A Comparison of Manual VS. Mechanical Chiropractic Manipulation Methods

手动与手动的比较。

基本信息

批准号：
8137141
负责人：
MICHAEL J SCHNEIDER
金额：
$ 23.95万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-08-01 至 2013-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8137141
关键词：
Adherence Advertising Am 80 Back Pain Belief Chiropractic manipulation Clinical Clinical Trials Clinical Trials Data Monitoring Committees Clinical effectiveness Data Effectiveness Enrollment Equilibrium Exercise Expectancy Frequencies Fright Future Grant Integrative Medicine Linear Regressions Literature Location Low Back Pain Mails Manuals Mechanics Mediator of activation protein Medical Methods Minor Minority Modeling Modification Monitor Outcome Outcome Measure Pain Participant Patients Pharmaceutical Preparations Procedures Questionnaires Randomized Recruitment Activity Reporting Research Research Design Review Literature Safety Sample Size Scheme Spinal Manipulation Techniques Time Visit chiropracty comparative effectiveness cost effective design disability effective therapy expectation follow-up indexing instrument interest primary outcome randomized trial research study secondary outcome success systematic review treatment effect

项目摘要

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.

本研究将是一项小型随机试验（每组 40 人），比较以下药物的临床效果：机械仪器辅助操纵（MIAM）与传统手动推力操纵（MTM）治疗腰痛（LBP）。对文献的系统回顾描述了至少 42 使用脊柱推拿治疗 LBP 的随机试验，其中大多数使用了一些方法各种 MTM，但没有利用 MIAM 的高质量研究。本试验探讨了临床上的差异这两种治疗腰痛的方法的有效性。将招募 80 名过去 12 周内新发 LBP 的患者，并随机分为两组； MTM 治疗或 MIAM 治疗。治疗频率每周两次为期 4 周（共 8 次就诊）。结果测量将在第 4、12 和 24 周时收集。主要结果指标是 4 周时的 Oswestry 残疾问卷 (ODQ) 评分。次要结果指标是数字疼痛评定量表（NPRS）。其他次要变量兴趣将包括每种操纵类型的治疗预期、回避恐惧信念得分以及存在来自先前验证的与以下相关的临床预测规则的预测变量操纵和稳定练习的成功。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期望分数作为模型中的协变量。二次分析将是使用 NPRS 分数作为因变量的类似回归模型。这项研究的主要目的是； (1) 获取用于设计大型临床试验的信息 (R01) 不同类型脊柱手法的比较效果并确定其可行性，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试验提供影响中介。