Anti-inflammatories, Physiotherapy and Knee Osteoarthritis
In the AP-KO feasibility trial, we explored 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 compared two groups of people who both received evidence-based physiotherapy care for their knee OA. In addition, one of the groups took NSAIDs, with a medicine to protect the stomach and digestive tract. The other group took placebo medication that looks the same but is completely inert. Participants should not be able to tell the difference.
eligible participants were:
- 45 years or over
- Had knee pain more than 15 days in the previous month
- Had knee stiffness in the morning
- Were not taking regular prescribed non-steroidal anti-inflammatories
- Did not have any health reasons for exclusion from the trial on grounds of safety
- Had not had knee joint replacement on your affected knee
Study procedures
Following phone or on-line screening for eligibility, an appointment was made with the study GP who further explained the trial and gained consent. Participants were asked not to take any NSAIDs for one week before coming, and were assessed for safety to exercise and be prescribed NSAIDs. Urinalysis and blood tests were undertaken. One blood sample was tested to check for safe participation in the study and to investigate biomarkers for inflammation.
Eligible participants were randomly allocated to one of two groups, either the NSAID group or the placebo group. Both groups attended 4 to 6 physiotherapy sessions over a 4-week period, including exercise, hands-on treatment, education, and home exercises. From week 5 to 12, there was a weekly group exercise session. The physiotherapy sessions were delivered at the School of Physiotherapy Clinics, 325 Great King Street, Dunedin
In addition, people in the NSAID group were 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 took 2 inactive placebo pills once every day for 4 weeks.
In addition to the physiotherapy sessions, participants attended four research assessments before starting treatment, at 5 weeks, 13 weeks, and then 6 months after starting treatment. These assessments involved patient reported questionnaires, timed functional tests such as walking and climbing stairs, urinalysis and blood tests. The urinalysis and blood testing were to monitor ongoing safety of being in the trial and to monitor the response of inflammatory biomarkers in the blood.
Trial recruitment closed in October 2024, and the last participants will have their final assessment in March 2025. Findings are expected to be available by June 2025, and will be shared with participants as well as on this site.
If you have any queries, please contact us.
Contact us
Email kneeOA@otago.ac.nz
Dr Cathy Chapple (Principle Investigator)
Email cathy.chapple@otago.ac.nz
This trial has been approved by the Health and Disability Ethics Committees (HDEC). Reference: 2023 EXP 18561