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NCT Number: NCT06413667

Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

Location status: Recruiting

Location contact

Nederveen

CONTACT

[email protected]

About this study

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.

Who can participate

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:

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Neurological examination scores

    Time frame: 18 months

    A neurological examination will be performed and scored during the participants' visit

  4. Quality of life scores

    Time frame: 18 months

    The scores will be obtained by using quality of life questionnaire

Secondary outcomes

  1. Muscle volume

    Time frame: 24 months

    Muscle volume (in mm3) will be measured from the quantitative MRI scans and compared across the groups.

  2. Fat fraction

    Time frame: 24 months

    Fat fraction (in %) will be measured from MRI and compared across the groups.

  3. Blood flow

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Afzali-Hashemi

CONTACT

[email protected]

Nederveen

CONTACT

[email protected]

+31 20 5629338

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Acronym: MRAtlas

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 14, 2024
Registry last updated
May 14, 2024

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.