Clinical trial NCT06413667: Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder
Official title: Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Whiplash Associated Disorder
Keywords: Atlas
MRI
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

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

Primary outcomes:
measure: Repeatability measurement
timeFrame: 12 months
measure: Alignment of the Atlas
timeFrame: 12 months
measure: Neurological examination scores
timeFrame: 18 months
measure: Quality of life scores
timeFrame: 18 months
Secondary outcomes:
measure: Muscle volume
timeFrame: 24 months
measure: Fat fraction
timeFrame: 24 months
measure: Blood flow
timeFrame: 24 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
Study officials:
References: