Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low...

Interventions for low back pain typically produce small and short-term effects. Cognitive functional therapy (CFT) has shown large effects up to 12 months, but long-term effects are unclear. We aimed to compare the long-term (3-year) effectiveness of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic disabling low back pain.

The RESTORE trial was a randomised, controlled, three-arm parallel group, phase 3, clinical trial that investigated CFT delivered with or without biofeedback compared with usual care for the treatment of chronic low back pain. Treatment was delivered in 20 primary care physiotherapy clinics in Australia. This study is the 3-year follow-up of the RESTORE trial. We recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation and average back pain of at least 4 on a 0-10 scale. Participants were randomly assigned (1:1:1) via a centralised adaptive schedule to usual care, CFT only, or CFT plus biofeedback. At the 1-year follow-up, all participants were invited to provide consent to be followed up 2 years later-ie, 3 years after randomisation. The primary outcome was pain-related physical activity limitation, self-reported via the Roland Morris Disability Questionnaire (0-24 scale) at 3 years. The secondary outcome was pain intensity at 3 years, assessed using the numeric pain rating scale. Adverse event data were not collected at the 3-year follow-up. All outcomes were assessed in the intention-to-treat population. Participants in both CFT groups received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked. People with lived experience of chronic low back pain were involved in the study design and conduct. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).

Between Oct 23, 2018, and Aug 3, 2020, 1011 people were assessed for eligibility for the RESTORE trial. 492 (49%) were eligible and randomly assigned to one of three treatments; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. At the 1-year follow-up, 359 (73%) of 492 participants provided consent to be contacted to complete the 3-year questionnaire. 312 (87%) of those 359 participants were successfully followed up at 3 years, with similar proportions across each treatment group; 104 (63%) of 164 in the CFT only group, 106 (65%) of 163 in the CFT plus biofeedback group, and 102 (62%) of 165 in the usual care group. 188 (60%) of 312 participants were female, 124 (40%) were male, and the mean age was 48·1 years (SD 14·6). CFT only (mean difference -3·5 [95% CI -4·9 to -2·0]) and CFT plus biofeedback (-4·1 [-5·6 to -2·6]) were both more effective than usual care in reducing activity limitation at 3 years. Differences between CFT only and CFT plus biofeedback treatments were small and not significant (mean difference -0·6 [95% CI -2·2 to 0·9]). For pain intensity at 3 years, CFT only (-1·0 [-1·6 to -0·5]) and CFT plus biofeedback (-1·5 [-2·1 to -0·9]) were also more effective than usual care, and differences between CFT only and CFT plus biofeedback were small and not significant (-0·5 [-1·1 to 0·1]).

Treatment sessions of CFT produced sustained effects at 3 years for people with chronic disabling low back pain. These long-term effects are novel and provide the opportunity to markedly reduce the effect of chronic back pain if the intervention can be widely implemented. Implementation requires scaling up of clinician training to increase accessibility and replication studies in diverse health-care systems.

Australian National Health and Medical Research Council and Curtin University.