PDF(Pubmed)
Abstract：
BACKGROUND: Mid-portion Achilles tendinopathy is a common condition, characterised by localised Achilles tendon load-related pain and dysfunction. 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. Heel lifts have also been advocated as a treatment for Achilles tendinopathy, but the efficacy and mechanism of action of this intervention is unclear. This proposal describes a randomised controlled trial comparing the effectiveness of heel lifts versus sham heel lifts for reducing pain associated with mid-portion Achilles tendinopathy, with an embedded biomechanical analysis.
METHODS: One hundred and eight men and women aged 18 to 65 years with mid-portion Achilles tendinopathy (who satisfy the inclusion and exclusion criteria) will be recruited. Participants will be randomised, using the website Sealed Envelope, to either a control group (sham heel lifts) or an experimental group (heel lifts). Both groups will be provided with education regarding acceptable pain levels to ensure all participants receive some form of treatment. The participants will be instructed to use their allocated intervention for at least 8 h every day for 12 weeks. The primary outcome measure will be pain intensity (numerical rating scale) at its worst over the previous week. The secondary outcome measures will be additional measures of Achilles tendon pain and disability, participant-perceived global ratings of change, function, level of physical activity and health-related quality of life. Data will be collected at baseline and the primary endpoint (week 12). Data will be analysed using the intention-to-treat principle. In addition, the acute kinetic and kinematic effects of the interventions will be examined at baseline in a subpopulation of the participants (n = 40) while walking and running using three-dimensional motion analysis.
CONCLUSIONS: The LIFT trial (efficacy of heeL lIfts For mid-portion Achilles Tendinopathy) will be the first randomised trial to compare the efficacy of heel lifts to a sham intervention in reducing pain and disability in people with Achilles tendinopathy. The biomechanical analysis will provide useful insights into the mechanism of action of heel lifts.
BACKGROUND: Australian New Zealand Clinical Trials Registry, ACTRN12623000627651 . Registered 7 June 2023.
METHODS: One hundred and eight men and women aged 18 to 65 years with mid-portion Achilles tendinopathy (who satisfy the inclusion and exclusion criteria) will be recruited. Participants will be randomised, using the website Sealed Envelope, to either a control group (sham heel lifts) or an experimental group (heel lifts). Both groups will be provided with education regarding acceptable pain levels to ensure all participants receive some form of treatment. The participants will be instructed to use their allocated intervention for at least 8 h every day for 12 weeks. The primary outcome measure will be pain intensity (numerical rating scale) at its worst over the previous week. The secondary outcome measures will be additional measures of Achilles tendon pain and disability, participant-perceived global ratings of change, function, level of physical activity and health-related quality of life. Data will be collected at baseline and the primary endpoint (week 12). Data will be analysed using the intention-to-treat principle. In addition, the acute kinetic and kinematic effects of the interventions will be examined at baseline in a subpopulation of the participants (n = 40) while walking and running using three-dimensional motion analysis.
CONCLUSIONS: The LIFT trial (efficacy of heeL lIfts For mid-portion Achilles Tendinopathy) will be the first randomised trial to compare the efficacy of heel lifts to a sham intervention in reducing pain and disability in people with Achilles tendinopathy. The biomechanical analysis will provide useful insights into the mechanism of action of heel lifts.
BACKGROUND: Australian New Zealand Clinical Trials Registry, ACTRN12623000627651 . Registered 7 June 2023.
摘要：
背景：中段跟腱病是一种常见病，以局部跟腱负荷相关疼痛和功能障碍为特征。已经提出了许多非手术治疗方法来治疗这种疾病，但其中许多治疗方法的证据基础较差或根本不存在。还提倡将高跟鞋抬起作为跟腱病的治疗方法，但这种干预措施的疗效和作用机制尚不清楚.该提案描述了一项随机对照试验，比较了脚跟抬高与假脚跟抬高在减轻与中段跟腱病相关的疼痛方面的有效性。嵌入式生物力学分析。
方法：招募108名年龄在18至65岁之间的中段跟腱病（符合纳入和排除标准）的男性和女性。参与者将被随机分配，使用网站密封信封，对照组（假脚跟抬起）或实验组（脚跟抬起）。两组都将接受有关可接受疼痛水平的教育，以确保所有参与者都接受某种形式的治疗。参与者将被指示使用他们分配的干预措施，每天至少8小时，持续12周。主要结果测量将是前一周最差的疼痛强度（数字评分量表）。次要结果指标将是跟腱疼痛和残疾的额外指标，参与者感知的全球变化评级，函数,体力活动水平和健康相关生活质量。将在基线和主要终点（第12周）收集数据。将使用意向治疗原则分析数据。此外,干预措施的急性动力学和运动学效应将在基线时在行走和跑步的参与者亚群(n=40)中使用三维运动分析进行检查.
结论：LIFT试验（heellfts对中段跟腱病的疗效）将是第一个比较足跟抬起与假干预在减轻跟腱病患者疼痛和残疾方面的疗效的随机试验。生物力学分析将为脚跟抬起的作用机制提供有用的见解。
背景：澳大利亚新西兰临床试验注册中心，ACTRN12623000627651。2023年6月7日注册。
方法：招募108名年龄在18至65岁之间的中段跟腱病（符合纳入和排除标准）的男性和女性。参与者将被随机分配，使用网站密封信封，对照组（假脚跟抬起）或实验组（脚跟抬起）。两组都将接受有关可接受疼痛水平的教育，以确保所有参与者都接受某种形式的治疗。参与者将被指示使用他们分配的干预措施，每天至少8小时，持续12周。主要结果测量将是前一周最差的疼痛强度（数字评分量表）。次要结果指标将是跟腱疼痛和残疾的额外指标，参与者感知的全球变化评级，函数,体力活动水平和健康相关生活质量。将在基线和主要终点（第12周）收集数据。将使用意向治疗原则分析数据。此外,干预措施的急性动力学和运动学效应将在基线时在行走和跑步的参与者亚群(n=40)中使用三维运动分析进行检查.
结论：LIFT试验（heellfts对中段跟腱病的疗效）将是第一个比较足跟抬起与假干预在减轻跟腱病患者疼痛和残疾方面的疗效的随机试验。生物力学分析将为脚跟抬起的作用机制提供有用的见解。
背景：澳大利亚新西兰临床试验注册中心，ACTRN12623000627651。2023年6月7日注册。
