Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/124063
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Type: Journal article
Title: KARAOKE: Krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial
Author: Laslett, L.L.
Antony, B.
Wluka, A.E.
Hill, C.
March, L.
Keen, H.I.
Otahal, P.
Cicuttini, F.M.
Jones, G.
Citation: Trials, 2020; 21(1):79-79
Publisher: BMC
Issue Date: 2020
ISSN: 1745-6215
1745-6215
Statement of
Responsibility: 
L. L. Laslett, B. Antony, A. E. Wluka, C. Hill, L. March, H. I. Keen, P. Otahal, F. M. Cicuttini and G. Jones
Abstract: Background: Knee osteoarthritis (OA) is a common and important cause of pain and disability, but interventions aimed at modifying structures visible on imaging have been disappointing. While OA affects the whole joint, synovitis and effusion have been recognised as having a role in the pathogenesis of OA. Krill oil reduces knee pain and systemic inflammation and could be used for targeting inflammatory mechanisms of OA. Methods/design: We will recruit 260 patients with clinical knee OA, significant knee pain and effusion-synovitis present on MRI in five Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth). These patients will be randomly allocated to the two arms of the study, receiving 2 g/day krill oil or inert placebo daily for 6 months. MRI of the study knee will be performed at screening and after 6 months. Knee symptoms, function and MRI structural abnormalities will be assessed using validated methods. Safety data will be recorded. Primary outcomes are absolute change in knee pain (assessed by visual analog score) and change in size of knee effusion-synovitis over 24 weeks. Secondary outcomes include improvement in knee pain over 4, 8, 12, 16 and 20 weeks. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per protocol analyses adjusting for missing data and for treatment compliance will be performed as the secondary analyses. Discussion: This study will provide high-quality evidence to assess whether krill oil 2 g/day reduces pain and effusion-synovitis size in older adults with clinical knee OA and knee effusion-synovitis. If krill oil is effective and confirmed to be safe, we will provide compelling evidence that krill oil improves pain and function, changes disease trajectory and slows disease progression in OA. Given the lack of approved therapies for slowing disease progression in OA, and moderate cost of krill oil, these findings will be readily translated into clinical practice.
Keywords: Krill oil, osteoarthritis; pain, knee pain; magnetic resonance imaging (MRI)
Rights: © The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
DOI: 10.1186/s13063-019-3915-1
Grant ID: http://purl.org/au-research/grants/nhmrc/1102732
http://purl.org/au-research/grants/nhmrc/1070586
http://purl.org/au-research/grants/nhmrc/1122596
http://purl.org/au-research/grants/nhmrc/1150102
http://purl.org/au-research/grants/nhmrc/1023222
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