Chronic Whiplash Associated DisorderMRAtlasNCT06413667
Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder
An observational study of Chronic Whiplash Associated Disorder, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Whiplash Associated Disorder
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Apr 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The aim of this study is to evaluate high resolution MR techniques to measure position and alignment of the Atlas and its surrounding structures in healthy participants, individuals with tension headache and individuals with chronic whiplash disorder.
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Afzali-Hashemi contact
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, 1105 AZ
Nederveen, a.j.nederveen@amsterdamumc.nl
About this study
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.
Read the 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:
- 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.
- Conditions
- Chronic Whiplash Associated Disorder
- Keywords
- Atlas, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control participants | Healthy control participants without intervention | |
| Chronic Whiplash Associated Disorder | Chronic Whiplash Associated Disorder without intervention | |
| Tension headache | Tension headache without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability measurement
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.
Measured: 12 months
Alignment of the Atlas
MRI images will be used to measure the angles between the Atlas and adjacent vertebrae in the patient groups.
Measured: 12 months
Neurological examination scores
A neurological examination will be performed and scored during the participants' visit
Measured: 18 months
Quality of life scores
The scores will be obtained by using quality of life questionnaire
Measured: 18 months
Secondary outcomes (3)
Muscle volume
Muscle volume (in mm3) will be measured from the quantitative MRI scans and compared across the groups.
Measured: 24 months
Fat fraction
Fat fraction (in %) will be measured from MRI and compared across the groups.
Measured: 24 months
Blood flow
Blood flow (in cm/s) in the brain feeding arteries will be obtained from the quantitative MRI scans and compared across the groups.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start8 Apr 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Whiplash Associated DisorderStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aart Nederveen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413667
- Sponsor's protocol ID
- 2023.0628
- Acronym
- MRAtlas
- Status last verified
- May 2024
- First submitted
- 15 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder
- ClinicalTrials.gov ID
- NCT06413667
- Acronym / sponsor ID
- MRAtlas / 2023.0628
- Conditions
- Chronic Whiplash Associated Disorder
- Keywords
- Atlas, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control participants | – | –Healthy control participants without intervention |
| Chronic Whiplash Associated Disorder | – | –Chronic Whiplash Associated Disorder without intervention |
| Tension headache | – | –Tension headache without intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The aim of this study is to evaluate high resolution MR techniques to measure position and alignment of the Atlas and its surrounding structures in healthy participants, individuals with tension headache and individuals with chronic whiplash disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Repeatability measurement
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.
Alignment of the Atlas
Time frame: 12 months
MRI images will be used to measure the angles between the Atlas and adjacent vertebrae in the patient groups.
Neurological examination scores
Time frame: 18 months
A neurological examination will be performed and scored during the participants' visit
Quality of life scores
Time frame: 18 months
The scores will be obtained by using quality of life questionnaire
3 secondary outcomes
Muscle volume
Time frame: 24 months
Fat fraction
Time frame: 24 months
Blood flow
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
Related trials for Chronic Whiplash Associated Disorder
Recruiting
Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
Whiplash Associated Disorder (WAD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Afzali-Hashemi contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Whiplash Associated Disorder, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nederveen (+31 20 5629338, a.j.nederveen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeatability measurement (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.