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临床试验/NCT06413667
NCT06413667招募中不适用

Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年4月8日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aart Nederveen

Professor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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