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TerminatedNCT05161767Updated Jan 12, 2024

Shifting Away From Pain: Neurocognitive Approach to Explain and Predict Recovery Following Whiplash Injury

An observational study in Whiplash Injuries, sponsored by University Ghent. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-12.

Sponsored by University Ghent · Observational

Why this study was terminated
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.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
37
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Whiplash Injuries

Keywords

  • whiplash
  • chronic pain
  • neuroimaging
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 37 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

University Ghent is the lead sponsor of 345 studies on the registry; 85 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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)

Whiplash patients

Inclusion criteria

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
37 participants (actual)
Patient registry
No

Groups and cohorts

  • Recovered group

    This will group will consists of people who have a remission of their symptoms at 6-months follow-up after whiplash injury.

    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.

    Diagnostic Test: Brain MRI (neuroimaging)

Interventions

  • Diagnostic testBrain MRI (neuroimaging)

    Structural and functional brain scans will be taken.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 6-months follow-up

  2. 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.

    Time frame: Baseline and 6-months follow-up

07

Study locations

1 site
  • Department of rehabilitation sciences (Ghent University)
    Ghent, 9000, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05161767
Lead sponsor
University Ghent
Responsible party
Sponsor
First posted
Dec 17, 2021
Start date
Jan 6, 2020
Primary completion
Jan 10, 2024
Completion
Jan 10, 2024
Last update
Jan 12, 2024

Study contacts

Iris Coppieters, PhD
principal investigator · Vrije Universiteit Brussel, KU Leuven

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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