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KARAOKE: krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial

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Laslett, LL ORCID: 0000-0002-4336-0095, Antony, B ORCID: 0000-0001-8704-6084, Wluka, AE, Hill, C, March, L, Keen, HI, Otahal, P ORCID: 0000-0003-4042-1769, Cicuttini, FM and Jones, Graeme ORCID: 0000-0002-9814-0006 2020 , 'KARAOKE: krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial' , Trials, vol. 21, no. 79 , doi: 10.1186/s13063-019-3915-1.

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Abstract

Background: Knee osteoarthritis (OA) is a common and important cause of pain and disability, but interventionsaimed 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 painand 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 effusionsynovitis present on MRI in five Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth). Thesepatients will be randomly allocated to the two arms of the study, receiving 2 g/day krill oil or inert placebodaily 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 berecorded. Primary outcomes are absolute change in knee pain (assessed by visual analog score) and changein size of knee effusion-synovitis over 24 weeks. Secondary outcomes include improvement in knee pain over4, 8, 12, 16 and 20 weeks. The primary analyses will be intention-to-treat analyses of primary and secondaryoutcomes. Per protocol analyses adjusting for missing data and for treatment compliance will be performedas the secondary analyses.Discussion: This study will provide high-quality evidence to assess whether krill oil 2 g/day reduces pain andeffusion-synovitis size in older adults with clinical knee OA and knee effusion-synovitis. If krill oil is effectiveand 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 forslowing disease progression in OA, and moderate cost of krill oil, these findings will be readily translated intoclinical practice.Trial registration : Australian New Zealand Clinical Trials Registry, ACTRN12616000726459. Registered on 02June 2016.Universal Trial Number (UTN) U1111–1181-7087.

Item Type: Article
Authors/Creators: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, Graeme
Keywords: krill oil, osteoarthritis, pain, knee pain, magnetic resonance imaging (MRI)
Journal or Publication Title: Trials
Publisher: BioMed Central Ltd.
ISSN: 1745-6215
DOI / ID Number: 10.1186/s13063-019-3915-1
Copyright Information:

Copyright 2020 The Authors. Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0) https://creativecommons.org/licenses/by/4.0/

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