Effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention for the prevention of low back pain recurrence in Australia (WalkBack): a randomised controlled trial

——原载《柳叶刀》2024年第404卷第10448期——

<The Lancet> Volume 404, Issue 10448, 2024

【摘要】背景：腰痛复发很常见，是腰痛疾病和经济负担的重要因素。建议进行锻炼以防止复发，但步行等方便且低成本的干预措施的有效性和成本效益尚未确定。我们旨在研究个性化、渐进式步行和教育干预在预防腰痛复发方面的临床有效性和成本效益。方法：WalkBack是一项双臂随机对照试验。本研究招募了来自澳大利亚各地的成年人（18岁或以上），他们最近从一场非特异性腰痛发作中恢复过来，这种疼痛不归因于特定的诊断，并且持续至少24小时。参与者被随机分配到个性化、渐进式步行和教育干预组，由物理治疗师在6个月内进行6次疗程，或无治疗对照组（1:1）。随机化方案由4、6和8个随机排列的区块组成，并根据两次以上腰痛发作史和转诊方法进行分层。物理治疗师和参与者对分配情况知情。根据入组日期，对参与者进行至少12个月、最多36个月的随访。主要结果是活动受限的腰痛发作首次复发的天数，通过每月自我报告从意向治疗人群中收集。成本效益从社会角度进行评估，并表示为每增加一个质量调整生命年（QALY）的增量成本。该试验是前瞻性注册的 (ACTRN12619001134112)。结果：2019年9月23日至2022年6月10日期间，筛选了3206名潜在参与者，排除2505名（78%），随机分配701名（351名进入干预组，350名进入无治疗对照组）。大多数参与者为女性（701名中有565名 [81%]），参与者的平均年龄为54岁（标准差12岁）。干预措施可有效预防活动受限性腰痛发作（风险比0.72 [95% CI 0.60–0.85]，p=0.0002）。干预组复发中位天数为208天（95% CI 149–295），对照组复发中位天数为112天（89–140）。每增加一个QALY的增量成本为7802澳元，因此，在愿意支付的门槛为28,000澳元的情况下，干预具有94%的成本效益。尽管干预组和对照组在12个月内经历至少一次不良事件的参与者总数相似（分别为351人中的183人 [52%] 和350人中的190人 [54%]，p=0.60），但干预组中与下肢相关的不良事件数量多于对照组（干预组为100人，对照组为54人）。解释：个性化、渐进式步行和教育干预显着减少了腰痛复发。这种方便、可扩展且安全的干预措施可能会影响腰痛的管理方式。

[Summary] Background: Recurrence of low back pain is common and a substantial contributor to the disease and economic burden of low back pain. Exercise is recommended to prevent recurrence, but the effectiveness and cost-effectiveness of an accessible and low-cost intervention, such as walking, is yet to be established. We aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain. Methods: WalkBack was a two-armed, randomised controlled trial, which recruited adults (aged 18 years or older) from across Australia who had recently recovered from an episode of non-specific low back pain that was not attributed to a specific diagnosis, and which lasted for at least 24 h. Participants were randomly assigned to an individualised, progressive walking and education intervention facilitated by six sessions with a physiotherapist across 6 months or to a no treatment control group (1:1). The randomisation schedule comprised randomly permuted blocks of 4, 6, and 8 and was stratified by history of more than two previous episodes of low back pain and referral method. Physiotherapists and participants were not masked to allocation. Participants were followed for a minimum of 12 months and a maximum of 36 months, depending on the date of enrolment. The primary outcome was days to the first recurrence of an activity-limiting episode of low back pain, collected in the intention-to-treat population via monthly self-report. Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained. The trial was prospectively registered (ACTRN12619001134112). Findings: Between Sept 23, 2019, and June 10, 2022, 3206 potential participants were screened for eligibility, 2505 (78%) were excluded, and 701 were randomly assigned (351 to the intervention group and 350 to the no treatment control group). Most participants were female (565 [81%] of 701) and the mean age of participants was 54 years (SD 12). The intervention was effective in preventing an episode of activity-limiting low back pain (hazard ratio 0·72 [95% CI 0·60–0·85], p=0·0002). The median days to a recurrence was 208 days (95% CI 149–295) in the intervention group and 112 days (89–140) in the control group. The incremental cost per QALY gained was AU$7802, giving a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28 000. Although the total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups (183 [52%] of 351 and 190 [54%] of 350, respectively, p=0·60), there was a greater number of adverse events related to the lower extremities in the intervention group than in the control group (100 in the intervention group and 54 in the control group). Interpretation: An individualised, progressive walking and education intervention significantly reduced low back pain recurrence. This accessible, scalable, and safe intervention could affect how low back pain is managed.

论文原文：Natasha C Pocovi, Chung-Wei Christine Lin, Simon D French, Petra L Graham, Johanna M van Dongen, Prof Jane Latimer, et al. (2024). Effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention for the prevention of low back pain recurrence in Australia (WalkBack): a randomised controlled trial. The Lancet, Volume 404, Issue 10448, Pages 134-144, July 19, 2024.

https://doi.org/10.1016/S0140-6736(24)00755-4

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