Niederer Daniel, Vogt Lutz, Wippert Pia-Maria, Puschmann Anne-Katrin, Pfeifer Ann-Christin, Schiltenwolf Marcus, Banzer Winfried, Mayer Frank
Department of Sports Medicine, Goethe University Frankfurt, Ginnheimer Landstraße 39, 40487, Frankfurt am Main, Germany.
Department of Sociology of Physical Activity and Health, Cluster of Excellence in Cognitive Sciences, University of Potsdam, Potsdam, Germany.
Trials. 2016 Oct 20;17(1):507. doi: 10.1186/s13063-016-1645-1.
Arising from the relevance of sensorimotor training in the therapy of nonspecific low back pain patients and from the value of individualized therapy, the present trial aims to test the feasibility and efficacy of individualized sensorimotor training interventions in patients suffering from nonspecific low back pain.
A multicentre, single-blind two-armed randomized controlled trial to evaluate the effects of a 12-week (3 weeks supervised centre-based and 9 weeks home-based) individualized sensorimotor exercise program is performed. The control group stays inactive during this period. Outcomes are pain, and pain-associated function as well as motor function in adults with nonspecific low back pain. Each participant is scheduled to five measurement dates: baseline (M1), following centre-based training (M2), following home-based training (M3) and at two follow-up time points 6 months (M4) and 12 months (M5) after M1. All investigations and the assessment of the primary and secondary outcomes are performed in a standardized order: questionnaires - clinical examination - biomechanics (motor function). Subsequent statistical procedures are executed after the examination of underlying assumptions for parametric or rather non-parametric testing.
The results and practical relevance of the study will be of clinical and practical relevance not only for researchers and policy makers but also for the general population suffering from nonspecific low back pain.
Identification number DRKS00010129. German Clinical Trial registered on 3 March 2016.
鉴于感觉运动训练在非特异性下背痛患者治疗中的相关性以及个体化治疗的价值，本试验旨在测试个体化感觉运动训练干预对非特异性下背痛患者的可行性和疗效。
开展一项多中心、单盲双臂随机对照试验，以评估为期12周（3周在中心监督下训练，9周居家训练）的个体化感觉运动锻炼计划的效果。在此期间，对照组保持不活动状态。结局指标为非特异性下背痛成人患者的疼痛、与疼痛相关的功能以及运动功能。每位参与者安排了五个测量时间点：基线（M1）、中心训练后（M2）、居家训练后（M3）以及M1后6个月（M4）和12个月（M5）这两个随访时间点。所有调查以及主要和次要结局指标的评估均按照标准化顺序进行：问卷调查 - 临床检查 - 生物力学（运动功能）。在检查参数检验或非参数检验的基本假设后，执行后续的统计程序。
该研究的结果及实际意义不仅对研究人员和政策制定者具有临床和实际相关性，对于患有非特异性下背痛的普通人群也具有重要意义。
识别号DRKS00010129。于2016年3月3日在德国临床试验注册。
