therapy , 2012, Chiropractic & Manual Therapies.

[10]  S. Reise,et al.  Item Banks for Measuring Emotional Distress From the Patient-Reported Outcomes Measurement Information System (PROMIS®): Depression, Anxiety, and Anger , 2011, Assessment.

[11]  J C Fairbank,et al.  The Oswestry low back pain disability questionnaire. , 1980, Physiotherapy.

[12]  P. Croft,et al.  A prognostic approach to defining chronic pain: Replication in a UK primary care low back pain population , 2008, PAIN®.

[13]  S. Southwick,et al.  The pain behavior check list (PBCL): Factor structure and psychometric properties , 1991, Journal of Behavioral Medicine.

[14]  Daniel J Buysse,et al.  Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. , 2010, Sleep.

[15]  R. Chou,et al.  Appropriate use of lumbar imaging for evaluation of low back pain. , 2012, Radiologic clinics of North America.

[16]  R. Ostelo,et al.  Reporting outcomes of back pain trials: A modified Delphi study , 2011, European journal of pain.

[17]  D. Miglioretti,et al.  A prognostic approach to defining chronic pain , 2005, Pain.

[18]  J. Ware,et al.  A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. , 1996, Medical care.

[19]  B. Löwe,et al.  A brief measure for assessing generalized anxiety disorder: the GAD-7. , 2006, Archives of internal medicine.

[20]  L. Manchikanti Epidemiology of low back pain. , 2000, Pain physician.

[21]  Kurt L. Johnson,et al.  Development of a crosswalk for pain interference measured by the BPI and PROMIS pain interference short form , 2013, Quality of Life Research.

[22]  A. Stone,et al.  Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[23]  P. Salovey,et al.  Reporting chronic pain episodes on health surveys , 1992 .

[24]  R. Deyo,et al.  Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. , 1992, Journal of clinical epidemiology.

[25]  D. Amtmann,et al.  Exploratory and confirmatory factor analysis of the PROMIS pain quality item bank , 2014, Quality of Life Research.

[26]  R. B. Margolis,et al.  A rating system for use with patient pain drawings , 1986, Pain.

[27]  M. Roland,et al.  A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. , 1983, Spine.

[28]  L. Paulozzi,et al.  Trends in prescriptions for oxycodone and other commonly used opioids in the United States, 2000–2010 , 2012, Open medicine : a peer-reviewed, independent, open-access journal.

[29]  N. Gusi,et al.  The Spanish version of the "STarT Back Screening Tool" (SBST) in different subgroups. , 2011, Atencion primaria.

[30]  C. Bombardier,et al.  Further Qualification of a Therapeutic Responder Index for Patients with Chronic Low Back Pain , 2011, The Journal of Rheumatology.

[31]  C. Kalkman,et al.  Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods. , 2011, British journal of anaesthesia.

[32]  S. Bryan,et al.  Comparison of Stratified Primary Care Management for Low Back Pain with Current Best Practice (STarTBack): A Randomised Controlled Trial , 2013, physioscience.

[33]  Roger Chou,et al.  Nonsurgical Interventional Therapies for Low Back Pain: A Review of the Evidence for an American Pain Society Clinical Practice Guideline , 2009, Spine.

[34]  D. Singer,et al.  The Maine-Seattle Back Questionnaire: A 12-Item Disability Questionnaire for Evaluating Patients with Lumbar Sciatica or Stenosis: Results of a Derivation and Validation Cohort Analysis , 2003, Spine.

[35]  J. Fritz,et al.  The STarT Back Screening Tool and Individual Psychological Measures: Evaluation of Prognostic Capabilities for Low Back Pain Clinical Outcomes in Outpatient Physical Therapy Settings , 2012, Physical Therapy.

[36]  S. Asch,et al.  Development and Initial Validation of the PEG, a Three-item Scale Assessing Pain Intensity and Interference , 2009, Journal of General Internal Medicine.

[37]  G. McIntosh,et al.  Effectiveness of a low back pain classification system. , 2009, The spine journal : official journal of the North American Spine Society.

[38]  Rochelle E. Watkins,et al.  Lives on Hold: A Qualitative Synthesis Exploring the Experience of Chronic Low-back Pain , 2013, The Clinical journal of pain.

[39]  Peter Croft,et al.  Chronic pain syndromes: You can’t have one without another , 2007, PAIN.

[40]  Gail M. Williams,et al.  A systematic review of the global prevalence of low back pain. , 2012, Arthritis and rheumatism.

[41]  R. Chou,et al.  Nonpharmacologic Therapies for Acute and Chronic Low Back Pain: A Review of the Evidence for an American Pain Society/American College of Physicians Clinical Practice Guideline , 2007, Annals of Internal Medicine.

[42]  D. Ehde,et al.  Pain site and the effects of amputation pain: further clarification of the meaning of mild, moderate, and severe pain , 2001, Pain.

[43]  D. Cella,et al.  Measuring social health in the patient-reported outcomes measurement information system (PROMIS): item bank development and testing , 2010, Quality of Life Research.

[44]  K. Stavem,et al.  Cutpoints for mild, moderate and severe pain in patients with osteoarthritis of the hip or knee ready for joint replacement surgery , 2008, BMC musculoskeletal disorders.

[45]  Ricky Mullis,et al.  A primary care back pain screening tool: identifying patient subgroups for initial treatment. , 2008, Arthritis and rheumatism.

[46]  Paul Karoly,et al.  Self-report scales and procedures for assessing pain in adults , 1992 .

[47]  C. Leboeuf‐Yde,et al.  Feasibility of the STarT back screening tool in chiropractic clinics: a cross-sectional study of patients with low back pain , 2011, Chiropractic & manual therapies.

[48]  Francis J. Keefe,et al.  The use of coping strategies in chronic low back pain patients: Relationship to patient characteristics and current adjustment , 1983, Pain.

[49]  R. Deyo,et al.  Expenditures and health status among adults with back and neck problems. , 2008, JAMA.

[50]  D. Singer,et al.  Assessing Health‐Related Quality of Life in Patients With Sciatica , 1995, Spine.

[51]  Chris J. Main,et al.  Comparing the responsiveness of a brief, multidimensional risk screening tool for back pain to its unidimensional reference standards: The whole is greater than the sum of its parts , 2012, PAIN®.

[52]  Karon F. Cook,et al.  Letting the CAT out of the Bag: Comparing Computer Adaptive Tests and an 11-Item Short Form of the Roland-Morris Disability Questionnaire , 2008, Spine.

[53]  Jeremy Fairbank,et al.  The Role of Classification of Chronic Low Back Pain , 2011, Spine.

[54]  Scott R. Bishop,et al.  The Pain Catastrophizing Scale: Development and validation. , 1995 .

[55]  R. Deyo Diagnostic evaluation of LBP: reaching a specific diagnosis is often impossible. , 2002, Archives of internal medicine.

[56]  Daniel J Buysse,et al.  The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. , 2010, Journal of clinical epidemiology.

[57]  C. Vojir,et al.  Determining mild, moderate, and severe pain equivalency across pain-intensity tools in nursing home residents. , 2007, Journal of rehabilitation research and development.

[58]  S. Dworkin,et al.  Grading the severity of chronic pain , 1992, Pain.

[59]  J. Farrar,et al.  Core outcome measures for chronic pain clinical trials: IMMPACT recommendations , 2003, Pain.

[60]  R. Spitzer,et al.  The PHQ-15: Validity of a New Measure for Evaluating the Severity of Somatic Symptoms , 2002, Psychosomatic medicine.

[61]  J. Lemaire,et al.  Discriminative and Predictive Validity Assessment of the Quebec Task Force Classification , 2002, Spine.

[62]  K. Dunn,et al.  Subgrouping low back pain: A comparison of the STarT Back Tool with the Örebro Musculoskeletal Pain Screening Questionnaire , 2010, European journal of pain.

[63]  E. Thomas,et al.  A prognostic approach to defining chronic pain: Application to knee pain in older adults , 2008, PAIN.

[64]  P. Croft,et al.  Prognostic factors for musculoskeletal pain in primary care: a systematic review. , 2007, The British journal of general practice : the journal of the Royal College of General Practitioners.

[65]  C. Cleeland,et al.  Pain assessment: global use of the Brief Pain Inventory. , 1994, Annals of the Academy of Medicine, Singapore.

[66]  M. Edelen,et al.  Correspondence of verbal descriptor and numeric rating scales for pain intensity: an item response theory calibration. , 2010, The journals of gerontology. Series A, Biological sciences and medical sciences.

[67]  Ware J.E.Jr.,et al.  THE MOS 36- ITEM SHORT FORM HEALTH SURVEY (SF- 36) CONCEPTUAL FRAMEWORK AND ITEM SELECTION , 1992 .

[68]  Bridget A. Martell,et al.  Systematic Review: Opioid Treatment for Chronic Back Pain: Prevalence, Efficacy, and Association with Addiction , 2007, Annals of Internal Medicine.

[69]  R. Spitzer,et al.  The PHQ-9: validity of a brief depression severity measure. , 2001, Journal of general internal medicine.

[70]  R. Lipton,et al.  Validity of an illness severity measure for headache in a population sample of migraine sufferers , 1999, PAIN.

[71]  E. Thomas,et al.  A Prognostic Approach to Defining Chronic Pain Across a Range of Musculoskeletal Pain Sites , 2013, The Clinical journal of pain.

[72]  D. Amtmann,et al.  Development of a PROMIS item bank to measure pain interference , 2010, PAIN.

[73]  R. Deyo,et al.  Overtreating Chronic Back Pain: Time to Back Off? , 2009, The Journal of the American Board of Family Medicine.

[74]  R L Brown,et al.  A two-item conjoint screen for alcohol and other drug problems. , 2001, The Journal of the American Board of Family Practice.

[75]  K. Dunn,et al.  Comparing the STarT Back Screening Tool's Subgroup Allocation of Individual Patients With That of Independent Clinical Experts , 2010, The Clinical journal of pain.

[76]  A. Beck,et al.  Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. , 1996, Journal of personality assessment.

[77]  Michael Kropf,et al.  Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc®-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease , 2007, Spine.

[78]  Jesse A. Berlin,et al.  Optimizing prediction of back pain outcomes , 2013, PAIN®.

[79]  M. Battié,et al.  Is level- and side-specific multifidus asymmetry a marker for lumbar disc pathology? , 2012, The spine journal : official journal of the North American Spine Society.

[80]  L. McLeod,et al.  Interpreting patient-reported outcome results: US FDA guidance and emerging methods , 2011, Expert review of pharmacoeconomics & outcomes research.

[81]  Andrew J Vickers,et al.  The use of percentage change from baseline as an outcome in a controlled trial is statistically inefficient: a simulation study , 2001, BMC medical research methodology.

[82]  C. Bombardier,et al.  Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. , 2000, Spine.

[83]  S. Hider,et al.  The Impact of Low Back-related Leg Pain on Outcomes as Compared With Low Back Pain Alone: A Systematic Review of the Literature , 2013, The Clinical journal of pain.

[84]  Kornelia Kulig,et al.  Multifidus atrophy is localized and bilateral in active persons with chronic unilateral low back pain. , 2012, Archives of physical medicine and rehabilitation.

[85]  R A Deyo,et al.  Outcome Measures for Low Back Pain Research: A Proposal for Standardized Use , 1998, Spine.

[86]  Shirley D Hon,et al.  Psychometric Properties of the PROMIS Physical Function Item Bank in Patients With Spinal Disorders , 2014, Spine.

[87]  J. Farrar,et al.  Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale , 2001, PAIN.

[88]  J. Reginster,et al.  Translation validation of a new back pain screening questionnaire (the STarT Back Screening Tool) in French , 2012, Archives of Public Health.

[89]  P. Kent,et al.  Translation and discriminative validation of the STarT Back Screening Tool into Danish , 2011, European Spine Journal.

[90]  A. Baker Volvo Award in Clinical Sciences: A New Clinical Model for the Treatment of Low-Back Pain , 2014 .

[91]  D. Amtmann,et al.  Measurement invariance of the PROMIS pain interference item bank across community and clinical samples , 2013, Quality of Life Research.

[92]  Roger Chou,et al.  Medications for Acute and Chronic Low Back Pain: A Review of the Evidence for an American Pain Society/American College of Physicians Clinical Practice Guideline , 2007, Annals of Internal Medicine.

[93]  F. Zaina,et al.  The chimera of low back pain etiology: a clinical rehabilitation perspective. , 2013, American journal of physical medicine & rehabilitation.

[94]  A. May,et al.  Structural Brain Changes in Chronic Pain Reflect Probably Neither Damage Nor Atrophy , 2013, PloS one.

[95]  M. Bushnell,et al.  Effective Treatment of Chronic Low Back Pain in Humans Reverses Abnormal Brain Anatomy and Function , 2011, The Journal of Neuroscience.

[96]  R. Delamarter,et al.  Spinal Fusion in the United States: Analysis of Trends From 1998 to 2008 , 2012, Spine.

[97]  C. Maher,et al.  A modified Delphi approach to standardize low back pain recurrence terminology , 2011, European Spine Journal.

[98]  R. Deyo,et al.  Predicting Poor Outcomes for Back Pain Seen in Primary Care Using Patients' Own Criteria , 1996, Spine.

[99]  Thomas J. Schnitzer,et al.  Corticostriatal functional connectivity predicts transition to chronic back pain , 2012, Nature Neuroscience.

[100]  K. Dunn,et al.  Chronic pain reconsidered , 2008, PAIN.

[101]  K. Barker,et al.  Changes in the Cross-Sectional Area of Multifidus and Psoas in Patients With Unilateral Back Pain: The Relationship to Pain and Disability , 2004, Spine.

[102]  J. Farrar,et al.  Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations , 2009, PAIN.

[103]  M Rose,et al.  Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). , 2008, Journal of clinical epidemiology.

[104]  John D. Childs,et al.  A Clinical Prediction Rule To Identify Patients with Low Back Pain Most Likely To Benefit from Spinal Manipulation: A Validation Study , 2004, Annals of Internal Medicine.

[105]  C. Bombardier,et al.  Preliminary development of a responder index for chronic low back pain. , 2007, The Journal of rheumatology.

[106]  Werner Ceusters,et al.  Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Group†. , 2014, Journal of oral & facial pain and headache.