Proposing six criteria to improve reproducibility of “usual care” interventions in back pain trials: a systematic review

  • Stephanie C. Pascoe
    Corresponding author. DSc Post-Graduate Physical Therapy Department, Bellin College, 3201 Eaton Road, Green Bay, WI 54311, USA. Tel.: +1 719 321 9837; fax: +1 920 433 1922.
    Doctor of Science in Physical Therapy Program, Bellin College, Green Bay, WI, USA

    Orthopaedic Physical Therapy Residency Program, Evidence in Motion, San Antonio, TX, USA

    Department of Physical Therapy and Integrative Care, Wardenburg Student Health Center, Boulder, CO, USA
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  • Steven L. Spoonemore Jr.
    Doctor of Science in Physical Therapy Program, Bellin College, Green Bay, WI, USA

    U.S. Public Health Service, Anchorage, AK, USA
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  • Jodi L. Young
    Doctor of Science in Physical Therapy Program, Bellin College, Green Bay, WI, USA
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  • Daniel I. Rhon
    Doctor of Science in Physical Therapy Program, Bellin College, Green Bay, WI, USA

    Department of Rehabilitation Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, USA
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      The aim of this study is to determine how usual care is defined in clinical trials for low back pain and the components of care that inform its definition. Six components were proposed and assessed for inclusion: type of practitioner providing care, type of self-management education, addressing physical activity, type of medication, dose of the intervention, and reporting whether care was consistent with current guidelines.

      Study Design and Setting

      Systematic review of clinical trials published between January 1993 and June 2020.


      One hundred eighty-four studies with 37,989 pooled participants from 11 various settings were included. Only one study provided all six components; 86 (47%) studies provided at least three of six components, the most common being practitioner type, use of self-management education, and addressing physical activity.


      Most studies had fewer than 50% of the components, limiting reproducibility. There was wide variability in the characterization and number of definition components. Usual care interventions are poorly defined in back pain trials and limit understanding of comparator treatment effect sizes and reproducibility of interventions.

      Graphical abstract


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        • Maher C.
        • Underwood M.
        • Buchbinder R.
        Non-specific low back pain.
        Lancet. 2017; 389: 736-747
        • Voss T.
        • Allen C.
        Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015.
        Lancet. 2016; 388: 1545-1602
        • Wu A.
        • March L.
        • Zheng X.
        • Huang J.
        • Wang X.
        • Zhao J.
        • et al.
        Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017.
        Ann Transl Med. 2020; 8: 299
        • Macklin R.
        • Natanson C.
        Misrepresenting “usual care” in research: an ethical and scientific error.
        Am J Bioeth. 2020; 20: 31-39
        • Arch J.J.
        • Stanton A.L.
        Examining the “usual” in usual care: a critical review and recommendations for usual care conditions in psycho-oncology.
        Support Care Cancer. 2019; 27: 1591-1600
        • Yorganci E.
        • Evans C.J.
        • Johnson H.
        • Barclay S.
        • Murtagh F.E.
        • Yi D.
        • et al.
        Understanding usual care in randomised controlled trials of complex interventions: a multi-method approach.
        Palliat Med. 2020; 34: 667-679
        • Thompson B.T.
        • Schoenfeld D.
        Usual care as the control group in clinical trials of nonpharmacologic interventions.
        Proc Am Thorac Soc. 2007; 4: 577-582
        • Traeger A.C.
        • Buchbinder R.
        • Elshaug A.G.
        • Croft P.R.
        • Maher C.G.
        Care for low back pain: can health systems deliver?.
        Bull World Health Organ. 2019; 97: 423-433
        • Foster N.E.
        • Anema J.R.
        • Cherkin D.
        • Chou R.
        • Cohen S.P.
        • Gross D.P.
        • et al.
        Prevention and treatment of low back pain: evidence, challenges, and promising directions.
        Lancet. 2018; 391: 2368-2383
        • Oliveira C.B.
        • Maher C.G.
        • Pinto R.Z.
        • Traeger A.C.
        • Lin C.-W.C.
        • Chenot J.-F.
        • et al.
        Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview.
        Eur Spine J. 2018; 27: 2791-2803
        • Traeger A.C.
        • Lee H.
        • Hübscher M.
        • Skinner I.W.
        • Moseley G.L.
        • Nicholas M.K.
        • et al.
        Effect of intensive patient education vs placebo patient education on outcomes in patients with acute low back pain: a randomized clinical trial.
        JAMA Neurol. 2019; 76: 161-169
        • Smelt A.F.H.
        • van der Weele G.M.
        • Blom J.W.
        • Gussekloo J.
        • Assendelft W.J.J.
        How usual is usual care in pragmatic intervention studies in primary care? An overview of recent trials.
        Br J Gen Pract. 2010; 60: e305-e318
        • Cherkin D.C.
        • Sherman K.J.
        • Balderson B.H.
        • Cook A.J.
        • Anderson M.L.
        • Hawkes R.J.
        • et al.
        Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: a randomized clinical trial.
        JAMA. 2016; 315: 1240-1249
        • Young H.M.
        • Miyamoto S.
        • Tang-Feldman Y.
        • Dharmar M.
        • Balsbaugh T.
        • Greenwood D.
        Defining usual care in clinical trials.
        Res Gerontol Nurs. 2020; 13: 125-129
        • Rodgers H.
        • Bosomworth H.
        • van Wijck F.
        • Krebs H.I.
        • Shaw L.
        Usual care: the big but unmanaged problem of rehabilitation evidence – authors’ reply.
        Lancet. 2020; 395: 337-338
        • Mann H.
        • Djulbegovic B.
        Comparator bias: why comparisons must address genuine uncertainties.
        J R Soc Med. 2013; 106: 30-33
        • Somerville S.
        • Hay E.
        • Lewis M.
        • Barber J.
        • van der Windt D.
        • Hill J.
        • et al.
        Content and outcome of usual primary care for back pain- a systematic review 2008.
        Br J Gen Pract. 2008; 58: 790-797
        • Moher D.
        • Liberati A.
        • Tetzlaff J.
        • Altman D.G.
        • PRISMA Group
        Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.
        PloS Med. 2009; 6: e1000097
        • Koes B.W.
        • van Tulder M.
        • Lin C.-W.C.
        • Macedo L.G.
        • McAuley J.
        • Maher C.
        An updated overview of clinical guidelines for the management of non-specific low back pain in primary care.
        Eur Spine J. 2010; 19: 2075-2094
      1. Risk of bias tools - current version of RoB 2 n.d.
        (Available at)
        • Hoffmann T.C.
        • Glasziou P.P.
        • Boutron I.
        • Milne R.
        • Perera R.
        • Moher D.
        • et al.
        Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide.
        BMJ. 2014; 348: g1687
        • Williams C.M.
        • Maher C.G.
        • Hancock M.J.
        • McAuley J.H.
        • McLachlan A.J.
        • Britt H.
        • et al.
        Low back pain and best practice care: a survey of general practice physicians.
        Arch Intern Med. 2010; 170: 271-277
        • Kamper S.J.
        • Logan G.
        • Copsey B.
        • Thompson J.
        • Machado G.C.
        • Abdel-Shaheed C.
        • et al.
        What is usual care for low back pain? A systematic review of health care provided to patients with low back pain in family practice and emergency departments.
        Pain. 2020; 161: 694-702
        • Cherkin D.C.
        • Deyo R.A.
        • Battié M.
        • Street J.
        • Barlow W.
        A comparison of physical therapy, chiropractic manipulation, and provision of an educational booklet for the treatment of patients with low back pain.
        N Engl J Med. 1998; 339: 1021-1029
        • Schneider M.
        • Haas M.
        • Glick R.
        • Stevans J.
        • Landsittel D.
        Comparison of spinal manipulation methods and usual medical care for acute and subacute low back pain: a randomized clinical trial.
        Spine. 2015; 40: 209-217
        • Søgaard R.
        • Bünger C.E.
        • Laurberg I.
        • Christensen F.B.
        Cost-effectiveness evaluation of an RCT in rehabilitation after lumbar spinal fusion: a low-cost, behavioural approach is cost-effective over individual exercise therapy.
        Eur Spine J. 2008; 17: 262-271
        • Hansen B.B.
        • Kirkeskov L.
        • Begtrup L.M.
        • Boesen M.
        • Bliddal H.
        • Christensen R.
        • et al.
        Early occupational intervention for people with low back pain in physically demanding jobs: a randomized clinical trial.
        Plos Med. 2019; 16: e1002898
        • Eadie J.
        • Van De Water A.T.
        • Lonsdale C.
        • Tully M.A.
        • Van Mechelen W.
        • Boreham C.A.
        • et al.
        Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial.
        Arch Phys Med Rehabil. 2013; 94: 2083-2092
        • Hurley D.A.
        • Tully M.A.
        • Lonsdale C.
        • Boreham C.A.G.
        • van Mechelen W.
        • Daly L.
        • et al.
        Supervised walking in comparison with fitness training for chronic back pain in physiotherapy: results of the SWIFT single-blinded randomized controlled trial (ISRCTN17592092).
        Pain. 2015; 156: 131-147
        • Danielsen J.M.
        • Johnsen R.
        • Kibsgaard S.K.
        • Hellevik E.
        Early aggressive exercise for postoperative rehabilitation after discectomy [with consumer summary].
        Spine. 2000; 25: 1015-1020
        • Ben-Ami N.
        • Shapiro Y.
        • Chodick G.
        • Mirovsky Y.
        • Pincus T.
        Increasing recreational physical activity in patients with chronic low back pain: a pragmatic controlled clinical trial.
        J Orthop Sports Phys Ther. 2017; 47: 57-66
        • Blomberg S.
        • Hallin G.
        • Grann K.
        • Berg E.
        • Sennerby U.
        Manual therapy with steroid injections--a new approach to treatment of low back pain. A controlled multicenter trial with an evaluation by orthopedic surgeons.
        Spine. 1994; 19: 569-577
        • Critchley D.
        • McCracken L.
        • Wileman V.
        • Galea Holmes M.
        • Norton S.
        • Godfrey E.
        Physiotherapy informed by acceptance and commitment therapy (PACT) for people with chronic low back pain: a randomised controlled trial.
        Physiotherapy. 2019; 105: e34-e35
        • Hill J.C.
        • Whitehurst D.G.
        • Lewis M.
        • Bryan S.
        • Dunn K.M.
        • Foster N.E.
        • et al.
        Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial.
        Lancet. 2011; 378 (North American Edition): 1560-1571
        • George S.Z.
        • Fritz J.M.
        • Bialosky J.E.
        • Donald D.A.
        The effect of a fear-avoidance-based physical therapy intervention for patients with acute low back pain: results of a randomized clinical trial.
        Spine. 2003; 28: 2551-2560
        • Petrozzi M.J.
        • Leaver A.
        • Ferreira P.H.
        • Rubinstein S.M.
        • Jones M.K.
        • Mackey M.G.
        Addition of MoodGYM to physical treatments for chronic low back pain: a randomized controlled trial.
        Chiropr Man Therap. 2019; 27: 54
        • Amorim A.B.
        • Pappas E.
        • Simic M.
        • Ferreira M.L.
        • Jennings M.
        • Tiedemann A.
        • et al.
        Integrating mobile-health, health coaching, and physical activity to reduce the burden of chronic low back pain trial (IMPACT): a pilot randomised controlled trial.
        BMC Musculoskelet Disord. 2019; 20: 71
        • Gardner T.
        • Refshauge K.
        • McAuley J.
        • Hübscher M.
        • Goodall S.
        • Smith L.
        Combined education and patient-led goal setting intervention reduced chronic low back pain disability and intensity at 12 months: a randomised controlled trial.
        Br J Sports Med. 2019; 53: 1424-1431
        • Ilves O.
        • Hakkinen A.
        • Dekker J.
        • Pekkanen L.
        • Piitulainen K.
        • Jarvenpaa S.
        • et al.
        Quality of life and disability: can they be improved by active postoperative rehabilitation after spinal fusion surgery in patients with spondylolisthesis? A randomised controlled trial with 12-month follow-up.
        Eur Spine J. 2017; 3: 777-784
        • Meng K.
        • Seekatz B.
        • Roband H.
        • Worringen U.
        • Vogel H.
        • Faller H.
        Intermediate and long-term effects of a standardized back school for inpatient orthopedic rehabilitation on illness knowledge and self-management behaviors: a randomized controlled trial.
        Clin J Pain. 2011; 27: 248-257
        • Murphy S.E.
        • Blake C.
        • Power C.K.
        • Fullen B.M.
        Comparison of a stratified group intervention (STarT back) with usual group care in patients with low back pain: a Nonrandomized controlled trial.
        Spine. 2016; 41: 645-652
        • Cuesta-Vargas A.I.
        • Adams N.
        • Salazar J.A.
        • Belles A.
        • Hazañas S.
        • Arroyo-Morales M.
        Deep water running and general practice in primary care for non-specific low back pain versus general practice alone: randomized controlled trial.
        Clin Rheumatol. 2012; 31: 1073-1078
        • Godfrey E.
        • Wileman V.
        • Galea Holmes M.
        • McCracken L.M.
        • Norton S.
        • Moss-Morris R.
        • et al.
        Physical therapy informed by acceptance and commitment therapy (PACT) versus usual care physical therapy for adults with chronic low back pain: a randomized controlled trial.
        J Pain. 2019; 21: 71-81
        • Critchley D.J.
        • Ratcliffe J.
        • Noonan S.
        • Jones R.H.
        • Hurley M.V.
        Effectiveness and cost-effectiveness of three types of physiotherapy used to reduce chronic low back pain disability: a pragmatic randomized trial with economic evaluation.
        Spine. 2007; 32: 1474-1481
        • Daulat A.
        A pragmatic randomized controlled trial to compare a novel group physiotherapy programme with a standard group exercise programme for managing chronic low back pain in primary care.
        Int Musculoskelet Med. 2016; 38: 97-108
        • Heberle H.
        • Meirelles G.V.
        • da Silva F.R.
        • Telles G.P.
        • Minghim R.
        InteractiVenn: a web-based tool for the analysis of sets through Venn diagrams.
        BMC Bioinformatics. 2015; 16: 169
        • Zuidgeest M.G.P.
        • Welsing P.M.J.
        • van Thiel G.J.M.W.
        • Ciaglia A.
        • Alfonso-Cristancho R.
        • Eckert L.
        • et al.
        Series: pragmatic trials and real world evidence: paper 5. Usual care and real life comparators.
        J Clin Epidemiol. 2017; 90: 92-98
        • Williams K.
        • Abildso C.
        • Steinberg L.
        • Doyle E.
        • Epstein B.
        • Smith D.
        • et al.
        Evaluation of the effectiveness and efficacy of Iyengar yoga therapy on chronic low back pain.
        Spine. 2009; 34: 2066-2076
        • Lisi A.J.
        • Scheinowitz M.
        • Saporito R.
        • Onorato A.
        A pulsed electromagnetic field therapy device for non-specific low back pain: a pilot randomized controlled trial.
        Adv Pain Res Ther. 2019; 8: 133-140
        • Kulig K.
        • Beneck G.J.
        • Selkowitz D.M.
        • Popovich Jr., J.M.
        • Ge T.T.
        • Flanagan S.P.
        • et al.
        An intensive, progressive exercise program reduces disability and improves functional performance in patients after single-level lumbar microdiskectomy.
        Phys Ther. 2009; 89: 1145-1157