Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pain Intensity as measured by subject pain diaries
研究概览
简要总结
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.
详细描述
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 (e.g. 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 (n=30 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participant must be able to swallow pills
- •fluent in English
- •incomplete or complete spinal cord injury
- •presence of at least moderately severe neuropathic pain at or below the level of injury
- •spinal cord injury at least 2 year prior to entering the study
- •pain for at least 6 months prior to entering the study
- •spinal cord injury level above L1
- •participants on anticonvulsants are considered
- •approval of primary physician
排除标准
- •pregnant women, or those contemplating pregnancy
- •prior history of use of Venlafaxine hydrochloride (Effexor)
- •current use of MAOI medications
- •persons who have a recent (past year) history of alcohol or drug abuse
- •persons with a history of renal disease, heart disease or uncontrolled hypertension, liver disease or hepatic cirrhosis, active major medical or psychiatric illness
- •persons with a significant post-traumatic encephalopathy from head trauma sustained at SCI
- •persons with tardive dyskinesia or narrow angle glaucoma
研究组 & 干预措施
1
Venlafaxine HCL (extended release)
干预措施: Venalafaxine hydrochloride (Drug)
2
Benztropine Mesylate
干预措施: Venalafaxine hydrochloride (Drug)
结局指标
主要结局
Pain Intensity as measured by subject pain diaries
时间窗: Baseline (2 Weeks); Phase 1 (1 week at max dose); Washout (2 weeks); Phase 2 (1 week at max dose)
次要结局
未报告次要终点