5 Hot Takes from the Recent RESTORE Trial
So the RESTORE clinical trial paper exploded onto the scene in the last few weeks and has deservedly been received with a great deal of interest from the clinical community. In this blog I wanted to break down the things I have learned from interacting with the resources from the trial group (1) and from a deeper dive into the paper itself (2). I want this to be a pragmatic take on how we as a community should see this paper fitting into and challenging our general understanding of chronic lower back rehabilitation practices.
This trial in essence took the philosophical clinical approach of cognitive functional therapy (CFT) +/- augmented feedback via sensors placed on the lower back, and pitted it against an unregulated free market patient driven standard care model. This was a very pragmatic and ingenious way to ensure the common argument of “well that standard care isn’t how I practice” can’t be used. Having a large sample of patients (165) able to go about the community and interact at their will with the healthcare system based on their usual care seeking behaviors, ensures that a broad spectrum of “standard care” would be sampled (2).
The underpinning philosophy behind the CFT is that of patient centredness within the biopsychosocial model of care, and revolves around 3 main areas of intervention that a clinician targets coaching on:
- Making sense of pain
- Exposure with control (graded exposure)
- Healthy lifestyle change (2)
To contextualize all that’s coming, I’ll put the main results out there now for all to see:
- Using a CFT approach showed quite substantially less pain related physical activity limitations at 13 and 52 weeks. Approximately 4.5 points on average on the Roland Morris Scale (both started around 13/25 points). This is a clinically and pragmatically significant different experience for these patients.
- Patient specific functional scale showed on average a 1.5-2 point greater improvement with CFT than with usual care. This finding is less impressive as it floats around the minimal clinically important difference and pragmatically both groups were still rating ease in their meaningful activities to be significantly less than what they were prior to their pain. (Usual care = 4.2-4.9, CFT = 4.2-6.5)
- Pain intensity also tended to be better for those in the CFT arm than usual care with a decrease from initial levels 6.2/10 to 5.6/10, or 4.2/10 respectively.
- The CFT intervention decreased the economic burden of lower back pain significantly (2).
So here are my hot takes….
Hot take 1 – Unfortunately, clinicians are woefully unprepared by standard education and clinical mentoring for this type of practice
Hot take 2 – The importance of ongoing clinical mentoring when working with complex conditions
CFT, in essence, asks us as clinicians to take off our paternalistic, biomedical hat which we were given with our graduation certificate. It asks us to think of ourselves less as a clinician and more as a coach (2). A CFT type approach; although I have never done any official training myself; has always appealed to me coming from a coaching background before landing in allied health. A coaching approach in general leans heavily on the theories that govern human motivation and behavior change. Of primary importance to consider here I believe are…
- Maslow’s hierarchy of needs: If a person isn’t achieving the basics here, making even the most basic of positive health related changes is difficult (3).
- Self determination theory: This primary motivational theory is important to give the fuel to make and sustain any changes the person is wanting to achieve. Importantly in this study, I would suggest defying autonomy could be why the CFT + biofeedback arm didn’t outperform CFT alone. This in spite of the history in our profession of clinical trials (A+B) > (A) study design findings (4).
- COM-B or Transtheoretical model of behavior change: These models identify where someone is in relation to a target behavior, and how to facilitate that journey. Importantly they honor the fact that behavior change can only be made by a person wanting to make it and in an environment that will allow the change (5,6).
After having done our due diligence as primary contact practitioners, a CFT model asks us to lean into this more humanistic skillset, where we no longer fix pathologies, we facilitate environments for people to achieve goals and heal themselves (2). That’s not to say I always get it right though myself, it’s so easy to slip back into that fixer mindset.
The most staggering bit here for me to show just how under prioritized these skill sets are, is how much training it took for clinicians to be competent to deliver care this way. 18 physiotherapists of varying skill levels underwent the following training:
- 80 hours of workshops over 5 months (the average clinician does 20 hours / year)
- Continual mentoring and online discussion groups
- Formalized 3 monthly mentoring check ins during the trial
- Personalized ad hoc mentoring as requested during the trial (2)
Hot take 3 – How few sessions the usual care control group received when compared to the CFT group for the same time course
Hot take 4 – How our current healthcare system isn’t equipped to manage the problem this way
Hot take 5 – How if the healthcare system incentives changed, short term economic pain could lead to long term economic and social gain
Being a well controlled trial, this one really surprised me. This is to say that at least that it hasn’t been discussed more, in the many forums discussing this paper, as a possible explanation for the size of the treatment effect from a purely statistical perspective. On average over the examined treatment period of 16 weeks the control group, who were basically navigating their own way through the current healthcare system only had 3 points of care, versus 7 for the CFT group (2).
The length of the sessions for standard care weren’t stated, whereas the CFT group saw initial 60 minute and follow up 30-40 minute appointments (2). Having my experience of practice, the usual care group at 4 years of pain presentation, are often constrained by the financial and social implications of having lived with a chronic condition for so long.
Due to current healthcare constraints, this would often see patients rationing a mix of their 5 Federal Government (Australian) funded Chronic Disease Management Team Care Arrangements (CDM-TCA’s) over a 12 month period plus any care they could / would seek alternatively being privately funded, or via emergency or outpatient hospital services. These sessions are generally “gap free” services, meaning for a private healthcare business or public hospitals to remain viable they usually require shorter session times (20 minutes is common). Alternatively a business can charge normal fees and allow a patient to claim the medicare funding back after the session. This presents obvious barriers to frequent care (7).
It is unfortunate but in the current free market driven healthcare system, those who seem to benefit the most from seeing a specialist trained practitioner, for extended consultations, are also those who are least likely to be able to receive this care (8). I am unable to ascertain whether this is a factor or not from the article, however it needs to be discussed. This is unfortunate as if the system incentives were set up differently, we can clearly see in the article that there is a large social economic benefit to be gained.
With the front end cost of a few extra sessions over a 16 and 52 week period, this patient group essentially saved society >$5000 per person in lost productivity costs. Further, this type of intervention has a far greater Quality Adjusted Life Years (QALY) improvement per patient, moving the area under the curve up by a significant 0.2. In essence this means that if we assume a same rate of decline between a person receiving CFT and someone receiving usual care, those receiving CFT could remain living a productive life for 20% longer than those receiving usual care (2,9).
Hopefully these 5 hot takes have been as thought provoking for you as this article was for me.
I personally hope we see a future where this model of care is more thoroughly examined and if worthwhile implemented in our social and healthcare policy.
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- Kent, P., Haines, T., O’Sullivan, P., Smith, A., Campbell, A., Schutze, R., … & Hancock, M. (2023). 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. The Lancet.
- Michie, S., van Stralen, M.M. & West, R. The behaviour change wheel: A new method for characterising and designing behaviour change interventions. Implementation Sci 6, 42 (2011). https://doi.org/10.1186/1748-5908-6-42
- Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38. PMID: 10170434.
- Traeger AC, Buchbinder R, Elshaug AG, Croft PR, Maher CG. Care for low back pain: can health systems deliver? Bull World Health Organ. 2019 Jun 1;97(6):423-433. doi: 10.2471/BLT.18.226050. Epub 2019 Apr 30. PMID: 31210680; PMCID: PMC6560373.
- Whitehead, S. J., & Ali, S. (2010). Health outcomes in economic evaluation: the QALY and utilities. British medical bulletin, 96(1), 5-21.
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