PainRelief.com Interview with:
Adjunct Associate Professor
Curtin School of Allied Health
Curtin University, Perth
PainRelief.com: What is the background for this study?
Response: Although there had been clinical trials of Cognitive Functional Therapy (CFT) with promising results, there had not been a fully powered trial comparing CFT with usual care, nor any trials in Australia. Previous trials had included a maximum of 3 CFT clinicians, whereas the RESTORE trial included the training of 18 physiotherapists to CFT competency who had minimal prior exposure to CFT. No previous CFT trial had included an evaluation of 6161615g8cost effectiveness of CFT, nor examined whether the use of wearable motion sensor biofeedback might enhance the effect of CFT.
PainRelief.com: Would you describe Cognitive Functional Therapy?
Response: Cognitive Functional Therapy is a behavioural intervention for people with chronic low back pain, which is aligned to ‘best practice care guidelines’ based on the current best scientific evidence. It puts into practice the contemporary recommendations for a biopsychosocial approach to care. CFT uses a multi-dimensional clinical reasoning framework to identify and target the factors important for each individual patient.
PainRelief.com: There are three broad components to the intervention:
Response: Making sense of pain: a reflective process that combines the person’s own narrative (interview) and experience (during guided behavioural experiments) to develop a personally-relevant, multidimensional understanding of pain for the patient.
Exposure with ‘control’: a process of behavioural change through experiential learning following a ‘graded exposure’ model, designed to challenge expectations of pain and damage consequences via guided physical behavioural experiments.
Lifestyle change: behavioural modification addressing unhelpful lifestyle factors aimed at increasing physical activity levels based on preference, sleep habits, regulation of stress (via relaxation techniques) and/or dietary advice, where relevant.
Cognitive Functional Therapy is underpinned by a strong therapeutic alliance and motivational interviewing style (open, non-judgmental, reflective) providing validation and facilitating disclosure. An individualised progressive self-management program is provided, monitored and progressed that includes cognitive restructuring, progressive functional exercises and lifestyle changes, tailored to each individual’s goals.
PainRelief.com: What are the main findings?
Response: Both the Cognitive Functional Therapy -only group and the CFT-biofeedback group demonstrated similar large and sustained (at 12-months) reductions in pain-related activity limitation (disability) and pain intensity compared to usual care. The proportion of people with a within-person clinically important reduction in activity limitation (5 points on the Roland Morris Disability Questionnaire) was 61% in the CFT groups compared with 19% in the usual care groups at 3 months and was 67% compared with 24% at 12 months. For pain intensity (2 points on 10-point VAS scale) the corresponding proportions were 48% in the CFT groups compared with 16% in the usual care groups at 3 months and 51% compared with 25% at 12 months. These large, sustained effects are unusual. We had a low drop-out rate from the trial (15% at the primary time point) giving us confidence in these results.
There were also large and sustained effects for all the secondary outcome measures: people had more positive pain beliefs (reduced pain catastrophising), they were more confident to engage in movement and activity (higher self-efficacy), and they were less fearful of movement, both immediately after the CFT intervention and at 12-months follow-up. Collectively, 82% of people receiving CFT were satisfied or very satisfied with the treatment compared to 19% receiving usual care.
There was no additional clinical benefit from sensor biofeedback. Cognitive Functional Therapy was safe.
In addition to being much more clinically effective, Cognitive Functional Therapy was also more cost-effective than usual care. There were large quality adjusted life year improvements in the CFT groups. Reductions in health-related costs and improvements in productivity valued (combined) produced more than AU$5000 in societal savings per person over a year, beyond the cost of the care. These cost savings were mainly driven by work productivity gains.
Is this therapy readily adaptable to wider therapeutic venues?
We have a plan to provide equitable training opportunities internationally to support clinicians who want to develop knowledge, skills and clinical competency in CFT.
We are conducting implementation studies to determine whether groups of clinicians can be trained to effectively deliver CFT in different care settings and countries.
We are interested in working with other health care providers to support the integration of CFT into multi-disciplinary care for people highly disabled with chronic low back pain, and with other health comorbidities.
We think CFT can be applied to other musculoskeletal pain conditions, and we are involved in research to explore if this is the case in a range of chronic musculoskeletal pain conditions.
PainRelief.com: What recommendations do you have for future research as a result of this study?
Response: Replication of this trial in other settings would be helpful, as would be trials of CFT in other musculoskeletal pain conditions, and implementation studies.
PainRelief.com: Is there anything else you would like to add? Any disclosures?
PainRelief.com: More information can be found at restorebackpain.com
Response: We would like to thank the patients who volunteered to participate in the trial, the physiotherapists who treated those patients, the trial team, and the funders (the Australian National Health and Medical Research Council, and Curtin University).
I have no disclosures to make.
Kent P, Haines T, O’Sullivan P, Smith A, Campbell A, Schutze R, Attwell S, Caneiro JP, Laird R, O’Sullivan K, McGregor A, Hartvigsen J, Lee DA, Vickery A, Hancock M; RESTORE trial team. Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): a randomised, controlled, three-arm, parallel group, phase 3, clinical trial. Lancet. 2023 May 2:S0140-6736(23)00441-5. doi: 10.1016/S0140-6736(23)00441-5. Epub ahead of print. PMID: 37146623.
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