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Clinical Trials/NCT05161767
NCT05161767
Terminated
Not Applicable

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

University Ghent1 site in 1 country37 target enrollmentJanuary 6, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Whiplash Injuries
Sponsor
University Ghent
Enrollment
37
Locations
1
Primary Endpoint
Blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 6, 2020
End Date
January 10, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

  • Neuropathic pain
  • Being pregnant
  • A history of a chronic pain syndrome
  • Chronic fatigue syndrome
  • Fibromyalgia
  • Cardiovascular disorders
  • Endocrinological disorders
  • Rheumatic disorders
  • Psychiatric disorders
  • History of neck surgery

Outcomes

Primary Outcomes

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.

Study Sites (1)

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