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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Whiplash Associated Disorder

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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Nederveen; Phone Number: +31 20 5629338; Email: a.j.nederveen@amsterdamumc.nl
• Study Contact Backup: Name: Afzali-Hashemi; Email: l.afzali-hashemi@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • Amsterdam UMC
    • Contact: Nederveen; Email: a.j.nederveen@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 months
Neurological examination scores	A neurological examination will be performed and scored during the participants' visit	18 months
Quality of life scores	The scores will be obtained by using quality of life questionnaire	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle volume	Muscle volume (in mm3) will be measured from the quantitative MRI scans and compared across the groups.	24 months
Fat fraction	Fat fraction (in %) will be measured from MRI and compared across the groups.	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.	24 months

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Atlas
• Additional Relevant MeSH Terms: Wounds and Injuries; Neck Injuries; Whiplash Injuries
• Other Study ID Numbers: 2023.0628

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No