Research in context
Evidence before this study
We searched four electronic databases (Cochrane CENTRAL, CINAHL, MEDLINE, and Embase) from inception up to Sept 27, 2022, without language restrictions, using a modified Cochrane Collaboration search strategy. That strategy used diverse search terms for low back pain (eg, “back pain”, “low back pain”, and “lumbago”), cognitive functional therapy (CFT; eg, “cognitive functional therapy” and “cognitive behavioural therapy”), and randomised controlled trials (eg, “controlled clinical trial” and “randomised”). We identified four randomised controlled trials of individualised CFT (reported in five papers). All four trials were judged to be of moderate risk of bias (scores 6–7 on 0–10 PEDro scale). Control interventions included manual therapy and exercise, group-based exercise and education, and no treatment. One study was inadequately powered (n=36), two showed persistent effects favouring CFT for reducing pain-related activity limitation (disability) up to 12 months' follow-up, and one did not show significant effects beyond the end of the treatment period. Three studies compared CFT with other interventions. Two reported on activity limitation up to 3 months and their pooled effects were a standardised mean difference of 0·89 (95% CI –0·03 to 1·81), a potentially large effect. Three reported long-term outcomes at 12 months and their pooled effects were a standardised mean difference of 0·44 (0·01 to 0·77), a moderate effect. We found considerable heterogeneity and imprecision at both timepoints. We found no high quality randomised controlled trials comparing CFT with usual primary care, no trials that included an analysis of economic efficiency, nor any that explored the potential added effect of movement sensor biofeedback.
Added value of this study
To the best of our knowledge, the RESTORE trial is the largest clinical trial of CFT and its findings indicate that this treatment resulted in substantial clinically important effects in both the short term and long term, when compared with usual care. CFT was effective for the primary outcome of activity limitation and all of the secondary outcome measures. The large effect sizes persisted to the end of the follow-up period (12 months), which is unusual in chronic low back pain. The use of wearable sensor biofeedback did not add to effectiveness. CFT was also much more cost-effective from a societal perspective than usual care.
Implications of all the available evidence
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.