Background

This a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS).

Objectives

TOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP.

Methods

TOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test.

Discussion

This paper will provide a detailed description of the planned analyses for the TOPS trial.

Trial registration

Australian New Zealand Clinical Trials Registry (ACTRN12615000939594).

中文翻译：

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TOPS-运动和教育以防止下腰痛复发的随机对照试验：统计分析计划。

背景

该先验统计分析计划描述了下腰痛预防策略试验（TOPS）的分析方法。

目标

TOPS旨在研究运动和教育课程与最小干预措施相比，在预防最近从LBP发作中恢复的下腰痛（LBP）复发方面的有效性和成本效益。

方法

TOPS是一项优越，实用，平行分组的随机对照试验，具有分配隐瞒，盲目的结果评估者和意向性治疗分析。参与者被随机分配到物理治疗师主导的运动和教育计划中，为期12周或最少干预。主要结果是LBP发作复发的天数。三个主要的次要结局是LBP​​发作复发的天数，从而导致（1）活动受限，（2）寻找LBP的护理；（3）缺勤至少1天。将使用Cox回归比较主要（复发天数）和次要结果（具有活动受限的LBP天数，因LBP导致寻求护理的天数和因LBP导致缺勤的天数）的生存曲线差异。将计算危险比（HRs）和中位生存时间以及95％置信区间（CI）。将报告不良事件的数量，包括严重不良事件，并使用卡方检验比较各组之间不良事件的比例。

讨论区

本文将详细介绍TOPS试验计划进行的分析。

试用注册

澳大利亚新西兰临床试验注册中心（ACTRN12615000939594）。