Objectives This randomized controlled trial investigated the efficacy of cognitive functional therapy (CFT) compared with manual therapy and exercise (MT-EX) for people with non-specific chronic low back pain (NSCLBP) at 3-year follow-up. Methods Hundred and twenty-one patients were randomized to CFT (n = 62) or MT-EX (n = 59). Three-year data were available for 30 (48.4%) participants in the CFT group, and 33 (55.9%) participants in the MT-EX group. The primary outcomes were disability (Oswestry disability Index [ODI]) and pain intensity (numerical rating scale) and secondary outcomes were anxiety/depression (Hopkins Symptoms Checklist) and pain-related fear (Fear-Avoidance Belief Questionnaire). A full intention to treat analysis was conducted using linear mixed models. Results Significantly greater reductions in disability were observed for the CFT group, with ODI scores at 3 years 6.6 points lower in the CFT than the MT-EX group (95%CI:-10.1 to -3.1, p < 0.001, standardized effect size = 0.70). There was no significant difference in pain intensity between the groups at 3 years (0.6 points 95%CI:-1.4-0.3, p = 0.195). Significantly greater reductions were also observed for the CFT group for Hopkins Symptoms Checklist and Fear-Avoidance Belief Questionnaire (Work). Conclusions CFT is more effective at reducing disability, depression/anxiety and pain-related fear, but not pain, at 3-year follow-up than MT-EX. Significance Cognitive functional therapy (CFT) was more effective than manual therapy and exercise (MT-EX) in reducing disability at 3-year follow-up, in people with non-specific chronic low back pain. The sustained reduction in disability without concomitant reductions in pain intensity in the CFT group suggests a de-coupling of the pain-disability relationship. CFT resulted in long-lasting reductions in anxiety and depression, and pain-related fear regarding work compared to MT-EX. The findings support the long-term benefits of a individualized behaviourally orientated intervention that targets pain beliefs, functional restoration and lifestyle factors.
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