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.

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研究概要

492 patients with chronic, disabling low back pain were randomized to receive cognitive functional therapy (CFT) with the use of biofeedback sensors (n=163) or without biofeedback sensors (n=164), or usual care (n=165). The primary outcome of interest was pain-related physical activity limitation. Secondary outcomes of interest included pain outcomes, functional limitation, global improvement, patient satisfaction, adverse events, and cost-utility. Follow-up was conducted over a 52 week period. Both CFT groups significantly outperformed the usual care group in all outcomes, resulting in greater improvements in physical function, pain relief, improvement in outcomes, and fear avoidance, up to 52 weeks. Moreover, the CFT groups were significantly more cost-effective than the usual care group, resulting in a greater gain in quality adjusted life-years and a larger reduction in productivity loss. However, the use of CFT with biofeedback sensors did not result in any meaningful difference over CFT only. The results of this trial suggest that CFT could provide lasting, effective relief of chronic, disabling low back pain in a cost-effective manner vs. existing treatments.