RESTORE Trial Infographic
The RESTORE Journey
The RESTORE chronic low back pain trial: what it is, why is it important and what’s next?
Below we explain the findings of our recent LANCET publication where we investigated the clinical and economic benefits of Cognitive Functional Therapy only versus Cognitive Functional Therapy + sensor biofeedback versus usual care for people with disabling chronic low back pain [1].
The Problem
Low back pain is the leading cause of disability, work loss, and early retirement worldwide. It affects almost everyone at some point from adolescence to later life and 20-30% of people who develop low back pain go onto develop chronic (persistent) low back pain [2]. Chronic low back pain impacts all aspects of peoples’ lives, such as their engagement in daily living, work, physical and social activity. It can result in high levels of distress. The societal costs of chronic pain exceed cancer and diabetes combined, mainly due to a loss of work productivity and participation. The disability burden caused by low back pain is projected to increase in coming decades.
Traditional treatments for back pain, such as massage, spinal manipulation, medication, injections and surgery only result in small to moderate effects that are often short lasting and do not change the trajectory of low back pain in most people. Importantly, some of these treatments can produce significant and harmful side effects. We urgently need to find better ways to care for people with chronic low back pain.
Over recent years there has been a shift to a broader understanding about back pain. This new understanding describes back pain as a result of a complex interaction between a range of biological, psychological, social, and cultural factors (Figure 1). This interaction is unique for each person.
Figure 1. Multidimensional factors associated with resilience and vulnerability to disabling low back pain.
From "Cognitive Functional Therapy: An Integrated Behavioral Approach for the Targeted Management of Disabling Low Back Pain". By O'Sullivan et al., 2018, Physical Therapy, 98(5), p.410. (https://doi.org/10.1093/ptj/pzy022). Copyright 2018 by the authors (Creative Commons).
Comprehensively addressing these factors demands a different approach to care [3]. Once serious pathology is excluded, best care guidelines call for clinicians to screen, explore and target the biopsychosocial barriers to recovery in people with low back pain. They also call for care to be person-centred, with the need to educate people about their pain and promote effective self-management of their condition [4,5,6]. To date there is an evidence-practice gap, where many clinicians report they don’t have the skills or confidence to deliver this type of care [7]. To overcome this gap, clinician-researchers developed a person-centred approach to manage back pain – Cognitive Functional Therapy.
Cognitive Functional Therapy
Cognitive Functional Therapy is a behavioural intervention for people with chronic low back pain, aligned to ‘best practice care guidelines’ based on the current best scientific evidence [4,5]. It puts into practice, the universal recommendations for a biopsychosocial approach to care.
It has evolved in the clinic and has been informed by people living with chronic low back pain. Cognitive Functional Therapy differs from traditional treatment approaches because it holistically addresses the wide range of individual factors that can lead to ongoing pain and disability, such as negative beliefs about back pain, emotional distress, and unhelpful behavioural responses to pain such as movement and activity avoidance. These factors are known to be important barriers to recovery for people with chronic low back pain [2]. Cognitive Functional Therapy places the ‘person’ at the centre of their care, where their individual concerns, worries, ways that they move, and their functional limitations and goals, become the focus of treatment. The clinician works as a coach rather than a ‘fixer’.
Cognitive Functional Therapy uses a multi-dimensional clinical reasoning framework to identify and target the factors important for each individual. This framework allows clinicians to rate, for each individual, the relative contribution of the various health domains to the patient’s condition (Figure 2):
Figure 2. Radar graph outlining the multidimensional profile of a case before and after the cognitive functional therapy (CFT) intervention.
From "Cognitive Functional Therapy: An Integrated Behavioral Approach for the Targeted Management of Disabling Low Back Pain". By O'Sullivan et al., 2018, Physical Therapy, 98(5), p.417. (https://doi.org/10.1093/ptj/pzy022). Copyright 2018 by the authors (Creative Commons).
Key components of Cognitive Functional Therapy:
Cognitive Functional Therapy [3] is a behavioural intervention that is:
-
Individualised person-centred care [8]
-
Aligned to best care guidelines [4]
-
screens for serious pathology
-
screens and explores for biopsychosocial barriers for recovery
-
educates people about their condition, prognosis and best management
-
targets care towards biopsychosocial barriers to recovery
-
promotes self-management including pain exacerbation plans
3. Inclusive of a multi-dimensional clinical reasoning framework to help
physiotherapists negotiate clinical complexities and identify modifiable
targets for care.
Cognitive Functional Therapy has three key foci:
Making sense of Pain
Guiding a re-conceptualisation of pain from a biopsychosocial perspective through the lens of the patients own story and experiences.
Exposure with Control
Guiding pain and movement control strategies to build confidence for people to re-engage in valued activities (physical, work, social etc).
Lifestyle Changes
Promoting positive physical, social and psychological health.
Figure 3. Interplay of clinician- and patient-specific factors in the clinical journey with cognitive functional therapy.
From "Cognitive Functional Therapy: An Integrated Behavioral Approach for the Targeted Management of Disabling Low Back Pain". By O'Sullivan et al., 2018, Physical Therapy, 98(5), p.419. (https://doi.org/10.1093/ptj/pzy022). Copyright 2018 by the authors (Creative Commons).
This takes more time than traditional consultations (i.e. requires 1 hour for the first session and 30-45 minute for follow-ups).
Why the RESTORE trial?
Previously two small trials of Cognitive Functional Therapy for people with chronic low back pain had been conducted in comparison with other physiotherapy interventions [9,10], and had demonstrated long-term efficacy of Cognitive Functional Therapy when delivered by three physiotherapists each trained to competency. Castro et al., (2022) [11], conducted a trial of Cognitive Functional Therapy compared to core exercise and manual therapy, that did not demonstrate long term benefits for people with chronic low back pain. In the Castro trial [11], the intervention was delivered by one new graduate physiotherapist, limiting the generalisability of these results. One very small trial (n-34) in rowers with chronic low back pain had compared Cognitive Functional Therapy to usual care, delivered by a single physiotherapist trained to competency, and while it demonstrated efficacy, the inclusion of a single physiotherapist again limits the generalisability of the results [12].
In addition, to date, no trials had explored Cognitive Functional Therapy from an economic perspective - information that is important if we are to determine whether the intensive training and longer consultations required to competently deliver Cognitive Functional Therapy at a high standard are both clinically and financially justified. We also wanted to know if booster sessions at 6 months could help maintain long term benefits, as previous trials had demonstrated reduced effect of Cognitive Functional Therapy after 6 months [9,13]. Lastly, we were also interested in whether providing clinicians and patients with personalised movement-related information via movement sensor biofeedback could improve Cognitive Functional Therapy outcomes, as a previous trial had shown large clinical effects using this technology [14].
What did we do in the RESTORE trial?
Who delivered the Cognitive Functional Therapy intervention?
First, we trained a group of 18 physiotherapists across Perth and Sydney who had at least 2 years' experience in treating people with chronic low back pain and minimal previous exposure to Cognitive Functional Therapy. They had a large range of clinical experience, from 2 to 30+ years. Training was conducted over 6 months. The training included knowledge, skills, and clinical competency, with in-person mentoring from trainers while the physiotherapists assessed and treated patients with chronic low back pain. The physiotherapists who underwent the training reported a positive mindset and behaviour change process and a shift towards their role as a coach, with a new understanding of people with low back pain and skills to confidently manage them. Competency standards had to be met before the physiotherapists could enter the trial and not all achieved competency at 6 months. Training was conducted by physiotherapists who had developed Cognitive Functional Therapy and had extensive experience using and teaching it. Towards the end of the training, the groups were randomly split into two where one group was also trained in the use of movement biofeedback.
See Simpson et al., (2021) [15] and the Clinician Journey page on this website for more detail on the training and intervention.
Who were the people in the trial?
492 people with persistent and disabling low back pain were recruited on the basis that they had sought care for their low back pain at least 6 weeks previously. Anecdotally, many had given up on care seeking. On average at entry to the trial the included people had a duration of 4 years of chronic low back pain. We included adults over 18 years with a mean age 47 years, which meant we included people over 65 years of age who are usually excluded from clinical trials. We also included people with prior spine surgery, mental health challenges and other health comorbidities. Exclusions were limited to people with serious pathology and those with an inability to fill in online questionnaires or attend consultations.
The people recruited were more disabled than people in previous large clinical trials for chronic low back pain (see Table 1).
Table 1. Participants in the RESTORE trial were even more disabled at baseline than those seen in other major low back pain trials.
What were the treatment groups?
There were three treatment groups in both Sydney and Perth, Australia.
Usual Care
People were able to seek care as usual with no restrictions.
Cognitive Functional Therapy only
-
Sensors were placed on the participant to assist blinding and provide movement information for the trial.
-
Data was not accessible by either the patient or physiotherapist.
Cognitive Functional Therapy + movement biofeedback sensors
-
Sensors were placed on the participant to provide personalised feedback on movement and posture, as directed by their physiotherapist.
-
Data was accessible by the patient and physiotherapist.
Wireless wearable movement sensors were placed on the back (T12) and pelvis (S2) in the clinic.
What did we measure?
Clinical Outcomes
Primary Outcome
-
Pain-related activity limitation (disability)
Secondary Outcomes
-
Pain intensity
-
Pain catastrophising
-
Pain self-efficacy
-
Pain related fear of movement
-
Patient perceived improvement
-
Satisfaction
-
Adverse events
Economic Outcomes
Quality adjusted life years
-
A measure of a person’s ability to carry out the activities of daily life, and freedom from pain and mental disturbance [25].
Direct health care costs
Productivity costs
-
Work absenteeism, presenteeism (reduced work productivity while at work)
What did we find?
Clinical outcomes
Both Cognitive Functional Therapy groups demonstrated large and sustained (at 12-months) reductions in pain-related activity limitation (disability) and pain intensity compared to usual care (Figure 4). The proportion of people with a within-person clinically important reduction in:
Activity limitation (5 points on the Roland Morris Disability Questionnaire) was
Activity Limitation
Usual Care
CFT
3-Months
12-Months
Time Point
Pain (2 points on 10-point VAS scale) was
Pain Intensity
3-Months
12-Months
Usual Care
CFT
Time Point
These large, sustained effects are particularly novel. 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 other measures (Figure 4): 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 Cognitive Functional Therapy intervention and at 12-months follow-up. 82% of people receiving Cognitive Functional Therapy were satisfied with the treatment compared to 19% receiving usual care.
There was no additional clinical benefit of sensor biofeedback. Cognitive Functional Therapy was safe.
Figure 4. All outcomes significantly reduced in both CFT groups compared to usual care.
Economic outcomes
In addition to being much more effective, Cognitive Functional Therapy was also much less costly than usual care. There were large quality adjusted life year improvements in the Cognitive Functional Therapy groups. Reductions in health-related costs and improvements in productivity valued (combined) produced more than AU$5000 in societal saving per person over a year, beyond the cost of the care. These cost savings were mainly driven by work productivity gains.
How do the results compare to previous research?
At the end of the treatment period the clinical effectiveness of Cognitive Functional Therapy for improvement in activity limitation and pain was larger than most interventions for chronic low back pain.
The sustained and large effects at 52 weeks are unusual in the low back pain field.
For example, recent systematic reviews of:
-
Psychological interventions showed that no treatments or combination of treatments had large effects for activity limitation or pain at 12-months compared with usual care [20,21].
-
Exercise interventions show effects on activity limitation that are only 25% of the size of those in RESTORE at 12-months compared with usual care [20,21].
-
Multi-disciplinary pain management programs have smaller long-term clinical effects than those in RESTORE compared with usual care [22].
These clinical effectiveness findings are noteworthy in the context of a recent case-control study that showed CFT was more effective, and was only 7% of the cost, compared to multi-disciplinary pain management for people with severe low back pain [23].
What do the results mean?
For clinicians
Clinicians with a range of years of clinical experience treating people with disabling chronic low back pain can be trained to competently deliver Cognitive Functional Therapy in primary care. However, we have also found in a previous study that learning to become competent to deliver Cognitive Functional Therapy is not just about doing a workshop [24]. It takes dedication, time and training under skilled mentoring to develop the specific skills to meet the competency standard. A central component in this training is direct mentoring from skilled trainers, while treating people with low back pain.
The results provide hope to patients and clinicians. Most people with persistent and disabling low back pain can be effectively treated with Cognitive Functional Therapy. Person-centred care puts the patient in charge of their health. It identifies and targets the patient’s individual biopsychosocial barriers to recovery. The role of the clinician is a ‘coach’ rather than a ‘treater’, taking patients on the journey to learn to self-manage their condition in line with their goals. The clinicians in the trial found the training challenging and rewarding. They found the new way of working both liberating and empowering, helping them bridge the evidence-practice gap in delivering person centred care [15].
For healthcare services
Cognitive Functional Therapy represents a high-value care option for many people with disabling chronic low back pain. To deliver this care in health systems, there is a need to invest in competency-based training of clinicians. Furthermore, a lack of time is a massive barrier for clinicians to the deliver high value care. So, in addition to clinician training, we need to invest in renumerating clinicians for the time they spend performing a suitable length consultation.
For governments/insurers
There is an urgent need to provide access and funding to support high-value care like Cognitive Functional Therapy, for people suffering from chronic low back pain. Continuing the way health systems are currently organised and funded will result in wasted resources, harm to patients and increasing disease burden. Sadly, it is often easier and cheaper for people to get low-value care such as a scan, injection, surgery and opioids, than to get documented high-value care such as Cognitive Functional Therapy.
For the public
There is an urgent need to educate the public about low back pain and build a more positive narrative. Low back pain can be really scary and disabling, and chronic low back pain is real. People suffering from chronic low back pain need to feel heard, understood and validated. Their pain is felt in the body and influenced by the body-mind interactions. Effective care that provides sustained reductions in pain, distress and disability is possible. The role of the clinician is to coach the person with low back pain to be in charge of their own care. The journey is different for everyone. For some this is a tough and long journey full of setbacks, while for others is relatively quick and straight forward. Importantly, there will be setbacks (flare ups) along the way for most people, and the key is to help and support people navigate these setbacks to stay on track.
Where to next?
In the RESTORE trial:
-
We are very interested in why people get better. We are exploring if changes in the way people move their back was associated with improvements in activity limitation and pain in the Cognitive Functional Therapy groups. We will also explore other mediators of outcome.
-
We want to know more about the people who we were not able to help in the trial, so we can develop better ways of helping them.
-
We are also exploring the lived experiences of people with chronic low back pain who underwent Cognitive Functional Therapy, so that we can learn more from their perspectives.
-
We are completing a 3-year follow-up of the people in the trial to see if the effects are sustained in the longer term.
-
We are very interested in the experience of physiotherapists who underwent the training and who delivered the Cognitive Functional Therapy intervention, so we can optimise future clinician training [15].
Beyond the RESTORE trial:
-
We have a plan to provide equitable training opportunities internationally to support clinicians who want to develop knowledge, skills and clinical competency in Cognitive Functional Therapy.
-
We are to conducting implementation studies to determine whether groups of clinicians can be trained to effectively deliver Cognitive Functional Therapy in different care settings and countries.
-
We are interested in working with other health care providers to support the integration of Cognitive Functional Therapy into multi-disciplinary care for people highly disabled with chronic low back pain, and with other health comorbidities [23].
-
We think Cognitive Functional Therapy 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.
Authors: Peter Kent, Peter O’Sullivan, Anne Smith, JP Caneiro, Rob Schutze, Jan Hartvigsen, Kieran O’Sullivan, Mark Hancock
References
-
Kent P, O'Sullivan P, Smith AD, et al. RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial. BMJ Open 2019; 9(8): e031133.
-
Chen Y, Campbell P, Strauss VY, Foster NE, Jordan KP, Dunn KM. Trajectories and predictors of the long-term course of low back pain: cohort study with 5-year follow-up. Pain 2018; 159(2): 252-60.
-
O’Sullivan PB, Caneiro J, O’Keeffe M, et al. Cognitive functional therapy: an integrated behavioral approach for the targeted management of disabling low back pain. Physical therapy 2018; 98(5): 408-23.
-
Lin I, Wiles L, Waller R, et al. What does best practice care for musculoskeletal pain look like? Eleven consistent recommendations from high-quality clinical practice guidelines: systematic review. Br J Sports Med 2019.
-
Bernstein IA, Malik Q, Carville S, Ward S. Low back pain and sciatica: summary of NICE guidance. BMJ 2017; 356: i6748.
-
ACSQHC. Low Back Pain Clinical Care Standard. Sydney: Australian Commission on Safety and Quality in Health Care, 2022.
-
Synnott A, O'Keeffe M, Bunzli S, Dankaerts W, O'Sullivan P, O'Sullivan K. Physiotherapists may stigmatise or feel unprepared to treat people with low back pain and psychosocial factors that influence recovery: a systematic review. J Physiother 2015; 61(2): 68-76.
-
Lin I, Wiles L, Waller R, et al. Patient-centred care: the cornerstone for high-value musculoskeletal pain management. Br J Sports Med 2020; 54(21): 1240-2.
-
O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med 2020; 54(13): 782-9.
-
Vibe Fersum K, O'Sullivan P, Skouen J, Smith A, Kvåle A. Efficacy of classification‐based cognitive functional therapy in patients with non‐specific chronic low back pain: A randomized controlled trial. European journal of pain 2013; 17(6): 916-28.
-
Castro J, Correia L, Donato BS, et al. Cognitive functional therapy compared with core exercise and manual therapy in patients with chronic low back pain: randomised controlled trial. Pain 2022; 163(12): 2430-7.
-
Ng L, Cañeiro JP, Campbell A, Smith A, Burnett A, O'Sullivan P. Cognitive functional approach to manage low back pain in male adolescent rowers: a randomised controlled trial. Br J Sports Med 2015; 49(17): 1125-31.
-
Ussing K, Kjaer P, Smith A, et al. Cognitive Functional Therapy for People with Nonspecific Persistent Low Back Pain in a Secondary Care Setting-A Propensity Matched, Case-Control Feasibility Study. Pain Med 2020; 21(10): 2061-70.
-
Kent P, Laird R, Haines T. The effect of changing movement and posture using motion-sensor biofeedback, versus guidelines-based care, on the clinical outcomes of people with sub-acute or chronic low back pain-a multicentre, cluster-randomised, placebo-controlled, pilot trial. BMC musculoskeletal disorders 2015; 16(1): 131.
-
Simpson P, Holopainen R, Schütze R, et al. Training of Physical Therapists to Deliver Individualized Biopsychosocial Interventions to Treat Musculoskeletal Pain Conditions: A Scoping Review. Phys Ther 2021; 101(10).
-
Kent P, O’Sullivan P, Smith A, et al. 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 2023.
-
Hill JC, Whitehurst DG, Lewis M, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. The Lancet 2011; 378(9802): 1560-71.
-
Lamb SE, Hansen Z, Lall R, et al. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. The Lancet 2010; 375(9718): 916-23.
-
Bagg MK, Wand BM, Cashin AG, et al. Effect of Graded Sensorimotor Retraining on Pain Intensity in Patients With Chronic Low Back PainA Randomized Clinical Trial. JAMA 2022; 328(5): 430-9.
-
Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev 2021; 9(9): Cd009790.
-
Ho EK, Chen L, Simic M, et al. Psychological interventions for chronic, non-specific low back pain: systematic review with network meta-analysis. BMJ 2022; 376: e067718.
-
Kamper SJ, Apeldoorn AT, Chiarotto A, et al. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ 2015; 350: h444.
-
Vaegter HB, Ussing K, Johansen JV, et al. Improvements in clinical pain and experimental pain sensitivity after cognitive functional therapy in patients with severe persistent low back pain. Pain Rep 2020; 5(1): e802.
-
Holopainen R, Piirainen A, Karppinen J, Linton SJ, O'Sullivan P. An adventurous learning journey. Physiotherapists' conceptions of learning and integrating cognitive functional therapy into clinical practice. Physiother Theory Pract 2022; 38(2): 309-26.
-
National Institute for Health and Care Excellence. Glossary [Internet]. United Kingdom; 2023 [cited 2023 May 1].