Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04256603 |
| Other study ID # |
IRB19-00117 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
April 1, 2020 |
Study information
| Verified date |
November 2021 |
| Source |
MetroHealth Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Neuropathic pain is a common complaint in those with spinal cord injury (SCI) that has a
significant negative effect on quality of life. Efficacy of various treatments, however,
remains controversial. There is evidence to support that gabapentin and pregabalin have some
benefit in reducing neuropathic pain. Gabapentin is effective in the management of symptoms
and concerns related to SCI including motor recovery, spasticity, and mood among others. This
makes gabapentin an important pharmacologic intervention, which compels providers to define
treatment guidelines related to its use. One aspect of which should relate to the timing of
initiation of therapy. The goal of this study is to determine whether timing of initiation of
treatment with gabapentin will decrease prevalence and intensity of neuropathic pain.
Description:
Neuropathic pain is a common complaint in those with spinal cord injury (SCI) that has a
significant negative effect on quality of life. This makes the treatment of neuropathic pain
a priority in the SCI population. Efficacy of various treatments, however, remains
controversial. There is evidence to support that gabapentin and pregabalin have some benefit
in reducing neuropathic pain. Other positive effects of gabapentin on those with SCI have
also been demonstrated. However, there has not been a study on the influence of timing of
initiation of gabapentin on the efficacy of using it to treat neuropathic pain in the SCI
population. Such a finding could change the standard of care in treatment of acute SCI.
The pooled prevalence of neuropathic pain post spinal cord injury is 53%. Not only common,
neuropathic pain is pervasive, affecting aspects of patients' lives including sleep, physical
function, and mood that in turn impact their activities- work and recreational alike. Thus,
neuropathic pain management contributes to quality of life for a majority of people with SCI.
Although a high priority, the treatment of neuropathic pain in SCI remains notoriously
difficult. Treatments options may be divided into pharmacologic and non-pharmacologic.
Pharmacologic agents studied include amitriptyline, gabapentin, pregabalin, opiates,
lidocaine, ketamine, valproate, lamotrigine, levetiracetam and carbamazepine; the most
studied of which are amitriptyline, gabapentin, and pregabalin.
Gabapentin's potential is not limited to neuropathic pain management, making it a
particularly compelling treatment option in the population with acute SCI. Gabapentin leads
to improvement in total motor scores, reduced spasticity, reduced autonomic dysreflexia, and
improved mood. Animal models suggest it may be neuroprotective in the acute phase of injury.
In those who undergo spine surgery, regardless of presence of SCI, gabapentin given
perioperatively leads to reduced opiate use and decreased pain in post-operative period.
Additionally, when compared to narcotic alternatives, gabapentin has minimal side effects.
Neuropathic pain in SCI is common, impactful, and difficult to treat. Gabapentin is effective
in the management of symptoms and concerns related to SCI including motor recovery,
spasticity, and mood among others. This makes gabapentin an important pharmacologic
intervention, which compels providers to define treatment guidelines related to its use. One
aspect of which should relate to the timing of initiation of therapy. The goal of this study
is to determine whether early initiation of treatment with gabapentin will decrease average
pain scores and opiate use when comparted to late initiation of treatment with gabapentin in
the population with acute SCI. Gabapentin, although used commonly, is not started in all
patients with acute SCI but is often started at the onset of neuropathic pain. If gabapentin
is found to be more effective when initiated early, it would be reasonable to start
gabapentin immediately following acute SCI in all patients in whom it is not otherwise
contraindicated.
