Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Repeatability measurement
研究概览
简要总结
Whiplash is an injury caused by the rapid forward and backward movement of the neck, leading to injuries in bones or soft tissues, along with various symptoms. Recent studies indicate that muscles affected by whiplash may show increased fat buildup and reduced muscle volume. However, these changes in muscle do not completely account for the pain and other symptoms reported. Besides soft tissues, whiplash can also injure bone structures, including the cervical spine. Until now, studies focused mainly on fractures of the cervical spine, often overlooking the position and alignment of the atlas and dens (C1 and C2). The aim of this study is to evaluate the position and alignment of the Atlas in chronic whiplash-associated disorder (grades 1 or 2) and compare it to patients with tension headache and healthy controls. Additionally, it will explore how these factors relate to pain intensity, neck movement limitations, daily activities, overall improvement, and quality of life.
详细描述
Treating some neurological conditions, like chronic whiplash-associated disorder (WAD), is highly challenging for medical practitioners. Patients with chronic WAD frequently visit their general practitioner because it's hard to pinpoint the cause of their symptoms. This makes finding the right treatment very difficult. The number of chronic WAD cases is rising worldwide, costing Europe an estimated 10 billion euros annually. Half of all whiplash injuries develop into chronic conditions, leading to significant disability and societal costs. These patients face major limitations in daily activities, greatly affecting their quality of life.
Whiplash is an injury caused by the rapid forward and backward movement of the neck, leading to injuries in bones or soft tissues, along with various symptoms. Recent studies indicate that muscles affected by whiplash may show increased fat buildup and reduced muscle volume. However, these changes in muscle do not completely account for the pain and other symptoms reported. Besides soft tissues, whiplash can also injure bone structures, including the cervical spine. Until now, studies focused mainly on fractures of the cervical spine, often overlooking the position and alignment of the atlas and dens (C1 and C2).
The aim of this study is to apply advanced imaging technologies to assess the position and alignment of the Atlas (C1) and the surrounding tissues. The study has three main goals:
i. Study the feasibility and repeatability of state-of-the-art MRI measurements in 30 healthy controls across an age range of 18 to 75 years.
ii. Assess the position and alignment of the Atlas and surrounding tissues using MRI in patients with WAD, compared to patients with tension headaches and healthy control participants;
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants fulfilling the criteria mentioned below:
- •Control participants In order to be eligible to participate in this study, a participant must meet the following criteria:
- •Healthy individuals
- •Ability to follow test instructions
- •Aged between 18 - 75 years
- •Chronic Whiplash Associated Disorder
- •In order to be eligible to participate in this study, a participant must meet the following criteria:
- •Healthy individuals
- •Ability to follow test instructions
- •WAD 1 or 2 Diagnosis
- •Aged between 18 - 75 years
- •Tension headache
- •In order to be eligible to participate in this study, a participant must meet the following criteria:
- •Healthy individuals
- •Ability to follow test instructions
- •Diagnosis Tension headache
- •Aged between 18 -75 years
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Inability to provide informed consent
- •Have a history of claustrophobia
- •Patient/ participant is not eligible to follow instructions
- •Contra-indication for MRI (e.g., pacemaker, claustrophobia)
- •Being under investigation for non-diagnosed disease at the time of investigation
结局指标
主要结局
Repeatability measurement
时间窗: 12 months
MRI images will be used to measure the angles between the Atlas and adjacent vertebrae at two different time points in the same healthy participants.
Alignment of the Atlas
时间窗: 12 months
MRI images will be used to measure the angles between the Atlas and adjacent vertebrae in the patient groups.
Quality of life scores
时间窗: 18 months
The scores will be obtained by using quality of life questionnaire
Neurological examination scores
时间窗: 18 months
A neurological examination will be performed and scored during the participants' visit
次要结局
- Fat fraction(24 months)
- Blood flow(24 months)
- Muscle volume(24 months)
研究者
Aart Nederveen
Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
