One of the great frustrations of treating low back pain is the limited efficacy of most interventions. While most people recover completely, as many as 20% to 30% of those with low back pain go on to develop chronic pain that is stubbornly resistant to therapeutic approaches and often leads to disability.1

The RESTORE study, a randomized, controlled, Phase 3 clinical trial, compared the effectiveness and economic efficiency of CFT versus usual care for chronic, disabling low back pain. Results were published May 2, 2023, in The Lancet.3

Comparing CFT to Usual Care

Participants included 492 adults with chronic low back pain of more than 3 months duration with an average back-pain intensity of 4 or greater on a 0-to-10 numeric pain-rating scale. All participants reported at least moderate pain-related interference with work or daily activities as measured by item 8 of the 36-item Short Form Health Survey. Subjects were excluded if they had serious spinal pathology (such as fracture, infection, or cancer), any medical condition that kept them from being physically active, or were pregnant or had given birth within the previous 3 months. The study was conducted across 20 primary care physiotherapy clinics in Australia.

The researchers divided subjects into three groups: usual care, CFT only, and CFT with biofeedback. Participants in the usual-care group received care that their healthcare providers had recommended or that they themselves had chosen. In both CFT groups, participants received up to seven CFT treatment sessions over the course of 12 weeks and a booster session at 26 weeks.

Physiotherapists conducting the training used a flexible clinical-reasoning approach based on information gathered from both interviews and physical examinations. This information included movement and postures, emotions and cognitions, and lifestyle factors that contributed to their pain. Communication was a key part of the process; patients were encouraged to tell the story of their “pain journey” and share their concerns and priorities. Personalized treatment plans were created based on this information.

The CFT treatment plans included three components:

  • Making sense of pain– a reflective process in which patients reconceptualized their pain based on their own stories and experiences
  • Exposure with control– graded exposure to movements and activities that the patient experienced as painful or frightening or something to be avoided
  • Lifestyle change –a coached approach to developing healthy behaviors such as paced activity, healthy sleep and dietary habits, stress management, and social engagement

Findings on Cognitive Functional Therapy for LBPs

The primary clinical outcome measure was pain-related limitation of physical activity. Secondary outcome measures were mean pain intensity, patient-specific functional limitation, pain catastrophization, pain self-efficacy, fear of movement, patient-perceived global improvement, patient satisfaction with care treatment, and adverse events noted by the physiotherapists or self-reported by participants.

For economic analysis, the primary outcome was quality-adjusted life-years. Included cost outcomes were direct health costs attributable to the use of all healthcare resources.

Both interventions were more effective than usual care at 13 weeks, results that were similar to previous trials of CFT as well as other combination therapies, the researchers noted. However, the effect sizes remained similar up to 52 weeks, showing a large and sustained effect of CFT, both with and without biofeedback. Interestingly, there was little difference between the CFT only and the CFT with biofeedback groups.

“We cannot be sure why no additional effect of movement sensor biofeedback was found,” the researchers wrote, “but in the context of CFT, an individualised intervention that already targets provocative movement patterns, additional movement information via biofeedback added no benefit. Sensor biofeedback with more feature-rich software might have resulted in different outcomes.”3

The CFT intervention was also much less expensive than usual care, the savings deriving primarily from improvements in productivity. More than 80% of participants reported that they were satisfied with the treatment.

“The results suggest to us that something important and positive had changed, and stayed changed, in the trajectory of these patients’ pain experience and in the consequences of that pain,” said Peter Kent, DC, PT, PhD, associate professor in the School of Allied Health at Curtin University and lead author of the study. “This is unusual in the research landscape, where few interventions show large and sustained effects for people with chronic low back pain. This is especially the case as we included patients who were more disabled that most previous back pain trials. We also included people usually excluded from back pain trials including elderly people, those with a past-history of spinal surgery, people with mental health challenges and other health comorbidities. This means that CFT can be helpful for the people who are most impacted by chronic back pain.”

Thus, noted Dr. Kent, an important next step is implementation studies to test whether CFT is scalable within diverse health systems and that self-sustaining communities of CFT practice can be created and supported through this training. “Critically, we need health systems to adequately fund treatments such as CFT so that clinicians have sufficient time to provide this care.”

REFERENCES
  1. Kongsted A, Kent P, Axen I, Downie AS, Dunn KM. What have we learned from ten years of trajectory research in low back pain? BMC Musculoskelet Disord. 2016;17:220. Published 2016 May 21. doi:10.1186/s12891-016-1071-2
  2. O’Sullivan PB, Caneiro JP, O’Keeffe M, et al. Cognitive functional therapy: An integrated behavioral approach for the targeted management of disabling low back pain [published correction appears in Phys Ther. 2018 Oct 1;98(10):903]. Phys Ther. 2018;98(5):408-423. doi:10.1093/ptj/pzy022
  3. Kent P, Haines T, O’Sullivan P, 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 [published online ahead of print, 2023 May 2]. Lancet. 2023;S0140-6736(23)00441-5.