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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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WRAP-efficacy-high-volume-injections-with-without-corticosteroid-compared-sham-Achilles-tendinopathy-2022.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons: Attribution-Noncommercial 4.0. Download (938Kb) | Preview |
Official URL: https://doi.org/10.1136/bmjsem-2021-001136
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 | ||||||
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| Subjects: | Q Science > QP Physiology R Medicine > RC Internal medicine R Medicine > RD Surgery R Medicine > RM Therapeutics. Pharmacology |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| 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: |
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| 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: |
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