Cognitive Functional Therapy for low back pain: A feasibility RCT V 1
Research type
Research Study
Full title
Cognitive Functional Therapy for persistent low back pain: A mixed methods feasibility randomised controlled trial.
IRAS ID
253668
Contact name
Christopher Newton
Contact email
Sponsor organisation
University Hospitals of Leicester NHS trust
ISRCTN Number
ISRCTN12965286
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
Low back pain (LBP) is the number one cause of disability worldwide, placing a huge financial burden on society with costs reaching an estimated £12 billion each year in the United Kingdom. Current management is failing to address the problem.How a person thinks (e.g. negative beliefs) and behaves (e.g. avoidance of movement) in response to LBP has a significant bearing on their recovery. The National Institute for Health Care and Excellence (NICE) guidelines recommend combined physical and behavioural treatment programmes for people with persistent LBP in order to address these factors. Despite this recommendation, there is a 'big gap' in service provision for these patients in the NHS. An integrated physiotherapist-led physical and behavioural intervention, called Cognitive Functional Therapy, has been developed and potentially meets this need.
Cognitive Functional Therapy aims to teach people to think, move and respond differently to LBP and has been shown to be more beneficial than traditional treatments for LBP in Norwegian private patients. A small study in the NHS has shown similar positive effects, with an estimated treatment cost saving of £120 per patient. However, Cognitive Functional Therapy has not been fully evaluated in the NHS, using a more suitable research design.
Before the effectiveness of Cognitive Functional Therapy can be measured in a clinical trial, a number of questions need to be answered. These are:
• Can a clinical trial of Cognitive Functional Therapy be completed within the NHS?
• Is Cognitive Functional Therapy acceptable to physiotherapists and people with LBP?The proposed study will be undertaken in two phases. Phase one will be a feasibility trial that will compare Cognitive Functional Therapy with usual physiotherapy care in 60 people with persistent LBP. In Phase two the acceptability of the intervention and research process will be explored using interviews and a focus group.
Summary of Results
This research was undertaken in two phases. Phase one was a feasibility study that compared Cognitive Functional Therapy with usual physiotherapy care in 60 patient participants with persistent LBP. In Phase two, a process evaluation of the feasibility study 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 Cognitive Functional Therapy and the second focus group comprised of the six physiotherapists who provided UPC within the trial) were conducted and analysed thematically.Phase one
Four physiotherapists received training in Cognitive Functional Therapy. Six separate physiotherapists received training to provide usual physiotherapy care. In total, 60 patient participants consented to participation and were allocated at random to one of the two treatment groups (30 in the Cognitive Functional Therapy group and 30 in the usual physiotherapy care group). Recruitment was completed six months ahead of schedule. Participant retention in the study was 80%, 72% and 50% at three, six and twelve-month follow-up respectively. It is unknown if the COVID-19 pandemic may have affected study retention which coincided with six and twelve-month follow-up data collection times.
Video analysis and a clinical records audit showed that Cognitive Functional Therapy was delivered as intended in the trial, that relevant and clinically important outcome data were rigorously collected and that the interventions were tolerated by patient participants with no safety concerns. Statistical analysis indicated a signal of clinical effectiveness in favour of Cognitive Functional Therapy across a range of outcome measures (inclusive of measures of pain, disability, general health, psychological functioning and quality of life) at three, six and twelve-month follow-up. The Roland Morris disability questionnaire (a measure of LBP disability) was decided as the most suitable outcome measure to be used in a future study and calculations of the number of people required to complete this definitive study were made.Phase two
Four main themes were identified; 1) Research processes 2) Physiotherapist training 3) Intervention delivery 4) Perceived mechanism of change after the intervention. The process evaluation confirmed that the research processes and interventions were acceptable to patient participants and physiotherapists, that participants with LBP could be recruited, they were happy to be randomised, completed the outcome measures and were retained within the study without safety concerns. The Cognitive Functional Therapy training programme provided the physiotherapists with the necessary knowledge, skills and confidence to deliver the intervention as intended. The usual physiotherapy care training programme was also acceptable to the physiotherapists but the intervention was not always delivered as intended in the study and evidence suggested that there was the potential for contamination with aspects of the Cognitive Functional Therapy intervention. Novel insights into how the Cognitive Functional Therapy intervention may work in the NHS were gained.Conclusion
The findings of this research suggests that it is feasible to deliver Cognitive Functional Therapy in a routine NHS setting, that NHS physiotherapists can be trained and can implement Cognitive Functional Therapy and that patients can be recruited on time and to target, with no safety concerns to a clinical trial. Furthermore, clinically relevant data can be collected using standardised outcome measures and there were positive indicators from these measures that Cognitive Functional Therapy was effective and may be superior to usual physiotherapy care. This study confirms it is feasible to conduct a randomised study of Cognitive Functional Therapy in comparison to usual physiotherapy care for NHS patients with persistent LBP and indicates a future, full scale trial to determine the clinical and cost effectiveness could be completed. Due to the potential for contamination between the interventions, this future study should be completed with the interventions delivered separately on different NHS sites.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0415
Date of REC Opinion
4 Feb 2019
REC opinion
Further Information Favourable Opinion