Musculoskeletal Research Centre, Faculty of Health Sciences, La Trobe University, Bundoora 3086, Victoria, Australia.
J Foot Ankle Res. 2009 Oct 24;2:27. doi: 10.1186/1757-1146-2-27.
Achilles tendinopathy is a common condition that can cause marked pain and disability. Numerous non-surgical treatments have been proposed for the treatment of this condition, but many of these treatments have a poor or non-existent evidence base. The exception to this is eccentric calf muscle exercises, which have become a standard non-surgical intervention for Achilles tendinopathy. Foot orthoses have also been advocated as a treatment for Achilles tendinopathy, but the long-term efficacy of foot orthoses for this condition is unknown. This manuscript describes the design of a randomised trial to evaluate the efficacy of customised foot orthoses to reduce pain and improve function in people with Achilles tendinopathy.
One hundred and forty community-dwelling men and women aged 18 to 55 years with Achilles tendinopathy (who satisfy inclusion and exclusion criteria) will be recruited. Participants will be randomised, using a computer-generated random number sequence, to either a control group (sham foot orthoses made from compressible ethylene vinyl acetate foam) or an experimental group (customised foot orthoses made from semi-rigid polypropylene). Both groups will be prescribed a calf muscle eccentric exercise program, however, the primary difference between the groups will be that the experimental group receive customised foot orthoses, while the control group receive sham foot orthoses. The participants will be instructed to perform eccentric exercises 2 times per day, 7 days per week, for 12 weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire. The secondary outcome measures will be participant perception of treatment effect, comfort of the foot orthoses, use of co-interventions, frequency and severity of adverse events, level of physical activity and health-related quality of life (assessed using the Short-Form-36 questionnaire - Version two). Data will be collected at baseline, then at 1, 3, 6 and 12 months. Data will be analysed using the intention to treat principle.
This study is the first randomised trial to evaluate the long-term efficacy of customised foot orthoses for the treatment of Achilles tendinopathy. The study has been pragmatically designed to ensure that the study findings are generalisable to clinical practice.
Australian New Zealand Clinical Trials Registry Number: ACTRN12609000829213.
跟腱病是一种常见病症，可导致明显的疼痛和残疾。目前已有许多非手术治疗方法被用于治疗这种疾病，但其中许多治疗方法的证据基础较差或不存在。这种情况的例外是离心小腿肌肉运动，它已成为跟腱病的一种标准非手术干预措施。足矫形器也被提倡用于治疗跟腱病，但长期使用足矫形器治疗这种疾病的效果尚不清楚。本文描述了一项随机试验的设计，该试验旨在评估定制足矫形器在减轻疼痛和改善跟腱病患者功能方面的疗效。
将招募 140 名年龄在 18 至 55 岁之间、患有跟腱病（符合纳入和排除标准）的社区居民。参与者将使用计算机生成的随机数序列随机分配到对照组（由可压缩乙烯-醋酸乙烯酯泡沫制成的假足矫形器）或实验组（由半刚性聚丙烯制成的定制足矫形器）。两组都将被规定进行小腿肌肉离心运动计划，但两组的主要区别在于实验组接受定制足矫形器，而对照组接受假足矫形器。参与者将被指示每天进行 2 次、每周 7 次的离心运动，持续 12 周。主要结局指标是维多利亚运动评估-跟腱（VISA-A）问卷的总评分。次要结局指标将是参与者对治疗效果的感知、足矫形器的舒适度、使用辅助干预措施的情况、不良事件的频率和严重程度、身体活动水平和健康相关生活质量（使用短表单-36 问卷-第二版评估）。数据将在基线时收集，然后在 1、3、6 和 12 个月时收集。将使用意向治疗原则进行数据分析。
这是第一项评估定制足矫形器治疗跟腱病的长期疗效的随机试验。该研究的设计具有务实性，以确保研究结果能够推广到临床实践中。
澳大利亚和新西兰临床试验注册中心编号：ACTRN12609000829213。
