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).
Due to the nature of this study, some information will be withheld from you until the end of your involvement. However, there is no added risk of harm or any reason to suspect you would not consent if you had all the details at the start. After testing is completed, you will be given a full explanation of the study, including reasons for concealing some details. Prior to commencement of the study we will ask you to provide written informed consent that states that you would like to be part of the study, based on the details provided here.
Do I have to participate?
No. As with all research at the University, participation is completely voluntary. Choosing not to take part in this study will not affect your current or future medical care in any way.
You can request to withdraw at any time without any prejudice, now or in the future, and any information collected prior to your withdrawal will not be used. You can do this by filling in the withdrawal form.
In the case of participants discontinuing the study without notification (i.e., if you do not contact us and let us know that you would no longer like to be part of the study), some of the information previously collected may be used (but without identification). If you decide to withdraw from the study more than 1 year after you commenced the study the information previously collected may be used (but without identification).
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 (>150 minutes per week) and do not purposefully walk for exercise more than 30 mins/day on 5 or more days/week can participate. We may ask you to wear an activity monitor/pedometer for a week prior to formal inclusion to determine whether or not you meet this activity level criteria.
People that 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 (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. Last, people who are not fluent in English or people who are unable to commit to study requirements (unable to attend study appointments or complete study outcomes) will not be able to participate. The study coordinator will go through these thoroughly with you.
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 in Adelaide and some of which will occur at the University of South Australia’s City East Campus (corner of North Terrace and Frome Road).
Treatment sessions: 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 with the physiotherapist. There will also be an additional phone call/telehealth session at 3 months. Whether these follow-up sessions with the physiotherapist occur via the telephone or via telehealth (online using a computer) is based upon your preference. Last, there will be two in-person follow-up appointments with the physiotherapist at 5 months and at 9 months. We will do our best to have these appointments at a physiotherapy clinic at a location that is convenient to you. Should you incur travel costs (e.g., public transport, parking, taxi/uber) to attend treatment appointments, please let the team know (maximum reimbursement of $20, via gift vouchers, with provision of receipts either at 12 week appointment or via mail/email).
Assessment sessions: 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. This includes attending 2 in-person appointments for assessment at the Clinical Trial facility (Bonython Jubilee Building, Level 1) 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 walking test. The remaining assessments will involve us mailing questionnaires to you (or you filling them in online) and mailing an activity monitor to you (more details provided below). We will also ask you a few brief questions about your view of the treatment after your first treatment session (online or via post). We will reimburse you $20 for each completed assessment using gift vouchers and if you complete all assessments, we will put you into a draw for a $250 prize. Note that some of the in-person appointments at the University may not be able to occur if the COVID situation changes. However, you will still receive full reimbursement.
Here we describe what will occur from the start to the end of your participation:
Before your baseline assessment at the University of South Australia, we will send you an activity monitor in the mail that you will wear on your wrist or your hip. We may ask you to wear the activity monitor on both your wrist and your hip (this helps us to improve the measurement), but if you do not want to do this, you do not have to. We will ask you to wear this for 7 days and to wear this as much as possible (e.g., all waking hours). We will call you after we send the activity monitor to make sure that you understand how to use it and to give you a chance to ask any questions. We will ask you to send the monitor back to us in the mail (we will supply a return reply paid envelope) or you can bring it in to your baseline assessment appointment at the university. If you are comfortable filling in questionnaires online, we will get you to do this before your university appointment, otherwise you can fill them in on paper (either mailed to you or at the baseline appointment). For the questionnaires, you will be asked to complete questionnaires asking you about your knee pain, your overall function (e.g., ability to do different activities), your mood, your beliefs about pain, your perception of your knee, your previous exercise history, how you learn, and your thoughts about physical activity and movement. At the baseline assessment at the University of South Australia, you will also be asked to draw a picture of your knee and perform some computer tasks that will ask you to put pictures into different categories, estimate the distance to a target, estimate the slant of a hill, and choose whether images of the lower limb are of the right side or the left side. We will also assess how well you are at detecting touch on your knee. We will also measure your height and your weight. Last, you will be asked to complete a short walking test (maximum 6 minutes of walking at your own pace with resting breaks permitted). Together the questionnaires, computer tasks, and walking test will take approximately ~60-90 minutes to complete.
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. All participants will receive four, one-on-one treatment sessions with an experienced, licensed physiotherapist. These will occur once a week, will last approximately 1-1.5hrs and will be scheduled over a one month period. You will need to attend the clinic of one of the study physiotherapists (located in various places around Adelaide).
In order to make sure the physiotherapist is providing the treatment correctly, we will be audio-recording these treatment sessions. This recording also allows us to review the content of the sessions. Your name/ID number will not be matched with these recordings – each will be given a random code such that we cannot identify which recording involved you. Only the research team will have access to these recordings and the recordings will be stored in a locked filing cabinet (C7-31, City East Campus) and/or on a secure UniSA server with a password protected file. You can choose not to be audio-recorded or you can cease the audio-recording at any time and this will not affect your treatment or participation in the study.
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 at-home activities, 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 Clinical Trials Facility at the University of South Australia, where the questionnaires will be repeated and we will re-assess all the things we measured at baseline. We will also ask you to wear the activity monitor again for a one week period. Again, a return reply envelope will be provided so that you can return the activity monitor (and paper questionnaires) to us.
As mentioned above, 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 with your treating physiotherapist at their clinic. This will occur at 5 months and 9 months after you started the study. These appointments will allow you to discuss with the physiotherapist any concerns you might have as well as advance your treatment program.
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. We will have you fill in the questionnaires (sent via mail or email or filled in online) and wear the activity monitor for a one week period (sent to via mail with a return reply paid envelope provided).
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).
Due to the restrictions imposed by COVID-19 that may change throughout the trial, it is possible that your in-person sessions with the physiotherapist will be switched to online sessions (telehealth). Should this happen, the physiotherapist and/or research staff will assist you in getting this set-up so that you are comfortable using the technology. If this is too difficult for you, this may result in you missing those treatment sessions, or possibly having those sessions over the telephone. Also, being unable to undertake treatment online via telehealth may result in you being unable to participate in the trial if COVID-19 restrictions against in-person treatment sessions are in place when you are recruited. We are happy to place you on a wait-list until in-person treatment sessions can recommence, but there is a possibility that you will not be included in the trial. It is also possible that the two outcome assessments occurring at the university (baseline and 12 weeks) will be assessed online as well (using a computer). Last, to monitor the effect of COVID-19 on your life, we will also ask you some questions at each assessment time-point about whether COVID-19 restrictions are affecting your normal routine.
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.
Who will have access to my information?
The researcher will take every care to remove any identifying material from the responses you provide as early as possible. Likewise, individuals’ responses will be kept confidential by the researcher and participants will not be identified in the reporting of the research. That is, information on the questionnaires will be grouped for reporting (e.g., we will present only group averages). Individual questionnaire results will not be presented in any way. All records containing personal information will remain confidential and no information which could lead to the identification of any individual will be released, unless as required by law. However, the researcher cannot ultimately guarantee the confidentiality or anonymity of material transferred by email or the internet.
The questionnaire, computer task, and activity data information supplied will be stored securely in room C7-26 in the School of Health Sciences, University of South Australia or in electronic format on a password protected file on the University server. This data will be stored for 5 years and the researcher will not supply this information to the public without explicit permission, unless required by law. The audio recordings of treatment sessions will be stored for 5 years on a UniSA secure server. Medicare and PBS data will be stored for 5 years from the publication of the projects’ final report. After these time periods, confidential information related to this research project will be completely destroyed. Hard-copy data and related information will be disposed of using a commercial secure document disposal service while electronic data will be properly deleted from the network and associated storage by University IT staff. Every effort is made so that the information you supply will remain completely confidential. Non-identifiable data may be used for future purposes, for which ethics approval will be sought (for example, we may combine this data with other similar datasets to explore things that can better predict treatment outcome).
Will you tell me the results of the research?
Yes. A summary of the results can be provided to you at the completion of the study if you indicate your interest at the end of the questionnaire together with an email or home address. In addition, should you wish to have a copy of your own personal activity level results (summarised in graphs), please let the research know.
If you would like your results to be sent to your general practitioner or medical team, please inform the researcher about this and provide the researcher with the medical team’s relevant contact information so that this can be undertaken.