Research Review By Dr. Jonathan Hill (Guest Contributor & lead author of this study)

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Date Posted:

December 2011

Study Title:

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

Authors:

Hill JC, Whitehurst DGT, Lewis M et al.

Author's Affiliations:

Arthritis Research UK Primary Care Centre, Primary Care Sciences, Keele University, Stoke-on-Trent, United Kingdom

Publication Information:

Lancet 2011; 378: 1560-1571.

Study Summary:

High Profile Back Pain Trial:

The results of the STarT Back Trial, published in The Lancet, have generated enormous international interest among the manual medicine community from Norway to America.

Back pain is not just extremely common, but also complicated. What for some people might be a painful if short-lived affair can too often become chronic (long-lasting) in others. Current guidelines for GPs highlight the need to give good advice to patients about taking painkillers, avoiding bed rest and continuing their daily activities, including staying at work. For most patients that is sufficient.

However, some people don’t recover so quickly and might need referral for exercise or manual therapy, while others may need their fears and anxieties about their pain, motivation, mood and work situation addressed. When back pain doesn’t clear up, and treatment doesn’t seem to help, the consequences can be severe, with sufferers at risk of becoming de conditioned, depressed and immobile, some losing their jobs and even self-confidence along the way.

Although trials have reported the benefits of a wide range of treatments such as exercise, manual therapy and cognitive behavioural approaches compared with standard care, a lack of evidence about which patients are likely to benefit from these interventions has reduced the efficiency of primary care management. The results of the STarT Back trial specifically address this gap in the existing evidence to better inform commissioners and providers of services about how back pain can be better managed in the early stages.

The STarT Back Trial, funded by Arthritis Research UK, set out to answer the question ‘is a risk-targeted approach effective for the treatment of low back pain in primary care?’ 851 patients aged 18 and over who consulted their GP with non-specific low back pain (plus those with radiculopathy) were recruited to the trial from 10 general practices within the North Staffordshire area of the UK. They were randomised to receive either targeted treatment (the STarT Back approach), or current best physiotherapy care.

Targeted approach:
The STarT Back model combined two important components: the use of a prognostic screening questionnaire, and matched treatment pathways. To assess prognosis and determine whether patients were at low, medium or high risk of having persistent, disabling symptoms from their back pain, the approach used the previously validated Keele STarT Back Screening Tool (freely available in numerous languages from www.keele.ac.uk/sbst). Decisions about their onward treatment pathway for patients allocated to the active treatment arm were based on the STarT Back Tool score. All patients were assessed by a physiotherapist and given an evidence-based package of advice on how to manage their back pain.

Patients in the low risk group only received this single session. Patients in the medium and high risk groups were referred for a course of physiotherapy treatment. High risk patients were seen during longer appointment times by experienced physiotherapists, who had received extra training about how to address psychosocial problems associated with chronic back pain.

Current best care:
For patients in this arm of the trial, decisions about their treatment pathway were made by the physiotherapists according to their clinical experience and intuition. These physiotherapists were not informed about the patients’ prognosis using the STarT Back Tool score, but used their clinical judgement to decide whether or not to refer the patient to the local physiotherapy service for further treatment.

Findings:
The results show that a STarT Back – stratified care approach changes the pattern of referral to physiotherapy in a way that is more appropriate for patients needs, with low risk patients receiving a single session of advice to help them self-manage, and medium and high risk patients receiving more intensive treatment. Crucially, those patients at highest risk of their back pain becoming long-term benefited from a more intensive and experienced approach that addressed their specific worries. The study found that, when compared to best current care, the STarT Back approach improved disability, pain and distress, and importantly, helped patients take less time off work.

Overall, the stratified management intervention also resulted in a greater health benefit, which was achieved at a lower average healthcare cost, with an average saving of £34.39 per patient and lower average societal cost saving of £675 per patient. These findings are reassuring and suggest that a targeted treatment approach is not only more clinically effective but also more cost effective than current best care.

The authors also examined whether the new approach was more acceptable to patients. The findings of this aspect of the trial were highlighted in a presentation given earlier this year at The World Congress of Physical Therapy by Elizabeth Mason. The results showed that patients were more satisfied than the control group in terms of their expectations met (66% vs. 54% p = 0.002), satisfaction with treatment (73% vs. 54% p < 0.001), willingness to receive the same care again (75% vs. 66% p < 0.001) and satisfaction with information (81% vs. 71% p = 0.008).

The study was also groundbreaking in being designed a priori to be sufficiently powered to analyse the differences between the new stratified approach and the control package at the subgroup level of the low, medium and high risk groups.

This revealed some interesting findings; among low risk patients a one-off assessment with advice reinforcing positive messages about self-management and then immediate discharge from care, led to better satisfaction with treatment (62% vs. 59% p < 0.05) and equivalent clinical outcomes compared to best current care. This was despite 49 per cent of low risk patients in the control group being referred for an average of five additional sessions of physiotherapy! The implications appear to be that for milder, less problematic back pain problems, additional treatment beyond standard care involving a self-management focus, can be detrimental.

The subgroup analysis also identified that the allocation of additional resources and skills to enable physiotherapists to better manage high risk patients lead to significantly better clinical outcomes and satisfaction levels. Furthermore, despite the intensive high risk pathways being slightly more costly for healthcare services to provide, the additional costs in better managing this more complex subgroup were substantially outweighed by societal savings, and in any case by the health care savings made among low and medium risk groups from the stratified care approach.

The authors say: ‘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.’ More information including a video interview with members of the STarT Back team, can be found on the STarT Back website: http://www.keele.ac.uk/sbst

Commentary from Dr. Hill:

At last we have some positive news from high quality research that is likely to impact how back patients are managed in our clinics. While on the face of it a simple screening tool that classifies back problems into low, medium and high risk groups doesn't seem very radical, it has the potential to cause a huge shake up of models of care provided for our patients. In fact, in the UK we are seeing a huge number of health commissioners actively wanting to see this stratified approach implemented within their locality.

In part, this unusual enthusiasm from health commissioners to adopt this research is driven by the current financial situation and their need to have solutions to help ration expensive health resources for common conditions such as back pain. However, we clinicians have a role to ensure that the adoption is not only about saving money by stopping the over treatment for low risk patients, but also focused on the re-allocation of resources to improve the treatments provided for complex, high risk patients, who at present so often get too little, too late!