Anti-inflammatories, Physiotherapy and Knee Osteoarthritis
In the AP-KO trial, we want to find out whether non-steroidal anti-inflammatory medication (NSAIDs) and physiotherapy, when used together, are any better than physiotherapy on its own for people with knee osteoarthritis (OA).
People with knee OA often experience pain and stiffness impacting everyday activities. NSAIDs like Voltaren, Ibuprofen and Nurofen are widely used to relieve pain; either on prescription from a doctor or purchased over the counter by individuals. However, there can be risks associated with taking NSAIDs , especially over a long period of time, and they are not recommended as a treatment on their own.
Research has shown that physiotherapy, such as exercise, physical activity, and education, should be the mainstay of care for people with knee OA . We also know that physiotherapy has few potential side effects.
In this study, we are comparing two groups of people who will both receive evidence-based physiotherapy care for their knee OA . In addition, one of the groups will also take NSAIDs , with a medicine to protect the stomach and digestive tract. The other group will take placebo medication that looks the same but is completely inert. Participants will not be able to tell the difference.
Please note that we are providing key information on this page. If you think you may be interested, please read the full version of the participant information sheet.
Participant information sheet and consent form (PDF)
You may be eligible if you:
- Are 45 years or over
- Have pain in your knee or knees (more than 15 days in the last month)
- Have knee stiffness in the morning
- Are not taking regular prescribed non-steroidal anti-inflammatories
- Do not have any health reasons for exclusion from the trial on grounds of safety
What will you be asked to do?
If you are interested in taking part, we will talk to you on the phone to find out if you are eligible or you can complete the screening questions on-line in the link below.
Following this, our study GP will see you in person to further explain the trial before asking you to sign a consent form. You are asked not to take any NSAIDs for one week before coming. You will be assessed to make sure it is safe for you to exercise and be prescribed NSAIDs. You will be asked about your health and to provide a urine sample. You will also be asked to attend Awanui Labs to provide two blood samples. These samples will be tested to check for safe participation in the study and to investigate biomarkers for inflammation.
If you are eligible and safe to participate in the study, you will be randomly allocated to one of two groups, either the NSAID group or the placebo group. You cannot choose your group, and will not know which group you are in. This is called blinding and is important to prevent bias in the trial. Both groups will attend 4 to 6 physiotherapy sessions over a 4-week period, which will include exercise, hands-on treatment, education, and home exercises. From week 5 to 12, you will have a weekly group exercise session. The physiotherapy sessions will be held at the School of Physiotherapy Clinics, 325 Great King Street, Dunedin
In addition, people in the NSAID group will be prescribed Naproxen 1000mg (an NSAID) and Omeprazole 20mg (a stomach protector pill, used to reduce the amount of acid produced in your stomach and prevent ulcers) once every day for 4 weeks. People in the placebo group will take 2 inactive placebo pills once every day for 4 weeks.
In addition to the physiotherapy sessions, you will be asked to attend four research assessments; once before you start treatment and again at 5 weeks, 13 weeks, then 6 months after you start treatment. These assessments will involve questionnaires about your knee and timed functional tests such as walking and climbing stairs.
You will also be asked to provide blood and urine samples at the follow-up research assessments. These tests are to monitor your ongoing safety of being in the trial and to monitor the response of inflammatory biomarkers in the blood.
Your involvement in the study will last over a period of 6 months. There is no cost to you in being part of this trial.
Complete this short questionnaire to find out if you are eligible to take part, and to let us know if you’d like us to contact you.
What happens during the AP-KO trial? (PDF)
Contact us
Email kneeOA@otago.ac.nz
This trial has been approved by the Health and Disability Ethics Committees (HDEC). Reference: 2023 EXP 18561