Pathophysiology of Post Amputation Pain (NCT01632709) | Clinical Trial Compass
CompletedPhase 4
Pathophysiology of Post Amputation Pain
United States16 participantsStarted 2012-05
Plain-language summary
The purpose of this study is to see how Post Amputation Pain (PAP) affects the body and brain by using sensory testing (such as pinprick testing), taking pictures of your brain (using a functional magnetic resonance imaging (fMRI) machine) and biomedical interventions (such as an injection of pain medicine). All medicines and the fMRI machine used during this study are FDA approved. The investigators hope that by learning the causes of PAP, the investigators can help future amputees.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. At least 18 years old
ā. Able to read and speak English and provide informed consent
ā. Single Amputation, upper or lower.
ā. Subject has chronic post amputation pain lasting longer than three months
ā. Subject has healed amputation wounds
ā. Pain must be ā„3 on a scale of 0-10, 0 being no pain, 10 being the worse pain imaginable.
ā. If subjects pain is non-existent during fMRI scans, the subject needs to be willing to have their pain induced by targeting pain trigger points (for example, study's postdoctoral fellow would massage certain regions of the affected limb to trigger PAP).
ā. Subject agrees to 1) Stop taking all aspirin seven days prior to their second visit (Bayer,Ecotrin,Alka Seltzer, etc.) 2) All inflammatory medications 48 hours prior to their second visit (Advil, Motrin, Indocin, Lodine , Ibuprofen, Aleve, Naproxen, etc. 3) Supplements such as Vitamin E and Fish Oil 48 hours prior to their second visit.
Exclusion criteria
ā. Subject is allergic to Isovue 300 or amide-type local anesthetics such as bupivicaine, lidocaine, or mepivacaine.
ā. Subject has a diagnosis of bleeding diathesis or an immune compromise.
ā. Subject has pain that is more severe than their post amputation pain.
What they're measuring
1
Change in Pain
Timeframe: Pain rating before and at 15 minutes and 1 hour post injection
. Subject has a clinical diagnosis of fibromyalgia.
ā. Subject has metal shavings and or is frequently in an environment where there is metal work being done or significant amounts of metal shavings.
ā. Subject has ferrous metal implants, aneurism clips, bioelectric devices, and other implants which can be affected by the magnetic field of the MRI.