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

NCT05161767 | Terminated

• 1 other identifier: B670201941074
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash Injuries

Keywords

whiplash; chronic pain; neuroimaging

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 6-months follow-up

Study Arms (2)

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

Brain MRI (neuroimaging) DIAGNOSTIC_TEST

Structural and functional brain scans will be taken.

Recovered group; non-recovered group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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.
• a history of a chronic pain syndrome

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Department of rehabilitation sciences (Ghent University)

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Whiplash Injuries; Chronic Pain

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Iris Coppieters, PhD

  Vrije Universiteit Brussel, KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 17, 2021
• Study Start: January 6, 2020
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

BE (1)