A Comparison of Manual VS. Mechanical Chiropractic Manipulation Methods

本研究将是一项小型随机试验（每组n=40），比较 机械器械辅助操作（MIAM）与传统的手动推力操作（MTM）， 下背痛（LBP）的治疗。文献的系统综述至少描述了42个 使用脊柱推拿作为LBP治疗的随机试验，其中大多数使用一些 各种MTM，但没有使用MIAM的高质量研究。本试验旨在探讨两组间临床疗效的差异。 这两种方法对LBP的有效性。 将招募80名在过去12周内新发LBP的患者，并将其随机分配至 两组分别用MTM和MIAM治疗。治疗频率为每周两次 4周（共8次访视）。将在第4、12和24周收集结局指标。 主要结局指标为4周时的奥斯韦斯特里残疾问卷（ODQ）评分。 次要结局指标为数字疼痛评定量表（NPRS）。其他次要变量 兴趣将包括对每种类型操作的治疗期望、恐惧回避信念评分， 存在来自先前验证的临床预测规则的预测变量， 操纵和稳定演习的成功。 主要分析将采用广义线性回归模型，以6周ODQ评分作为 因变量和治疗组作为关键自变量;同时控制基线 随机化变量和治疗预期评分作为模型中的协变量。所述二级分析 将是一个类似的回归模型，使用NPRS评分作为因变量。 本研究的主要目的是：（1）获得将用于设计大型临床试验的信息 (R01)不同类型的脊柱推拿的比较效果，并确定其 可行性，以及（2）获得效应量的参数估计值，并探索潜在的混杂因素或治疗 为将来更大规模的试验提供有效的调解人。

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. The 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 linear 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 similar regression model using NPRS score as the dependent variable. The key aims of this study are; (1) to acquire information that will be used to design a large clinical trial (R01) on the comparative effectiveness of different types of spinal manipulation 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.