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

January 10, 2024 updated by: University Ghent
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.

Study Overview

Status

Terminated

Conditions

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

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

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)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Recovered group
This will group will consists of people who have a remission of their symptoms at 6-months follow-up after whiplash injury.
Structural and functional brain scans will be taken.
non-recovered group
This will group will consists of people who develop persistent symptoms at 6-months follow-up after whiplash injury.
Structural and functional brain scans will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6-months follow-up
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.
Baseline and 6-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Iris Coppieters, PhD, Vrije Universiteit Brussel, KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2020

Primary Completion (Actual)

January 10, 2024

Study Completion (Actual)

January 10, 2024

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B670201941074

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Whiplash Injuries

Clinical Trials on Brain MRI (neuroimaging)

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