Laslett, LL and Antony, B and Wluka, AE and Hill, C and March, L and Keen, HI and Otahal, P and Cicuttini, FM and Jones, G, KARAOKE: Krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial, Trials, 21, (1) Article 79. ISSN 1745-6215 (2020) [Refereed Article]
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Copyright 2020 The Authors. Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0) https://creativecommons.org/licenses/by/4.0/
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: 260 patients with clinical knee OA, significant knee pain and effusion-synovitis present on MRI will be recruited in 5 Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth). They will be randomly allocated to the two arms of the study, receiving 2g/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 2g/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.
Australian New Zealand Clinical Trials Registry, ACTRN12616000726459. Registered on 02 June 2016.
Universal Trial Number (UTN) U1111–1181-7087.
|Item Type:||Refereed Article|
|Keywords:||knee osteoarthritis, knee pain, pain, effusion, inflammation, randomised controlled trial, krill oil, magnetic resonance imaging (MRI), osteoarthritis|
|Research Division:||Biomedical and Clinical Sciences|
|Research Group:||Clinical sciences|
|Research Field:||Rheumatology and arthritis|
|Objective Group:||Clinical health|
|Objective Field:||Clinical health not elsewhere classified|
|UTAS Author:||Laslett, LL (Dr Laura Laslett)|
|UTAS Author:||Antony, B (Dr Benny Eathakkattu Antony)|
|UTAS Author:||Otahal, P (Mr Petr Otahal)|
|UTAS Author:||Jones, G (Professor Graeme Jones)|
|Funding Support:||National Health and Medical Research Council (1102732)|
|Web of Science® Times Cited:||9|
|Deposited By:||Menzies Institute for Medical Research|
|Downloads:||3 View Download Statistics|
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