Pathophysiology of Post Amputation Pain (PPAP)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Pathophysiology of Post Amputation Pain|
- Change in Electronic Pain Diary Ratings [ Time Frame: Ratings 3 times a day for 5 weeks ] [ Designated as safety issue: No ]A time series analysis will be utilized to compare the change in pain diary 0-10 numeric ratings before and after the injection.
- Quantitative Sensory Testing [ Time Frame: Visit 1 (Week 0), Visit 2 (Week 1), and Visit 3 (Week 5) ] [ Designated as safety issue: No ]To test whether the afferent response in the residual limb is dysfunctional in patients with PAP, we will compare the residual limb to the contra-lateral (non-amputated) limb on responses to Quantitative Sensory Testing stimuli. QST results in the residual limbs will be compared to the intact limbs for all patients with within-subject t-tests.
- fMRI Imaging [ Time Frame: Visit 2 (Week 1) ] [ Designated as safety issue: No ]fMRI images will be taken to assess activity related with post-amputation pain in the orbital frontal cortex, insula, anterior cingulated cortex, amygdala, and hypothalamus. Within-subject and between group comparisons will be conducted to identify patterns.
- Infrared telethermography [ Time Frame: Visit 1(Week 0), Visit 2(Week 1), and Visit 3 (Week 5) ] [ Designated as safety issue: No ]To test whether some patients with post-amputation pain exhibit dysfunctional activity, spontaneous temperatures in the residual limb versus the contralateral intact limb will first be recorded with infrared telethermography. Temperatures will then be assesed after provacative testing. Temperatures in the residual limbs will be compared to temperatures in the intact limbs for all patients using within subject t-tests.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Sympathetic nerve block of bupivacaine||
one injection of 10ml of .25%
|Placebo Comparator: Dry needling||
|Active Comparator: Neuroma injection of bupivacaine||
one injection of 10ml of .25%
|Placebo Comparator: dry needling at the neuroma||
Your participation in this study will last for 5 weeks and you will be asked to come to a total of 3 visits. The first visit will be during the first week of the study, the second visit during the second week of the study and the third (final) visit will be during the fifth (and final) week of the study. For your first visit you will have a physical examination with some sensory stimulation tests (such as vibration and pinprick tests), some questionnaires about your health and pain history, hot and cold sensory tests, and we will take thermal pictures of your body before and after receiving a quick electrical stimulus. You will also be trained on how to use the finger-span device to rate your pain during the second visit, and how to use an electronic pain diary to record your pain scores three times a day during the five weeks of the study.
The second visit will begin with questionnaires from the first visit and thermal images with a quick electrical stimulus. You will then be brought to an fMRI scanner room at Northwestern University. For an hour and fifteen minutes we will take pictures of your brain and these pictures will help us understand the changes in your brain relating to pain. You will then be put into one of four treatment groups randomly.
The study treatment that you will get will be decided randomly or by chance, like flipping a coin. Injections in this study will use the local anesthetic bupivacaine (a long lasting drug like the numbing agent novocaine used by dentists). This drug causes numbness, blocks pain and other nerve function near the injection site for 6-8 hours. Group 1 will get a sympathetic nerve block of bupivacaine, which changes how your nerves transmit pain, in either the neck or lower back (depending on where the amputation is located), Group 2 will get a placebo injection (no active medicine) in either the neck or lower back (depending on where the amputation is located), Group 3 will get a neuroma injection of bupivacaine (a neuroma is a group of nerves at the end of your residual limb), and Group 4 will get a placebo injection (no active medicine) at the neuroma. Some people get the bupivacaine injection and some people get the placebo injection so that we can compare the groups and see if the bupivacaine brings more, less or the same pain relief as a placebo injection. We scan your brain before the injection so that we can see how your brain responds to pain. We also scan your brain after the injection so that we can see if your brain responds differently to pain after the injection has been done.
You will know the location of your injection before you receive the treatment (neck, lower back or neuroma on your affected limb), but you will not know if you are getting a pain medication injection or placebo injection. Only the study doctors will know this information, and it can be told to you in case of an emergency. After the injection, you will have a second hour of brain scanning. After the scanning, you will be asked to complete some questionnaires, sensory tests, hot and cold temperature testing and we will take thermal pictures of your body before and after a quick electrical stimulus.
Your third visit will be four weeks after your second visit. For your third visit you will have the same questionnaires as during the first and second visits, sensory tests, hot and cold temperature testing and we will take thermal pictures of your body before and after a quick electrical stimulus.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632709
|United States, Illinois|
|Rehabilitation Institute of Chicago|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Norman Harden, M.D.||Rehabilitation Institute of Chicago|