背景:慢性髋部疼痛是常见且致残的,主要是由于骨关节炎(OA)。国际OA临床指南推荐自我管理,但很少有有效的治疗选择。鞋类已被建议作为一种自我管理方法,考虑到脚的运动会影响髋关节力。目前,指南提倡为OA患者提供“稳定的支持性”鞋子,然而,这仅仅是基于专家意见,因为没有研究调查这些鞋子是否能有效减轻OA相关慢性髋痛患者的症状.因此,这项随机对照试验(RCT)旨在确定在符合OA的慢性髋部疼痛患者中,与柔性平鞋相比,稳定性支撑鞋是否能减轻行走时的髋部疼痛.
方法:本试验为期6个月,参与者-和评估者-盲,务实,比较有效性,优势RCT在墨尔本进行,澳大利亚。我们从社区招募了120名45岁以上患有与OA一致的慢性髋部疼痛的参与者。在基线评估之后,参与者随机接受i)稳定支撑鞋或ii)平底鞋。允许参与者从符合预先指定的鞋子分类标准的一系列选项中选择分配的组中的两双不同的鞋子。建议他们每天穿任何一双学习鞋,每天至少6小时,持续6个月。主要结果是上周步行时平均髋部疼痛的6个月变化。次要结果包括髋部疼痛其他指标的变化,症状,在日常生活、运动和娱乐中发挥作用,髋关节相关的生活质量,其他部位疼痛,不良事件,和身体活动。其他措施包括共同干预,坚持,鞋子舒适,描述性特征,鞋类特点,和客观的足部措施。
结论:这项RCT将确定稳定的支撑鞋是否比平地柔性鞋更能减轻慢性髋部疼痛患者的步行过程中的髋部疼痛。结果将有助于在OA相关慢性髋部疼痛的国际临床指南中提供鞋类建议。迄今为止,由于缺乏RCT,这些意见仅基于专家意见。
背景:澳大利亚新西兰临床试验注册参考:ACTRN12621001532897。
BACKGROUND: Chronic hip pain is common and disabling and is largely due to osteoarthritis (OA). Self-management is recommended by international OA clinical guidelines yet there are few effective treatment options.
Footwear has been suggested as a self-management approach, given that foot motion influences hip forces. Currently, guidelines advocate \'stable supportive\' shoes for people with OA, however this is based solely on expert opinion given no research has investigated whether these shoes are effective at reducing symptoms in people with OA-related chronic hip pain. Therefore, this randomized controlled
trial (RCT) aims to determine if stable supportive
footwear reduces hip pain during walking compared to flat flexible
footwear in people with chronic hip pain consistent with OA.
METHODS: This
trial is a 6-month, participant- and assessor-blinded, pragmatic, comparative effectiveness, superiority RCT conducted in Melbourne, Australia. We are recruiting 120 participants aged over 45 years with chronic hip pain consistent with OA from the community. Following baseline assessment, participants are randomized to receive either i) stable supportive shoes or ii) flat flexible shoes. Participants are permitted to choose two different pairs of shoes in their allocated group from a range of options that match prespecified shoe classification criteria. They are advised to wear either pair of
study shoes daily for a minimum of 6 hours each day for 6 months. The primary outcome is the 6-month change in average hip pain on walking in the last week. Secondary outcomes include changes in other measures of hip pain, symptoms, function in daily living and sports and recreation, hip-related quality of life, pain at other sites, adverse events, and physical activity. Other measures include co-intervention use, adherence, shoe comfort, descriptive characteristics, footwear characteristics, and objective foot measures.
CONCLUSIONS: This RCT will determine whether stable supportive shoes reduce hip pain during walking more than flat flexible shoes in people with chronic hip pain. Outcomes will help to inform footwear recommendations in international clinical guidelines for OA-related chronic hip pain, which to date have been based solely on expert opinion because of an absence of RCTs.
BACKGROUND: Australian New Zealand Clinical Trials Registry reference: ACTRN12621001532897.