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Sorting back pain patients by their risk of a slow recovery and matching each to the right level of care led to less disability, fewer days off work, and lower costs than usual care.

Bottom line

In UK primary care, matching back pain treatment to a patient's prognostic risk improved disability outcomes and reduced costs versus usual best practice, though benefits for the highest-risk group were not sustained to 12 months.

Strong evidence

Published

2011
15 years ago
Older study

Evidence hierarchy

Meta-analysis
Systematic Review
RCT ◀ this study
Cohort
Case-Control
Case Report
Expert Opinion

Study participants

851 randomised (568 intervention, 283 control)18-87 years (mean 50)59% women (500 of 851)

Adults aged 18+ consulting about back pain (with or without radiculopathy) at ten general practices in England

Full research — for clinicians and curious readers

Study Summary

This UK randomised controlled trial tested whether matching back pain treatment to a patient's risk of poor recovery (low, medium, or high risk, sorted by the Keele STarT Back Screening Tool) works better than current best primary care. Among 851 adults with back pain at ten English general practices, the stratified-care group had significantly greater reductions in disability (Roland Morris Disability Questionnaire) at both 4 and 12 months than the control group, with effect sizes of 0.32 and 0.19 respectively. Stratified care also produced a small gain in quality-adjusted life years and was less costly, including fewer days off work. The authors conclude that prognostic screening with matched treatment pathways may improve outcomes and efficiency in back pain care, though some risk-group benefits (notably the high-risk group at 12 months) were not statistically significant.

84/100
Evidence StrengthStrong
Study Quality
Sample Size
Replication

Key Findings

Stratified care reduced disability more than usual best practiceHigh

Adjusted mean change in RMDQ score was significantly higher in the intervention group at 4 months (4.7 vs 3.0; between-group difference 1.81, 95% CI 1.06-2.57) and at 12 months (4.3 vs 3.3; difference 1.06, 95% CI 0.25-1.86), equating to effect sizes of 0.32 and 0.19.

Stratified care saved money and slightly improved quality of lifeHigh

At 12 months stratified care was associated with 0.039 additional QALYs and lower mean back-pain-related health-care costs (£240.01 vs £274.40), with the intervention dominant (greater benefit at lower cost) in 92% of bootstrap replications.

Low-risk patients did just as well with minimal treatmentHigh

Outcomes in the low-risk group were non-inferior even though far fewer low-risk intervention patients (7%) were referred for further treatment than low-risk controls (49%), supporting that many low-risk patients receive unnecessary treatment under usual care.

High-risk benefit was significant short-term but not at 12 monthsMedium

For high-risk patients, the between-group RMDQ difference was significant at 4 months (mean change 6.8) but the 12-month difference (5.9) was not significant; the authors note further research is needed to confirm whether benefits are sustained.

Reduced work absence and resource useMedium

The intervention group took fewer days off work, attended fewer physiotherapy sessions (mean 4.2 vs 5.1) over a shorter span (47.7 vs 69.4 days), and was associated with a mean indirect productivity cost saving of £675 over 12 months.

Study Methodology
Study Design
Pragmatic, two-arm randomised controlled trial with parallel economic (cost-effectiveness) evaluation; computer-generated stratified block randomisation, 2:1 ratio (intervention:control); intention-to-treat analysis with multiple imputation; assessor (research nurse) masked to allocation. Registered ISRCTN37113406.
Sample Size
851 patients randomised (568 intervention, 283 control); 1573 adults responded to assessment-clinic invitations
Duration
12-month follow-up, with outcomes at baseline, 4 months, and 12 months
Population
Adults aged 18 and older consulting about back pain (with or without radiculopathy) at ten general practices in England; mean age 50 years (range 18-87), 59% women; classified by STarT Back as 26% low, 46% medium, 28% high risk. Excluded serious spinal/systemic disorders, current axis 1/2 mental health treatment, recent spinal surgery, and pregnancy.
Outcome Measures
Roland Morris Disability Questionnaire (RMDQ, primary outcome at 12 months) · Back pain intensity · Pain Catastrophizing Scale · Tampa Scale of Kinesiophobia (fear-avoidance) · Hospital Anxiety and Depression Scale · EuroQol EQ-5D and Short Form 12 (quality of life) · QALYs and back-pain-related health-care costs · Days off work · Treatment satisfaction and global change · STarT Back risk-subgroup reduction

Strengths

  • High internal validity: remote randomisation, protocol-driven treatments, and masking of outcome assessors
  • Large sample powered to examine effects separately within low-, medium-, and high-risk subgroups
  • Consistent results across several distinct outcomes (disability, pain, mood, quality of life, work days)
  • Sensitivity analyses (complete-case and adjustment for therapist effects) did not change clinical or economic conclusions
  • Integrated within-trial economic evaluation with bootstrap cost-effectiveness analysis

Limitations

  • Greater-than-anticipated loss to follow-up (about 25%) with a slight imbalance in attrition between groups; non-responders were younger than responders
  • Participants, administrators, and physiotherapists could not be masked to allocation
  • Complex physiotherapy delivery (variable sessions and therapists) meant therapist-effect adjustment was limited to a designated main therapist, leaving possible residual variability
  • The high-risk group's benefit was not statistically significant at 12 months, so durability of benefit is uncertain
  • Conducted in UK primary care; results may not generalise to other health-care settings or to other musculoskeletal complaints
  • The design cannot determine whether subgroup benefits came from better referral patterns or from the content/quality of follow-up physiotherapy

Key Takeaways for Patients

What This Means for You

  1. 01A short questionnaire (the STarT Back Screening Tool) can sort people with back pain into low, medium, or high risk of a slow recovery, helping match each person to the right level of care.
  2. 02If your back pain is low risk, you may recover just as well with advice, education, and self-management (such as staying active and using resources like the Back Book) as with extra physiotherapy referrals.
  3. 03Matching treatment to risk was linked to less disability, fewer days off work, and lower costs over a year compared with usual care.
  4. 04Higher-risk patients may benefit from more intensive, psychologically informed physiotherapy, though the longer-term (12-month) benefit for the highest-risk group was less certain in this trial.
  5. 05This approach was tested in UK primary care and may not apply identically to other health systems or to other musculoskeletal conditions.

Read the Full Paper

Access the complete peer-reviewed study from The Lancet

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