Dietary Intervention to Reduce Pain in Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in pain rating as measured by the Numerical Rating Scale
研究概览
简要总结
The purpose of this research is to assess the effectiveness of a nutrition intervention on diet quality in managing pain in individuals with spinal cord injury (SCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 y)
- •With SCI (motor complete or incomplete American Spinal Injury Association Impairment Scale (AIS) A-D, paraplegia or ventilator-independent tetraplegia)
- •Have chronic pain
排除标准
- •Adults unable to consent Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women (self-report)
- •Prisoners
- •Those not meeting inclusion criteria will be excluded (e.g., no pain).
研究组 & 干预措施
Nutrition Group
Participants will be in this group for up to 4 months.
干预措施: Nutrition Education Program (Behavioral)
Nutrition Group
Participants will be in this group for up to 4 months.
干预措施: Nutrition Counseling (Behavioral)
结局指标
主要结局
Change in pain rating as measured by the Numerical Rating Scale
时间窗: Baseline, 4-months (after intervention)
The primary pain outcome will be measured using a 0 to 10 numerical rating scale (NRS) of average pain intensity during the past week, with higher scores indicating higher pain intensity.
Change in neuropathic pain severity as measured by the Neuropathic Pain Symptom Inventory
时间窗: Baseline, 4-months (after intervention)
Neuropathic pain severity outcome will be measured using the Neuropathic Pain Symptom Inventory (NPSI; 0-100) with higher scores indicating greater pain levels. This neuropathic pain rating will be captured at baseline and after the intervention period (4 months).
次要结局
未报告次要终点
研究者
Elizabeth Felix
Research Professor
University of Miami