Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413667
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-15
Brief Title:
Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MRAtlas
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 its 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None