Participants needed - research study looking at the differences in lower back of a wide range of people: an ultrasound study.

Aim of research study: The aim of this project is to look at changes that occur in the lower back of people with and without lower back pain.

Background information: Researchers have studied the causes of back pain for many years. The joints in the spine are known to play a part; however, more recent research has shown that other areas of the lower back may also be important. In fact, it may be the stuff that joins muscles and bones together, which is known as connective tissue or fascia, changes over time and these changes may lead to pain in some people. The aim of this project is to look at these changes in people at different stages of their lives.

What does the project involve?
We want to look at people who suffer or have suffered from back pain, and those that don’t. This is why you are being asked to take part.
We’re going to take pictures of the lower back by using ultrasound. Most people have heard of ultrasound because it is used in pregnancy as a quick, safe and painless way of looking inside the body.

What do I have to do?
You will be invited for a 1 hour session at a time convenient for you at either the University of Kent Sports Clinic at Medway Park, Mill Road, Gillingham, Kent or another suitable venue, for an ultrasound scan.

• Before you have your ultrasound scan you will be asked to complete a questionnaire about your general health, activity levels, and if applicable, your lower back pain.

• A member of the research team will measure your height, weight and waist circumference.
• You will then partially undress to uncover your lower back, and lie down on a couch. A water-based gel will be used to help the scanner move about.

• A series of ultrasound pictures will be taken.

It is important to note that no diagnosis will be made. However, if you have concerns about your lower back, we are able to refer you to suitable health practitioners. We also provide sources for further information about lower back pain at the end of this leaflet.

Who can be included in this project?
• If you are over 18 years of age , both men and women.
• If you have no lower back pain
• If you currently have, or have had lower back pain in the last 12 months
Who cannot take part?
• If you have a serious infection, you will have to wait 2 weeks before taking part
• If you have had a previous severe back or leg injury, or surgery on your back
• If you have a spinal deformity, ankylosing spondylitis, or rheumatoid arthritis in any part of your body
• If you ever had a spinal fracture, a tumour in your back, or an infection around your spine
• If you ever had nerve root compression or spinal disc damage
• If you have cancer
• If you have a bleeding disorder, for example, haemophilia. Or if you take Warfarin or similar blood thinning medication
• If you take corticosteroid medication, e.g. Prednisolone. Or high doses of inhaled steroids. Or if you have injections in your lower back
• If you are pregnant, or are planning pregnancy

Are there any risks?
• Ultrasound is a safe non-invasive method to take pictures.
• You will not be exposed to any harmful radiation.
• Ultrasound consists of low frequency sound waves, which create a picture, it poses no harm
• This is the same technology used to scan unborn babies. It is used in many other areas of medicine as well.

If I decide to take part in the project, can I change my mind?
• Yes, you can change your mind and withdraw from the project, without providing a reason, at any time.

How does taking part affect my usual health or back care?
• You can have any treatment or care you have for your back. Continue to take any medication as normal. Taking part in this project will not affect your normal care; you can continue visits to your doctor, or any other healthcare practitioner.
Will I know the results of this project?
• We can send you a summary of the results when the study is completed. If you wish to receive this, please indicate this on the consent form.

Will the information be confidential?
• All data will be kept in accordance with the Data Protection Act 2003. All ultrasound scans will be coded, no names will appear on the images. All data will be stored in a locked filing cabinet at the University of Kent, and can only be accessed by the main researcher. The aim is to publish the project, however, no identifiable details will be made public.

How can I take part?
• If you would like to take part, either:

• email the researcher Kyra De Coninck, please include your name and contact phone number K.De-Coninck@kent.ac.uk

• or call Kyra on 01634 88 88 09 (answerphone, please leave a message with your name and number)

• A member of the research team will contact you to arrange a suitable time for your ultrasound scan.

Who is in the research team?
Researcher: Kyra De Coninck

Kyra is a lecturer in Sports Therapy, at the Centre for Sports Studies at the University of Kent. Kyra has also worked as a sports massage therapist for more than 15 years. She is particularly interested in differences in the lower back of a wide range of people. This project is part of her PhD research, investigating changes in connective tissue in a wide range of people. Kyra has undergone training in musculoskeletal ultrasound imaging at the Centre for Ultrasound Studies, at the Anglo-European College of Chiropractic.

PhD Supervisor: Prof Louis Passfield
Professor Passfield is the Director of the Centre for Sports Studies at the University of Kent. He is Kyra’s main supervisor.

This study has been approved by the Centre for Sports Studies Research Ethics Committee.

Address for ultrasound scan by prior appointment with the main researcher:
University of Kent Sports Clinic
Medway Park
Mill Road
Gillingham, Kent ME7 1HF
Directions:
http://www.medwaypark.org.uk/medway_park/map_directions/

Sources of information about back pain:
NHS website:
http://www.nhs.uk/conditions/back-pain/Pages/Introduction.aspx

BackCare, a charity for people with back pain
http://www.backcare.org.uk

Information on being involved in research:
A public information booklet produced by Involve, a national advisory group on good practice in research
http://www.invo.org.uk/pdfs/PIP1whatisitallabout.pdf

If you are unsure about eligibility or have further questions about this project , please contact Kyra De Coninck, the main researcher.

Email K.De-Coninck@kent.ac.uk Phone: 01634 88 88 09