Research Proposal: Knee Osteoarthritis and Pain Types

Project title: Knee Osteoarthritis and Pain Types: Effect on Joint Position Sense (JPS) and Quantitative Sensory Testing(QST)

• Principal Investigators: Tracey Bettridge; Michelle Quinn; Jeny Macapulay
• Project Supervisor: Professor Tony Wright
• Co-Supervisor: Dr Penny Moss

Dear Sir/Madam,

Thank you for showing your interest to take part in our research project. This observational study is performed as part of our Master of Clinical Physiotherapy Course requirement for Physiotherapy Project 651 at Curtin University. You are required to read through the information provided below before signing the attached consent form.

This study will be conducted at Curtin School of Physiotherapy, Bentley Campus. You are invited to participate in this study as you meet the inclusion of the project. It is safe and identified as low risk (brief discomfort or pain will be noted during quantitative sensory testing). It is approved by Human Research Ethics Committee (HREC) Curtin University of Technology.

Before you decide, you may want to talk about the study with your family, friends, or healthcare providers. Whether or not you take part is your important personal decision. You should be aware that even you agree to participate; you are free to withdraw at any time.

This Participant Information Sheet will help you decide if you would like to take part to on our study. It informs why we are doing this study, what is your participation, what are the benefits, discomfort and risks to you might be experienced, and what would happen during and after the study. We will go through this information with you and answer any questions you may have. You will be asked to sign the Consent Form on the last page of this document. You will be given a copy of both the Participant Information Sheet and the Consent Form to keep.

This document is 5 pages long, including the Consent Form. Please make sure you have read and understood all the pages. If you have any questions as a result of reading this information sheet, you should ask the researcher before the study begins.

Purpose of Research

Neural function and proprioceptive acuity plays a role in the integrity of joint. The purpose of this observational study is to determine the effect of knee osteoarthritis and pain type on the knee joint position sense (JPS) and quantitative sensory testing (QST). This research involves data collection from three sub-groups: knee OA participant with nociceptive pain, knee OA participant with neuropathic like pain and age-matched control groups. The ability to clinically detect this group will lead to more appropriate interventions and management strategies targeting central pain factors.

Your role

You have been chosen because you have knee pain which is thought to be due to osteoarthritis. We plan to recruit about ____ participant with knee osteoarthritis to create a significant result in our study. If you decide to take part, you will be contacted by one of the research team who will ask you a number of questions to ensure that you are eligible for participation. The researcher will then arrange a mutually convenient time for you to attend for the assessment sessions.

At your first visit you will be asked to complete the Pre-Test Questionnaire to confirm that you are eligible for the study. You will be asked to sign a consent form that will give your consent to take part in the study as well. You will be given a copy of your signed consent form with this information sheet.

At this visit, you will be asked to fill up some standard test which routinely used as preliminary screens for clinical conditions, the WOMAC Osteoarthritis Index (assess pain, stiffness, and physical function) and Pain Catastrophizing Scale (assess individuals thoughts and feelings related to pain and distress). Scores from these tests will be treated as your baseline data and would not be used for diagnostic purposes in this study.

The data collection of this project will be divided into two phases: pre-test before participating in the project and post-test after participating the project. You will be allocated into any of the three subgroups, knee OA participant with nociceptive pain, knee OA participant with neuropathic like pain and control groups. Data Collection will be done during the QST and joint position sense error of the knee assessment as described below:

For Joint Position Sense Error (JPSE)

We will measure your joint position sense error using a Penny & Giles electrogoniometer. You will be asked to indicate the target position predetermine by the researcher between the target angle of 20 to 40 deg of knee flexion. It compasses 1 familiarization trial and 5 recorded trials. Data will then be recorded using LabView software.

For Quantitative Sensory Testing (QST)

Pressure Pain Threshold (PPT). We will measure minimum force applied to produce pain using digital algometer. PPT will be tested at three sites: the medial knee joint line, tibialis anterior and extensor aspect of the ipsilateral forearm. You will have a foot control switch to press when you experience an uncomfortable sensation. Researchers then stop adding pressure and record the data.

Thermal Pain Threshold (TPT). We will measure heat pain threshold and cold pain threshold using Thermode TSA II. TPT will be tested with the same sites tested as PPT above. Heat detection threshold (HDT) and cold detection threshold (CDT) are tested first indicating change in temperature. Heat pain threshold (HPT) and cold pain threshold (CPT) will be tested as the onset of pain or discomfort. You will have a foot control switch to press when you experience an uncomfortable sensation. Test will be stopped immediately and data will then be recorded.

Vibration Perception Threshold (VPT). We will measure vibration perception threshold using vibrameter. VPT will be tested at three bony prominence: the tibial plateau, lateral malleolus and lateral epicondyle. Researcher will maintain contact pressure and the vibration will gradually increase in amplitude until participant perceives them. The frequency of vibration at which the participant perceives them is then recorded. It is repeated three times for each site.

You will be required to participate 2 assessment sessions on both JPSE and QST, and each session will be conducted for _____hours.

Risks and Discomforts

Throughout the assessment sessions, your safety is paramount and will not be compromised. At least one assessor has to be present with you throughout the ___hour session to ensure safety.

Please inform us if you are feeling tired or fatigue during the session. If in the unfortunate event, you experience untoward reactions during the test which is unlikely to happen, you will receive appropriate and immediate medical attending.

However, no compensation or liability will be provided by Curtin University School of Physiotherapy.

Benefits

You won’t be benefited directly by the study but the data collected will give way to future studies in developing outcome measures, advancement of treatment strategies/management and appropriateness in the diagnosis of knee osteoarthritis and its pain types. We hope that the result of the study will add to the evidence that neuropathic like pain group exist in knee osteoarthritis and to have a better understanding on the cause of pain in patients with knee osteoarthritis.

We will provide free parking during the assessment session.

Confidentiality

The data collected will be treated as strictly confidential and will only be used for research purposes in connection with the study. You will not be identified by the name in any reports which arises from this study. Information on you and your history will be coded so that these are all anonymous. No other use of the data will be undertaken without seeking your prior consent. Moreover, we will only present data average over many participants and your data will not be identifiable. We will let you know the outcome of the study when it is complete if you would like us to do so.

Any videotapes and photographs taken will only be used for scientific purposes and with your consent as well. Your details will be stored on computer during the research project but your data will only be looked at by members of the research team. The data will be stored for 7 years in a secure storage facility before it will be destroyed.

Refusal or Withdrawal

Your involvement is voluntary, you may choose to withdraw from this study at any point of time without explanation and we will respect that decision. You have the right to ask that any data you have supplied to that point will be withdrawn or destroyed.

Further Information

This study has been approved under Curtin University’s process for lower-risk Studies (Approval Number ). This process complies with the National Statement on Ethical Conduct in Human Research (Chapter 5.1.7 and Chapters 5.1.18-5.1.21). For further information on this study contact the researchers named above or the Curtin University Human Research Ethics Committee. c/- Office of Research and Development, Curtin University, GPO Box U1987, Perth 6845 or by telephoning 9266 9223 or by emailing hrec@curtin.edu.au.

CONSENT SHEET

This study has been approved by the Curtin University Human Research Ethics Committee

(Approval Number ).

• I understand the purpose and procedures of the study.
• I have been provided with the participant information sheet.
• I understand that the procedure itself may not benefit me.
• I understand that my involvement is voluntary and I can withdraw at any time without problem.
• I understand that no personal identifying information like my name and address will be used and that all information will be securely stored for 7 years before being destroyed.
• I know whom to contact if I have any questions about the study in general.
• I have been given the opportunity to ask questions.
• I agree to participate in the study outlined to me.

_______________________________________________________ Participant’s Signature over Printed Name Date

_____________________________________________________

Witness Signature over Printed Name Date