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Introduction to the Study:
We are inviting you to be in a research study for
people with chronic pain.
Purpose:
The purpose of this study is to see which parts of
the body are most commonly affected by chronic pain,
and what types of symptoms occur with chronic pain
in different parts of the body.
We hope to use what we learn from the study to help
in the diagnosis of the different causes of chronic
pain.
What Will Happen During the
Study:
1. We will ask you to fill in a questionnaire for
this study.
2. We will ask whether you have chronic pain (constant
or recurring pain lasting more than 30 days and causing
significant discomfort or limitation of activity)
in at least one part of your body.
3. We will ask about the types of symptoms associated
with your pain and about the extent to which the pain
affects your movement and ability to perform ordinary
activities of life.
4. For each part of the body where you have pain,
we will ask you to draw an outline of the pain area
on a human body diagram, and to mark the point inside
each outline where the pain is worst.
5. We will also ask you some additional questions
about your symptoms in the part of the body with the
pain that is most troublesome to you.
6. You will be informed of an additional eleven pain
questionnaires (at http://masterdocs.com/pain.htm)
that you can complete. These look more closely at
the following types of pain: Headache, Lower
Back/Sciatica Pain, Knee Pain, Shoulder Pain, Hip
Pain, Toothache, Jaw Pain/TMJ Pain, Chest Pain,
Peripheral Neuropathy Pain, Hand/Wrist/Carpal Tunnel
Pain, Find Your Pain Type (e.g., neuropathic or
musculoskeletal pain).
If you have any questions or concerns about being
in this study, you should contact Colin R. Taylor,
MD (who is in charge of this study) by email at crtaylor@masterdocs.com,
or by regular mail at TMT Inc, 196 E 75th Street (Suite
18A), New York, NY 10021, USA.
Please realize that we are not giving you any medical
advice, and that we will not pay you any money for
taking part in the study. We will give you the Internet
addresses of some reputable sites that provide medical
information to the public (for example, sites run
by the National Institutes of Health of the US government,
or by major medical schools) where you can read up
on those diagnoses if you wish to do so. In addition,
if you are eligible for the study, give informed consent
for the study, and return a completed pain questionnaire,
we will provide you with some more detailed information
on pain. However, please realize that the possible
diagnoses provided may not include the cause of your
own pain, and that a reliable diagnosis can only be
obtained by contacting your own health care provider.
Your Privacy is Important:
We will make every effort to protect your privacy.
We will not use your name or contact information in
any of the summaries, research documents or other
written, verbal or other material resulting from the
study.
Risks and Discomforts:
We do not know of any personal risk or discomfort
you will have from being in this study.
Your Rights:
You decide on your own whether or not you want to
be in this study.
If you decide to be in the study, you will have the
right to stop being in the study at any time.
This study has been approved by an Institutional Review
Board (IRB) constituted and operating according to
the US Code of Federal Regulations. In addition, this
study has a Confidentiality Certificate (CC) from
the US government that adds special protection for
the research information about you. It says we do
not have to identify you, even under a US court order
or US subpoena. Still, there may be rare circumstances
under which your identity might not be protected.
The CC does not mean the US government approves or
disapproves of our project. If you have questions or
concerns about participating as a study subject,
please contact IRC. They are the Institutional
Review Board that that reviewed this study. Their
email address is subject@irb-irc.com and phone
number is 800.472.3241.
By clicking the "Accept" button, you signify
that you have had the chance to ask any questions
you have about this study, and any such questions
have been answered for you. You have read the information
in this consent form, and you agree to be in the study.
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