Spinal Cord InjuriesPhase 4NCT04256603
Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in SCI
A Phase 4 study testing Gabapentin and No gabapentin in people with Spinal Cord Injuries and Neuropathic Pain, run by MetroHealth Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neuropathic Pain
- What is being tested?
- Gabapentin and No gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Apr 2020
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute spinal cord injury
- Admission to acute inpatient rehabilitation
Who cannot join
- Unable to communicate verbally or by writing, unable to follow basic instructions, or unable to answer questions regarding their symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in Spinal Cord Injury (SCI)
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.
Read the detailed 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.
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Being tested
- Gabapentin, No gabapentin
- Keywords
- neuropathic pain, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Timing of gabapentin initiation
No gabapentinOther
No gabapentin
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin early | Other | Gabapentin prior to admission Receives: Drug: Gabapentin |
| Gabapentin late | Other | Gabapentin during admission Receives: Drug: Gabapentin |
| No gabapentin | Other | No gabapentin Receives: Other: No gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain
To determine if the time from injury influences the prevalence of neuropathic pain in acute SCI. Average of the pain during the previous 7 days on self-identified nerve or neuropathic pain levels (0-10) on 5 different measurements at the time of discharge on the Neuropathic Pain Scale. 0 being best (no pain)- 10 being worst pain. Total score range from 0 to 50.
Measured: Through completion of the study, up to 4 weeks after injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Aug 2019
- Primary completion30 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Kim, MetroHealth Medical Center
- Investigators
- C Kim, Principal investigator, Metro Health, Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256603
- Sponsor's protocol ID
- IRB19-00117
- Status last verified
- Nov 2021
- First submitted
- 1 Feb 2020
- Last updated
- 15 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No