Cambron Jerrilyn A, Schneider Michael, Dexheimer Jennifer M, Iannelli Grant, Chang Mabel, Terhorst Lauren, Cramer Gregory D
Professor, Department of Research, National University of Health Sciences, Lombard, IL.
Assistant Professor, Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA.
J Manipulative Physiol Ther. 2014 Jul-Aug;37(6):396-406. doi: 10.1016/j.jmpt.2014.05.005. Epub 2014 Aug 6.
The purpose of this pilot clinical trial was to assess the feasibility of recruiting older adults with lumbar spinal stenosis (LSS) into a clinical trial that used different dosages of flexion-distraction manipulation.
This randomized controlled trial used a 4-group design. Three groups consisted of chiropractic flexion-distraction manipulation applied at different dosages (8, 12, or 18 treatments). The fourth group was given 8 treatments of placebo care. Feasibility measures included recruitment goals, adherence to various treatment schedules, credibility of the placebo treatment, and rates of adverse events. The primary outcome measure was the Swiss Spinal Stenosis Questionnaire, a validated self-report of LSS symptom severity and physical function.
The recruitment and adherence goals of the study were met with a total of 60 subjects randomized (n = 15 per group) and most subjects attending at least 75% of their scheduled visits. No adverse events were reported by any of the subjects in the trial. Our placebo treatment did not appear to be credible; most subjects correctly guessed that they were receiving a placebo treatment. Between-group effect size estimates were small, indicating larger samples are needed for future studies.
This pilot study showed that it is feasible to recruit patients with LSS and that most subjects will adhere to a 6-week treatment schedule. The information gained from this trial will be useful to inform the design of larger trials.
本初步临床试验的目的是评估招募腰椎管狭窄症（LSS）老年患者参加使用不同剂量屈伸牵引手法的临床试验的可行性。
本随机对照试验采用四组设计。三组采用不同剂量（8、12或18次治疗）的脊椎按摩屈伸牵引手法。第四组接受8次安慰剂治疗。可行性指标包括招募目标、对各种治疗方案的依从性、安慰剂治疗的可信度以及不良事件发生率。主要结局指标是瑞士腰椎管狭窄症问卷，这是一份经过验证的关于LSS症状严重程度和身体功能的自我报告。
该研究的招募和依从性目标均已实现，共有60名受试者被随机分组（每组n = 15），且大多数受试者至少参加了75%的预定就诊。试验中没有任何受试者报告不良事件。我们的安慰剂治疗似乎不可信；大多数受试者正确猜出他们接受的是安慰剂治疗。组间效应量估计值较小，表明未来研究需要更大的样本量。
这项初步研究表明，招募LSS患者是可行的，且大多数受试者会遵守为期6周的治疗方案。从该试验中获得的信息将有助于为更大规模试验的设计提供参考。
