Menzies Institute for Medical Research, University of Tasmania, Private Bag 23, Hobart, TAS, 7000, Australia.
Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, 3004, Australia.
Trials. 2020 Jan 14;21(1):79. doi: 10.1186/s13063-019-3915-1.
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.
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.
Australian New Zealand Clinical Trials Registry, ACTRN12616000726459. Registered on 02 June 2016. Universal Trial Number (UTN) U1111-1181-7087.
膝骨关节炎（OA）是一种常见且重要的疼痛和残疾原因，但针对影像学可见结构进行干预的效果并不理想。虽然 OA 会影响整个关节，但滑膜炎和关节积液已被认为在 OA 的发病机制中起作用。磷虾油可减轻膝关节疼痛和全身炎症，可用于针对 OA 的炎症机制。
方法/设计：我们将在澳大利亚的五个城市（霍巴特、墨尔本、悉尼、阿德莱德和珀斯）招募 260 名患有临床膝关节 OA、膝关节疼痛明显且 MRI 显示有积液-滑膜炎的患者。这些患者将被随机分配到研究的两个组中，每天分别接受 2g 磷虾油或惰性安慰剂治疗 6 个月。在筛选时和 6 个月后将对研究膝关节进行 MRI 检查。使用经过验证的方法评估膝关节症状、功能和 MRI 结构异常。记录安全性数据。主要结局是膝关节疼痛的绝对变化（通过视觉模拟评分评估）和 24 周内膝关节积液-滑膜炎的大小变化。次要结局包括 4、8、12、16 和 20 周时膝关节疼痛的改善。主要分析将是对主要和次要结局的意向治疗分析。将对缺失数据和治疗依从性进行调整的符合方案分析作为次要分析。
这项研究将提供高质量的证据，以评估每天 2 克磷虾油是否能减轻患有临床膝关节 OA 和膝关节积液-滑膜炎的老年人的疼痛和积液-滑膜炎的大小。如果磷虾油有效且被证实安全，我们将提供有力的证据表明磷虾油可改善疼痛和功能，改变疾病轨迹并减缓 OA 的疾病进展。鉴于缺乏批准的治疗方法来减缓 OA 的疾病进展，以及磷虾油的适度成本，这些发现将很容易转化为临床实践。
澳大利亚新西兰临床试验注册中心，ACTRN12616000726459。于 2016 年 6 月 2 日注册。通用试验编号（UTN）U1111-1181-7087。
