Explanatory Statement
Title: Kneed: A pilot randomised trial of an online pain rehabilitation program to treat persistent pain after knee replacement
Project ID: 41207
Project Sponsor: nil
Coordinating Principal Investigator/ Principal Investigator: Professor John Olver/ Dr Nathan Johns
Associate Investigator(s): Conjoint Professor Justine Naylor, A/Prof Dean McKenzie and Dr Bernadette Brady
Location: Online
Introduction
You are invited to take part in this research project because you have responded to the advertisement.
This statement tells you about the research project and explains the processes involved with taking part. Knowing what is involved will help you decide if you want to take part in the research.
Please read this information carefully.
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to.
If you decide you want to take part in the research project, you will be able to start a short survey at the bottom of this statement to check your eligibility to participate. If you are eligible, a researcher will then contact you for you to sign a consent form.
What is the purpose of this research?
This research is part of a PhD (Doctor of Philosophy) degree being undertaken by Dr Nathan Johns and is being conducted by the Epworth Monash Rehabilitation Medicine Research Unit.
This research is intended to test the feasibility and potential benefit of an online pain rehabilitation program (Kneed) in people with persistent knee pain after their total knee replacement. There are few other research studies that have been tested in people with pain after knee replacement.
What does participation in the research involve?
We aim to recruit 50 people to take part in this study. Once consented and enrolled, 25 people will be randomly allocated to the experimental group (Kneed program) and 25 people to the control group (usual care) for 8 weeks. Both groups will complete a number of surveys that use rating scales to tell the researchers about your background, pain, function, mood and quality of life prior to starting the research (baseline), at 4 weeks after starting (midpoint) and at 8 weeks (finish).
Kneed group: A research assistant will help you log on to the online program to get started. Following an introduction to the program, you are able to choose which parts of the program you want to do, in your own time and how often you choose. You can choose from educational modules designed to improve pain, sleep, relaxation and medication understanding, modules to improve exercise ability and function, and treatment modules to desensitise, manage flare-ups of pain and restore normal movements.
You will be invited at the conclusion of the 8 week trial to participate in a 1 hour interview to tell us how you felt about the program and how it can be improved to help others benefit in the future. The interview will be conducted over the internet at a convenient time for yourself and will be recorded. A written version of this interview will be sent to you to verify your responses.
Control group: After 8 weeks, you will be able to do the Kneed program but this won’t be recorded for research.
A research assistant will be available to provide technical assistance throughout the trial and may contact participants throughout the study to monitor how they are going.
Researchers will not have access to your personal records or contact your health providers or other agencies.
During the trial, you are still able to consult with your usual healthcare providers such as your GP, specialist, psychologist or physiotherapist as you feel you need to. You are also able to do all of your usual activities including exercise and recreation, take holidays, work and attend the gym or pool.
Expected benefits
We cannot guarantee or promise that you will receive any benefits from this research; however, the aim of Kneed is to reduce pain, improve function (such as walking and exercising), improve mood, improve sleep and improve quality of life. The knowledge gained by your participation is likely to benefit other people who have persistent pain after a knee replacement.
Possible risks
There are not expected to be any risks or adverse events to you whilst participating in this research program. The online program includes instruction on safe exercising when you have pain and is self-paced – you decide what you want to do and how much you are able to do. If you experience worsening pain or distress during the trial, you will be encouraged to see your GP or specialist and you will have details for free online psychological resources.
Additional costs and reimbursements
There are no costs associated with participating in this research project, nor will you be paid. However, you will be reimbursed for your time and any incidental expenses associated with the research project with a $100 gift voucher after completing the surveys at baseline, 4 and 8 weeks.
What if I choose to withdraw consent?
If you change your mind, you can choose to withdraw consent and stop participating at any time. Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your routine care, your relationship with professional staff or your relationship with Monash University.
If you decide to withdraw from the project, please notify the research assistant before you withdraw as you will be asked to complete and sign a ‘Withdrawal of Consent’ form.
If you decide to leave the research project, the researchers will not collect additional personal information from you, although personal information already collected will be retained to ensure that the results of the research project can be measured properly and to comply with law. You should be aware that data collected up to the time you withdraw will form part of the research project results.
The information that we collect
We collect personal information from surveys and your participation in the online program (experimental group) and any information gathered from post program interview.
Any information obtained in connection with this research project that can identify you will remain confidential and stored in Monash University’s online data repository for 15 years. Your information will only be used for the purpose of this research project and it will only be disclosed with your permission, except as required by law.
Any information obtained during the research project is subject to inspection (for the purpose of verifying the procedures and the data) by the relevant authorities and authorised representatives, Monash University or as required by law.
It is anticipated that the results of this research project will be published and/or presented in a variety of forums in the years after May 2025. In any publication and/or presentation, information will be provided in such a way that you cannot be identified.
In accordance with relevant Australian and/or Victorian privacy and other relevant laws, you have the right to request access to the information about you that is collected and stored by the research team. You also have the right to request that any information with which you disagree be corrected. Please inform the research team if you would like to access your information.
Funding of this research
Funding for reimbursement of your time is provided by the Epworth Monash Rehabilitation Medicine Unit. No member of the research team will receive a personal financial benefit from your involvement in this research project (other than their ordinary wages).
Dr Nathan Johns or Monash University may benefit financially from this research project if, for example, the project assists Dr Nathan Johns or Monash University in any commercial enterprise.
There will be no benefit financially to you or your family from your involvement in this research project even if, for example, knowledge acquired from your participation proves to be of commercial value to Dr Nathan Johns or Monash University.
