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Clinical Trials in the Netherlands / NCT06413667
Recruiting Observational

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

NCT06413667 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase
Observational
Started
2024-04-08
Last updated
2024-05-14

Condition(s) studied

Chronic Whiplash Associated Disorder

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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 outcome measure(s)

  • Repeatability measurement — 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 — 12 months
    MRI images will be used to measure the angles between the Atlas and adjacent vertebrae in the patient groups.
  • Neurological examination scores — 18 months
    A neurological examination will be performed and scored during the participants' visit
  • Quality of life scores — 18 months
    The scores will be obtained by using quality of life questionnaire

Trial sites (1)

FacilityCityRegionStatus
Amsterdam UMC Amsterdam Netherlands Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06413667 on ClinicalTrials.gov ↗ ← All trials in the Netherlands