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Clinical Trials/NCT04077619
NCT04077619
Completed
Not Applicable

Shifting Away From Pain: Neurocognitive Approach to Explain and Predict the Response to the Modern Neuroscience Approach for Treating Patients With Whiplash Associated Disorders

University Ghent1 site in 1 country95 target enrollmentSeptember 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Whiplash Injuries
Sponsor
University Ghent
Enrollment
95
Locations
1
Primary Endpoint
blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The broad aim of this study is to investigate the effect of a modern neuroscience approach, which combines education on pain neuroscience with cognition-targeted exercise therapy and stress management, on brain structure and networks in patients with chronic whiplash-associated disorders (CWAD) in comparison to a control physiotherapy treatment.

Detailed Description

This project runs in parallel to a larger randomized-controlled trial (RCT) in which the 'modern neuroscience approach to WAD' is compared to usual care evidence-based physiotherapy (clinical trial registration number: NCT03239938). For the current study, additional magnetic resonance imaging (MRI) measures will be taken in a subsample of patients, who will be recruited from this larger RCT. In addition, a pain-free age- and sex-matched control group will be recruited for comparison. The current study consists of 2 MRI measurements that will take place at the University Hospital of Ghent (UZ Gent): baseline (pre-treatment) and follow-up (post-treatment; approximately 16 weeks after baseline). After pre-treatment assessment, the patients will be randomly allocated to the modern neuroscience approach or usual care physiotherapy, as part of the RCT.

Registry
clinicaltrials.gov
Start Date
September 4, 2019
End Date
October 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Experienced a whiplash trauma which is at least 3 months old and causes pain since at least 3 months, with pain experience with a mean pain frequency of 3 or more days per week, and with self-reported moderate to severe pain-related disability, established by a score of 15 or more of a maximum of 50 on the Neck Disability Index
  • Patients classified as WAD II or WAD III on the modified Quebec Task Force Scale
  • Native Dutch speaker
  • Not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state)
  • Refraining from consuming caffeine, alcohol and nicotine in the hour before the MRI scans (in both measurement times: before the start of the rehabilitation and after the end of the rehabilitation).

Exclusion Criteria

  • Neuropathic pain
  • Being pregnant or having given birth in the preceding year
  • Chronic fatigue syndrome
  • Fibromyalgia
  • Cardiovascular disorders
  • Endocrinological disorders
  • Rheumatic disorders
  • Psychiatric disorders
  • History of neck surgery
  • Loss of consciousness during/after the whiplash trauma

Outcomes

Primary Outcomes

blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state

Time Frame: Baseline (pre-treatment) assessment and follow-up assessment after 16 weeks of therapy (end of treatment).

change between baseline assessment and the follow-up assessment after 16 weeks (after end of treatment) will be examined

structural MRI measures (i.e., grey and white matter)

Time Frame: Baseline (pre-treatment) assessment and follow-up assessment after 16 weeks of therapy (end of treatment).

change between baseline assessment and the follow-up assessment after 16 weeks (after end of treatment) will be examined

Study Sites (1)

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