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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04077619
Enrollment
95
Registered
2019-09-04
Start date
2019-09-04
Completion date
2022-10-01
Last updated
2022-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Whiplash Injuries

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.

Interventions

Modern pain neuroscience approach. The modern pain neuroscience approach includes 3 sessions (1 group and 2 individual sessions) of therapeutic pain neuroscience education followed by 15 individual sessions of dynamic and functional cognition-targeted exercise therapy and stress management techniques. In addition, participants will be instructed to perform a daily set of home exercises. The exercises will be performed in a time-contingent way. The 18 sessions will be spread over a period of 16 weeks.

Usual care evidence-based physiotherapy The usual care evidence-based physiotherapy includes 3 sessions (1 group and 2 individual sessions) of neck school followed by 15 individual sessions of graded and active exercise therapy focusing on strength, flexibility, endurance, and ergonomic principles. In addition, participants will be instructed to perform a daily set of home exercises. The exercises will be performed in a symptom-contingent way. The 18 sessions will be spread over a period of 16 weeks.

Sponsors

Research Foundation Flanders
CollaboratorOTHER
University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

The other trial (NCT03239938) will randomize patients with chronic WAD to the experimental (modern neuroscience approach) or the control treatment (usual care physiotherapy). The WAD patient sample for the present MRI study will be a subsample recruited from this larger RCT. After inclusion in the large RCT, participants will be asked about the possibility of participating in the additional MRI study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

CWAD group: 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

Design outcomes

Primary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026