Amsterdam UMC
Amsterdam, 1105 AZ, Netherlands
Location status: Recruiting
NCT Number: NCT06413667
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Amsterdam, 1105 AZ, Netherlands
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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:
Chronic Whiplash Associated Disorder
In order to be eligible to participate in this study, a participant must meet the following criteria:
Tension headache
In order to be eligible to participate in this study, a participant must meet the following criteria:
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Time frame: 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.
Time frame: 12 months
MRI images will be used to measure the angles between the Atlas and adjacent vertebrae in the patient groups.
Time frame: 18 months
A neurological examination will be performed and scored during the participants' visit
Time frame: 18 months
The scores will be obtained by using quality of life questionnaire
Time frame: 24 months
Muscle volume (in mm3) will be measured from the quantitative MRI scans and compared across the groups.
Time frame: 24 months
Fat fraction (in %) will be measured from MRI and compared across the groups.
Time frame: 24 months
Blood flow (in cm/s) in the brain feeding arteries will be obtained from the quantitative MRI scans and compared across the groups.
Contact information is provided by the study sponsor or research team.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
Acronym: MRAtlas
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.