Pain Clinical Trial
Official title:
Evaluation and Treatment of Pain (Training Protocol)
This study offers evaluation and treatment for patients with a spectrum of acute and chronic
pain syndromes. The protocol is not designed to test new treatments; rather, patients will
receive current standard of care treatments. The purposes of the study are: 1) to allow
physicians in NIDCR's Pain and Neurosensory Mechanisms Branch to gain more knowledge about
treating acute and chronic pain and possibly identify new avenues of research in this area;
and 2) to establish a pool of patients who may be eligible for new studies as they are
developed. (Participants in this protocol will not be required to join a new study; the
decision will be voluntary.)
Patients 12 years of age and older with an acute or chronic pain syndrome may be eligible for
this study. Women of childbearing potential and women who are pregnant or breastfeeding will
not be enrolled in this study, drugs may have unknown or untoward side effects on the baby.
Participants will provide a medical history, as well as occupational and social information.
They will have a standard neurological examination, including a test of cognitive (thinking)
abilities, muscular function, reflexes and sensory examination. The latter involves testing
with a pin placed on the surface of the skin. Participants will also have routine blood tests
and will fill out questionnaires on their daily functioning and psychological well being.
Additional procedures may include magnetic resonance imaging (MRI) scans and possible
referral to a psychiatrist for evaluation of depression or emotional difficulties.
Participants will be treated according to their individual pain problem. Treatments may
include medicines, exercises, physical therapy, nerve blocks and dietary changes. Medicines
given in this study are commonly used by doctors to treat pain, but for many, there is little
research to back up their use. This study will provide information on the effectiveness of
these treatments. Participants will keep a daily log in which they rate their pain, record
any procedures they undergo outside the study, such as injections and exercises, and record
medication side effects.
Participation in the study will end based on the researcher's assessment of the patient's
response to treatment. The study doctor will provide the patient's referring doctor a report
of medications or other treatments used in the study. At the last visit, patients will fill
out the same questionnaires they filled out during the first visit.
The function of this protocol is to allow the clinic pain research fellows to gain additional
knowledge in the management of acute and chronic pain. Patients enrolled in this protocol
will be evaluated and treated according to available procedures and therapeutic modalities
used in clinical practice. The evaluation and treatment of these patients may lead to ideas
for future protocols.
By allowing for the care of persons with a spectrum of pain syndromes, this protocol will be
valuable for the training of the pain fellow as well. The pain group at the NIDCR is free to
choose those diseases that interest them.
Patients in this patient evaluation and treatment protocol will be evaluated for potential
eligibility in any of the new clinical studies of the Pain and Neurosensory Mechanisms branch
of the NIDCR as they are developed. If eligible, patients may be asked to participate in the
new protocol. However they will not be required to enter any new protocol and their decision
to participate will be entirely voluntary.
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