La Trobe Sport and Exercise Medicine Research Centre, La Trobe University, Melbourne, Victoria, Australia
Discipline of Physiotherapy, LaTrobe University, Melbourne, Victoria, Australia, La Trobe University, Bundoora, Victoria, Australia.
BMJ Open. 2022 Sep 6;12(9):e062954. doi: 10.1136/bmjopen-2022-062954.
The aim of this randomised feasibility trial is to determine the feasibility of conducting an adequately powered randomised controlled trial (RCT) investigating the efficacy of prefabricated contoured foot orthoses in people with hip osteoarthritis (OA). The secondary aims of the trial are to compare the effect of prefabricated contoured foot orthoses to a flat shoe insert comparator on outcomes of hip-related pain, physical activity and quality of life. We hypothesise that the demand, implementation, acceptability and practicality of foot orthoses as a treatment option for people with hip OA will be deemed feasible, informing the development of an adequately powered RCT to evaluate the efficacy and long term outcomes.
We will recruit 28 people with hip OA who will be randomised to receive either prefabricated contoured foot orthoses or flat shoe inserts to use for a 6-week period. Both groups will receive standardised education on hip OA and physical activity. The study's primary outcome is the feasibility domains of demand, implementation, acceptability and practicality. The secondary outcomes include the change in Hip Osteoarthritis Outcome Score-12, Patient Health Questionnaire-9, Brief Fear of Movement Scale for OA, Physical activity accelerometry and the Physical Activity Questionnaire-short form. Descriptive statistics will be used to describe feasibility outcomes with limited efficacy analysis used for the secondary outcomes. Linear mixed models will be used to analyse between-group differences at 6 weeks, with baseline values used as covariates, treatment allocation as a fixed factor and participant as a random factor.
This trial has been approved by the La Trobe University Human Research Ethics Committee (HEC20427), St. Vincent's Hospital Melbourne, Human Research Ethics Committee (HREC 266/20) and Northern Health Research Governance (NH-2021-292862). The results will be disseminated via a peer-reviewed journal and presented at international conferences.
NCT05138380.
本随机可行性试验的目的是确定研究预制塑形足弓矫正器对髋关节骨关节炎（OA）患者疗效的充分功率随机对照试验（RCT）的可行性。试验的次要目的是比较预制塑形足弓矫正器和平板鞋插入物对照物对髋关节相关疼痛、身体活动和生活质量的影响。我们假设预制塑形足弓矫正器作为髋关节 OA 患者的治疗选择的需求、实施、可接受性和实用性将被认为是可行的，为评估其疗效和长期结果的充分功率 RCT 提供信息。
我们将招募 28 名髋关节 OA 患者，将他们随机分配接受预制塑形足弓矫正器或平板鞋插入物，使用 6 周。两组均接受髋关节 OA 和身体活动的标准化教育。研究的主要结果是需求、实施、可接受性和实用性的可行性领域。次要结果包括髋关节骨关节炎评分-12、患者健康问卷-9、骨关节炎简要恐惧运动量表、身体活动加速度计和身体活动问卷-简短形式的变化。将使用描述性统计来描述可行性结果，并对次要结果进行有限的疗效分析。将使用线性混合模型在 6 周时分析组间差异，以基线值作为协变量，治疗分配作为固定因素，参与者作为随机因素。
本试验已获得拉筹伯大学人类研究伦理委员会（HEC20427）、墨尔本圣文森特医院人类研究伦理委员会（HREC 266/20）和北健康研究治理（NH-2021-292862）的批准。结果将通过同行评议的期刊发表，并在国际会议上展示。
NCT05138380。
