Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03030079 |
| Other study ID # |
16-1063 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2017 |
| Est. completion date |
June 28, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
University of Colorado, Denver |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this pilot study is to assess the effectiveness of an electrical stimulation
therapy option for the treatment of chronic phantom limb pain in upper or lower limb
amputees. This therapy has been previously used for sports and joint injuries and is marketed
for relaxation of muscle spasms, re-education of muscle action, prevention of disuse atrophy,
increased local blood circulation, and maintaining or increasing range of motion. The
investigators would like to explore the idea that physically exercising the muscles of the
residual limb and increasing blood flow to the site of amputation through the promotion of
motor contraction using electrical stimulation decreases chronic phantom limb pain.
Description:
There are a large number of people living with an amputation due mainly to cardiovascular
disease, diabetes, and trauma; and of these there is evidence to show that up to 80% of
amputees experience phantom limb pain (PLP). PLP is classified as cramping, burning,
shooting, or stabbing pain in the missing limb following an amputation. Current treatments
include pharmacological drugs, anesthesia, additional surgery, mirror therapy, transcutaneous
electrical nerve stimulation (TENS) and others. TENS, as usually implemented, has been used
to effectively reduce pain in multiple spots of the body, but has shown little effect in
reducing phantom limb pain especially long term even with varying the frequency and intensity
of the electrical stimulation. These current treatments can be invasive, costly, and have
shown only to offer immediate relief. Using an electrical stimulator at a higher intensity
has proven to to reduce pain and increase healing in numerous sports and joint related
injuries. Anecdotally, the investigators have learned that a similar treatment protocol when
applied to persons with phantom limb pain can mitigate their pain. The goal of this pilot
study is to assess the effectiveness of higher intensity electrical stimulation in the
management of PLP and also to acquire data to inform the investigators to the most
appropriate study design and power for a future more formal clinical trial. To accomplish
this the investigators will utilize the ACP Omnistim FX2 Pro electrical stimulator, that has
been provided to us by Accelerated Care Plus (ACP) Corporation, to physically exercise the
muscles of the residual limb and hence increase the local blood flow and explore it's
potential for treatment of PLP both short and long term. The self-identified subject will be
hooked up to the ACP electrical stimulator using surface electrodes that will pass a current
through the skin first at a low intensity for 5 minutes to allow the subject to adjust to the
tingling sensation. The current will then be gradually increased to a level sufficient to
elicit a non-painful motor contraction for 15 minutes. Using a numerical pain scale and short
answer questions about the characteristics of the pain the investigators will track both
short term and long term changes in pain.
