School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada
School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, QLD, Australia.
BMJ Open. 2021 Jan 20;11(1):e042792. doi: 10.1136/bmjopen-2020-042792.
Exercise therapy is the most recommended treatment for chronic low back pain (LBP). Effect sizes for exercises are usually small to moderate and could be due to the heterogeneity of people presenting with LBP. Thus, if patients could be better matched to exercise based on individual factors, then the effects of treatment could be greater. A recently published study provided evidence of better outcomes when patients are matched to the appropriate exercise type. The study demonstrated that a 15-item questionnaire, the Lumbar Spine Instability Questionnaire (LSIQ), could identify patients who responded best to one of the two exercise approaches for LBP (motor control and graded activity). The primary aim of the current study isill be to evaluate whether preidentified baseline characteristics, including the LSIQ, can modify the response to two of the most common exercise therapies for non-specific LBP. Secondary aims include an economic evaluations with a cost-effectiveness analysis.
Participants (n=414) will be recruited by primary care professionals and randomised (1:1) to receive motor control exercises or graded activity. Participants will undergo 12 sessions of exercise therapy over an 8-week period. The primary outcome will be physical function at 2 months using the Oswestry Disability Index. Secondary outcomes will be pain intensity, function and quality of life measured at 2, 6 and 12 months. Potential effect modifiers will be the LSIQ, self-efficacy, coping strategies, kinesiophobia and measures of nociceptive pain and central sensitisation. We will construct linear mixed models with terms for participants (fixed), treatment group, predictor (potential effect modifier), treatment group×predictor (potential effect modifier), physiotherapists, treatment group×physiotherapists and baseline score for the dependent variable.
This study received ethics approval from the Hamilton Integrate Research Ethics Board. Results will be submitted for publication in peer-reviewed journals.
NCT04283409.
运动疗法是治疗慢性下腰痛(LBP)最推荐的治疗方法。运动疗法的效果大小通常为小到中等,这可能是由于患有 LBP 的人群存在异质性。因此,如果能够根据个体因素更好地将患者与运动相匹配,那么治疗效果可能会更大。最近发表的一项研究提供了证据,表明当患者与适当的运动类型相匹配时,治疗效果会更好。该研究表明,一项包含 15 个问题的问卷,即腰椎不稳定问卷(LSIQ),可以识别出对 LBP 的两种运动方法(运动控制和分级活动)反应最佳的患者。本研究的主要目的是评估预先确定的基线特征,包括 LSIQ,是否可以改变两种最常见的非特异性 LBP 运动疗法的反应。次要目标包括进行成本效益分析的经济评估。
将通过初级保健专业人员招募参与者(n=414),并将其随机(1:1)分为接受运动控制运动或分级活动的两组。参与者将在 8 周的时间内接受 12 次运动治疗。主要结果将是使用 Oswestry 残疾指数在 2 个月时的身体功能。次要结果将是在 2、6 和 12 个月时测量的疼痛强度、功能和生活质量。潜在的效应修饰剂将是 LSIQ、自我效能、应对策略、运动恐惧和伤害感受及中枢敏化的测量。我们将构建具有参与者(固定)、治疗组、预测因子(潜在效应修饰剂)、治疗组×预测因子(潜在效应修饰剂)、物理治疗师、治疗组×物理治疗师和因变量基线得分的线性混合模型。
这项研究得到了汉密尔顿综合研究伦理委员会的伦理批准。研究结果将提交给同行评议的期刊发表。
NCT04283409。