Vitamin C Supplementation for Lumbar Spine Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Adherence feasibility outcome
研究概览
简要总结
By doing this study, researchers hope to learn effects of Vit C on lumbar spine surgery outcomes.
详细描述
Lumbar spine surgeries are common procedures for management of low back pain and their prevalence is increasing. However, their outcomes are less than optimal.
An effective and inexpensive solution to minimizing surgical complications and expediting recovery following lumbar spine surgery could be supplementation using high doses of vitamin C, also known as ascorbic acid. Vit C can help reduce oxidative stress and inflammation and improve immune system and body's own chemicals to fight pain.
The researchers want to examine if Vit C is effective in decreasing pain and pain medications and improving function. Gaining a better understanding of effects of Vit C on patient recovery may lead to improved outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Blinded pilot randomized control trial
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to have a lumbar spine fusion
- •Can read and understand the English language
- •BMI 35 or less
排除标准
- •Patients taking certain medications
- •lumbar spine laminectomy or discectomy
- •taking a Vit C supplement
- •pregnancy
- •Cauda equine syndrome or spinal tumor
- •neurological, neurodegenerative or cognitive issues
- •renal pathology
- •sickle cell anemia
- •iron metabolism disorder
结局指标
主要结局
Adherence feasibility outcome
时间窗: up to 7 weeks
Calculate adherence in percentage as subjects enrolled versus completed
Function
时间窗: up to 7 weeks
Gait distance in feet will be obtained during physical therapy visit
Would healing
时间窗: up to 7 weeks
Surgical incision observation
Pain intensity: numeric rating pain scale
时间窗: up to 7 weeks
self reported 0-10 numeric rating pain scale where 0=no pain and 10=most pain imagined
Pain medication consumption
时间窗: up to 7 weeks
Use of opioids and non-opioids analgesics documented in patients' health records
Recruitment feasibility outcome
时间窗: up to 7 weeks
The number of participants recruited and enrolled.
次要结局
- Vit C level(up to 7 weeks)
- Beck depression inventory(up to 7 weeks)
- Beck anxiety inventory(up to 7 weeks)
- 2011 Fibromyalgia (FM) survey(up to 7 weeks)
- fatigue questionnaire(up to 7 weeks)
- Pittsburg sleep scale(up to 7 weeks)
- Pain catastrophizing scale(up to 7 weeks)