The Role of Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures: a Randomized Control Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
研究概览
简要总结
Complex Regional Pain Syndrome type 1 is a pain syndrome that develops after a trauma, surgery, or idiopathically. The incidence after distal radius varies significantly in the literature. There are known contributing factors, such as the female sex but no effective treatment or prophylactic method. This study aims to investigate vitamin C's efficacy in preventing CRPS type 1 following distal radius fractures, as the literature states that it might play a role in prophylaxis.
详细描述
Complex regional pain syndrome is the most challenging complication to overcome following distal radius fractures. The precise etiology still needs to be fully understood. It is thought that ways of prevention could be the most effective way of managing this dilemma, as no effective treatment is yet to be found.
One of the ways of prevention is vitamin C supplementation, as it is thought that the toxic oxygen radicals play a significant role in the inflammatory process that ultimately manifests as CRPS. Vitamin C, as an antioxidant, could play a role in stopping this process.
The theoretical background of this research is that CRPS commonly occurs following distal radius fractures, and vitamin C supplementation could play a role in prophylaxis. To assess that, the investigator is conducting a randomized controlled trial.
The trial is designed as a multicenter, randomized, controlled study. Two hospitals in Syria, Damascus, participated in this study using the same experimental design.
Adults (18 years or above) with distal radius fractures who will be seen in the emergency department of each hospital will be asked to participate in this study. Patients will be asked to start the trial medication on the day of the fracture following the suitable treatment method chosen by the orthopedics consultant in each hospital. Capsules had to be taken once daily for 90 days. Patients will be allocated randomly to receive either a placebo or 1g of vitamin C daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All participants and the consultants making definite treatment decisions and the researcher assistant collecting participants' data will be unaware of allocation until the completion of the study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participants who were injured with distal radius fractures and classified using the AO classification as A1, A2, A3, B1, and C1.
排除标准
- •Multiple trauma patients.
- •patients who have neurovascular injuries.
- •Patients with fractures are classified using the AO classification as B2, B3, C2, and C
- •Patients who are eligible for open reduction internal fixation of their fractures.
- •Patients with chronic or acute renal failure.
- •Patients who already take multi-vitamin supplementation or vitamin C supplementation.
研究组 & 干预措施
Participants with distal radius fractures taking vitamin c supplementation.
Participants who give informed consent and successfully pass the eligibility criteria will take 1g of oral vitamin C daily for three months.
干预措施: Vitamin C (Drug)
Participants with distal radius fractures taking a placebo.
Participants who give informed consent and successfully pass the eligibility criteria will take a placebo daily for three months.
干预措施: Placebo (Drug)
结局指标
主要结局
The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.
时间窗: checked twelve months after definitive treatment.
BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.
次要结局
未报告次要终点