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首页> 外文期刊>Journal of physiotherapy >Trial Protocol: Cognitive functional therapy compared with combined manual therapy and motor control exercise for people with non-specific chronic low back pain: protocol for a randomised, controlled trial
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Trial Protocol: Cognitive functional therapy compared with combined manual therapy and motor control exercise for people with non-specific chronic low back pain: protocol for a randomised, controlled trial

机译：试验方案：认知功能疗法与手动治疗和运动控制锻炼相结合，用于非特异性慢性下腰痛患者：一项随机对照试验的方案

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Introduction Chronic low back pain is a public health problem, and there is strong evidence that it is associated with a complex interaction of biopsychosocial factors. Cognitive functional therapy is an intervention that deals with potentially modifiable multidimensional aspects of pain (eg, provocative cognitive, movement and lifestyle behaviours). There is evidence (from a single randomised, controlled trial) that cognitive functional therapy is better than combined manual therapy and motor control exercise. However, this study had significant methodological shortcomings including the failure to carry out an intention-to-treat analysis and a considerable loss of follow-up of participants. It is important to replicate this study in another domain through a randomised clinical trial with similar objectives but correcting these methodological shortcomings. Aim To investigate the efficacy of cognitive functional therapy compared to combined manual therapy and exercise on pain and disability at 3 months in patients with chronic non-specific low back pain. Design Two-group, randomised, multicentre controlled trial with blinded assessors. Participants and settings One hundred and forty-eight participants with chronic low back pain that has persisted for >3months and no specific spinal pathology will be recruited from the school clinic of the Centro Universitário Augusto Motta and a private clinic in the city of Rio de Janeiro, Brazil. Intervention A Four to 10 sessions of cognitive functional therapy. The physiotherapists who will treat the participants in the cognitive functional therapy group have previously attended 2 workshops with two different tutors of the method. Such physiotherapists have completed 106 hours of training, including workshops and patient examinations, as well as conducting a pilot study under the supervision of another physiotherapist with>3 years of clinical experience in cognitive functional therapy. Intervention B Four to 10 sessions of combined manual therapy and motor control exercises. Participants in the combined manual therapy and exercise group will be treated by two physiotherapists with an average of >10years of clinical experience in manual therapy and motor control exercises, including isolated contractions of the deep abdominal muscles. Measurements The primary outcome measures will be pain intensity and disability 3 months after randomisation. Secondary outcomes will be pain and disability assessed 6 and 12 months after randomisation, and both global perceived effect and patient satisfaction at 3, 6 and 12 months after randomisation. The potential outcome mediators will be assessed at 3 and 6 months after randomisation, with brief screening questions for anxiety, social isolation, catastrophisation, depression, fear of movement, stress and sleep. Non-specific predictors and moderators will include age, gender, duration of chronic low back pain, chronicity risk (?rebro and Start Back score), number of pain areas, stressful life event, MRI scan imaging, and family history. Analysis Intention-to-treat analysis will be performed. Linear mixed models will be used to compare the mean differences in pain intensity, disability and global perceived effect between the intervention arms. The analysis of the effect of potential mediators of the treatment will be performed using the causal mediation methods described by Imai and colleagues. The baseline variables will be evaluated as predictors and moderators of treatment, including terms and interaction models. A level of statistical significance of 5% will be used in the analysis. All the analyses will be performed using RStudio. Significance This study will investigate whether the results of the first cognitive functional therapy randomised clinical trial are reproducible. The present study will have a sample size capable of detecting clinically relevant effects of the treatment with a low risk of bias. In pragmatic terms, this clinical trial is designed to reproduce the intervention as it would be performed in clinical practice by a trained physiotherapist who works with cognitive functional therapy, which increases the relevance of this study. The combined manual therapy and exercise group comprises an intervention strategy widely used by physiotherapists to treat low back pain. As evidence of efficacy is still limited, the results of a randomised, controlled clinical trial of high methodological quality will help physiotherapists in clinical decision-making.
机译：引言慢性腰痛是一个公共卫生问题，有充分的证据表明它与生物心理社会因素的复杂相互作用有关。认知功能疗法是一种针对疼痛的潜在可修改多维方面（例如，挑衅性认知，运动和生活方式行为）的干预措施。有证据（来自单个随机对照试验）表明，认知功能治疗优于手动治疗和运动控制锻炼相结合。但是，这项研究存在重大的方法学缺陷，包括未能进行意向性治疗分析，并且参与者的随访损失很大。重要的是，要通过一项具有相似目标但要纠正这些方法缺陷的随机临床试验，在另一个领域中复制本研究。目的探讨认知功能治疗与手动治疗相结合和运动对慢性非特异性下背痛患者3个月疼痛和残疾的疗效。设计采用盲法评估者的两组，随机，多中心对照试验。参与者和环境148名持续性腰背痛持续时间超过3个月的参与者，将不会从奥古斯托·莫塔中心大学的学校诊所和里约热内卢市的一家私人诊所招募特殊的脊柱病理， 巴西。干预A认知功能治疗的4至10个疗程。负责治疗认知功能治疗小组参与者的物理治疗师以前曾参加过两次研讨会，由两名不同的方法辅导员进行。这些理疗师已经完成了106个小时的培训，包括工作坊和患者检查，并且在另一位在认知功能治疗方面具有3年以上临床经验的理疗师的指导下进行了初步研究。干预B手动治疗和运动控制练习相结合的四到十节课。两名手动治疗和运动联合治疗组的参与者将由两名物理治疗师进行治疗，他们平均在手动治疗和运动控制运动（包括深部腹部肌肉的收缩）方面具有超过10年的临床经验。测量主要的结果测量指标是随机分配后3个月的疼痛强度和残疾程度。次要结果是在随机分配后6和12个月评估疼痛和残疾，以及在随机分配后3、6和12个月评估总体感觉效果和患者满意度。在随机分组后的3个月和6个月内，将评估潜在的结局中介者，并对焦虑，社交孤立，灾难性，抑郁，运动恐惧，压力和睡眠的简短筛查问题进行评估。非特异性的预测因素和调节因素将包括年龄，性别，慢性下腰痛的持续时间，慢性病风险（？rebro和Start Back评分），疼痛部位的数量，应激性生活事件，MRI扫描成像和家族史。分析将进行意向治疗分析。线性混合模型将用于比较干预组之间疼痛强度，残疾和总体感觉效果的平均差异。将使用Imai及其同事描述的因果调解方法对可能的治疗介质的作用进行分析。基线变量将作为治疗的预测变量和调节变量进行评估，包括术语和交互模型。分析中将使用5％的统计显着性水平。所有分析将使用RStudio进行。重要性本研究将调查第一个认知功能疗法随机临床试验的结果是否可重复。本研究的样本量能够以低偏倚风险检测出治疗的临床相关效果。用务实的话说，该临床试验旨在重现干预措施，就像受过训练的理疗师在认知功能治疗中在临床实践中所进行的那样，这增​​加了本研究的相关性。手动疗法与运动疗法相结合的治疗方法包括一种理疗师广泛采用的干预策略，可用于治疗腰痛。由于疗效的证据仍然有限，因此，高质量方法的随机对照临床试验的结果将有助于物理治疗师进行临床决策。

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