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

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.

Study Overview

• Status: Completed
• Conditions: Whiplash Injuries
• Intervention / Treatment: Behavioral: Modern pain neuroscience approach; Behavioral: Usual care physiotherapy

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 Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Department of rehabilitation sciences (Ghent University)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modern pain neuroscience approach; Behavioral: Modern pain neuroscience approach	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.
Active Comparator: Usual care evidence-based physiotherapy; Behavioral: Usual care evidence-based physiotherapy	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Research Foundation Flanders
• Investigators: Principal Investigator: Mira Meeus, PhD, University Ghent; Study Director: Iris Coppieters, PhD, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Neck Injuries; Whiplash Injuries
• Other Study ID Numbers: B143201630602; G001419N (Other Grant/Funding Number: Research Foundation Flanders)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No