Abstract
Background
One untested back pain treatment model is to stratify management depending on prognosis (low, medium or high-risk). This 2-arm RCT investigated: (i) overall clinical and cost-effectiveness of stratified primary care (intervention), versus non-stratified current best practice (control); and (ii) whether low-risk patients had non-inferior outcomes, and medium/high-risk groups had superior outcomes.
Methods
1573 adults with back pain (+/− radiculopathy) consulting at 10 general practices in England responded to invitations to attend an assessment clinic, at which 851 eligible participants were randomised (intervention n=568; control n=283). Primary outcome using intention-to-treat analysis was the difference in change in the Roland-Morris Disability Questionnaire (RMDQ) score at 12 months. Secondary outcomes included 4-month RMDQ change between arms overall, and at risk-group level at both time-points. The economic evaluation estimated incremental quality-adjusted life years (QALYs) and back pain-related health care costs.
Results
Overall, between-group differences in RMDQ adjusted mean change scores significantly favoured stratified care; 1·8 (95%CI 1·1, 2·6) at 4-months and 1·1 (95%CI 0·3, 1·9) at 12-months. Stratified care was associated with an increase in generic health benefit (0.039 additional QALYs) and cost savings. Low-risk patients had non-inferior outcomes compared with controls, and there were significant between-group differences in RMDQ adjusted mean change scores for medium-risk patients at 4 (1·99 [95%CI 0·75, 3·22]) and 12 months (1·33 [95%CI 0·15, 2·52]), and high-risk patients at 4 months (2·53 [95%CI 0·90, 4·16]).
Conclusion
A stratified approach of prognostic screening with treatment matched pathways for patients in primary care with back pain provides significant improvements in clinical and economic outcomes compared to current best practice.
Conflicts of Interest
None
Source of Funding
Arthritis Research UK.
This abstract has been presented at 3 international conferences but not yet at a national conference. It has also been accepted for publication in the Lancet – but is not yet published.
