Whiplash InjuriesNCT05161767
Shifting Away From Pain: Neurocognitive Approach to Explain and Predict Recovery Following Whiplash Injury
An observational study of Whiplash Injuries, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Whiplash Injuries
- What is being tested?
- Brain MRI (neuroimaging)
- How many people
- 37 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Jan 2020to 10 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Whiplash injury is a type of neck injury caused by sudden movement of the head forwards, backwards or sideways (i.e. motor vehicle accident)
Who may be able to join
- 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
Who cannot join
- Neuropathic pain
- Being pregnant
- A history of a chronic pain syndrome
- Chronic fatigue syndrome
- Fibromyalgia
- Cardiovascular disorders
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of rehabilitation sciences (Ghent University)
Ghent, 9000
About this study
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.
Read the 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.
- Conditions
- Whiplash Injuries
- Being tested
- Brain MRI (neuroimaging)
- Keywords
- whiplash, chronic pain, neuroimaging
- Medical subject headings
- Whiplash Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRI (neuroimaging)Diagnostic test
Structural and functional brain scans will be taken.
| Study group | Role | What they receive |
|---|---|---|
| Recovered group | This will group will consists of people who have a remission of their symptoms at 6-months follow-up after whiplash injury. Receives: Diagnostic Test: Brain MRI (neuroimaging) | |
| non-recovered group | This will group will consists of people who develop persistent symptoms at 6-months follow-up after whiplash injury. Receives: Diagnostic Test: Brain MRI (neuroimaging) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state
Change between baseline assessment (within 4 weeks after the trauma) and the 6-months follow-up assessment.
Measured: Baseline and 6-months follow-up
Structural MRI measures (i.e., grey and white matter)
Change between baseline assessment (within 4 weeks after the trauma) and the 6-months follow-up assessment.
Measured: Baseline and 6-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start6 Jan 2020
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash InjuriesStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iris Coppieters, PhD, Principal investigator, Vrije Universiteit Brussel, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161767
- Sponsor's protocol ID
- B670201941074
- Status last verified
- Jan 2024
- First submitted
- 3 Dec 2021
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shifting Away From Pain: Neurocognitive Approach to Explain and Predict Recovery Following Whiplash Injury
- ClinicalTrials.gov ID
- NCT05161767
- Acronym / sponsor ID
- B670201941074
- Conditions
- Whiplash Injuries
- Keywords
- whiplash, chronic pain, neuroimaging
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovered group | – | Diagnostic Test: Brain MRI (neuroimaging)This will group will consists of people who have a remission of their symptoms at 6-months follow-up after whiplash injury. |
| non-recovered group | – | Diagnostic Test: Brain MRI (neuroimaging)This will group will consists of people who develop persistent symptoms at 6-months follow-up after whiplash injury. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Whiplash injury is a type of neck injury caused by sudden movement of the head forwards, backwards or sideways (i.e. motor vehicle accident)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- Neuropathic pain
- Being pregnant
- A history of a chronic pain syndrome
- Chronic fatigue syndrome
- Fibromyalgia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRI (neuroimaging)Structural and functional brain scans will be taken. | Diagnostic test | Recovered group, non-recovered group |
Primary outcome
Blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state
Time frame: Baseline and 6-months follow-up
Change between baseline assessment (within 4 weeks after the trauma) and the 6-months follow-up assessment.
Structural MRI measures (i.e., grey and white matter)
Time frame: Baseline and 6-months follow-up
Change between baseline assessment (within 4 weeks after the trauma) and the 6-months follow-up assessment.
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
Related trials for Whiplash Injuries
Active, not recruiting
Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.
Whiplash-associated Disorders
Not yet recruiting
StressModex for Post-Traumatic Neck Pain
Post-Traumatic Neck Pain, Whiplash-associated Disorders
Recruiting
Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
Whiplash Associated Disorder (WAD)
Recruiting
Virtual Reality Rehabilitation in Neck Pain Subjects
Neck Pain, Chronic Pain
Not yet recruiting
Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome
Whiplash Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris Coppieters, PhD principal investigator
Vrije Universiteit Brussel, KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Whiplash Injuries, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state (time frame: Baseline and 6-months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.