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

Peter Malliaras, David Connell, Anders Ploug Boesen, Rebecca S Kearney, Hylton B Menz, Dylan Morrissey, Shannon E Munteanu, Karin G Silbernagel, Martin Underwood, Terry P Haines

1 Citationer (Scopus)

Abstract

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).

OriginalsprogEngelsk
Artikelnummer001136
TidsskriftBMJ Open Sport & Exercise Medicine
Vol/bind7
Udgave nummer4
Sider (fra-til)1-10
Antal sider10
ISSN2055-7647
DOI
StatusUdgivet - 22 okt. 2021

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