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Efficacy of high-volume injections with and without corticosteroid compared with sham for Achilles tendinopathy: a protocol for a randomised controlled trial

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posted on 2021-12-10, 04:46 authored by P Malliaras, D Connell, AP Boesen, RS Kearney, Hylton MenzHylton Menz, D Morrissey, Shannon MunteanuShannon Munteanu, KG Silbernagel, M Underwood, TP Haines
Introduction 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. Methods and analysis 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 and dissemination 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. Trial registration number Australia and New Zealand Clinical trials registry (ACTRN12619001455156).


This research has been funded by a National Health and Medical Research Council (NHMRC) Project Grant (APP1164268).


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BMJ Open Sport and Exercise Medicine





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