The University of Queensland, School of Health and Rehabilitation Sciences, Sports Injuries Rehabilitation and Prevention for Health research unit, CCRE Spine, Brisbane, Australia.
Research Unit for General Practice in Aalborg and Department of Clinical Medicine, Aalborg, Denmark.
J Foot Ankle Res. 2017 Jan 25;10:5. doi: 10.1186/s13047-017-0186-5. eCollection 2017.
Patellofemoral pain (PFP) is a prevalent, often recalcitrant and multifactorial knee pain condition. One method to optimize treatment outcome is to tailor treatments to the patient's presenting characteristics. Foot orthoses and hip exercises are two such treatments for PFP with proven efficacy yet target different ends of the lower limb with different proposed mechanisms of effect. These treatments have not been compared head-to-head, so there is a dearth of evidence for which to use clinically. Only foot orthoses have been explored for identifying patient characteristics that might predict a beneficial effect with either of these two treatments. Preliminary evidence suggests patients will do well with foot orthoses if they have a midfoot width in weight bearing that is ≥ 11 mm more than in non-weight bearing, but this has yet to be verified in a study that includes a comparator treatment and an adequate sample size. This trial will determine if: (i) hip exercises are more efficacious than foot orthoses, and (ii) greater midfoot width mobility will be associated with success with foot orthoses, when compared to hip exercises.
Two hundred and twenty participants, aged 18-40 years, with a clinical diagnosis of PFP will be randomly allocated with a 1:1 ratio to receive foot orthoses or progressive resisted hip exercises, and stratified into two subgroups based on their presenting midfoot width mobility ( defined as ≥11 mm). The primary outcome will be a 7-point Likert scale for global rating of change. All analyses will be conducted on an intention-to-treat basis using regression models.
This trial is designed to compare the efficacy of foot orthoses versus hip exercise, as well as to determine if high midfoot width mobility is associated with better outcomes with foot orthoses when compared to hip exercises. Results of this trial will assist clinicians in optimising the management of those with PFP by testing whether a simple measure of midfoot width mobility can help to determine which patients are most likely to benefit from foot orthoses.
This trial is registered on the Australian New Zealand Clinical Trials Register (ACTRN12614000260628).
髌股疼痛（PFP）是一种常见的、往往难以治愈的多因素膝关节疼痛病症。优化治疗效果的一种方法是根据患者的表现特征为其量身定制治疗方案。足部矫形器和髋关节运动是两种针对 PFP 的治疗方法，它们已被证明具有疗效，但针对下肢的不同部位，其作用机制和效果也不同。这两种治疗方法尚未进行过直接比较，因此在临床应用方面缺乏证据。只有足部矫形器曾被用于探索可能预测这两种治疗方法中任何一种治疗效果的患者特征。初步证据表明，如果患者在负重状态下的中足宽度比非负重状态下宽≥11 毫米，则使用足部矫形器的效果良好，但这一点尚未在一项包括对照治疗和足够大的样本量的研究中得到验证。本试验将确定：（i）髋关节运动是否比足部矫形器更有效，（ii）与髋关节运动相比，更大的中足宽度活动性是否与足部矫形器的成功相关。
将招募 220 名年龄在 18-40 岁之间、临床诊断为 PFP 的参与者，按 1:1 的比例随机分配接受足部矫形器或渐进性抗阻髋关节运动，并根据其当前的中足宽度活动性（定义为≥11 毫米）分为两个亚组。主要结局将是 7 分 Likert 量表的整体变化评分。所有分析均将基于意向治疗原则使用回归模型进行。
本试验旨在比较足部矫形器与髋关节运动的疗效，以及确定与髋关节运动相比，中足宽度活动性较高是否与足部矫形器的更好结局相关。本试验的结果将通过测试中足宽度活动性的简单测量是否有助于确定哪些患者最有可能从足部矫形器中受益，从而帮助临床医生优化 PFP 患者的管理。
本试验在澳大利亚和新西兰临床试验注册中心（ACTRN12614000260628）注册。
