Cognitive Functional Therapy Appears Effective for Managing Chronic Low Back Pain

Chronic low back pain is considered a global disability that affects people’s quality of life and is costly.

So, what to do?

Australian researchers conducting a randomized trial found that cognitive functional therapy (CFT) may be effective in helping individuals manage their chronic low back pain. CFT focuses on understanding the causes of pain, as well as the emotions associated with it and behaviors that trigger it. They also found that CFT alone is more cost-effective than standard care or CFT coupled biofeedback for the treatment of back pain.

"The societal costs of chronic pain exceed that of cancer and diabetes combined, and most costs from chronic low back pain are due to loss of work participation and on-going care-seeking," Peter Kent, PhD, from the Curtin School of Allied Health, Curtin University, Perth, Australia, and colleagues wrote in Lancet. They also noted that current treatment options are insufficient in helping people get pain relief, and that "chronic low back pain is considered a complex multifactorial biopsychosocial condition," which is why guidelines suggest treatment needs to embrace not just the physical components of the pain but also the psychological aspects that might trigger episodes.

Thus, Kent and colleagues undertook the RESTORE trial—a randomized, controlled, three-arm, parallel group, phase III trial that took place from Oct. 23, 2018, to Aug. 3, 2020, in 20 primary care physiotherapy clinics in Australia. The individuals recruited for the study were 18 years or older and experiencing low back pain for more than 3 months.

Of the 1,011 individuals assessed for the trial, 492 were randomized as follows:

• 164 to CFT alone.
• 163 to CFT plus biofeedback.
• 165 to usual care.

Exclusion criteria included "serious spinal pathology (e.g., fracture, infection, or cancer), any medical condition that prevented being physically active, being pregnant or having given birth within the previous 3 months, inadequate English literacy for the study’s questionnaires and instructions, a skin allergy to hypoallergenic tape adhesives, surgery scheduled within 3 months, or an unwillingness to travel to trial sites."

The researchers explained that the aim of CFT is to help "patients to self-manage [pain] by targeting their individual pain-related cognitions, emotions, and behaviors that contribute to their pain and disability." They also noted that it differs from cognitive behavioral therapy, in that "CFT addresses pain provocative movement patterns that contribute to low back pain, such as protective muscle guarding and movement avoidance." When CFT is combined with biofeedback, movement detectors "can help patients to develop an awareness of how they move during normal activities, enhancing their ability to correct unhelpful movement habits," the study authors explained.

For both the CFT alone and the CFT plus biofeedback, the study participants were able to get up to seven treatment sessions over 12 weeks, and at 26 weeks they were also given a booster session that "aimed to review and optimize the participants self-management plan, including responding to future flare-ups, and address any barriers.

"The physiotherapists used a flexible clinical-reasoning approach, which was based on information gathered by interview and physical examination to identify movements, postures, pain-related cognitions, emotions, and lifestyle factors contributing to each individual’s ongoing pain and disability," Kent and colleagues wrote. "Patient-centered communication was central to this process in which patients were asked to ’tell their story’ (eliciting a personal narrative of the patient’s pain journey to share their concerns, identify which elements of their history were important to them, and what their priorities were). Patients’ concerns were validated and their goals for seeking care explored. This approach informed an individualized treatment plan orientated to the patient’s goals, with three broad components."

The usual care arm of the study consisted of recommendations from the patient’s provider as well as patient choice of physiotherapy, massage, chiropractic care, medicine, injections, or surgical interventions, Kent et al explained.

"The primary clinical outcome was activity limitation at 13 weeks, self-reported by participants using the 24-point Roland Morris Disability Questionnaire. The primary economic outcome was quality adjusted life-years (QALYs)," they wrote.

At this timepoint, the researchers noted that 85% of the participants completed the primary outcome—85% in the usual care group, 86% in the CFT only group, and 83% in the CFT plus biofeedback group. They found that both CFT alone and CFT plus biofeedback were more effective than usual care (CFT only: mean difference, –4.6 [95% CI, –5.9 to –3.4]; CFT plus biofeedback: mean difference, –4.6 [–5.8 to –3.3]) for activity limitation at 13 weeks. They noted that the effect sizes were similar at the end of the year.

"Differences between the CFT only and CFT plus biofeedback treatments were trivial and not significant at 13 weeks (mean difference, 0.0 [–1.3 to 1.3]; SMD, 0.00 [–0.22 to 0.23]). The proportions of participants with a within-person clinically important reduction of 5 or more points of activity limitation at 13 weeks were 27 (19%) of 141 in the usual care group, 86 (61%) of 141 in the CFT only group, and 82 (60%) of 136 in the CFT plus biofeedback group," explained researchers.

They also noted that the CFT and the CFT plus biofeedback interventions were more effective than usual care for QALYs and also cost less than usual care (direct and indirect costs and productivity losses; –AU$5,276 [–10,529 to –24) and –8,211 (–12,923 to –3500).

Across all arms, most of the participants were female (58%-60%), the mean age was around 47 years, around half had a university education, BMI was just 28.3-28.9, the length of the current pain episode was 4-5 years, and more than half of the participants were taking any kind of pain medication, with 17%-23% taking opioids, 28%-30% taking analgesics, and 26%-36% taking anti-inflammatories.

Kent et al noted that their results tally with other analyses of previous studies of CFT.

"However, our results were sustained at 52 weeks, which is unusual, by contrast with the same systematic review’s findings that no treatments, nor combination of treatments, had statistically significant effects at 52 weeks for either activity limitation or pain," they wrote. "Additionally, the long-term effects we observed were much greater than those of more expensive multidisciplinary pain management programs compared with usual care for activity limitation, although our interventions were delivered by solo primary care physiotherapists."

The fact that the CFT plus biofeedback did not best CFT alone was surprising.

"Our hypothesis that CFT plus biofeedback would have a larger clinical effect than CFT only was not confirmed. We cannot be sure why no additional effect of movement sensor biofeedback was found, but in the context of CFT, an individualized 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 outcome," wrote Kent and colleagues.

That said, the fact that biofeedback was not necessary led them to conclude: "CFT might offer a high value, low-risk, and low-cost clinical pathway for patients with persistent disabling low back pain. The results of this study have ramifications for the management of low back pain in primary care and might have implications for the training of all health-care professionals who deliver care for people with chronic disabling low back pain."

However, Kent et al’s study does have some limitations, as Ney Meziat-Fiho from Postgraduate Program in Rehabilitation Sciences, Centro Universitário Augusto Motta (UNISUAM), Rio de Janeiro, Brazil, and colleagues noted in an editorial comment. How CFT would perform against placebo is not known. They point out that the "usual care group received minimal treatment, and that performance bias may have been in play in regard to the CFT groups that received more attention.

"Furthermore, participants were told that the trial compared usual care with two evidence-based interventions and were aware of their group allocation. This unmasking could have negatively influenced the expectations of participants in the usual care group," the editorialists wrote.

Kent and colleagues also noted some other limitations, including that about a third of the participants did not consent to access to their medical claims and Pharmaceutical Benefits Scheme Data, the clinical and other outcomes were self-reported, and the unblinding again could have introduced bias.

This study was supported by the Australian National Health and Medical Research Council and Curtin University, Perth, WA, Australia.

Kent declared no relevant relationships.

Meziat-Filho declared no relevant relationships.

Kent 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" Lancet 2023; 401: 1866–77.

Meziat-Filho N, et al "Cognitive functional therapy for chronic disabling low back pain" Lancet 2023; DOI: 10.1016/ S0140-6736(23)00571-8.