Newton, Christopher
(2021)
Cognitive Functional Therapy for persistent low back pain: A mixed methods feasibility study.
PhD thesis, University of Nottingham.
Abstract
Background
Low back pain (LBP) is the most disabling and costly health condition globally, causing persistent pain and disability for more than ten million people in the United Kingdom (UK). Persistent LBP is characterised by a complex interplay of biopsychosocial factors that results in variable and fluctuating levels of pain and disability for each person. However, the contemporary management of persistent LBP has failed to integrate the multidimensional complexity of the disorder or target treatment towards individuals’ needs. A plethora of physical, behavioural, combined (physical and behavioural) and psychologically informed physiotherapy interventions have all resulted in modest reductions in pain and disability when compared to minimal treatment or care as usual, with no one type of intervention demonstrating superiority over another.
Cognitive Functional Therapy (CFT) is an individually tailored, psychologically informed physiotherapist-led intervention, specifically developed to target the biopsychosocial complexity of persistent LBP. CFT has demonstrated encouraging results in two randomised controlled trials (RCT), in Norway and Ireland, with superior and sustained clinically important outcomes in comparison to guideline recommended care. However, CFT has not previously been evaluated in the UK National Health Service (NHS). Before the clinical and cost-effectiveness of CFT can be measured in a suitably powered RCT the feasibility of completing such a trial, in the UK health setting, needed to be established. This PhD thesis examines the feasibility of completing a future definitive RCT that would evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care (UPC) for patients with persistent LBP in the UK NHS.
Method
The feasibility of applying CFT in the UK NHS was investigated using a mixed methods approach over three studies. Study one (Chapter two), established the barriers and facilitators to implementing CFT within the NHS from the perspectives of physiotherapists (n=10) and a purposive sample of patient participants (n=8) using semi-structured interviews and framework method. Study two (Chapter three), was a pragmatic two-arm parallel feasibility RCT that compared CFT with UPC for 60 patient participants with persistent LBP. The criteria to progress to a definitive RCT were established a priori. In study three (Chapter four), a qualitative process evaluation of the feasibility RCT explored the acceptability of the research processes and the experiences of the interventions from the perspectives of patient participants and their treating physiotherapists. Eight semi-structured interviews (patient participants) and two focus groups (the first focus group included the four physiotherapists who delivered CFT and the second focus group comprised of the six physiotherapists who provided UPC within the trial) were conducted and analysed thematically.
Results
Study one
Ten NHS physiotherapists who completed a three-day CFT training programme learnt a new biopsychosocial understanding of LBP and additional skills that they could apply to their clinical practice. Ongoing peer support and mentorship following CFT training was suggested to sustain changes to their clinical practice. Barriers to implementing CFT included concerns from physiotherapists about extending their scope of practice in addressing psychological factors with patients and the difficulty of letting go of biomedical treatments. Patient participants (n=8) recognised the difference between CFT and UPC when interviewed. They welcomed the CFT approach as beneficial and it enabled self-management of their LBP. Healthcare system barriers included lack of appointment time and limited availability of follow-up appointments. Key findings were incorporated into study two. For example, the CFT training programme was expanded to include six months of practice-based learning with mentorship sessions provided by a CFT educator, initial appointment times were increased to one hour and follow-up appointments were reserved in clinician’s diaries.
Study two
In total, 60 patient participants (n=30 CFT and n=30 UPC) were recruited to the feasibility RCT with >70% retained at six-month follow-up. CFT was delivered to fidelity, relevant and clinically important outcome data were rigorously collected and CFT was tolerated by patients with no safety concerns. Intention to treat analysis indicated a signal of effect in favour of CFT with moderate and large between group effect sizes observed for a range of outcome measures at three and six-month follow-up. The Roland Morris disability questionnaire was the most suitable primary outcome measure and sample size calculations were completed for a future definitive RCT.
Study three
The embedded process evaluation confirmed that the feasibility RCT procedures were acceptable to patients and the CFT training programme provided the physiotherapists with the necessary knowledge, skills and confidence to deliver CFT as intended. The UPC training programme was also acceptable to the physiotherapists but the intervention was not always delivered to fidelity and evidence suggested that there was the potential for contamination of UPC with aspects of the CFT intervention. The Common Sense Model of Illness Representations was used to interpret and understand the perceived mechanisms of effect of CFT and differentiate the two interventions.
Conclusion
This PhD thesis confirms it is feasible to conduct a randomised study of CFT in comparison to UPC for NHS patients with persistent LBP and indicates a future, fully powered RCT to determine the clinical and cost effectiveness could be completed. Novel insights into the barriers, facilitators, feasibility, acceptability and the perceived mechanisms of effect of CFT in the context of the UK NHS have been provided. CFT also appeared to result in improved treatment outcomes in comparison to UPC, further supporting the need for a definitive RCT to be completed. Due to the potential contamination observed, a multi-centre cluster RCT design is recommended for the future study.
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