澳大利亚麦格理大学Natasha C Pocovi团队研究了个性化、渐进式步行和教育干预预防腰痛复发的临床有效性和成本效益。该研究于2024年6月19日发表于《柳叶刀》杂志。

腰痛复发很常见，也是造成腰痛的疾病和经济负担的主要原因。建议进行锻炼以防止复发，但步行等可获得的低成本干预措施的有效性和成本效益尚待确定。研究组旨在研究个性化、渐进式步行和教育干预预防腰痛复发的临床有效性和成本效益。

WalkBack是一项双臂随机对照试验，招募来自澳大利亚各地的成年人（18岁或以上），他们最近从非特定诊断的非特异性腰痛发作中康复，并持续了至少24小时。参与者被随机分配到一个个性化、渐进的步行和教育干预组，由理疗师在6个月内进行六次治疗，或被分配到一组不接受治疗的对照组（1:1）。随机化时间表包括4、6和8个随机排列的区块，并根据两次以上腰痛病史和转诊方法进行分层。理疗师和参与者双盲。根据报名日期，参与者被跟踪至少12个月，最多36个月。主要结局是通过每月自我报告在意向治疗人群中收集的活动受限性腰痛首次复发的天数。成本效益从社会角度进行评估，并表示为每质量调整生命年（QALY）的增量成本。

2019年9月23日至2022年6月10日，研究组对3206名潜在参与者进行了资格筛选，2505名（78%）被排除在外，701名被随机分配（351人被分配到干预组，350人被分配到无治疗对照组）。大多数参与者是女性（701人中有565人[81%]），参与者的平均年龄为54岁（SD 12）。干预措施可有效预防活动受限性腰痛发作（危险比0.72[95%CI 0.60–0.85]，p=0.0002）。干预组复发的中位天数为208天（95%CI 149–295），对照组为112天（89–140）。每QALY获得的增量成本为7802澳元，在意愿支付28000美元的门槛下，干预措施具有成本效益的潜力为94%。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（351人中分别有183人[52%]和350人中分别为190人[54%]，p=0.60），但干预组与下肢相关的不良事件数量多于对照组（干预组100例，对照组54例）。

研究结果表明，个性化、渐进式的步行和教育干预显著减少了腰痛的复发。这种可访问、可扩展和安全的干预措施可能会影响腰痛的治疗方式。

附：英文原文

Title: 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

Author: Natasha C Pocovi, Chung-Wei Christine Lin, Simon D French, Petra L Graham, Johanna M van Dongen, Jane Latimer, Dafna Merom, Anne Tiedemann, Christopher G Maher, Ornella Clavisi, Shuk Yin Kate Tong, Mark J Hancock

Issue&Volume: 2024-06-19

Abstract:

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 $28000. 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.

DOI: 10.1016/S0140-6736(24)00755-4

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00755-4/abstract