Informed Consent Form – Clinical Trial of SDR Therapy for Chronic Pain

    INFORMED CONSENT FORM
    The Lifeworks Group Pty Ltd
    Title of Trial: Finally Eliminating Chronic Pain: efficacy of SDR Therapy for non-malignant chronic pain without sufficient explanatory pathology
    Principal Investigator: Christine Sutherland

    Please complete your details at the end of this form and click on “I accept” before clicking “Send” in order to complete your registration in this clinical trial.

    INTRODUCTION

    We invite you to take part in this online study which seeks to identify a more effective means of treating the most common type of persistent pain, being non-malignant chronic pain without sufficient explanatory pathology.

    Taking part in this study is entirely voluntary. We urge you discuss any questions about this study with our staff members. Talk to your family and friends about it and take your time to make your decision. If you decide to participate, you must click “I accept” at the bottom of this form to show that you agree to take part.

    Your participation will remain voluntary throughout the trial and after the trial, meaning that you may withdraw at any time, and although we will ask you to complete a regular survey, you are not obliged to continue to provide any information regarding your experience of pain.

    Section 1. PURPOSE OF THE RESEARCH

    You are being offered the opportunity to take part in this research study because your doctor has provided a referral which states that you have been diagnosed with non-malignant chronic pain without sufficient explanatory pathology, and that you meet the inclusion criteria for the trial.

    This study is being done to find out whether SDR Therapy is a worthwhile treatment option for this type of chronic pain and the aim of the study is to greatly reduce, or completely eliminate, the pain.

    It is expected that some 1,000 participants will take part in the trial.

    Section 2. PROCEDURES

    Every person engaged in the trial will receive the treatment program and there is no placebo/control group, no randomization, and no “blinding”. The reason that this is not a randomised, controlled, double-blind trial is not only the difficulty or impossibility of some of these factors for this type of study, but also because there is already an extraordinarily massive “synthetic control arm” due to the vast array of earlier research using other treatment methods.

    This study is being run almost entirely online. The program consists of a series of learning and practice units which participants work through at their own pace. The learning material has an objective of actually switching off the pain. So the focus is not about coping with the pain, but about eliminating the pain and allowing you to return to living life unencumbered by pain.

    Your online study is meant to be highly interactive because we want to give you as close as possible an experience of being supported as you might find in face-to-face sessions with a health professional.

    To this end the online learning is supplemented by private support groups (on the study site itself, and also on Facebook for those who prefer that platform), by weekly teleconferences which are recorded for your convenience, and by email and limited telephone support.

    You are also welcome to work with your own psychologist or other health professional as you move through the program.

    Prior to starting the first unit you’ll be asked to complete a survey which will give us a benchmark to measure progress against. The survey will ask questions about your pain level, your medication use, your ability to function as you wish, and your quality of life.

    At approximately 1 month into the program, and again at 6, 12, and 24 months, you’ll be invited to complete the survey again.

    The data collected from the surveys will be collated and analysed as part of the scientific paper resulting from the trial. No confidential information will be shared, and your anonymity is assured.

    Section 3. TIME DURATON OF THE PROCEDURES AND STUDY

    If you agree to take part in this study, your involvement will last approximately 2-6 months, depending how quickly you move through the study units, and to what extent you lean on us to get support. Although everyone will be starting at different times and working through the units at their own rate, we are hopeful that most people will complete the program well within 6 months.

    Following completion of the trial, you will still be able to access the program units for up to 12 months, at no cost.

    Section 4. DISCOMFORTS AND RISKS

    While on the study, you may be at risk for some factors and this will vary from person to person.

    We know that psychological factors can play a part in chronic pain signalling, triggering and/or intensifying neurological activity which results in even the most agonizing pain. So it is usually necessary to examine those factors and try to resolve them. Some people may find this uncomfortable and are encouraged either to work with us on these issues, or engage with their own psychologist to do so.

    If you find the process distressing, you may choose to withdraw.

    Another issue which may occur but which we do our best to avoid, is the risk of stopping or decreasing medication without consultation with your doctor. Some medications cannot be abruptly decreased or ceased, and we urge you to never vary your medication without first consulting with your supervising physician.
    Finally, do not underestimate the significance of new pain which is different to your current pain, or in a different location. New or different symptoms should not be written off as just a part of old symptoms, and you should consult your doctor about those if they arise.

    Section 5. POTENTIAL BENEFITS

    Possible Benefits to You

    The possible benefit you may experience from the treatment program relates to decrease or elimination of your chronic pain, increased functionality, and increased enjoyment of life. However there is no such thing as a treatment which works for 100% of people, and there is no guarantee that you will benefit from taking part in this study.

    Likewise if you do not fully engage with the program, or complete the program, it is unlikely that there will be any significant benefit. This includes not doing the homework suggested, or not taking an active role in the support group/s.

    Possible Benefits to Other

    The results of this research may guide the future treatment of non-malignant chronic pain without sufficient explanatory pathology. Currently there is no treatment program which helps the majority of people, so there is strong potential here to bring relief to well over 1 billion people world wide.

    In addition medical science may gain further understanding of the nature of this type of chronic pain which in turn may drive future research directions.
    Finally, the economic cost of untreated pain may be significantly reduced, and the health system itself may be able to function much better than is currently the case.

    Section 6. STATEMENT OF CONFIDENTIALITY

    A description of this clinical trial will be available on https://www.sdrtherapy.com, https://www.lifeworkspainclinic.com, and https://www.researchgate.com It will be submitted for peer review and may be published in a science/medical journal. This will not include information that can identify you. A copy of the paper will be made available to all participants who complete the trial, and will be in the public domain for easy access.

    6.1 Privacy and Confidentiality Measures

    Your research records that are reviewed, stored, and analyzed at The Lifeworks Group Pty Ltd, will be kept in a secured area and/or will be stored electronically via encryption. No identifying information will be included in any resulting paper, and only raw data will ever be shared publicly.

    In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared.

    6.2 The Use of Private Health Information

    Health information about you will be collected if you choose to be part of this research study. This will consist of regular surveys of your pain levels, your medication use, your ability to function as you wish, and your quality of life.

    Because it is potentially unsafe to engage in therapy outside of the supervision of your doctor, part of your agreement relates to regular reporting to your doctor on your progress throughout the program. This is for your safety, particularly in relation to supervising medication, and refinement of the treatment protocol which your doctor is advising.

    Health information is protected by law. At Lifeworks Pain Clinic your information will only be used or shared as explained and authorized in this consent form or when required by law. It is possible that some of the other people or groups who receive your health information may not be required by Federal privacy laws to protect your information and may share it without your permission. For example if your condition is being case managed by a number of health professionals, it is possible that they may discuss the information provided to them in order to support you to get the greatest benefit possible.

    To participate in this research you must allow the study team to use your health information. If you do not want us to use your protected health information, you may not participate in this study.

    Your permission for the use, retention, and sharing of your identifiable health information will expire upon publication of a paper at 2-year follow up, and at that time all identifying information will be destroyed. However the raw data from the trial will be retained, as this may be highly useful to other researchers who wish to examine the accuracy of our analyses, and/or decide upon direction of future studies.

    If you choose to participate, you are free to withdraw your permission for the use and sharing of your health information at any time. You must do this in writing. Write to the Director of Clinical Studies, Christine Sutherland, at office@lifeworks-group.com.au and let her know that you are withdrawing from the research study. You are not required to give a reason and you will be treated with courtesy and respect.

    If you withdraw your permission:

     We will no longer use or share medical information about you for this research study, except when the law allows us to do so
     We are unable to take back anything we have already done or any information we have already shared with your permission
     We may continue using and sharing the information obtained prior to your withdrawal if it is necessary for the soundness of the overall research
     We will keep our records of the care that we provided to you as long as the law requires.

    Your doctor or pain support team (eg physiotherapist, occupational therapist, psychologist, and others) may use your health information and share it amongst themselves in order to serve you better.

    Section 7. COMPENSATION FOR PARTICIPATION

    There is no cost of participation in this study, and you will not receive any compensation for being in this study.

    Section 8. RESEARCH FUNDING

    The institution and investigators are not in receipt of any grants to support this research.

    Section 9. VOLUNTARY PARTICIPATION

    Taking part in this research study is voluntary. If you choose to take part in this research, your major responsibilities will include conscientiously working through the online study units, completing surveys when asked (pre-trial, at approximately 1 months, then at 6, 12 and 24 months), and conscientiously taking part in support groups and completing the homework assignments.

    You do not have to participate in this research. If you choose to take part, you have the right to stop at any time. If you decide not to participate or if you decide to stop taking part in the research at a later date, there will be no penalty or loss of benefits to which you are otherwise entitled.

    Your investigator may take you out of the research study without your permission. Some possible reasons for this are: not engaging with the program, not completing surveys, not working with the support group. The reason for this is that it would not allow us to determine whether or not SDR Therapy is useful for chronic pain if we were to mix together results of people who did the program, with people who did not do the program.

    However, even though you may not be in the study, your access to the program may continue at the discretion of the Director of Clinical Studies, at no cost to you.

    Section 10. CONTACT INFORMATION FOR QUESTIONS OR CONCERNS

    You have the right to ask any questions you may have about this research. If you have questions, complaints, or concerns or believe you may have experienced some harm related to this research, contact Christine Sutherland at office@lifeworks-group.com.au.

    FORMAL CONSENT/PERMISSION TO BE IN THE RESEARCH

    Before making the decision regarding enrollment in this research, you should have:

     Reviewed the information in this form
     Had the opportunity to ask any questions you may have.

    By Completing your information below, and clicking “I consent” you affirm that you have received this information, have asked the questions you currently have about the research, and have received answers to those questions. You are encouraged to print a copy of this completed form for future reference.

    I consent to being a participant in this research and confirm that I have read through and agree with all of the conditions described in this consent form. I recognise that my participation in this study is voluntary and that I may withdraw this consent at any time without reason, and without penalty.

    I have read through and understand this consent form:

    I consent to being a participant in this study: