The number of participants reported to be very satisfied or satisfied was high in the group receiving CFT
CFT used as a chronic back pain treatment was reported to be more effective and less costly than usual care
The effects were sustained at the 1-year follow-up
Low back pain is a disabling condition that affects nearly every individual once in a lifetime. Up to 1 in 5 (some studies even say 1 in 3) people develop chronicity. Treatments for low back pain mostly have small to moderate effects and, unfortunately, recurrence remains a problem. As it is a condition that is influenced by many factors, the whole biopsychosocial model should be incorporated into treatment. Probably, the lack of including psychological contributors in the treatment for low back pain leads to the small to moderate effects of treatment that aren’t sustained in the long term. Therefore, guidelines recommend including it in standard care for chronic low back pain. Cognitive functional therapy aims to facilitate patients to self-manage their chronic low back pain condition by addressing their individual psychological contributors. There appears to be some preliminary evidence that cognitive functional therapy would be of value for chronic back pain treatment. To study this, this rigorous randomized controlled trial was conducted with the question: “Can cognitive functional therapy be an effective chronic back pain treatment?”.
This randomized controlled trial included three parallel groups. The application of cognitive functional therapy with and without movement sensor biofeedback was compared to usual care. Eligible participants were at least 18 years of age and had chronic low back pain (for more than 3 months). They had sought care from a primary care physician in the previous 6 weeks. Further, they had a pain intensity of at least 4/10 on the numeric rating scale and at least moderate pain-related interference with normal work or daily activities, as measured by item 8 of the 36-item Short Form Health Survey.
Cognitive functional therapy (CFT) seeks to help patients self-manage their persistent low back pain by addressing specific psychological pain-related cognitions, emotions, and behaviors that contribute to their pain and disability. These include for instance fear avoidance, seeing pain as a threat, protective muscle guarding, etc.
Seven CFT treatment sessions spread over 12 weeks, plus a “booster” session at 26 weeks, will be administered to both CFT treatment groups at the same frequency (first consultation: 60 minutes; follow-ups: 30–40 minutes). In both CFT groups, healthcare professionals employed an organized strategy to address the important functional and lifestyle (behavioral, emotional, and cognitive) aspects judged pertinent to the individual’s presentation. The only difference was that one of the CFT groups also wore a wearable movement sensor. This was accessible to the physiotherapists to use the movement sensor data for assessment, movement retraining, and biofeedback.
These two groups were compared to usual care which was defined as “the care pathway that the participant’s health providers recommended or the participant chose, for example, physiotherapy, massage, chiropractic care, medicines, injections, or surgical interventions. The control group participants were informed that “If you are allocated to the usual care group, your treatment options can be any of those offered by the health-care professionals you would normally choose to see in the community. In other words, you will choose your treatment, but it is not determined by the study or funded by it.” They received a reimbursement for their time spent filling in the required questionnaires.
The primary outcome was pain-related physical activity limitation as measured by the 0-24 Roland Morris Disability Questionnaire (RMDQ) at 13 weeks. Higher scores represent higher levels of pain-related disability. The Minimal Clinically Important Difference is reported to be a 30% reduction in baseline score.
A total of 492 participants were recruited and randomized, 165 to usual care, 164 to CFT only, and 163 to CFT with biofeedback. They were on average 47.3 years old and slightly more women were included (59%). At baseline, the median pain duration was 260 weeks (5 years), and the mean RMDQ was 13.5.
In the usual care group, more than half of the patients were taking medications for their chronic low back pain. Thirty-eight percent sought care from a healthcare provider. The median number of consultations was 3 but ranged from 1-22 (IQR: 2-7). In both CFT groups, the number of consultations was individualized and the median number of consultations was seven (IQR: 4-8).
Of the 492 participants, 85% completed the 13-week follow-up. In the table hereunder, you can see that in both CFT groups, the RMDQ nearly halved. This means that both CFT groups largely exceeded the MCID. No differences were observed between the CFT group with and without biofeedback from a wearable movement sensor, making CFT alone a very applicable approach to chronic back pain treatment.
How to apply CFT? First of all, the physiotherapist gave room to patients to tell their stories. In this story, the patient’s concerns emerged and these were validated. They asked why they were seeking care and identified which elements of their history were important to them. Next, the findings were used to create a personalized treatment plan. This started by making sense of pain using the patient’s story and experiences. In this way, the aim was to reconceptualize their low back pain from a biopsychosocial perspective. So all aspects of the story were captured and the pain-related cognitions (e.g. beliefs about tissue damage), emotions (e.g. pain-related fear and distress), social factors (e.g. life stressors), and behavioral responses (e.g. protective guarding, avoidance of activities, poor sleep) were identified. In case these were modifiable, they became “targets for change to break the pain and disability cycle”.
In the second stage, the patients were exposed to their feared activities and to the movements and activities they rated as being painful or that they have avoided. Through graded exposure, this experiential learning created an opportunity to reduce pain and increase confidence. Here, body relaxation techniques, abolishing protective and safety behaviors, and movement control and postural modifications were used.
As a third component of this CFT program, patients were coached towards more healthy lifestyle behaviors. Here, for example, pacing of activities, healthy sleep and dietary habits, stress management, and social engagement were targeted.
What was particularly interesting was the sustained effectiveness of CFT after 1 year. Especially because this study included chronic low back pain patients who had complaints for 5 years. These are mostly the type of patients that get excluded from RCTs. Hats off!
The analysis found CFT to be more cost-effective than usual care, which is reflected in the figure below.
The CFT program uses a personalized approach to target an individual’s risk factors that are known to be important predictors of outcomes. This treatment aims to build self-efficacy and skills for self-management and reduce pain catastrophizing, and fear avoidance. The aim is to make the individual with chronic low back pain resilient. There was only 1 booster session at 6 months, so the fact that these effects from the 13-week timepoint were sustained after one year, indicates that the patients indeed became more resilient.
The treating physios got a very intense course to deliver CFT, but they had various clinical expertise and minimal previous experience with or training in CFT. Therefore, it seems doable to implement CFT in primary care. However, when I look at the details of CFT, I personally think that these concepts of reframing pain, targeting unhelpful beliefs, and creating new helpful cognitive and behavioral responses (functional and lifestyle) are already being employed by many physiotherapy practitioners. Central sensitization, in relation to chronic pain, is for example taught by Jo Nijs in his course.
Cognitive Functional Therapy was found to be more effective than usual care for activity limitations at 13 weeks. The effect sizes for this chronic back pain treatment were retained at the 52-week follow-up. Physiotherapists were trained very rigorously to help patients with chronic low back pain reconceptualize pain and address their pain-provocative movement patterns. A flexible clinical reasoning approach was used based on the individual’s presentation and history. The outcomes revealed that CFT was able to produce large differences in activity limitations, with a low number needed to treat (NNT = 2.4). Importantly, all secondary outcomes achieved similar improvements to the primary outcome and these were also sustained to the 1-year follow-up. More than eighty percent of the participants indicated they were very satisfied with following CFT.
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.
Jordan K, Dunn KM, Lewis M, Croft P. A minimal clinically important difference was derived for the Roland-Morris Disability Questionnaire for low back pain. J Clin Epidemiol. 2006 Jan;59(1):45-52. doi: 10.1016/j.jclinepi.2005.03.018. Epub 2005 Nov 4. PMID: 16360560.
Watch this FREE video lecture on Nutrition & Central Sensitisation by Europe’s #1 chronic pain researcher Jo Nijs. Which food patients should avoid will probably surprise you!