Clinical Efficacy of Diazepam After Whiplash
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- change in Whiplash Disability Questionnaire score 6 months after injury (0-130; 0 no disability, 130 maximal disability)
研究概览
简要总结
Whiplash injury is very common and lot of patients which suffered the injury have chronic symptoms despite different treatment options. One of main symptoms include muscle spasm and pain caused by neck movement. Diazepam is a well known drug which can be used to treat muscle spasms. The aim of this study is to determine whether short term Diazepam therapy can have positive effect on long term outcomes after whiplash injury.
详细描述
This randomized, assessor-blinded study was conducted on patients presented due to a cervical spine injury caused by a traffic accident in the previous 48 hours from 1st January 2020 to 31st December 2020. All the patient which were included in this study were divided into 2 groups: group A, the Test group, and group B, the control group. All patients signed the consent to participate in the study prior to randomization. During the initial examination a detailed history was taken and it included Visual Analog Pain Scale (VAS). On follow up examinations 7 days, 6 weeks and 6 months after the injury, all patients completed Neck disability index (NDI), Whiplash disability questionnaire (WDQ) as well as Visual Analog Pain Scale (VAS). Any patient which didn't complete all the follow up examination was excluded from the study.
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
- Single (Investigator)
盲法说明
Patients were presented with a sealed opaque envelope which contained a piece of A4 paper with inscriptions Group A or Group B. After choosing one envelope they would tell the nurse which letter they got without the assessor's knowing the group.
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
- 是
入选标准
- •patients who suffered cervical spine injury caused by a traffic accident in the previous 48 hours
排除标准
- •younger than 18 years of age; older than 70 years of age; the presence of associated injuries; previous surgery on the cervical spine; previously diagnosed arthrosis of the cervical spine; the presence of a malignant process and previous cervical spine injuries; history of Diazepam allergy
研究组 & 干预措施
group A (the Test group)
arm which received Diazepam 5 mg therapy for 7 days after whiplash
干预措施: Diazepam Tablets (Drug)
结局指标
主要结局
change in Whiplash Disability Questionnaire score 6 months after injury (0-130; 0 no disability, 130 maximal disability)
时间窗: 6 months
Comparation of same score at the follow up examination 7 days after the injury
change in Neck Disability Index score 6 months after injury (0-50, 0 - no disability 50 maximal disability)
时间窗: 6 months
Comparation of same score at the follow up examination 7 days after the injury
次要结局
- changes in Visual Analog Scale scores 7 days after the injury (0-10; 0-no pain 10 maximum pain level)(7 days)
- changes in Visual Analog Scale scores 6 weeks after the injury (0-10; 0-no pain 10 maximum pain level)(6 weeks)
- changes in Visual Analog Scale scores 6 months after the injury (0-10; 0-no pain 10 maximum pain level)(6 months)
- change in Whiplash Disability Questionnaire score 6 weeks after injury (0-130; 0 no disability, 130 maximal disability)(6 weeks)
- change in Neck Disability Index score 6 weeks after injury (0-50, 0 - no disability 50 maximal disability)(6 weeks)
研究者
Edin Mešanović
orthopedic surgeon
Cantonal Hospital Dr. Safet Mujic Mostar