Low back pain is the leading cause of years lived with disability globally, but most interventions have only short-lasting, small to moderate effects. Cognitive functional therapy (CFT) is an individualised approach that targets unhelpful pain-related cognitions, emotions, and behaviours that contribute to pain and disability. Movement sensor biofeedback might enhance treatment effects. We aimed to compare the effectiveness and economic efficiency of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling low back pain. RESTORE was a randomised, controlled, three-arm, parallel group, phase 3 trial, done in 20 primary care physiotherapy clinics in Australia. We recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation. Exclusion criteria were serious spinal pathology (eg, fracture, infection, or cancer), any medical condition that prevented being physically active, being pregnant or having given birth within the previous 3 months, inadequate English literacy for the study's questionnaires and instructions, a skin allergy to hypoallergenic tape adhesives, surgery scheduled within 3 months, or an unwillingness to travel to trial sites. Participants were randomly assigned (1:1:1) via a centralised adaptive schedule to usual care, CFT only, or CFT plus biofeedback. The primary clinical outcome was activity limitation at 13 weeks, self-reported by participants using the 24-point Roland Morris Disability Questionnaire. The primary economic outcome was quality-adjusted life-years (QALYs). Participants in both interventions received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001396213. Between Oct 23, 2018 and Aug 3, 2020, we assessed 1011 patients for eligibility. After excluding 519 (51·3%) ineligible patients, we randomly assigned 492 (48·7%) participants; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. Both interventions were more effective than usual care (CFT only mean difference –4·6 [95% CI –5·9 to –3·4] and CFT plus biofeedback mean difference –4·6 [–5·8 to –3·3]) for activity limitation at 13 weeks (primary endpoint). Effect sizes were similar at 52 weeks. Both interventions were also more effective than usual care for QALYs, and much less costly in terms of societal costs (direct and indirect costs and productivity losses; –AU$5276 [–10 529 to –24) and –8211 (–12 923 to –3500). CFT can produce large and sustained improvements for people with chronic disabling low back pain at considerably lower societal cost than that of usual care. Australian National Health and Medical Research Council and Curtin University.

中文翻译：

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带或不带运动传感器生物反馈的认知功能治疗与慢性、致残性腰痛的常规护理 (RESTORE)：随机、对照、三臂、平行组、3 期临床试验

腰痛是全球范围内导致多年残疾的主要原因，但大多数干预措施仅产生短期、小到中度的影响。认知功能治疗 (CFT) 是一种个体化方法，针对导致疼痛和残疾的与疼痛相关的无益认知、情绪和行为。运动传感器生物反馈可能会增强治疗效果。我们的目的是比较 CFT（有或没有运动传感器生物反馈）与常规护理对慢性、致残性腰痛患者的有效性和经济效率。 RESTORE 是一项随机、对照、三组、平行组、3 期试验，在澳大利亚 20 个初级保健物理治疗诊所进行。我们招募了腰痛持续超过 3 个月且至少中度与疼痛相关的体力活动受限的成年人（年龄≥18 岁）。排除标准是严重的脊柱病变（例如骨折、感染或癌症）、任何妨碍身体活动、在过去 3 个月内怀孕或分娩的医疗状况、研究问卷和说明的英语读写能力不足、皮肤病对低过敏性胶带粘合剂过敏、计划在 3 个月内进行手术或不愿意前往试验地点。通过集中适应性时间表将参与者随机分配（1:1:1）至常规护理、仅 CFT 或 CFT 加生物反馈。主要临床结果是 13 周时的活动受限，由参与者使用 24 点罗兰莫里斯残疾问卷自行报告。主要经济结果是质量调整生命年（QALY）。两项干预措施的参与者在 12 周内接受了最多 7 次治疗，并在 26 周时接受了加强治疗。物理治疗师和患者均未佩戴口罩。该试验已在澳大利亚新西兰临床试验注册中心注册，ACTRN12618001396213。 2018年10月23日至2020年8月3日期间，我们评估了1011名患者的资格。排除 519 名（51·3%）不符合条件的患者后，我们随机分配了 492 名（48·7%）参与者； 164 名（33%）仅接受 CFT，163 名（33%）接受 CFT 加生物反馈，165 名（34%）接受常规护理。两种干预措施均比常规护理更有效（仅 CFT 平均差 –4·6 [95% CI –5·9 至 –3·4]，CFT 加生物反馈平均差 –4·6 [–5·8 至 –3·4] 3]）13周时的活动限制（主要终点）。 52 周时的效果大小相似。这两种干预措施也比 QALY 的常规护理更有效，并且在社会成本方面成本低得多（直接和间接成本以及生产力损失；–5276 澳元 [–10 529 至 –24）和 –8211（–12 923 至 – 3500）。 CFT 可以为慢性致残性腰痛患者带来巨大且持续的改善，而社会成本比常规护理低得多。澳大利亚国家健康与医学研究委员会和科廷大学。