An Australian trial shows personalised, biopsychosocial care slashes pain and disability and keeps patients moving for at least three years.
Cognitive functional therapy delivers durable improvements for people with chronic disabling low back pain, say Australian researchers.
Their findings, published in The Lancet Rheumatology, confirmed that a personalised program grounded in a biopsychosocial framework not only reduced pain and disability but sustained those gains for at least three years.
The phase 3 RESTORE trial involved 492 adults across 20 primary care physiotherapy clinics in Australia.
Participants, who had experienced back pain for more than three months, with moderate functional limitation and average pain scores of at least 4/10, were randomly assigned to usual care, CFT alone, or CFT combined with movement-sensor biofeedback.
Both CFT groups received up to seven sessions over 12 weeks, plus a booster at 26 weeks.
Of the original cohort, 312 participants (87%) completed the three-year follow-up. Both CFT arms maintained clinically meaningful reductions in pain-related activity limitation compared to usual care, measured via the Roland Morris Disability Questionnaire.
Mean differences versus usual care were –3.5 (95% CI –4.9 to –2.0) for CFT alone and –4.1 (–5.6 to –2.6) for CFT plus biofeedback. Pain intensity improvements were also sustained, with reductions of –1.0 and –1.5 points respectively compared to usual care. Adding biofeedback conferred no significant advantage over CFT alone.
“Treatment sessions of CFT produced sustained effects at three years for people with chronic disabling low back pain,” the authors wrote.
“These long-term effects are novel and provide the opportunity to markedly reduce the effect of chronic back pain if the intervention can be widely implemented.
“Implementation requires scaling up of clinician training to increase accessibility and replication studies in diverse health-care systems.”
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The persistent effect of CFT over time was a new and very important finding, said lead author Professor Mark Hancock, professor of physiotherapy at Macquarie University.
“This the first large, high-quality study investigating the long-term impact of CFT, and shows that it’s effective and remains effective,” he said.
“In fact, our previous systematic review shows there are relatively few long-term outcome studies of other treatments for chronic low back pain.”
The researchers said interventions for chronic low back pain typically produced small and short-term effects that were not sustained. However, there was emerging evidence that interventions that target a person’s physical and psychosocial barriers to recovery and provide people with self-management skills could produce larger and more sustained effects.
“Cognitive functional therapy (CFT) is one such promising intervention, but the long-term effectiveness of this and other interventions for chronic low back pain remains unclear due to the scarcity of high-quality trials reporting outcomes beyond 12 months,” the authors wrote.
CFT is an individualised, person-centred approach that guides individuals to self-manage their own condition by targeting biopsychosocial barriers to recovery. For example, pain-related cognitions such as damage beliefs about pain and the body are targeted through providing a biopsychosocial understanding of pain and cognitive reassurance.
Pain-related fear and movement and activity avoidance are targeted through guided exposure to painful, feared and avoided movements and goal-oriented activities. Lifestyle behaviours are targeted through coaching individuals to engage in graded physical activity based on their preference, develop healthy sleep habits and improve social engagement.
“Improved pain self-efficacy, reductions in pain-related fear, enhanced pain control and less protective movement behaviours have been identified as potential mediators of CFT,” the authors wrote.
“By targeting these causal factors and changing the way individuals think about, and respond to, pain, CFT aims to produce lasting change.”
Professor Hancock told Rheumatology Republic that almost all treatments for back pain had only been investigated in the short term.
“There’s a big focus on short-term management of back pain, which really doesn’t make much sense when we know that, for most people, it’s a long-term, fluctuating, recurrent condition,” he said.
“So that’s the focus on the long term in terms of the actual intervention itself, cognitive functional therapy. It’s a framework for pulling together what we’ve now understood about back pain for a long time, which is, it’s complex, and there’s many factors that contribute to it.
“It’s really nice to actually now have some evidence that we’re getting bigger, longer-term effects, because most of the previous interventions for back pain had pretty small but also short-term effects.
“You typically see effects that last for the duration of two or three months or an intervention period and then are usually gone by six months.
“In the original study we published a couple of years ago, we’re really pleased to see that by one year the effects were as large, if not larger, than the three months. And here we’ve shown that they get a little bit smaller by three years, but the majority of the effect is still there. And that’s super novel and exciting.”
Professor Hancock said he believed the treatment had the capacity to expand into other conditions, especially musculoskeletal.
“This is putting people in charge of their own health, getting them to manage it, giving them the skills again, rather than just turning up for treatment,” he explained.
Implementation remains the next challenge, requiring workforce training and system-level strategies to make CFT widely accessible. Replication in diverse healthcare settings is also needed to confirm generalisability.
So far only physiotherapists have been trained in the delivery of the treatment, although he said this did not mean other health professionals couldn’t do it.
He said the research team had not considered following the cohort for longer, but he did not rule it out.
“People are making me think about that, but we want to run and we’re in the process of running other trials,” he said.
“We want to test; can we train clinicians with less time so that we can scale it up more? Can we deliver it remotely?
“So we’re really exploring some of some of those types of options, all things really about scalability, to be honest, is what we’re interested in.”
The researchers said future studies should explore the acceptability of CFT in different contexts and cultures and its cost-effectiveness in different healthcare systems, both in the short and long term.
“In the original trial, we showed cost-effectiveness at one year in Australia, but it is important to know if CFT can also have long-term effects on health-care use and productivity in other contexts,” they wrote.
“Furthermore, investigations into different models of training of clinicians to competency is warranted – e.g., whether this can be achieved online or with a hybrid model of online and face-to-face training.”
