A Comparison of Two Different Self-management Programmes for Patients With Back Pain: A Double-blind Randomised Controlled Trial.

Research Questions The overarching aim of this mixed methods study is to investigate whether the use of a structured self-management programme (the Pain Toolkit) results in better outcomes for patients with chronic back pain compared to usual care. There will be a quantitative and qualitative component to the work. In the quantitative component patients will complete outcome measure scores at baseline and then 6 and 12 months after receiving the Pain Toolkit or the standard programme for self-management. In the qualitative component a group of patients will be invited to participate in semi-structured interviews after using the Pain Toolkit. The interviews will explore their experience of using of the toolkit, its acceptability and ease of use.

The principle research question is:

1. To investigate the effectiveness of structured self-management (the Pain Toolkit) compared to unstructured advice/information on function for patients discharged to self-management from an evidence based back pain pathway.

The secondary research question is: 2. To investigate the effectiveness of structured self-management (the Pain Toolkit) compared to unstructured self-management advice/information on pain for patients discharged to self-management from an evidence based back pain pathway. 3. To investigate the effectiveness of structured self-management (the Pain Toolkit) compared to unstructured self-management advice/information on quality of life for patients discharged to self-management from an evidence based back pain pathway 4. To investigate the effectiveness of structured self-management (the Pain Toolkit) compared to unstructured self-management advice/information on healthcare utilisation for patients discharged to self-management from an evidence based back pain pathway 5. To explore patients' experiences of using the Pain Toolkit for self-management of pain

Background There is a wealth of literature outlining the disease burden of chronic pain and in particular back pain, which forms the basis of the background to this study. Pain is widespread in the UK with almost 10 million people affected almost every day (British Pain Society 2015). More locally, for Durham Dales, Easington and Sedgefield Clinical Commissioning Group (DDES CCG) where the student researcher works, the highest cost prescribed drug is Pregabalin which is primarily used as a pain relieving medication. The CCG spends in excess of £2m per year on this one drug alone (DDES 2016). Focussing on the literature relating to back pain, the World Health Organisation state that: 'back pain is not a disease but a constellation of symptoms. In most cases, the origins remain unknown' (WHO 2013). In 2010 the Global Burden of Disease Study estimated that low back pain was among the top 10 diseases and injuries that account for the highest number of Disability Adjusted Life Years worldwide (Al Mazroa 2013). The impact of this is demonstrated in the UK, by the Trades Union Congress (TUC 2008) who reported that British businesses lose an estimated 4.9 million days per year to work related back pain, with the North East of England suffering more than most. Other authors concur that most people will experience low pain at some point in their lives (Hoy, Brooks et al 2010 p769; Yang et al 2016 p459).