Case study: STarT Back Trial
Comparison of stratified primary care management for low back pain with current best practice: a randomised controlled trial
It is widely known that back pain can be a considerable problem for some people and remains a challenge for GPs and physiotherapists to treat. The STarT Back Trial, funded by Arthritis Research UK, is an example of a stratified care approach according to a patient’s prognosis (low, medium or high risk). By using a targeted questionnaire tool, primary care clinicians can identify the correct course of treatment for the patient.
The study compared the clinical and cost effectiveness of those participants who received the stratified care approach with those that did not. The study recruited 1573 participants, 18 years and over who were suffering from back pain. Consultations took place at 10 general practices within West Midlands North region. Potential participants were identified via support from the National Institute for Health Research Clinical Research Network. The study ran from June 2007 until November 2008.
At an assessment clinic patients were screened for risk and placed into three ‘risk’ groups, with a matched treatment pathways to target the right treatment to the right patient. This included avoiding over treatment and supporting self-management for low risk patients and teaching physiotherapists to provide a combined physical and psychologically informed treatment approach for high risk patients. The Roland and Morris Disability Questionnaire, a widely used health status measure for low back pain, was used to measure whether the treatments helped relieve back pain and improved patients’ ability to function. For the economic evaluation, the study focused on estimated incremental quality adjusted life years (QALYs) and health-care costs related to back pain. Trial recruitment exceeded expectation with full recruitment achieved four months ahead of time.
- 16 months study: June 2007 to November 2008
- Prevalence study: 1573 participants over 18 years of age
- 10 general practices in the West Midlands North region
- Funded by Arthritis Research UK
- Principal Investigator: Dr Jonathan Hill, Musculoskeletal Senior Research Physiotherapist at Keele University
Outcomes and findings
The STarT Back Trial resulted in five key findings:
- At both four and 12 months, participants in the intervention group showed a significant improvement in disability scores compared with participants in the control group
- At 12 months the intervention group were more likely to report reduced pain, less depression and better general health
- Participants given the stratified care intervention were also significantly more likely to be satisfied with their treatment compared with current best care at four months
- Participants in the intervention group took fewer days off work because of back pain over the 12 month study period
- The stratified management intervention resulted in a greater health benefit; achieved at a lower healthcare cost
Value to the NHS
The STarT Back Tool is recommended in the latest NICE Low Back Pain guidelines 2016. The West Midlands Academic Health Science Network supported the wider adoption of the STarT Back approach and upskilling physiotherapists to provide combined physical and psychologically informed treatment for more complex (high-risk) patients.
It has been taken up more widely than the West Midlands, for example, more than 80 GP practices in Liverpool have adopted the tool so far and it has been translated into over 30 languages. It has been included in the Allied Health Professional Musculoskeletal toolkit, Map of Medicine Pain Pathways and a Royal College of General Practitioners’ e-learning module.
The STarT Back Tool has been embedded in local clinical pathways, but also in the Strategic pathways designed for the Staffordshire Sustainability Transformation Plan (NHS England). The approach has been recommended by NHS England National Low Back and Radicular Pathway 2017.
The research team is working with healthcare services in Australia, Canada, Israel, Germany, Norway, Sweden and the USA; these collaborations include five replication randomised controlled trials, four implementation studies and numerous translation and validation studies of the STarT Back prognostic tool.
Dr Jonathan Hill, Musculoskeletal Senior Research Physiotherapist at Keele University and STarT Back Principal Investigator said:
“For many years, the potential for targeting treatment has been emphasised as a research priority for back pain. The results of this trial provide the first evidence that a stratified management approach to target the provision of primary care significantly improves patient outcomes and is associated with substantial economic benefits compared with current best practice.”