Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Whiplash Associated Disorder. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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;
iii. Relate these MRI parameters to neurological examinations and questionnaires (patient- reported outcome measures) in patients with WAD and tension headaches.
Primary outcome measures
- Repeatability measurement [Time frame: 12 months]
- Alignment of the Atlas [Time frame: 12 months]
- Neurological examination scores [Time frame: 18 months]
- Quality of life scores [Time frame: 18 months]
Secondary outcome measures (3)
- Muscle volume [Time frame: 24 months]
- Fat fraction [Time frame: 24 months]
- Blood flow [Time frame: 24 months]
Eligibility criteria
Inclusion Criteria: 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
Exclusion Criteria: 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Netherlands · 1 center
- Amsterdam UMC — Amsterdam
Identifiers
NCT: NCT06413667 · 2023.0628