Shifting Away From Pain: a Neurocognitive Approach in Treatment of Whiplash

Not Applicable

Completed

• Conditions: Whiplash Injuries

• Registration Number: NCT04077619
• Lead Sponsor: University Ghent

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.

Study Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-09-02
• Study Start: 2019-09-04
• Study First Posted: 2019-09-04
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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
• 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)
• Psychiatric condition and ongoing medication that would alter emotional or sensory processing
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of rehabilitation sciences (Ghent University); 🇧🇪 Ghent, Belgium