Trial Outcomes & Findings for Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in SCI (NCT NCT04256603)
NCT ID: NCT04256603
Last Updated: 2021-11-15
Results Overview
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.
COMPLETED
PHASE4
27 participants
Through completion of the study, up to 4 weeks after injury.
2021-11-15
Participant Flow
Participant milestones
| Measure |
Gabapentin Group
The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin prior to admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records.
|
No Gabapentin Group
The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin during inpatient rehabilitation admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records. g care.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
6
|
|
Overall Study
COMPLETED
|
21
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in SCI
Baseline characteristics by cohort
| Measure |
Gabapentin
n=21 Participants
Gabapentin prior to admission
Gabapentin: Timing of gabapentin initiation
|
No Gabapentin
n=6 Participants
Gabapentin during admission
Gabapentin: Timing of gabapentin initiation
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through completion of the study, up to 4 weeks after injury.Population: 21 subjects were enrolled in the group treated with gabapentin, vs 6 in then no gabapentin
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.
Outcome measures
| Measure |
Gabapentin Group
n=21 Participants
The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin prior to admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records.
|
No Gabapentin Group
n=6 Participants
The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin during inpatient rehabilitation admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records. g care.
|
|---|---|---|
|
Neuropathic Pain
|
13.3 units on a scale
Standard Deviation 18.8
|
15.6 units on a scale
Standard Deviation 18.0
|
Adverse Events
Gabapentin Group
No Gabapentin Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place