Kent Peter, O'Sullivan P, Smith Anne, Haines Terry, Campbell Amity, McGregor Alison H, Hartvigsen Jan, O'Sullivan Kieran, Vickery Alistair, Caneiro J P, Schütze Robert, Laird Robert A, Attwell Stephanie, Hancock Mark
School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia
Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
BMJ Open. 2019 Aug 18;9(8):e031133. doi: 10.1136/bmjopen-2019-031133.
Low back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP.
Pragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0-10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a 'booster' session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L .
Approved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations.
Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).
腰痛（LBP）是全球残疾的主要原因，其成本超过癌症和糖尿病的总和。最近的证据表明，个性化的认知和运动康复结合生活方式建议（认知功能疗法（CFT））可能比传统方法产生更大、更持久的效果，并且运动传感器生物反馈可能会提高治疗效果。因此，这项三臂随机对照试验（RCT）旨在比较提供或不提供运动传感器生物反馈的个性化CFT与慢性致残性LBP患者常规护理的临床效果和经济效率。
实用的三臂随机平行组优效性RCT，比较常规护理（n = 164）、CFT（n = 164）和CFT加运动传感器生物反馈（n = 164）。纳入标准包括：患有当前腰痛发作>3个月的成年人；在≥6周前因本次腰痛发作寻求初级护理；平均腰痛强度≥4（0 - 10分制）；至少有中度疼痛相关的工作或日常活动干扰。仅接受CFT和接受CFT加运动传感器生物反馈的参与者将在12周内接受7次治疗，并在26周时接受一次“强化”治疗。所有参与者将在基线、3、6、13、26、40和52周时进行评估。主要结局是与疼痛相关的身体活动受限（罗兰·莫里斯残疾问卷）。线性混合模型将用于评估治疗在所有时间点对身体活动受限的影响，主要比较是在13周时对组间调整后平均差异的正式检验。对于经济（成本效用）分析，临床效果的主要结局将是使用欧洲五维健康量表（EuroQol EQ - 5D - 5L）在12个月随访期间测量的质量调整生命年。
经科廷大学人类研究伦理委员会批准（HRE2018 - 0062，2018年2月6日）。研究结果将通过在同行评审期刊上发表和在会议上展示进行传播。
澳大利亚新西兰临床试验注册中心（ACTRN12618001396213）
