Abstract
BackgroundKnee 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/designWe 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.DiscussionThis 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.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12616000726459. Registered on 02 June 2016.Universal Trial Number (UTN) U1111–1181-7087.
Highlights
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
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
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
Summary
We propose a multicentre, randomised, double blind placebo-controlled trial to determine whether krill oil 2 g/day improves knee pain and reduces size of knee effusion-synovitis compared to placebo in people with clinical knee OA, significant knee pain and knee effusion-synovitis. Krill oil (300 mg/day) reduced inflammation (as measured by CRP) by 30% in 30 days vs 25% increase in patients receiving placebo [34]. This may have important clinical implications, with low level inflammation associated with increased loss of tibial cartilage volume (β = − 1.18% per annum per quartile of IL-6) [62]). Two small trials [34, 35] suggest that krill oil will improve knee pain and may reduce systemic inflammation in people with OA.
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