None listed
Conditions
Brief summary
Background: Knee osteoarthritis (OA) is a significant and increasing cause of pain and disability in the Australian population. So far, interventions aimed at structural modification have been disappointing. OA affects the whole joint, and inflammation of the joint lining (synovitis and joint fluid) is now recognised as a key part of OA. Animal studies suggest that krill oil is anti–inflammatory. Pilot data in humans shows that krill oil reduces knee pain and systemic inflammation after 30 days, suggesting that an approach targeted at specific mechanisms of disease may be effective for OA. However, this study was of short duration, did not collect any data on structural factors, and included patients with a variety of disorders. Longer, larger follow up studies are required. Aim: To compare, using a randomised, placebo–controlled double–blind design over six months, the efficacy of krill oil vs identical placebo to treat knee osteoarthritis (OA) (both pain and structure) in 260 patients with clinical knee OA, significant knee pain and effusion on imaging. Primary hypothesis: 1) Krill oil decreases pain (assessed by 100mm VAS) by 10mm more than identical placebo over 24 weeks in patients with clinical knee OA, significant knee pain and effusions. 2) Krill oil decreases effusion size by 20% over 24 weeks in patients with symptomatic OA of the knee and knee effusion. Significance and Innovation: If krill oil can both improve symptoms and decrease effusion in OA it has the potential to slow progression to joint replacement. The proposed study represents an innovative approach to this and lends itself to easy implementation as krill oil is already available over–the–counter in Australian pharmacies.
Interventions
130 patients with clinical knee osteoarthritis, significant knee pain and effusion on imaging will receive 2g (2 capsules of 1 g each) of krill oil per day for 24 weeks. Adherence to treatment will be monitored by counting the return capsules at 12 and 24 week visits.
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed