This study will examine the effectiveness of the drug neurotropin in treating chronic pain
after injury to a limb or a large nerve.
Two groups of patients will participate in this study: patients with complex regional pain
syndrome type 1, or CRPS-I (also called reflex sympathetic dystrophy) and patients with
complex regional pain syndrome type 2, or CRPS-II. CRPS-I is pain that develops after
relatively minor injury to an arm or leg, but lasts much longer and is much more severe than
would normally be expected. CRPS-II is pain resulting from injury to a large nerve.
Candidates will have a history and physical examination, blood tests, and electrocardiogram.
Participants will undergo the following tests and procedures:
Patients with CRPS I and II will receive an individualized regimen of physical therapy and
standard treatment to control their pain. In addition, they will receive neurotropin or
placebo tablets for 5 weeks, then no trial medicine for at least 1 week, and then the other
trial drug for the next 5 weeks. That is, patients who took placebo the first 5 weeks will
take neurotropin the second 5 weeks and vice versa. Neither the patients nor the doctors will
know who received which drug during the two intervals until the study is over. Patients will
complete questionnaires about their pain, quality of life, and ability to perform daily
living activities. They will have various tests to measure pain (such as sensitivity to heat
and cold, to an electric current, to a mild pin prick, etc.); to provide information about
changes in their condition (such as tests of range of motion of joints and limb size); to
measure blood circulation and sweating in the arm or leg (such as measurements of blood flow
to the limb, skin temperature, and sweat production), and other procedures.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Nursing Research (NINR)
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Neurological Disorders and Stroke (NINDS) National Institutes of Health Clinical Center (CC)