Frequently asked questions:

What is the purpose of the study?

The aim of the study is to test the effectiveness of an early intervention pain rehabilitation programme called Pain Disability Prevention Programme (PDP).  This programme aims to help patients with back pain to increase their level of activity and reduce their level of long term disability.  We want to test the effectiveness of the programme.  We will do this by comparing two groups of patients: one group who receive their usual medical care plus the PDP intervention (Intervention Condition) and another group who receive medical care as usual only (Control Condition).

What will happen if I take part?

If you agree to participate, you will be requested to read an information leaflet and consent form given to you by your GP.  If you agree to take part you will then be asked to complete a questionnaire.  This questionnaire will be posted to you at home.  This will take about 20 minutes to complete.  After you have returned the questionnaire you will be contacted by the researcher to let you know if you are suitable to take part in the study.  Your suitability will be based on your particular level of disability.  This is a randomised trial which means that if you are suitable to take part in the research, you will be randomly assigned to one of two conditions: the intervention condition or the control condition.    

What happens if I am part of the intervention condition?

If you are assigned to the intervention condition you will take part in the Pain Disability Prevention Programme.  The effectiveness of this intervention is being trialled as part of this research study.  It will involve a maximum of 10 weekly one-to-one meeting with the psychologist who is trained in pain management.  These meetings will last 1 hour and will take place locally.  They will help you to increase your level of physical activity and reduce your worry over re-injury by gradually increasing your activity at a pace you feel comfortable with.  You will still receive your medical care as usual and you are free to access additional services if you wish (e.g. private physiotherapy etc).  You will be asked to complete a questionnaire booklet at the end of the 10 week programme.  You will also be sent another questionnaire after 12 months.  These questionnaires will take about 20 minutes to complete.

What happens if I am part of the control condition?

If you are assigned to the control condition you will not receive the Pain Disability Prevention Programme.  No aspect of your usual care will be affected.  You will be asked to complete a questionnaire after 10 weeks and again after 12 months.   These questionnaires will take about 20 minutes to complete.  This comparison information will help us decide if the intervention is effective for people with pain. 

What are the possible benefits of taking part?

If you are part of the intervention condition you will have the opportunity to have a maximum of 10 one-to-one sessions with a psychologist trained in pain rehabilitation.  This will be provided free of charge and will take place over the course of 10-14 weeks.  This may help you to structure your activities and improve your level of activity. 

If you are part of the control condition you will not benefit directly from taking part in this study.  However the information we will obtain may provide further knowledge of the effectiveness of this programme for people with pain.   

Do I have to take part?

Your participation is entirely voluntary. 

If you decide not to participate in this study your treatment will not be affected in any way. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect your rights in any way.  Furthermore your doctor may decide to withdraw you from this study if he/she feels it is in your best interest. 

What happens at the end of the study?

At the end of the intervention (or after 10 weeks, if you were in the Treatment as Usual group) you will be asked to complete another questionnaire booklet.  This will take about 20mins to complete.  This questionnaire measures your feelings now and in the recent past.  You might find that while you are answering them you would like to talk to someone about the issues raised.  We would be happy to recommend someone to you. 

Has ethical approval been granted for the study?

Yes.  Ethical approval has been granted by the research Ethics Committee at NUI Galway & each of the participating HSE regional ethics boards.  All methods of approaching patients and dealing with confidential information are in accordance with best practice guidelines outlined by the UK Medical Research Council, the Irish Data Protection Commission and the NUI Galway Ethics committee

Is the information I give treated confidentially? 

All information collected about you during the course of the study will be kept strictly confidential and will not be shared with anyone else.  All participants will be assigned a study ID number so all data will be stored anonymously.  All individual patient data will be stored securely and will only be accessed by a member of the research team.

Whom do I contact for more information or if I have further concerns?

If you would like to discuss any aspect of the study further please contact Ms Miriam Raftery, Researcher, miriam.rafterynuigalway.ie Ph: 091 - 495830 or the Principal Investigator: Dr. Brian McGuire: brian.mcguirenuigalway.ie Ph: 091- 492954

• Disclaimer
• Privacy
• Copyright
• Accessibility