A Comparison of Manual VS. Mechanical Chiropractic Manipulation Methods

这项研究将是一项小型随机试验(每组40例)，比较两种药物的临床疗效 机械仪器辅助操作(MIAM)与传统的手动推力操作(MTM)相结合 治疗腰背痛(LBP)。对文献的系统评价已经描述了至少42 使用脊柱手法作为治疗LBP的随机试验，大多数试验利用了一些 MTM种类繁多，但没有利用MIAM进行的高质量研究。本试验旨在探讨两者在临床上的差异。 这两种手法治疗下腰痛的有效性。 80名在过去12周内新发的LBP患者将被招募并随机分配到 两组：MTM组和MIAM组。ITie治疗频率为每周两次 治疗4周(共8次就诊)。结果测量将在4周、12周和24周收集。 主要的结果衡量标准将是4周后的OSwestry残疾问卷(ODQ)评分。 第二个结果衡量标准将是数字疼痛评定量表(NPR)。其他次要变量 兴趣将包括对每种类型的操纵的治疗预期，恐惧回避信念得分，以及 来自先前验证的临床预测规则的预测变量的存在与 操纵和稳定演习取得成功。 主要的分析将是一个以6周ODQ得分为基础的广义IMEAR回归模型 因变量和治疗组作为关键自变量；同时控制基线 随机化变量和治疗期望评分作为模型中的协变量。二次分析 将以NPRS得分为因变量的Shnilar回归模型。 这项研究的主要目的是：(1)获得用于设计大型临床试验的信息。 (ROL)不同类型脊柱手法的疗效比较 可行性，以及(2)获得效应大小的参数估计，并探索潜在的混杂因素或治疗方法 为未来更大规模的审判发挥调解人的作用。

This Study will be a small randomized trial (n=40 per group) comparing the clinical effectiveness of mechanical instrument assisted manipulation (MIAM) with traditional manual thrust manipulation (MTM) for the treatment of low back pain (LBP). Systematic reviews of the literature have described at least 42 randomized trials using spinal manipulation as a treatment for LBP, the majority of which utilized some variety of MTM but no high quality studies utilizing MIAM. This trial mil explore the differences in clinical effectiveness of these two manipulative methods for LBP. Eighty patients with a new onset of LBP within the past 12 weeks will be recruited and randomized into two groups; treatment with MTM or treatment with MIAM. ITie treatment frequency will be twice per week for 4 weeks (8 visits in total). Outcome measures will be gathered at 4,12, and 24 weeks. The primary outcome measure will be the Oswestry Disability Questionnaire (ODQ) score at 4-weeks. The secondary outcome measure will be the Numeric Pain Rating Scale (NPRS). Other secondary variables of interest will include treatment expectancy for each type of manipulation, fear-avoidance beliefs score, and presence of predictor variables from previously validated clinical prediction rules associated with manipulation and stabilization exercise successes. The primary analysis will be a generalized Imear regression model with 6-week ODQ score as the dependent variable and treatment group as the key independent variable; while controlling for baseline randomization variables and treatment expectation scores as covariates in the model. The secondary analysis will be a shnilar regression model using NPRS score as the dependent variable. The key aims of this study are; (1) to acquire infonnation that will be used to design a large clinical trial (ROl) on the comparative effectiveness of different types of spinal manipxUation and to determine its feasibility, and (2) to obtain parameter estimates of effect sizes and explore potential confounders or treatment effect mediators for the future larger trial.