Denteneer Lenie, Stassijns Gaetane, De Hertogh Willem, Truijen Steven, Jansen Nienke, Van Daele Ulrike
Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610 Wirlijk, Belgium.
Trials. 2015 Jan 6;16:4. doi: 10.1186/1745-6215-16-4.
There is a consensus that exercise therapy should be used as a therapeutic approach in chronic low back pain (CLBP) but little consensus has been reached about the preferential type of therapy. Due to the heterogeneity of the population no clear effect of specific therapy interventions are found. Probably a specific subgroup of the investigated population will benefit from the intervention and another subgroup will not benefit, looking at the total investigated population no significant effects can be found. Therefore there is a need for the development of clinical prediction rules (CPRs). Objectives for this trial are first, the derivation of CPRs to predict treatment response to three forms of exercise therapy for patients with nonspecific CLBP. Secondly, we aim to validate a CPR for the three forms of exercise therapy for patients with nonspecific CLBP.
METHODS/DESIGN: The study design is a randomized controlled trial. Patients with nonspecific CLBP of more than three months duration are recruited at the Antwerp University Hospital (Belgium) and Apra Rehabilitation Hospital. After examination, patients are randomly assigned to one of three intervention groups: motor control therapy, general active exercise therapy and isometric training therapy. All patients will undergo 18 treatment sessions during nine weeks. Measurements will be taken at baseline, nine weeks, six months and at one year. The primary outcome used is the Modified Oswestry Disability Questionnaire score. For each type of exercise therapy a CPR will be derived and validated. For validation, the CPR will be applied to divide each treatment group into two subgroups (matched and unmatched therapy) using the baseline measurements. We predict a better therapeutic effect for matched therapy.
A randomized controlled trial has not previously been performed for the development of a CPR for exercise therapy in CLBP patients. Only one CPR was described in a single-arm design for motor control therapy in sub-acute non-radicular LBP patients. In this study, a sufficiently large sample will be included in both the derivation and validation phase.
This trial was registered with Clinicaltrials.gov on 10 February 2014, registration number: NCT02063503.
人们普遍认为运动疗法应用于慢性下腰痛（CLBP）的治疗，但对于哪种运动疗法更为有效却未达成共识。由于研究人群的异质性，尚未发现特定治疗干预措施的明显效果。可能在整个研究人群中，某一特定亚组会从干预措施中获益，而另一亚组则不会，因此，需要制定临床预测规则（CPR）。本试验的目的，一是推导CPR，以预测非特异性CLBP患者对三种运动疗法的治疗反应；二是验证针对非特异性CLBP患者三种运动疗法的CPR。
方法/设计：本研究为随机对照试验。在比利时安特卫普大学医院和阿普拉康复医院招募病程超过三个月的非特异性CLBP患者。检查后，患者被随机分配到三个干预组之一：运动控制疗法、一般主动运动疗法和等长训练疗法。所有患者将在九周内接受18次治疗。分别在基线、九周、六个月和一年时进行测量。主要结局指标为改良Oswestry功能障碍问卷评分。针对每种运动疗法推导并验证CPR。为进行验证，将使用基线测量结果，通过CPR将每个治疗组分为两个亚组（匹配治疗和不匹配治疗）。我们预测匹配治疗的疗效更佳。
此前尚未针对CLBP患者运动疗法的CPR开展随机对照试验。仅在一项单臂设计中描述了针对亚急性非根性LBP患者运动控制疗法的一个CPR。在本研究中，推导和验证阶段均将纳入足够大的样本量。
本试验于2014年2月10日在Clinicaltrials.gov注册，注册号：NCT02063503。
