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What is the purpose of the trial?
Professor Suzanne McDonough and her team are running a research trial which is investigating how well standard medical care works for people with low back pain. If you are receiving standard care from your GP for low back pain lasting at least three months, we would like to monitor your back pain to see how it changes as a result of treatment you receive from your GP.
Do I have to take part?
It is up to you to decide. When you contact us, we will describe the trial and go through an information sheet. We will then ask you to sign a consent form to show you have agreed to take part. You will be given this information sheet and a copy of the signed consent form to keep. You are free to withdraw at any time, without giving a reason. This would not affect the standard of care you receive.
What will happen to me if I take part?
The trial is based at the Centre for Rehabilitation Research at the University of Ulster and will last for 25 weeks, but you may only need to attend the treatment centre one time. If this is not acceptable to you, we are willing to visit your home to complete a short assessment. The flow diagram on the next page shows each stage of the trial and how long it is expected to last.
Travel costs to and from the Centre for Rehabilitation Research at the University of Ulster that are directly related to the trial will be reimbursed (£15 per visit). All postage will be pre-paid by the University.
What will I have to do?
You do not have to make any changes to your normal daily routine by taking part in this trial. You can continue taking any painkillers that you now take for your back pain. Any changes to the amount or type of painkillers that you take can be recorded in your daily activity log book. The research team will perform an initial assessment of you and then ask you to complete questionnaires related to your back pain on four occasions over a 25 week period. On three occasions, you will be asked to wear a small monitor called the activPAL for a period of seven days. This monitor will automatically collect information about your daily level of activity.
What are the side effects of any treatment received when taking part?
There is a small risk of injury if excessive force is applied to the front of the activPAL monitor. This will be minimised if due care is taken when wearing the activPAL.
What are the possible benefits of taking part?
You will receive baseline assessment for your low back pain from a chartered physiotherapist and will have the opportunity to learn more about your activity levels and how they change as a result of the current standard medical care you receive from your GP.
Will my taking part in this trial be kept confidential?
All information that is collected about you during the course of the trial will be kept strictly confidential, and will not be passed on to any third party.
What will happen to the results of the trial?
The results of the trial will be published in a scientific journal. You will not be identified in any publication. When the trial is complete, a letter will be sent to you to give you the main results.
Who has reviewed the study?
This study has been reviewed and given a favourable opinion by the Northern Ireland Office for Research Ethics Committees (ORECNI), the Research and Development Office for Northern Ireland, and the School of Health Sciences Internal Research Review Board at the University of Ulster.