Malliaras Peter, Connell David, Boesen Anders Ploug, Kearney Rebecca S, Menz Hylton B, Morrissey Dylan, Munteanu Shannon E, Silbernagel Karin G, Underwood Martin, Haines Terry P
School of Primary and Allied Health Care, Monash University, Frankston, Victoria, Australia.
Imaging @ Olympic Park, Melbourne, Victoria, Australia.
BMJ Open Sport Exerc Med. 2021 Oct 22;7(4):e001136. doi: 10.1136/bmjsem-2021-001136. eCollection 2021.
Achilles tendinopathy (AT) is a common and disabling musculoskeletal condition. First-line management involving Achilles tendon loading exercise with, or without, other modalities may not resolve the problem in up to 44% of cases. Many people receive injections. Yet there are no injection treatments with demonstrated long-term efficacy. The aim of the trial is to examine the 12-month efficacy of high-volume injection (HVI) with corticosteroid and HVI without corticosteroid versus sham injection among individuals with AT.
The trial is a three-arm, parallel group, double-blind, superiority randomised controlled trial that will assess the efficacy of HVI with and without corticosteroid versus sham up to 12 months. We will block-randomise 192 participants to one of the three groups with a 1:1:1 ratio, and both participants and outcome assessors will be blinded to treatment allocation. All participants will receive an identical evidence-based education and exercise intervention. The primary outcome measure will be the Victorian Institute of Sport Assessment - Achilles (VISA-A) at 12 months post-randomisation, a validated, reliable and disease-specific measure of pain and function. Choice of secondary outcomes was informed by core outcome domains for tendinopathy. Data will be analysed using the intention-to-treat principle.
Ethics approval was obtained via the Monash University Human Ethics Committee (no: 13138). The study is expected to be completed in 2024 and disseminated via peer review publication and conference presentations.
Australia and New Zealand Clinical trials registry (ACTRN12619001455156).
跟腱病（AT）是一种常见且会导致功能障碍的肌肉骨骼疾病。一线治疗包括进行跟腱负荷锻炼，无论是否结合其他治疗方式，在高达44%的病例中可能无法解决问题。许多人接受注射治疗。然而，尚无已证明具有长期疗效的注射治疗方法。该试验的目的是比较高容量注射（HVI）联合皮质类固醇、HVI不联合皮质类固醇与假注射对跟腱病患者的12个月疗效。
该试验为三臂、平行组、双盲、优效性随机对照试验，将评估HVI联合和不联合皮质类固醇与假注射长达12个月的疗效。我们将按1:1:1的比例对192名参与者进行区组随机分组，参与者和结果评估者都将对治疗分配情况不知情。所有参与者都将接受相同的循证教育和运动干预。主要结局指标将是随机分组后12个月时的维多利亚运动评估机构跟腱量表（VISA - A），这是一种经过验证的、可靠的且针对疾病的疼痛和功能测量方法。次要结局的选择参考了肌腱病的核心结局领域。数据将采用意向性分析原则进行分析。
已获得莫纳什大学人类伦理委员会的伦理批准（编号：13138）。该研究预计于2024年完成，并通过同行评审发表和会议报告进行传播。
澳大利亚和新西兰临床试验注册中心（ACTRN12619001455156）
