Screening

Thank you for considering to participate in a randomised controlled study evaluating two different treatments that aim to improve health outcomes in people with knee osteoarthritis. Before you complete the screening process, please read the following information.

What is the study about?
This study aims to test two different physiotherapy treatments that involve education and activity for people with painful knee osteoarthritis. Specifically, we are interested to see if these programs have long-term positive effects on health. We are also interested to see if these treatments might reduce costs to the health system.
This research is funded by the National Health & Medical Research Council of Australia. It involves collaboration with researchers from the University of Adelaide, Flinders University, the University of Melbourne, and Stanford University (USA).

Who can participate?
People who have painful knee osteoarthritis (which has been present for at least 6 months and impairs performance of daily activity), who do not currently meet physical activity recommendations for moderate or vigorous activity and do not purposefully walk for exercise.
People who have health conditions that prevent safe participation in physical activity (e.g., severe heart or lung disease) will not be eligible to participate. Additionally, people with neurological problems affecting the lower limb (e.g., stroke, multiple sclerosis), inflammatory arthritis, fibromyalgia, previous or planned knee replacement surgery, use of intra-articular therapy (injections into your knee in the previous 3 months), severe depression, cognitive impairment (e.g., diagnosed Alzheimer's disease or dementia), or those with other injuries/pain conditions that will limit their ability to exercise will not be eligible to participate.

What will I have to do?
If you choose to participate in this study you will need to attend 8 in-person appointments, some of which will occur at a physiotherapist clinic and some of which will occur at the University.

Participation in this study involves undertaking 4 weeks of in-person treatment with a physiotherapist, followed by 4 weeks of at home activities with weekly telephone calls or telehealth (online) sessions (your choice) with the physiotherapist. There will also be an additional phone call/telehealth session at 3 months. Last, there will be two in-person follow-up appointments with the physiotherapist at 5 months and at 9 months.

Participation in this study also involves completing assessments (via filling in questionnaires) and having your physical activity levels measured at baseline, 12 weeks, 6 months, and 1 year (by use of an activity monitor you will wear for one week). This includes attending 2 in-person appointments for assessment at the University of South Australia. These 2 in-person appointments will involve a baseline assessment and a follow-up assessment (at 12 weeks) where you will also perform some computer tasks and a short walking test.

We will reimburse you $20 for each completed assessment and if you complete all assessments, we will put you into a draw for a $250 prize.

Specific trial details:

After the baseline assessment, you will be randomised into one of two treatment groups. Both groups will receive a treatment that has been shown to be helpful in reducing pain and increasing function in people with osteoarthritis. You will need to attend the clinic of one of the study physiotherapists (located in various places around [insert site specific info here]).

After the 4 in-person treatment sessions, you will be given workbook activities as well as an updated exercise plan for you to complete at home over the next 4 weeks (i.e., weeks 5-8). During these 4 weeks, the physiotherapist will contact you once a week (via telephone or telehealth) to see how you are going and to answer any questions you might have. We will ask you to fill in a diary to record how often you are completing these workbook activities and exercises. After this, we will ask you to attend the University of South Australia, where the questionnaires will be repeated and we will re-assess all the things we measured at the first assessment appointment.

Your physiotherapist will contact you again at 3 months (via telephone or telehealth) to see how you are going with your activity plan. You will also be asked to attend two further in-person treatment appointments (at 5 months and 9 months) with your treating physiotherapist at their clinic.

The final questionnaire and activity level assessments will occur at 6 months and 12 months after you enrolled in the study. This will allow us to understand if the treatments had longer lasting effects.

Last, we will be evaluating the cost effectiveness of these treatments. This involves collecting information on what type of medical services and prescriptions that you have accessed over the study period. You will be asked to fill out a consent form authorising the study access to your complete Medicare and Pharmaceutical Benefits Scheme (PBS) data as outlined on the back of the consent form. Medicare collects information on your doctor visits and the associated costs, while the PBS collects information on the prescription medications you have filled at pharmacies. The consent form is sent securely to the Services Australia who holds this information confidentially. We will also access the frequency and duration of any hospital in-patient admissions during the trial duration (accessed from administrative data-sets held by the Department of Health).

What are the risks in participating?

As with any physiotherapy intervention, there is a risk that you may sustain a physical injury. However, all treatments are provided by an experienced, licensed physiotherapist and you will be screened for any conditions that might make physical activity unsafe. This makes the risk of such injury very small. If you suffer a physical injury, please let the treating physiotherapist know as soon as possible. The physiotherapist will provide you with advice and if needed, will arrange a time to see you. Further, if necessary, the study team will also coordinate a medical follow-up with your GP.

There is also a risk that you may experience increased pain or discomfort as a result of the treatment. This pain or discomfort is commonly short-lasting (< 2 days). The physiotherapist will monitor this very closely and will help you to make changes to your treatment should an increase pain or discomfort not abate.

One of the tests that we will have you do at baseline and 12 weeks involves virtual reality. Some people can feel dizzy or nauseous with virtual reality. If this happens to you, you can immediately close your eyes and the feeling will subside. If you experience these side effects, you do not have to undertake the testing that involves use of virtual reality. Experiencing these side effects is very unlikely due to the type of virtual reality we are using.

Last, there is a small risk that you may find talking about your knee pain distressing. If this is the case, please notify the physiotherapist. If needed, the study team will coordinate a follow-up with your GP or with a psychologist.

What are the benefits to participating?

All participants will receive treatments that have been shown to increase function and reduce pain in people with knee osteoarthritis. Thus you may receive personal benefit from participating. Your participation will also provide wider benefits to the community by providing important information on the treatment so that we can determine if this type of treatment should be provided to those with knee OA.

To download the full Patient Information Sheet, please click here.

Thank you for considering to participate in a randomised controlled study evaluating two different treatments that aim to improve health outcomes in people with knee osteoarthritis. Before you complete the screening process, please read the following information.

What is the study about?
This study aims to test two different physiotherapy treatments that involve education and activity for people with painful knee osteoarthritis. Specifically, we are interested to see if these programs have long-term positive effects on health. We are also interested to see if these treatments might reduce costs to the health system.
This research is funded by the National Health & Medical Research Council of Australia. It involves collaboration with researchers from the University of Adelaide, Flinders University, the University of Melbourne, and Stanford University (USA).

Who can participate?
People who have painful knee osteoarthritis (which has been present for at least 6 months and impairs performance of daily activity), who do not currently meet physical activity recommendations for moderate or vigorous activity and do not purposefully walk for exercise.
People who have health conditions that prevent safe participation in physical activity (e.g., severe heart or lung disease) will not be eligible to participate. Additionally, people with neurological problems affecting the lower limb (e.g., stroke, multiple sclerosis), inflammatory arthritis, fibromyalgia, previous or planned knee replacement surgery, use of intra-articular therapy (injections into your knee in the previous 3 months), severe depression, cognitive impairment (e.g., diagnosed Alzheimer's disease or dementia), or those with other injuries/pain conditions that will limit their ability to exercise will not be eligible to participate.

What will I have to do?
If you choose to participate in this study you will need to attend 8 in-person appointments, some of which will occur at a physiotherapist clinic and some of which will occur at the University.

Participation in this study involves undertaking 4 weeks of in-person treatment with a physiotherapist, followed by 4 weeks of at home activities with weekly telephone calls or telehealth (online) sessions (your choice) with the physiotherapist. There will also be an additional phone call/telehealth session at 3 months. Last, there will be two in-person follow-up appointments with the physiotherapist at 5 months and at 9 months.

Participation in this study also involves completing assessments (via filling in questionnaires) and having your physical activity levels measured at baseline, 12 weeks, 6 months, and 1 year (by use of an activity monitor you will wear for one week). This includes attending 2 in-person appointments for assessment at the University of Melbourne. These 2 in-person appointments will involve a baseline assessment and a follow-up assessment (at 12 weeks) where you will also perform some computer tasks and a short walking test.

We will reimburse you $20 for each completed assessment and if you complete all assessments, we will put you into a draw for a $250 prize.

Specific trial details:

After the baseline assessment, you will be randomised into one of two treatment groups. Both groups will receive a treatment that has been shown to be helpful in reducing pain and increasing function in people with osteoarthritis. You will need to attend the clinic of one of the study physiotherapists (located in various places around Melbourne).

After the 4 in-person treatment sessions, you will be given workbook activities as well as an updated exercise plan for you to complete at home over the next 4 weeks (i.e., weeks 5-8). During these 4 weeks, the physiotherapist will contact you once a week (via telephone or telehealth) to see how you are going and to answer any questions you might have. We will ask you to fill in a diary to record how often you are completing these workbook activities and exercises. After this, we will ask you to attend the University of Melbourne, where the questionnaires will be repeated and we will re-assess all the things we measured at the first assessment appointment.

Your physiotherapist will contact you again at 3 months (via telephone or telehealth) to see how you are going with your activity plan. You will also be asked to attend two further in-person treatment appointments (at 5 months and 9 months) with your treating physiotherapist at their clinic.

The final questionnaire and activity level assessments will occur at 6 months and 12 months after you enrolled in the study. This will allow us to understand if the treatments had longer lasting effects.

Last, we will be evaluating the cost effectiveness of these treatments. This involves collecting information on what type of medical services and prescriptions that you have accessed over the study period. You will be asked to fill out a consent form authorising the study access to your complete Medicare and Pharmaceutical Benefits Scheme (PBS) data as outlined on the back of the consent form. Medicare collects information on your doctor visits and the associated costs, while the PBS collects information on the prescription medications you have filled at pharmacies. The consent form is sent securely to the Services Australia who holds this information confidentially. We will also access the frequency and duration of any hospital in-patient admissions during the trial duration (accessed from administrative data-sets held by the Department of Health).

What are the risks in participating?

As with any physiotherapy intervention, there is a risk that you may sustain a physical injury. However, all treatments are provided by an experienced, licensed physiotherapist and you will be screened for any conditions that might make physical activity unsafe. This makes the risk of such injury very small. If you suffer a physical injury, please let the treating physiotherapist know as soon as possible. The physiotherapist will provide you with advice and if needed, will arrange a time to see you. Further, if necessary, the study team will also coordinate a medical follow-up with your GP.

There is also a risk that you may experience increased pain or discomfort as a result of the treatment. This pain or discomfort is commonly short-lasting (< 2 days). The physiotherapist will monitor this very closely and will help you to make changes to your treatment should an increase pain or discomfort not abate.

One of the tests that we will have you do at baseline and 12 weeks involves virtual reality. Some people can feel dizzy or nauseous with virtual reality. If this happens to you, you can immediately close your eyes and the feeling will subside. If you experience these side effects, you do not have to undertake the testing that involves use of virtual reality. Experiencing these side effects is very unlikely due to the type of virtual reality we are using.

Last, there is a small risk that you may find talking about your knee pain distressing. If this is the case, please notify the physiotherapist. If needed, the study team will coordinate a follow-up with your GP or with a psychologist.

What are the benefits to participating?

All participants will receive treatments that have been shown to increase function and reduce pain in people with knee osteoarthritis. Thus you may receive personal benefit from participating. Your participation will also provide wider benefits to the community by providing important information on the treatment so that we can determine if this type of treatment should be provided to those with knee OA.

To download the full Patient Information Sheet, please click here.