Vitamin C for Acute Musculoskeletal Pain in Emergency Department Patients: A Triple-Blind Randomized Control Trial (VICAMED)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 4
- 主要终点
- Time-weighted sum of the pain-intensity difference (SPID)
研究概览
简要总结
Musculoskeletal (MSK) injuries such as sprains, strains, bruises, and fractures are among the most common reasons people visit the emergency department. These injuries often cause significant pain in the first few days, making it difficult to move, work, or sleep. Usual pain medications like ibuprofen or acetaminophen can help, but they are not safe or effective for everyone. Some people cannot take them because of heart, kidney, stomach, or liver problems. Others still experience strong pain despite treatment. Because of these limits, some patients receive opioids, which can cause side effects and carry a risk of dependence. Safer and more accessible options are needed.
Vitamin C is widely known for supporting the immune system, but research suggests it may also help reduce pain and inflammation. Studies in surgical patients have shown that vitamin C can lower pain levels, reduce the need for opioids, and support healing. These effects may be linked to its antioxidant properties and its role in tissue repair. However, no study has tested whether vitamin C can help people with recent MSK injuries treated in the emergency department.
The VICAMED study aims to answer this question. Adults arriving with an MSK injury that occurred within the past 48 hours can participate if they have at least moderate pain. Participants are randomly assigned to receive either vitamin C or a placebo. The first dose is given in the emergency department, followed by twice daily capsules for three days. Pain is measured using a simple 0-100 scale, recorded in an electronic or paper diary. A follow-up on day six helps the research team understand each participant's recovery, medication use, and overall experience.
Vitamin C is inexpensive, widely available, and very safe at the doses used in this study. If it proves effective, it could offer a simple, low risk option to help patients manage pain after an MSK injury and reduce the need for opioids in emergency care.
详细描述
Background:
Acute musculoskeletal (MSK) injuries are a major cause of emergency department (ED) visits and frequently result in moderate to severe pain during the first days following presentation. First-line analgesics such as NSAIDs and acetaminophen have important contraindications and safety limitations, particularly in older adults and patients with comorbidities, underscoring the need for safe, accessible, opioid-sparing alternatives. Preclinical studies and postoperative trials suggest that vitamin C (ascorbic acid) may provide analgesic and anti-inflammatory effects through reduction of oxidative stress, protection of neural tissues, and enhanced collagen synthesis. Meta-analyses have reported reductions in postoperative opioid consumption, pain intensity, and inflammatory markers. However, no randomized controlled trial has evaluated vitamin C for acute traumatic MSK pain in the ED.
Objective:
The primary objective is to determine whether a single 900 mg oral dose of vitamin C reduces pain intensity one hour after administration compared with placebo in adults presenting with acute MSK injuries. The main secondary objective is to assess whether 900 mg of vitamin C taken twice daily for three days reduces the time-weighted sum of pain-intensity difference (SPID) over 72 hours.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Age ≥ 18 years old
- •Presenting to the ED with acute MSK pain of ≤ 48 hours duration at triage
- •Verbal numerical rating scale pain intensity at triage of ≥ 4 on a 0-10 scale
- •Triaged to the ambulatory section of the ED
- •Able to communicate in French or English
排除标准
- •Usage of Vit C supplements in the last week
- •Active cancer
- •Treated with opioids for any pain within 24 hours prior to recruitment
- •Treatment for chronic pain
- •Unable to fill out a pain intensity diary or unavailable for follow-up
- •Allergy to milk (lactose in the placebo) or Vit C
- •Treated with cyclosporine or warfarin
- •Pre-existing oxalate nephropathy, liver cirrhosis or hemochromatosis
- •Hospitalized after clinician evaluation
研究组 & 干预措施
Placebo
Placebo taken orally twice a day
干预措施: Placebo (Other)
Vitamin C
900 mg vitamin C taken orally twice a day
干预措施: Vitamin C (Dietary Supplement)
结局指标
主要结局
Time-weighted sum of the pain-intensity difference (SPID)
时间窗: Three days
The primary outcome is the time-weighted sum of the pain-intensity difference (SPID) over the three-day treatment period on a 0-100 visual analog scale (VAS), where 0 is no pain and 100 the worst pain imaginable. The SPID accounts for both the magnitude of the pain change and its duration, producing a single value that reflects the patient's overall experience.
次要结局
- Difference in pain intensity(Three days)
- Consumption of as-needed pain medication(Three days)
- Time for significant pain relief(Six days)
- Time to pain-free(Six days)
- Percentage of days with adequate relief(Six days)
- New analgesic prescriptions(Three days)
- Adverse events(Three days)
- Quality of life improvement at six days(Six days)
- Quantity of Healthcare visits(Six days)
研究者
Raoul Daoust
Dr Emergency Medicine, Professor, Clinician Researcher
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal