Title: Developing an activity pacing framework for the management of chronic pain/fatigue
Funder: Health Education England

Abstract: Background Patients with chronic pain/fatigue (such as chronic low back pain, chronic widespread pain/fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis) are often referred to the healthcare services; accounting for almost 20% of patients who frequently attend secondary care (Reid et al., 2002). The impact of such conditions includes disability, anxiety, depression and reduced quality of life (Clauw and Crofford, 2003; NICE, 2007). These conditions place a heavy financial burden on healthcare services due to repeat referrals/investigations/treatments, together with greater indirect costs from reduced employment/productivity (Burton et al., 2012; Konnopka et al., 2013). In the UK, low back pain alone costs healthcare services over 1600 million, with indirect costs of over 10500 million (as estimated in 1998) (Maniadakis and Gray, 2000). Healthcare professionals advise patients with chronic pain/fatigue to implement activity pacing; considered a key facet of cognitive behavioural therapy and graded exercise therapy (Wallman et al., 2004; Beissner et al., 2009). Despite anecdotal support and frequent recommendations of pacing, there is a paucity of empirical evidence (Andrews et al., 2012). Of the existing findings, pacing is associated with better symptoms (increased pain control, and decreased physical impairment, fatigue, anxiety and depression) (Nielson et al., 2001; Murphy et al., 2010; Cane et al., 2013). However, pacing has also been associated with worsened symptoms (increased pain, avoidance and disability) (McCracken and Samuel, 2007; Andrews et al., 2012). The mixed findings may be partly due to the absence of pacing guidelines. For some, pacing involves reducing activities (slowing down, breaking down tasks and using rest breaks) (White et al., 2007; Cane et al., 2013). For others, pacing involves planning, setting goals and gradually increasing activities (Sharpe, 2002; Birkholtz et al., 2004; Nielson et al., 2013). Therefore, patients, healthcare professionals and researchers may interpret/implement pacing differently. There is currently no pacing framework to standardise how it is instructed. Aim Develop an activity pacing framework to guide healthcare professionals in the management of chronic pain/fatigue. Research question What should be included in a comprehensive and clinically useful pacing framework for multi-disciplinary healthcare professionals? Study plan Stage I: Healthcare professional survey A mapping exercise of current pacing interventions will be undertaken across English NHS healthcare services/professionals (physiotherapists/occupational therapists/nurses/doctors/clinical psychologists). A sample of these professionals will complete an online survey regarding pacing interventions. The survey findings will help to develop the initial pacing framework. Stage II: Nominal Group Technique (NGT) Using a structured methodology, an expert panel of 4-5 patients and 5-8 healthcare professionals/experts will discuss the pacing framework in a NGT (consensus meeting). The panel will reach an agreement on what to include in the framework. Stage III: Feasibility and acceptability studies The pacing framework will be tested clinically in a physiotherapy rehabilitation programme for patients with chronic pain/fatigue (n=50). Self-report measures will be completed at the beginning and end of the programme, and at 3-months follow up including: pacing, self-efficacy and symptoms (pain, fatigue, anxiety, depression, avoidance and function). Exit interviews with 15-20 patients and the 6-8 physiotherapists facilitating the programmes will discuss the acceptability of the framework. Potential benefits to patients/NHS Pacing is currently instructed in varying ways and the implementation of different pacing facets is not evidence-based. The framework will standardise how pacing is instructed across different healthcare services/professionals which would enable a full trial to investigate the effects of pacing on patients' symptoms, quality of life and economic impact on the NHS. These findings could provide evidence to inform national guidelines, such as the NICE clinical guidelines (NICE, 2007), in which pacing is cautiously advised. Future study will develop a patient-friendly pacing manual to promote the independent long-term management of chronic pain/fatigue.

Lay abstract: What is the purpose of this research? Activity pacing is frequently advised by healthcare professionals for patients with chronic pain/fatigue; found to be among the most common coping strategies advised by physiotherapists. Pacing involves undertaking manageable activity levels to help cope with symptoms of pain and fatigue (tiredness/lack of energy) and improve function. This research will develop a framework for healthcare professionals (physiotherapists/occupational therapists/nurses/doctors/clinical psychologists) on how to instruct pacing for patients with chronic pain/fatigue (chronic low back pain, chronic widespread pain/fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis, CFS/ME). How will patients benefit from this research? The pacing framework will standardise how healthcare professionals across different services instruct pacing. The framework will improve treatments by providing guidance on the specific pacing components that have been found to benefit patients. Why does this research need to be done now? Many patients find pacing helpful based on research in which pacing was related to better symptoms (decreased fatigue, anxiety and depression). However, other studies found pacing was related to worsened symptoms (increased pain and disability). Presently, activity pacing is instructed in various ways by different healthcare professionals. For some, pacing involves reducing activities to manage symptoms (for example, breaking down tasks, spreading out activities and using rest breaks). For others, pacing involves trying to improve activity levels (for example, planning, setting goals and gradually increasing activities). While chronic pain/fatigue is a common and debilitating problem, there is no consistency of pacing instructions across different services and no framework to ensure that the pacing instructions are evidence-based. What is the scale of the issue? Almost one in five patients who frequently attend secondary care for investigations/treatments report symptoms of chronic pain/fatigue. There are huge costs associated with these conditions, including reductions in quality of life, and costs on the UK healthcare services and society due to reduced employment/productivity totalling over 12,000 million (in one year) for back pain alone. What methods have been chosen? The study has been designed around three phases to develop a pacing framework that is based on patients' and healthcare professionals' opinions, together with research evidence. Stage I: Survey of current pacing interventions The researcher will map out NHS healthcare services/professionals implementing pacing in England. A sample of these professionals will complete an online survey regarding current pacing interventions. The survey findings will help to develop the initial pacing framework. Stage II: Consensus meeting The pacing framework will be discussed in a meeting with 4-5 patients and 5-8 healthcare professionals/experts. This meeting will reach an agreement on what should be included in the pacing framework. Stage III: Testing the pacing framework The framework will be tested clinically by using it as the basis for a physiotherapy rehabilitation programme for patients with chronic pain/fatigue. Approximately 50 patients will be invited to complete a questionnaire booklet at the beginning and end of the programme and at 3-months follow up to measure pacing and symptoms (such as pain, fatigue, anxiety, depression and disability). Approximately 15-20 patients and 6-8 physiotherapists will be interviewed after the programme to discuss their opinions on the pacing framework. How have patients/public been involved so far? A meeting with five patients with chronic pain/fatigue provided advice on the study priorities/aims, methods, a draft questionnaire booklet and ways of reporting the findings. How will patients/public be involved in this study? An Advisory group including two patients, one researcher and one healthcare professional will meet regularly to discuss the research methods, information sheets and how to report the findings. The two advisory patients will be invited to help analyse the interview transcripts from Stage III. The researchers will work with other patients on Stages II and III to develop the pacing framework. How will the findings be reported? The researcher will work with the Advisory group to ensure that the findings are widely accessible. Participants will be informed of the study outcomes via a newsletter. The findings will be shared with patients/carers at patient forums/support groups (for example, CFS/ME and fibromyalgia groups, the NIHR Leeds Musculoskeletal Biomedical Research Unit (LMBRU)'s PPI group). The study outcomes will be distributed via traditional and social media, for example, the LMBRU webpage. The findings will be reported to healthcare professionals/researchers through scientific journals/presentations. What happens after this study? Future funding will be sought to support research to undertake a clinical trial to evaluate the pacing framework by assessing the effects of pacing on patients' symptoms. Based on these findings, a patient-friendly pacing manual will be developed to promote patients' independent long-term management of their condition.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: DISPUTED AETIOLOGY AND OTHER