A Randomized Early Intervention Study Comparing the Effect of Stiff Neck Collar, "Act-as-Usual" and Active Mobilisation on the One Year Outcome Following Whiplash Injury.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Neck disability
研究概览
简要总结
Background: Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after forced flexion-extension trauma to the cervical spine. Mechanisms behind WAD are virtually unknown, as are the possible effects of early intervention. This trial was undertaken to compare the effect of three early intervention strategies for the prevention of developing chronic WAD following acute whiplash injury.
Methods: 458 participants were randomised to one of 1) stiff neck collar, 2) advice to act-as-usual, or 3) an active mobilisation regime. Participants were followed for one year and treatment effects were compared in terms of lasting neck pain, headache, disability and sick-leave.
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
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
- 否
入选标准
- •Been exposed to rear-end or frontal car collision
- •Experienced symptoms within 72 hours
- •18 - 70 years
排除标准
- •Could not be enrolled within 10 days of the collision
- •Fractures or dislocations of the cervical spine
- •Amnesia for the accident
- •Unconsciousness in relation to the accident
- •Injuries other than the whiplash injury
- •Average neck pain during the preceding 6 months exceeding 2 on a box scale 0-10, where 0= no pain and 10= worst possible pain
- •Significant pre-existing somatic or psychiatric disease
- •Alcohol or drug abuse
- •Does not read or understand Danish.
结局指标
主要结局
Neck disability
Neck pain intensity
Headache intensity
Sick leave during the 12 month after inclusion
次要结局
- Number of non-painful complaints
- General health
- Medication