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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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Malliaras, Peter, Connell, David, Boesen, Anders Ploug, Kearney, Rebecca S., Menz, Hylton B., Morrissey, Dylan, Munteanu, Shannon E., Silbernagel, Karin G., Underwood, Martin and Haines, Terry P. (2021) Efficacy of high-volume injections with and without corticosteroid compared with sham for Achilles tendinopathy : a protocol for a randomised controlled trial. BMJ Open Sport & Exercise Medicine, 7 (4). e001136. doi:10.1136/bmjsem-2021-001136 ISSN 2055-7647.

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Official URL: https://doi.org/10.1136/bmjsem-2021-001136

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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)

Item Type: Journal Article
Subjects: Q Science > QP Physiology
R Medicine > RC Internal medicine
R Medicine > RD Surgery
R Medicine > RM Therapeutics. Pharmacology
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
SWORD Depositor: Library Publications Router
Library of Congress Subject Headings (LCSH): Achilles tendon -- Wounds and injuries, Achilles tendon -- Wounds and injuries -- Treatment, Injections , Adrenocortical hormones , Sports medicine
Journal or Publication Title: BMJ Open Sport & Exercise Medicine
Publisher: BMJ Publishing Group
ISSN: 2055-7647
Official Date: 22 October 2021
Dates:
DateEvent
22 October 2021Published
1 October 2021Accepted
Volume: 7
Number: 4
Article Number: e001136
DOI: 10.1136/bmjsem-2021-001136
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)
Date of first compliant deposit: 1 July 2022
Date of first compliant Open Access: 1 July 2022
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
APP1164268National Health and Medical Research Councilhttp://dx.doi.org/10.13039/501100000925

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