- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05161767
Shifting Away From Pain: Neurocognitive Approach to Explain and Predict Recovery Following Whiplash Injury
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ghent, Belgium, 9000
- Department of rehabilitation sciences (Ghent University)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Whiplash patients
Inclusion Criteria:
- Neck pain within 4 weeks after the trauma
- Native Dutch speaker
- Refraining from consuming caffeine, alcohol and nicotine in the hour before the MRI scans in both measurement times
Exclusion Criteria:
- Neuropathic pain
- Being pregnant
- A history of a chronic pain syndrome
- Chronic fatigue syndrome
- Fibromyalgia
- Cardiovascular disorders
- Epilepsy
- Endocrinological disorders
- Rheumatic disorders
- Psychiatric disorders
- History of neck surgery
- Loss of consciousness during/after the whiplash trauma
- MRI incompatible health condition (e.g., pacemaker, metal prosthetic devices)
- Claustrophobia.
Healthy volunteers: (matched for age and gender). Additional exclusion criteria include for healthy volunteers
- a history of a chronic pain syndrome
- a pain condition in the last six months for which treatment was sought
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Recovered group
This will group will consists of people who have a remission of their symptoms at 6-months follow-up after whiplash injury.
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Structural and functional brain scans will be taken.
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non-recovered group
This will group will consists of people who develop persistent symptoms at 6-months follow-up after whiplash injury.
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Structural and functional brain scans will be taken.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state
Time Frame: Baseline and 6-months follow-up
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Change between baseline assessment (within 4 weeks after the trauma) and the 6-months follow-up assessment.
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Baseline and 6-months follow-up
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Structural MRI measures (i.e., grey and white matter)
Time Frame: Baseline and 6-months follow-up
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Change between baseline assessment (within 4 weeks after the trauma) and the 6-months follow-up assessment.
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Baseline and 6-months follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Iris Coppieters, PhD, Vrije Universiteit Brussel, KU Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B670201941074
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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