Appendix 15: LPC Website
The Painful Channelopathies Study is an initiative of the Wellcome Trust
funded LONDON PAIN CONSORTIUM to try to understand the mechanisms
of pain in genetically determined conditions.
You are being invited to take part in a research study. Before you decide, it is important for you to
understand why the research is being done and what it will involve. Please take time to read the
following information carefully and discuss it with others if you wish.
What is the purpose of this study?
You have been invited to take part in this study because you either experience increased or reduced
pain which may have unusual characteristics and could be an inherited condition. Little is currently
known about the characteristics of sensory disturbance and brain activation responses in patients
with inherited pain syndromes. These can cause either increased or reduced sensation of pain in
affected individuals. Some such pain syndromes have been classified and given names such as:




Erythromelalgia,
Paroxysmal extreme pain disorder,
Familial episodic pain syndrome and
Congenital insensitivity to pain.
There are other pain syndromes that have not been clearly classified.
This study is designed to better understand what causes these changes in sensation and the
consequences of such changes for patients. This will include investigation of the specific genetic
changes associated with inherited pain syndromes as well as the changes in sensory processing and
brain activity. The study involves you filling in questionnaires, undergoing detailed neurologic and
sensory testing of your skin, the taking of a small skin biopsy, a blood sample and a magnetic
resonance scanning of the brain.
Does this study concern me?
If you have an alteration in pain sensation and there is a possibility that this may be genetic as the
same condition has affected previously other of your family members, you may consider to
participate in this study.
What will happen to me if I take part?
If you are interested in taking part in the study, an appointment with a researcher will be made at a
time convenient for you. The study is completed in 1 or 2 appointments:
 Guy’s Hospital Campus, London (How to get there: http://goo.gl/maps/Chy0f ).
 FMRIB Centre at the John Radcliffe Hospital, Oxford (How to get there:
http://goo.gl/maps/uNT2t ).
Appendix 15: LPC Website
During these appointments you will be able to ask any further questions that you may have
regarding the study. We will also check if you are eligible for the study. If you wish to take part in
the study, you will be asked to sign a consent form and given:
1. Questionnaires:

A simple diary in which we would like you to record your daily (if any) pain twice a day for
7 days.

A questionnaire about you, your past medical history, medications you are or have been
taking,

5 questionnaires, which will take approximately 1 hour to complete will ask you about the
impact of any pain you have, has on your mood, sleep and quality of life.
2. Blood Sample:
We will take a blood sample. DNA will be extracted for genetic studies and this sample will be
stored in locked freezers located at King’s College London and University College London. Genetic
analyses will be strictly restricted to causes of altered pain sensation, all samples will not have your
name, address or any other label from which you could be identified. In the future as new genes are
discovered we may collaborate with other research groups around the world which may involve
sending these anonymised research samples to other laboratories.
Because these tests are performed on a research basis and can’t yet predict the risk of developing
pain on an individual basis you will not receive these results.
In certain clinical conditions genetic testing is available as a clinical service in which case we will
inform you of where this service is if you would like to consider formal genetic testing.
In addition during the research appointment a researcher will review your medical notes. These
details will remain anonymous all the time and will not be shared under any circumstances.
3. General Neurological Examination:
We will examine you clinically for muscle strength, reflexes and changes in your skin’s ability to feel
different stimules in your arms and legs. We will also measure your weight, height, and blood
pressure.
4. Quantitative Sensory Testing of both feet:
This is a more detailed method of testing the function of the small sensory nerve fibres in your skin,
which detect changes in temperature, pressure, sharpness and touch. It is in routine diagnostic use
in our clinic.
Your ability to sense changes in temperature is determined using a small probe applied to your skin
which changes temperature, i.e. becomes cool or warm. You will be asked to say when you can feel
any change.
Appendix 15: LPC Website
Your ability to detect light touch is determined using very fine filaments, again you will be asked to
say when you can feel them.
For sharpness a small probe designed not to puncture the skin, is applied to your skin. You are
asked to say when it begins to feel sharp.
A blunt pressure gauge is used to apply pressure. You will be asked to say when the pressure just
begins to become uncomfortable.
We will also lightly touch a small area of your skin with a Q-tip, cotton wool, a paint brush and a
tuning fork and ask you to describe the sensation that you experience.
Some of these tests may cause slight discomfort, however you will be able to stop at any point if you
are not happy.
5. Skin Biopsy:
You can still be included in the study if you decline this investigation (a picture of skin
biopsy).
A very small: 3 or 4 mm (~1/10 inch) circular piece of skin (skin biopsy) will be taken. A single
suture may be required following the procedure. The sites from which the skin biopsy is likely to be
taken are the lower leg, the arm or the scalp. A small plaster will be applied and an ointment will be
provided to keep it clean afterwards. Sometimes a small suture is needed in which case you can
either attend your GP to have it removed or you can also come to us. This procedure is routine
practice in dermatology clinics and is being increasingly used in pain and neurology clinics. We are
highly experienced in this technique. There is a low risk of infection, scarring and reduced hair
growth at the site of the biopsy. Healing usually occurs in 7-10 days.
This skin biopsy will then be examined under a microscope to determine the degree of small nerve
fibre damage (if present) in your skin. We will also keep the remaining unused tissue in a locked
freezer at King’s College London for future biochemical analysis investigating channelopathies and
pain. In some cases cells will be extracted from the skin biopsy and grown in the laboratory prior to
being stored in a locked freezer. They will be studied in the future to try and understand how
genetic changes in cells cause altered pain sensation. To study theses cells they may be transferred
to collaborators at other institutions outside of King’s College London such as Newcastle University.
The samples will not have your name, address or any other label from which you could be
identified.
6. Magnetic Resonance Scanning:
You can still be included in the study if you decline this investigation.
This procedure is called functional magnetic resonance imaging (FMRI). This is a safe technique
that is performed routinely and allows an insight in the brain processing of stimuli. This method is a
safe and non-invasive technique and does not carry radiation risks. MRI scans will be carried out by
trained MR technicians at the FMRIB centre of the University of Oxford (www.fmrib.ox.ac.uk).
Appendix 15: LPC Website
During the experimental acquisition of data, the skin temperature of the patients may be externally
adjusted to trigger some features of pain crisis or to provide relief, temperature changes can range
from 5°C to 40°C. This method accompanied by the real time scanning of cerebral responses will
provide invaluable information about the determination of the origins of pain.
The procedure is extremely safe, and only causes mild discomfort.
You are also able to take breaks, for whatever reason, at any point during the study if you
wish.
What are the possible disadvantages and risks of taking part?
The main disadvantage is that you will need to give up some of your time to take part. Another
disadvantage is that you will be required to travel to one of the study sites (either King’s College
London, London or John Radcliffe Hospital, Oxford) for an appointment. We will reimburse your
travelling expenses if required.
What are the possible benefits of taking part?
We cannot promise the study will help you, but the information we get might help improve the
treatment of people with altered pain sensation. We will get more information about how your
sensory nervous system works and if you are in agreement we will send information about the skin
biopsy analysis and the quantitative sensory testing to your doctor.
At the end of the study we hope to:
1. Identify the specific impact of different aspects/ components of pain on quality of life and
psychological well being.
2. Find the brain areas involved in the central processing of pain.
3. Our hope is that through a greater understanding of the genetic changes causing these
conditions and the effects that they have on the processing of sensation we will be able to
develop better treatments for pain in the future.
Will my taking part in this study be kept confidential?
All information that is collected about you during the course of the research will be kept strictly
confidential. We will store data from these studies into research sites computers for analysis and
also include it in computer databases which are used to store and analyse data about
channelopathies and pain; these are the Wolfson CARD, King’s College London, the Wolfson
Institute for Biomedical Research at University College London and the FMRIB at John Radcliffe
Hospital, Oxford University. By comparing the information from this research with that from other
studies we will be able to learn more about these conditions.
Contact for Further Information:
Appendix 15: LPC Website
For further information regarding this study please contact:
Dr Juan D Ramirez Rozo
Tel 07902 114851- 02078486184 or email:
juan.ramirez-rozo@kcl.ac.uk