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

Whiplash Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077619
• Other study ID #: B143201630602
• Secondary ID: G001419N
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2022
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 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

Related Conditions & MeSH terms

• Whiplash Injuries

Intervention

Behavioral:
• Modern pain neuroscience approach
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 physiotherapy
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.

Locations

Country	Name	City	State
Belgium	Department of rehabilitation sciences (Ghent University)	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state	change between baseline assessment and the follow-up assessment after 16 weeks (after end of treatment) will be examined	Baseline (pre-treatment) assessment and follow-up assessment after 16 weeks of therapy (end of treatment).
Primary	structural MRI measures (i.e., grey and white matter)	change between baseline assessment and the follow-up assessment after 16 weeks (after end of treatment) will be examined	Baseline (pre-treatment) assessment and follow-up assessment after 16 weeks of therapy (end of treatment).