Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial
Open accessAbstract
Background Back pain remains a challenge for primary care internationally. One model that has not been tested is stratification of the management according to the patient's prognosis (low, medium, or high risk). We compared the clinical effectiveness and cost-effectiveness of stratified primary care (intervention) with non-stratified current best practice (control).Methods 1573 adults (aged ≥18 years) with back pain (with or without radiculopathy) consultations at ten general practices in England responded to invitations to attend an assessment clinic. Eligible participants were randomly assigned by use of computer-generated stratified blocks with a 2:1 ratio to intervention or control group. Primary outcome was the effect of treatment on the Roland Morris Disability Questionnaire (RMDQ) score at 12 months. In the economic evaluation, we focused on estimating incremental quality-adjusted life years (QALYs) and health-care costs related to back pain. Analysis was by intention to treat. This study is registered, number ISRCTN37113406.Findings 851 patients were assigned to the intervention (n=568) and control groups (n=283). Overall, adjusted mean changes in RMDQ scores were significantly higher in the intervention group than in the control group at 4 months (4·7 [SD 5·9] vs 3·0 [5·9], between-group difference 1·81 [95% CI 1·06-2·57]) and at 12 months (4·3 [6·4] vs 3·3 [6·2], 1·06 [0·25-1·86]), equating to effect sizes of 0·32 (0·19-0·45) and 0·19 (0·04-0·33), respectively. At 12 months, stratified care was associated with a mean increase in generic health benefit (0·039 additional QALYs) and cost savings (£240·01 vs £274·40) compared with the control group.Interpretation The results show that a stratified approach, by use of prognostic screening with matched pathways, will have important implications for the future management of back pain in primary care.Funding Arthritis Research UK.
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There is substantial uncertainty about the generalizability of formal prognostic scales such as the STarT Back instrument to subspecialty patients and older adults.
“After considerable discussion about formal prognostic scales for stratification, such as the Subgroups for Targeted Treatment (STarT) Back instrument,60 the RTF decided there remained substantial uncertainty about generalizability to subspecialty patients and older adults.”
From Report of the NIH Task Force on research standards for chronic low back pain. (2014) · cites this paper as [60]
Recent work, such as the STarT Back project, has made important advances in prognostic stratification of patients with chronic low back pain.
“Recent work such as the STarT Back project from the U.K. has made important advances in this regard,57–60”
From Report of the NIH Task Force on research standards for chronic low back pain. (2014) · cites this paper as [60]
In this study, the completion rate of 87.5% was higher than that reported for conventional or home-based rehabilitations (range 30-76.3%) and by other digital MSK interventions (73-87%).
“In this study, we observed a completion rate of 87.5%, higher than that reported for conventional or home-based rehabilitations (range 30–76.3%) [34, 77, 78], and by other digital MSK interventions (73–87%) [62, 79].”
From Telerehabilitation of acute musculoskeletal multi-disorders: prospective, single-arm, interventional study (2022) · cites this paper as [77]
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Self-citation
- Authors
- Hill, J. C., Whitehurst, D. G., Lewis, M., Bryan, S., Dunn, K. M., Foster, N. E., Konstantinou, K., Main, C. J., Mason, E., Somerville, S., Sowden, G., Vohora, K., & Hay, E. M.
- Affiliations
- Arthritis Research UK (GB)
- University of British Columbia (CA)
- Corresponding author
- Hill, Jonathan C
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2011-10
- Volume
- 378
- Issue
- 9802
- Pages
- 1560-1571
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC3208163
- OpenAlex
- W2160769294
- Cited by
- 1,306
- References
- 39
- Citations by year
- 2026: 45 · 2025: 63 · 2024: 71 · 2023: 79 · 2022: 98 · 2021: 108 · 2020: 104 · 2019: 104 · 2018: 103 · 2017: 103 · 2016: 105 · 2015: 96 · 2014: 85 · 2013: 98 · 2012: 38
- FWCI
- 52.48
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute for Health and Care Research (RP-PG-0707-10131)
- Versus Arthritis (17741)
- Topics
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Pathology and Forensic Medicine › Spine and Intervertebral Disc Pathology
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Medical Practices and Rehabilitation
- Keywords
- low back pain, stratified care, primary care, radiculopathy, disability, quality-adjusted life years, cost-effectiveness, general practice
- MeSH terms
- Adult, Aged, Combined Modality Therapy, Cost-Benefit Analysis, Female, United Kingdom, Humans, Male, Middle Aged, Pain Measurement, Practice Patterns, Physicians', Prognosis, Reference Values, Severity of Illness Index, Treatment Outcome, Cost Savings, Low Back Pain, Risk Assessment, Quality-Adjusted Life Years, Disease Management, General Practice
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