Integrating physical and psychological approaches to treatment in low back pain: the development and content of the STarT Back trial's ‘high-risk’ intervention (StarT Back; ISRCTN 37113406)
Introduction
The recent National Institute for Health and Clinical Excellence guidelines for low back pain recommend a combined physical and psychological treatment programme for patients with low back pain presenting with a high level of disability or distress [1], although there are no specific guidelines on how to do this. Previous research in this field has demonstrated that although cognitive-behavioural approaches appear to be acceptable to patients, and are able to achieve comparable clinical outcomes to other active interventions [2], evidence for their superiority over other treatments is far from robust. A recent Cochrane review of clinical trial evidence concluded that the benefits from the use of early psychosocial interventions for patients with musculoskeletal pain were limited [3]. In low back pain, a number of plausible reasons have been suggested to explain these findings, including: the selection of heterogeneous patient populations in clinical trials; insufficient targeting of interventions on modifiable risk factors; insufficient competencies of care providers; insufficient intensity or duration of the intervention; inadequate adherence to treatment protocols; and inadequate assessment of outcome [4]. Alternatively, it may be that psychosocial interventions are ineffective. However, a recent trial in chronic low back pain demonstrated the superiority of a group cognitive-behavioural therapy intervention package compared with usual care in terms of more effectiveness (Roland and Morris Disability Questionnaire) at 1 year, and cost-effectiveness, mainly as a consequence of the group treatment format [5]. Further research is clearly needed.
In response to the limitations described by van der Windt et al. [4], the present authors developed a novel way of stratifying patients with low back pain according to prognostic risk factors, and targeting treatment accordingly [6]. This new approach to stratifying for targeted treatment (the Keele STarT Back approach) is currently being evaluated in clinical studies [7], [8]. The aim of this paper is to describe the rationale, development process, key learning objectives, structure and methods of delivery of the training package for physiotherapists delivering treatment to those patients classified as ‘high risk’ for poor outcome in the future.
Section snippets
Rationale for the high-risk treatment and training package
The Keele STarT Back Screening Tool produces two scores: an overall score and a distress subscale score [9]. The distress subscale score is used to identify the high-risk group. Responses to the following five items are added to score this subscale: fear, anxiety, catastrophising, depression and bothersomeness. Subscale scores therefore range from 0 to 5, with patients that score 4 or 5 being classified as high risk. The overall score is used to separate the low-risk patients from the
Development of the training package for clinicians delivering the high-risk intervention
The content of the high-risk intervention was guided by the risk profile of patients in the high-risk subgroup, so that the new intervention could be designed to target their clinical characteristics specifically. Hence, the eight specific risk factors measured by the screening tool (disability, comorbid pain, referred pain, anxiety, mood, fear, catastrophising/negative future expectations and overall bothersomeness) were the framework for the intervention, and the training package focused on
Key learning objectives of the STarT Back high-risk training course
The overall aims of the course are to give participants knowledge of the relevant evidence base, an adequate understanding of key processes involved in the transition from acute to chronic pain, the opportunity to develop the relevant clinical skills to tackle obstacles to recovery through psychologically informed re-activation, and to establish their confidence to utilise these skills effectively. The key learning objectives are shown in Box 3.
Structure and methods of delivery of the STarT Back high-risk training course
The structure of the final high-risk training course comprises a 6-day programme, consisting of blocks of 2 days with time in between to put skills into practice, with additional mentoring sessions. The methods of delivery include a mixture of didactic teaching, small group discussion, role play and elicitation of psychosocial risk factors with simulated patients, supplemented by comprehensive written material and handouts. Prior to attending the course, trainees are given key references
Discussion
This paper has described the rationale underpinning the Keele STarT Back approach, and the development of the key learning objectives, structure and methods of delivery of the training programme for the physiotherapists who treat the complex (high-risk) patients in the STarT Back approach to managing low back pain in primary care [7].
The authors have attempted to extend the core expertise in biomedical management with a clear and explicit additional focus on psychosocial aspects of pain of the
Further challenges
There are, of course, unanswered questions in terms of screening, efficacy of the training in the establishment of enhanced skills, establishing the extent to which trained physiotherapists implement the training in clinical practice, and the feasibility of delivering this training in routine clinical practice. The clinical and cost-effectiveness of this new approach have been reported in the main trial outcome papers [7] and the aforementioned implementation study [27]. The evidence-based
Acknowledgements
The authors wish to thank the rest of the StarT Back team: Kate M. Dunn, Martyn Lewis, Elizabeth E. Mason, Kika Konstantinou, Simon Somerville, Kanchan Vohora and David Whitehurst, and the physiotherapy trainees; Professors Linton, Morley and Sullivan for their invaluable help and advice in developing the training programme; and Arthritis Research UK, Keele University, NHS Stoke and North Staffordshire, the North Staffordshire Primary Care Research Consortium and the primary care delivery arm
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