Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated D… (NCT06413667) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder
Netherlands90 participantsStarted 2024-04-08
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Repeatability measurement
Timeframe: 12 months
2
Alignment of the Atlas
Timeframe: 12 months
3
Neurological examination scores
Timeframe: 18 months
4
Quality of life scores
Timeframe: 18 months
Trial details
NCT IDNCT06413667
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)