Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167856
Status:
COMPLETED
Last Update Posted:
2014-03-27
First Post:
2005-09-09
Brief Title:
Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the pain-relieving effects of venlafaxine hydrochloride Effexor in chronic neuropathic burning shock-like electric pain after spinal cord injury SCI Although a number of medications have been used to treat SCI pain no drug has been consistently helpful and therefore many people with SCI continue to have difficult chronic pain Venlafaxine is a new anti-depressant drug that has not been tested for use in SCI neuropathic pain but has been helpful for other types of neuropathic pain
Detailed Description:
Persistent pain is one of the most common reasons for impaired quality of life following spinal cord injury SCI Although numerous interventions are often used to manage neuropathic pain following SCI most people receive inadequate relief and continue to suffer many years after the original injury The long-term goal of our pain research is to improve the management of chronic neuropathic pain following SCI
This study examines the effect of Venlafaxine hydrochloride VH in the treatment of chronic neuropathic pain associated with SCI VH is a second-generation structurally novel antidepressant medication with a mild side-effect profile compared to these older tricyclic antidepressants eg imipramine and amitriptyline Previous clinical trials suggest that approximately 60-70 of people with heterogeneous neuropathic pain report at least moderate reductions in pain with older antidepressants However reported side-effects have been numerous and few trials have been conducted on neuropathic pain due to SCI
The current study is a two-period 24-week crossover randomized placebo-controlled trial A sample of 60 persons with chronic neuropathic pain and SCI will be randomly assigned to either of two treatment groups n30 for each group in a double-blind fashion One group will receive VH first and then placebo whereas the second group will start with the placebo followed by the VH There will be weekly contacts between the research staff and the study participants to assess pain relief and medication side effects presence and severity Several measures of pain intensity psychosocial well-being quality of life and sensory function will be taken throughout the study to examine the effects of VH on neuropathic pain
We expect that VH will help to relieve neuropathic pain in persons with SCI and that this decrease in pain intensity will correlate with a reduced psychosocial impact improved mood increased participation in daily activities and increased life satisfaction
This study examines the effect of Venlafaxine hydrochloride VH in the treatment of chronic neuropathic pain associated with SCI VH is a second-generation structurally novel antidepressant medication with a mild side-effect profile compared to these older tricyclic antidepressants eg imipramine and amitriptyline Previous clinical trials suggest that approximately 60-70 of people with heterogeneous neuropathic pain report at least moderate reductions in pain with older antidepressants However reported side-effects have been numerous and few trials have been conducted on neuropathic pain due to SCI
The current study is a two-period 24-week crossover randomized placebo-controlled trial A sample of 60 persons with chronic neuropathic pain and SCI will be randomly assigned to either of two treatment groups n30 for each group in a double-blind fashion One group will receive VH first and then placebo whereas the second group will start with the placebo followed by the VH There will be weekly contacts between the research staff and the study participants to assess pain relief and medication side effects presence and severity Several measures of pain intensity psychosocial well-being quality of life and sensory function will be taken throughout the study to examine the effects of VH on neuropathic pain
We expect that VH will help to relieve neuropathic pain in persons with SCI and that this decrease in pain intensity will correlate with a reduced psychosocial impact improved mood increased participation in daily activities and increased life satisfaction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None