Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial

Abstract

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.

Figure 1

Trial profile Two patients in the control group died during the study (one before 4-month follow-up and one before 12-month follow-up), one developed a serious comorbidity in the intervention group (before 4-month follow-up), and 20 contacted the National Health Service centre to withdraw from the study (14 in intervention group [12 before 4-month follow-up and two before 12-month follow-up] and six in control group [three before 4-month follow-up and three before 12-month follow-up]). At 4 months, 622 (90%) of 689 responders sent their responses in the post (419 [90%] of 466 in intervention group and 203 [91%] of 223 in control group); the remaining 67 (10%) responders supplied key outcome responses by telephone (47 [10%] in intervention group and 20 [9%] in control group). At 12 months, 567 (87%) of 649 responders sent their responses in the post (386 [88%] of 440 in intervention group and 181 [87%] of 209 in control group); 82 (13%) of 649 patients responded by telephone (54 [12%] in intervention group and 28 [13%] in control group). Of 689 responders at the 4-month follow-up, one patient in the control group did not complete the primary outcome measure (Roland and Morris Disability Questionnaire).

Figure 2

Mean change from baseline in RMDQ (primary outcome measure) scores at 4-month and 12-month follow-ups in all participants (A), low-risk participants (B), medium-risk participants (C), and high-risk participants (D) RMDQ=Roland and Morris Disability Questionnaire.

Figure 3

Cost-effectiveness plane for the comparison of the stratified management approach (intervention group) with current best practice (control group), based on 25 000 bootstrapped cost-effect pairs QALYs=quality-adjusted life years.