Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
Study NCT ID:
NCT05161767
Status:
TERMINATED
Last Update Posted:
2024-01-12
First Post:
2021-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shifting Away From Pain: Neurocognitive Approach to Explain and Predict Recovery Following Whiplash Injury
Sponsor:
University Ghent
Organization:
Study Overview
Official Title:
Shifting Away From Pain: Neurocognitive Approach to Explain and Predict Recovery Following Whiplash Injury
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficult recruitment of acute patients via emergency services due to COVID-19. The required sample size was consequently not reached within the PhD period of the involved researchers.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Around half of the patients with neck pain after trauma (whiplash) will develop chronic pain. Understanding the transition from acute to chronic pain after whiplash is a priority since will help to identify those which patients are likely to fully recover and who do not. In the last years, there have been a call for an investigation of new biomarkers; particularly in brain structure and function. Alterations in the structure of the brain (gray matter, white matter and cortical thickness) as well as the brain function have been found in people with chronic WAD; which are also correlated with pain, disability and symptoms of central sensitization such as hyperalgesia. Previous research has found structural and functional brain differences between people who develop chronic low back pain compared to those who recovered; but research in this vein is still lacking in people with whiplash. Consequently, this study aims to examine the neural correlates of recovery following whiplash injury.
Detailed Description:
This study aims to investigate whether or not there are differences in brain structure and function between people who recover after whiplash and those who do not. Thus, patients with acute neck pain after whiplash will be recruited. Also, a pain-free age- and sex-matched control group will be recruited for comparison.
A longitudinal prospective study will be conducted with two follow-up measurements (3 and 6 months). All measurements will take place at University Hospital of Ghent (UZ Gent), Ghent (Belgium). MRI measures will be taken at baseline (\<4 weeks after the accident) and 6-months follow-up. The 3-months follow-up will only consist of the assessment of the online questionnaires; so, patients will not be required to come to UZ Gent.
A longitudinal prospective study will be conducted with two follow-up measurements (3 and 6 months). All measurements will take place at University Hospital of Ghent (UZ Gent), Ghent (Belgium). MRI measures will be taken at baseline (\<4 weeks after the accident) and 6-months follow-up. The 3-months follow-up will only consist of the assessment of the online questionnaires; so, patients will not be required to come to UZ Gent.
Study Oversight
Has Oversight DMC:
False
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?: