The Restore Trial published in the Lancet Medical Journal looked into the effect of a new treatment method called Cognitive Functional Therapy (CFT) and how it can enhance the management of low back pain.

It has shown promising, unprecedented results in the management of low back pain! Not only did it result in a large reduction in pain-related physical activity limitation and pain intensity, but also, these results lasted for 52 weeks, which is unusual in the low back pain field.

Low Back Pain: Living a Life on Hold

Low back pain is the leading cause of worldwide disability, work loss, and early retirement. Patients experiencing low back pain often report feeling disconnected from their own world, as it interferes with everyday activities like going to work, exercising, socializing and many more. 
CFT patient told the story of her condition “I was locked in, I avoided multiple activities that would have any chance of any risk of my body being in an unstable state, I would avoid. That would even involve pushing a shopping trolley” 

“I avoided activities with my kids I didn't play soccer with them or play tennis anything because I lived in a state of fear that one foul move would just have this disastrous effect”

While most people experiencing episodic low back pain tend to improve rapidly, 20-30% of people who have experienced low back pain, develop chronic persistent low back pain (pain lasting >3 months). Making low back pain carry the greatest burden of disease in terms of years lived with disability.
In terms of its economic impact, the financial burden of low back pain is staggering, with its societal costs exceeding that of cancer and diabetes combined.
And it keeps on getting worse!
Low back pain related disability has increased by 45% from 1990 to 2010 [2], with the current care models failing to manage low back pain!

Something Had to Change.

Low back pain management is widely variable. With many people receiving interventions that are not recommended in international guidelines.
Low back pain guidelines recommend starting management with patient education and then progressing to other interventions such as anti-inflammatory medication, exercise therapy and manual therapies. Those who fail to respond, escalate in their management rapidly to more invasive interventions such as opioids, injections and surgery.
Professor Mark Hancock, Sydney lead investigator, commented on traditional LBP management, saying:

Unfortunately, even those interventions that are widely recommended such as exercise and psychological therapies produce relatively small and short-lasting effects.”
“This is not, however, entirely surprising, given that most current interventions fail to address the wide range of factors that we now know that contribute to chronic low back pain, things such as unhelpful beliefs about pain, physical, social and life-style factors...

As our understanding of low back pain has evolved over the years, there has been a shift in patient management from the biomedical model to the biopsychosocial model, which describes back pain as a result of a complex interaction between a range of biological, psychological, social, and cultural factors. Each combination is unique for each individual patient.

While psychosocial management is recommended in best practice guidelines, many clinicians report they don’t have the skills or confidence to deliver this type of care. 
Ciaran O’ Shaughnnessy, a Physical Therapist in the trial who received CFT training, said:

I had difficulty integrating the psychosocial elements of a patient's pain experience in stem management the training process helped me develop a new repertoire of skills around person-centered care communication and behavioral experiments”
“It taught me how to help patients make sense of pain and more effectively manage relevant psychosocial factors

CFT: Person-Centered Approach

Cognitive Functional Therapy (CFT) is an individualized behavioral intervention for people with chronic disabling low back pain.
Professor Peter O’Sullivan, Developer of Cognitive Functional Therapy and Trainer, explains CFT: “cognitive functional therapy is a person-centered approach that is aligned to Best Care principles, it explores the patients’ beliefs, emotions and behavioral responses to pain and then takes the person on a journey this journey first explores the person's understanding of their pain”
“It helps to reconceptualize their pain as not so much about damage but as the body's responses to overprotect themselves”

“It helps them to find new ways of responding to their pain in terms of moving and relaxing and having new control over their body to build confidence in their body to go back to the things in life that they value”

“It gives them a sense of autonomy to have control over their body and their health so that they can independently manage them their own health concerns”

CFT differs from other traditional treatment methods as it is a self-management approach that places the person as the “center” of their own care and the clinician as the “coach” rather than the fixer.
It takes the patient through a journey. First, patients reflect on their own pain experience and develop a multi-dimensional understanding of pain. Secondly, functional movement training helps patients build confidence to engage in functional activities. Lastly, patients are encouraged to adopt a healthy lifestyle.

Central to CFT is building a strong therapeutic alliance with the patient to facilitate patient-centred care. This is characterized by open, reflective, empathetic, and validating communication.

In order to individualize the patient’s care, with respect to their goals, the clinician estimates the relative contribution of the various multi-dimensional factors within 8 key domains:

Three key aspects of the CFT provide a framework for person-centered care.

1. Making sense of pain: This aspect seeks to make the patient develop his own biopsychosocial understanding of his pain (taking into account his history and experiences). That new understanding helps the patient develop more helpful ways of responding to pain. [3]

2. Exposure with 'control': This aspect is a graded exposure approach and seeks to reduce protective, safety and avoidance behaviors to provide pain control and build confidence to re-engage in painful, feared valuable movements, postures and functional tasks or avoided; in other words, to increase the patient's self-efficacy and return to activities that are valued to him. [3]

3. Lifestyle changes: This last aspect focuses on developing healthy lifestyle habits that may be relevant to the patient, that is, they are relevant in the areas that the person identified as an important objective to improve their health or quality of life. Some examples may be: the person has a poor quality of sleep (strategies are provided to improve sleep habits), the person identifies that they have difficulty controlling their stress level (stress management strategies such as meditation techniques are provided and relaxation), etc. [3]

The RESTORE trial

While other studies have looked into CFT, they included mostly a low number of patients, which resulted in limited generalizability of the results.
In the RESTORE Trial 492 patients were recruited and randomized into 3 groups: Usual Care, CFT and CFT with movement sensory bio-feedback.
Individuals included were adults over 18 years old, with a current episode of back pain. Unlike previous trials, the RESTORE Trial included individuals with at least moderate low back pain (VAS ≥4). Individuals with serious spinal pathologies were excluded from the study. 
The trial didn’t only look at the pain related physical activity limitation but also at the economic impact.

What Were the Results?
The trial resulted in large and sustained (at 12-months) reductions in pain-related activity limitation (disability) and pain intensity compared to usual care.
Also, people had more positive pain beliefs, were more confident to engage in movement and activity and they were less fearful of movement.
The patient satisfaction was high, with 82% of people receiving Cognitive Functional Therapy were satisfied with the treatment compared to 19% receiving usual care.
Not only was CFT more effective, it was also much less costly than usually care. Reductions in health-related costs and improvements in productivity valued (combined) resulted in more than AU$5000 in societal saving per person over a year, beyond the cost of the care. [4]

Finally, Professor Peter O’Sullivan commented:

The restore trial gives hope to people with chronic low back pain, it gives hope that there is a change in, narrative around pain instead of scanning people identifying you know what's on a scan and telling them they're damaged and setting rules around pain, to give people a new understanding of pain.

Find more information about the RESTORE trial and CFT here:

RESTORE Trial

Learn more about CFT on our course: Cognitive Functional Therapy Course with Prof. Kieran O'Sullivan.

CFT Course with Prof. Kieran O'Sullivan