Background: Interventions for low back pain typically produce small and short-term effects. Cognitive Functional Therapy (CFT) has demonstrated large effects up to 12-months, but longer-term effects are unclear. We compared the longer-term (3-year) effectiveness of (CFT), delivered with or without movement sensor biofeedback, with usual care for patients with chronic low back pain.
Methods: Randomised, controlled, three-arm, parallel group design conducted in 20 primary care clinics in Australia. We recruited adults with low back pain lasting >3-months with at least moderate pain-related physical activity limitation. A total of 492 participants were randomly assigned (1:1:1) to usual care, CFT-only, or CFT plus biofeedback. CFT is an individualised approach that targets unhelpful pain-related cognitions, emotions, and behaviours that contribute to ongoing pain and disability. The main outcome was pain-related physical activity limitation (activity limitation) using the Roland Morris Disability Questionnaire (RMDQ) (0–24 scale) self-reported at 3-year follow-up.
Results: The mean age of participants was 47·3 years (SD 15·2; range 19–87), 200 (41%) were male and 292 (59%) of 492 were female. CFT-only and CFT plus biofeedback were both more effective than usual care for activity limitation at 3-years (mean difference -3·5 [95% CI -4·9 to -2·0] and -4·1 [95% CI-5·6 to -2·6] respectively). Differences between the CFT-only and CFT plus biofeedback were small and not significant (mean difference -0·6, [95% CI -2·2 to 0·9]). For pain intensity, CFT-only (mean difference -1·0 [95% CI -1·6 to -0·5]) and CFT plus biofeedback (-1·5 [95% CI -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 (mean difference -0·5 [95% CI -1·1 to 0·1]).
Conclusions: Seven treatment sessions of CFT over 12-weeks plus a booster session at 26-weeks produced large effects on activity limitation, which are largely sustained at 3-years.