Cognitive functional therapy for low back pain: a feasibility randomised controlled trial

INTERVENTION: Eligible and consenting participants will be randomly allocated to receive either usual physiotherapy care or Cognitive Functional Therapy. Cognitive Functional Therapy (CFT) is an individualised self‐management intervention for low back pain. CFT employs a multidimensional clinical reasoning framework to identify and target the biopsychosocial complexity of low back pain. Management is tailored towards each person’s unique clinical presentation and context. The intervention comprises three integrated components: 1. Making sense of pain: a reflective process that combines the person’s own narrative (interview) and experience (during guided behavioural experiments) to developing a personally‐relevant, multidimensional understanding of pain for the patient. In this process, unhelpful beliefs are dispelled. 2. Exposure with ‘control’: a process of graded movement exposure to feared, painful and or avoided movements and activities, in order to build self‐efficacy to engage in goal orientated functional tasks. 3. Lifestyle change: a process of behavioural modification addressing unhelpful lifestyle factors aimed at increasing physical activity levels based on preference, enhancing sleep habits, regulation of stress (via relaxation techniques) and/or dietary advice where relevant. Usual physiotherapy care Participants will receive usual physiotherapy care in keeping with standard assessment procedures and decision making by the treating physiotherapist. Physiotherapy treatment for low back pain typically includes education, manual therapy and stretching, strengthening and cardiovascular exercise. Both interventions will be delivered over three months with no restriction on the number of sessions undertaken during this period. The first appointment will be for 1 hour and follow‐up appointments for 30 minutes for both interventions. CONDITION: Low back pain ; Musculoskeletal Diseases PRIMARY OUTCOME: ; To determine the feasibility of completing a future fully powered randomised controlled trial by;; 1. Measuring eligibility, recruitment and retention rates of participants.; 2. Measuring response rates to patient‐reported outcome measures.; 3. Decide the primary outcome measure for a definitive trial.; 4. Calculate the sample size for the definitive RCT, should feasibility be assured.; 5. Record any arising adverse events.; 6. Evaluate intervention adherence.; 7. Explore the acceptability of the intervention and the research process as experienced by participants and physiotherapists.; INCLUSION CRITERIA: 1. Dominant low back lasting for more than three months 2. Activity and/or functional limitations due to low back pain 3. A Numeric Pain Rating Scale (NPRS) score =3/10 during the last week 4. Being independently mobile to be capable of participating in a rehabilitation programme SECONDARY OUTCOME: ; The following patient‐reported outcome measures will be collected at baseline, three, six and twelve‐month follow‐up periods;; 1. Roland Morris Disability Questionnaire; 2. Numeric Pain Rating Scale; 3. Fear Avoidance Beliefs Questionnaire; 4. Keele STarT Back Screening Tool; 5. Pain Self‐efficacy Questionnaire; 6. Pain Catastrophising Scale; 7. Distress, Anxiety and Stress Scale (DASS 21); 8. Euro‐Qol (Eq‐5D‐5L); 9. Global Rating of Change and participant satisfaction will be collected at three, six and twelve‐month follow‐up only.; 10. Working Alliance Theory of Change Inventory will be collected at three‐month follow‐up only.;