A randomised placebo controlled trial to evaluate the effect of krill oil on pain and effusion size in patients with knee osteoarthritis

niversity of Tasmania0 个研究点目标入组 260 人开始时间: 2016年6月2日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1.Aged over 40 years old.
•2.Men and women with significant knee pain on most days (defined as a VAS >40mm).
•3.Knee effusion–synovitis on MRI: In TASOAC study the proportion of participants who had effusion–synovitis on MRI was high (67%), suggesting that localised knee inflammation is common and that MRI is an appropriate screening tool.
•4.Meet American College of Rheumatology (ACR) clinical criteria for knee OA confirmed by a rheumatologist.

•1.Inability to have an MRI (claustrophobia, metal in eyes or selected knee, pacemakers).
•2.Severe knee OA (joint space narrowing (JSN) on X-ray of Grade 3 using the Osteoarthritis Research Society International (OARSI) atlas).
•3.Use of anticoagulants, high dose aspirin or non-steroidal anti–inflammatory drugs (NSAIDs), as krill oil is contra–indicated in such people.
•4.Unwillingness to stop taking krill oil and fish oil medications 30 days prior to the trial and during the trial.
•5.Other forms of inflammatory arthritis (especially rheumatoid arthritis and gout).
•6.Seafood allergy.
•7.Significant knee injury within the last 6 months.
•8.Arthroscopy or open surgery in the index knee in the last 12 months, or planned.
•9.Injections of corticosteroids (last 3 months) or hyaluronic acid (last 6 months) in the index knee.
•10.Pregnancy or breastfeeding.
•11.Use of any investigational drug(s) and/or devices within 30 days prior to randomisation
•12.Presence of any serious medical illness that may preclude 24 week follow up.
•13.Inability to provide informed consent.

发起方

niversity of Tasmania