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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Northwestern University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sympathetic nerve block of bupivacaine | Active Comparator | Sympathetic nerve block of bupivacaine |
|
| Dry needling at the sympathetic ganglion | Placebo Comparator | Placebo/ Dry needling at the sympathetic ganglion |
|
| Neuroma injection of bupivacaine | Active Comparator | Neuroma injection of bupivacaine |
|
| dry needling at the neuroma | Placebo Comparator | Placebo/ dry needling at the neuroma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | one injection of 10ml of .25% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain | Pain rating before and after injection on a 0-10 NRS pain scale (0=no pain, 10= worst pain imaginable) | Pain rating before and at 15 minutes and 1 hour post injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perceived Disability (PDI) | The PDI is a seven-item validated instrument that assesses perceived disability in 7 key life areas. The Pain Disability Scale is a scale from 0-70 where 0= no disability and 70=the most disability | PDI collected pre injection and 1 week post injection |
| Change in Perceived Anxiety (PASS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norman Harden, M.D. | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States |
Subjects were not assigned to an arm until Visit 2 (randomization).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sympathetic Nerve Block of Bupivacaine | |
| FG001 | Dry Needling at Sympathetic Ganglion | |
| FG002 | Neuroma Injection of Bupivacaine | |
| FG003 | Dry Needling at the Neuroma |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sympathetic Nerve Block of Bupivacaine | |
| BG001 | Dry Needling at Sympathetic Ganglion | |
| BG002 | Neuroma Injection of Bupivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain | Pain rating before and after injection on a 0-10 NRS pain scale (0=no pain, 10= worst pain imaginable) | all available data was analyzed (some subjects did not complete all outcomes) | Posted | Mean | Standard Deviation | units on a scale | Pain rating before and at 15 minutes and 1 hour post injection |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/Sham Injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Center for Pain Studies | Rehabilitation Institute of Chicago | 312.238.5654 | centerforpainstudies@ric.org |
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| ID | Term |
|---|---|
| D009463 | Neuroma |
| ID | Term |
|---|---|
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo | Drug | Dry needling |
|
|
The Pain Anxitey Symptoms Scale (PASS) is a validated instrument that assesses anxiety in.The PASS is a scale from 0-100 where 0= no anxiety and 100=the most anxiety |
| PASS collected pre injection and 1 week post injection |
| Change in Depression (CES-D 10) | The Center for Epidemiologic Studies Short Depression Scale (CES-D 10) is a validated instrument that assesses depression. The CES-D 10 is a scale from 0-30 where 0= no depression and 30=the most depression | CES-D 10 collected pre injection and 1 week post injection |
| Pain Visual Analogue Scale (VAS) | The Pain Visual Analogue Scale (VAS) is a scale from 0-100 where 0= no pain and 100=the worst pain | VAS collected pre injection and 1 week post injection |
| BG003 | Dry Needling at the Neuroma |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Bupivacaine: one injection of 10ml of .25% |
| OG003 | Dry Needling at the Neuroma | Placebo: Dry needling |
|
|
| Secondary | Change in Perceived Disability (PDI) | The PDI is a seven-item validated instrument that assesses perceived disability in 7 key life areas. The Pain Disability Scale is a scale from 0-70 where 0= no disability and 70=the most disability | all available data was analyzed (some subjects did not complete all outcomes) | Posted | Mean | Standard Deviation | units on a scale | PDI collected pre injection and 1 week post injection |
|
|
|
| Secondary | Change in Perceived Anxiety (PASS) | The Pain Anxitey Symptoms Scale (PASS) is a validated instrument that assesses anxiety in.The PASS is a scale from 0-100 where 0= no anxiety and 100=the most anxiety | all available data was analyzed (some subjects did not complete all outcomes) | Posted | Mean | Standard Deviation | units on a scale | PASS collected pre injection and 1 week post injection |
|
|
|
| Secondary | Change in Depression (CES-D 10) | The Center for Epidemiologic Studies Short Depression Scale (CES-D 10) is a validated instrument that assesses depression. The CES-D 10 is a scale from 0-30 where 0= no depression and 30=the most depression | all available data was analyzed (some subjects did not complete all outcomes) | Posted | Mean | Standard Deviation | units on a scale | CES-D 10 collected pre injection and 1 week post injection |
|
|
|
| Secondary | Pain Visual Analogue Scale (VAS) | The Pain Visual Analogue Scale (VAS) is a scale from 0-100 where 0= no pain and 100=the worst pain | all available data was analyzed (some subjects did not complete all outcomes) | Posted | Mean | Standard Deviation | units on a scale | VAS collected pre injection and 1 week post injection |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Treatment Group | 0 | 9 | 0 | 9 |
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| D000588 |
| Amines |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| Change in VAS-Residual Limb Pain |
|