The Association Between Low Cortisol Level and Whiplash Syndrome and the Effect of a Single Hydrocortisone Injection on Neck Symptoms Among Motor Vehicle Accident Victims: a Randomized Placebo Controlled Double Blinded Study
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Prevention of whiplash syndrome according to validated scales of pain and neck motion disability.
研究概览
简要总结
The investigators hypothesis is that low (or low relatively to the situation) cortisol levels might be a causative factor of whiplash injury or post traumatic stress disorder following road accidents. In this study the investigators enroll patients who sustained a road accident. From all patients a blood sample will be withdrawn to measure cortisol concentrations. Than, the patients will be divided into 2 groups: the study group will receive a single injection of intravenous Hydrocortisone 100 milligram (a synthetic steroid used routinely for many years). The control group will receive a same volume of normal saline which would be used as a placebo treatment. The investigators assume that patients with low cortisol levels would tend to have a higher incidence of whiplash injuries and / or post traumatic stress disorders, and that a single bolus of hydrocortisone may prevent these untoward sequelas of trauma.
详细描述
Study protocol Patients arriving during day time (08:00 - 16:00) to the Soroka Hospital emergency department following a motor vehicle accident and will be found eligible will be asked to participate in the study. Following an informed consent the recruited patients will be randomly divided into a study group or a control group. From all the participants a volume of 5 milliliter of peripheral blood will be withdrawn for cortisol concentration determination prior to the study intervention. After withdrawing the blood sample patients will receive a single bolus of intravenous Hydrocortisone 100 milligram (study group) or normal saline (0.9%) at a similar volume to that of the study drug, 5 ml (control group). Patients will be otherwise receiving the regular management of a trauma patient. The enrolled patients will fill simple, short questionnaires including demographic data, neck disability index, (NDI), numeric pain rating scale (NPRS), Tampa scale for kinesiophobia (TSK-11), PTSD questionnaire (PDA), and will be assessed by the treating physician for the degree of whiplash (WAD 0-4).
The patients will be followed-up by one of the investigators for a period of 6 months. In each visit the patient will be assessed again by the above mention tools.
Sample size: 45 patients in each arm. Blinding and randomization: triple blinding and using a randomization software. Statistical assessment will be performed to identify differences of developing WAD (whiplash associated disorder) between patients who had an admission low level of cortisol compared with those who had a high or normal level, and also between patients who received hydrocortisone compared to those who received placebo.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •victims of motor vehicle accidents
- •signed informed consent
排除标准
- •pregnancy
- •traumatic brain injury
- •psychiatry disorders
- •active cancerous conditions
- •adrenal diseases
- •medical treatment by estrogens, anti-depressants, melatonin, pain control.
- •substance abuse
- •hospitalization due to the trauma
- •contra indication to hydrocortisone treatment
- •over 6 hours from time of injury
研究组 & 干预措施
Hydrocortisone injection
I.V Hydrocortisone 100 mg single bolus.
干预措施: Hydrocortisone (Drug)
normal saline
I.V normal saline 0.9% a single bolus of 5 ml.
干预措施: normal saline 0.9% (Drug)
结局指标
主要结局
Prevention of whiplash syndrome according to validated scales of pain and neck motion disability.
时间窗: Six months following the motor vehicle accident.
Accomplishment of the primary outcome is measured by a composite of several variables. The following indices will be used to measure the primary outcome among the enrolled patients: neck disability index, numeric pain rating scale, Tampa scale for kinesiophobia, PTSD questionnaire (PDA), and will be assessed by the treating physician for the degree of whiplash (0-4).
次要结局
未报告次要终点