Schneider Michael J, Brach Jennifer, Irrgang James J, Abbott Katherine Verdolini, Wisniewski Stephen R, Delitto Anthony
Assistant Professor, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA 15241, USA.
J Manipulative Physiol Ther. 2010 Mar-Apr;33(3):193-200. doi: 10.1016/j.jmpt.2010.01.010.
This is an observational prospective cohort study to explore the treatment effect of mechanical vs manual manipulation for acute low back pain.
Ninety-two patients with a history of acute low back pain were recruited from 3 private chiropractic offices, 2 of which used manual lumbar manipulation and 1 used mechanical instrument manipulation (Activator) as their primary modes of treatment. The chiropractors used their "treatment-as-usual" protocols for a maximum of 8 visits or 4 weeks, whichever occurred first. Primary outcome measures were changes in Numeric Pain Rating Scale (NPRS) and Oswestry Disability Index (ODI) scores from baseline to 4 weeks. The linear regression models were adjusted for baseline NPRS and ODI scores, age, and treatment expectancy.
Comparison of baseline characteristics did not show any significant differences between the groups except for age (38.4 vs 49.7 years, P < .001) and treatment expectancy (5.7 vs 6.3, P = .003). Linear regression revealed significantly lower NPRS scores in the manual manipulation group at 4 weeks (beta = -1.2; 95% confidence interval, -2.1 to -.28) but no significant difference in ODI scores between the 2 groups at 4 weeks (beta = 1.5; 95% confidence interval, -8.3 to 2.4). Treatment expectancy, but not age, was found to have a significant main effect on both NPRS and ODI scores at 4 weeks. Exploratory analysis of the clinical patterns of care between the clinicians revealed significant differences in treatment frequency, duration, modality, and radiograph use between the 2 cohorts.
This study highlights the challenges inherent with conducting research that allows for "treatment as usual." The data and experience derived from this investigational study will be used to design a future randomized clinical trial in which tighter controls will be imposed on the treatment protocol.
这是一项观察性前瞻性队列研究,旨在探讨机械手法与手动手法治疗急性下背痛的效果。
从3家私人脊椎按摩诊所招募了92例有急性下背痛病史的患者,其中2家使用手动腰椎手法,1家使用机械器械手法(激活器)作为主要治疗方式。脊椎按摩师采用他们的“常规治疗”方案,最多就诊8次或4周,以先到者为准。主要结局指标是从基线到4周时数字疼痛评分量表(NPRS)和奥斯威斯利功能障碍指数(ODI)评分的变化。线性回归模型根据基线NPRS和ODI评分、年龄和治疗预期进行了调整。
除年龄(38.4岁对49.7岁,P <.001)和治疗预期(5.7对6.3,P =.003)外,两组基线特征比较未显示任何显著差异。线性回归显示,4周时手动手法治疗组的NPRS评分显著更低(β=-1.2;95%置信区间,-2.1至-.28),但两组4周时的ODI评分无显著差异(β=1.5;95%置信区间,-8.3至2.4)。发现治疗预期而非年龄对4周时的NPRS和ODI评分均有显著的主效应。对临床医生之间护理临床模式的探索性分析显示,两个队列在治疗频率、持续时间、方式和X线片使用方面存在显著差异。
本研究突出了进行“常规治疗”研究所固有的挑战。从这项调查研究中获得的数据和经验将用于设计未来的随机临床试验,其中将对治疗方案实施更严格的控制。