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

Sponsor
University Ghent (Other)
Overall Status
Recruiting
CT.gov ID
NCT04077619
Collaborator
Research Foundation Flanders (Other)
97
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2
51.9
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Modern pain neuroscience approach
  • Behavioral: Usual care physiotherapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
97 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Sep 4, 2019
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of rehabilitation sciences (Ghent University) Ghent Belgium 9000

Sponsors and Collaborators

  • University Ghent
  • Research Foundation Flanders

Investigators

  • Principal Investigator: Mira Meeus, PhD, University Ghent
  • Study Director: Iris Coppieters, PhD, University Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Ghent
ClinicalTrials.gov Identifier:
NCT04077619
Other Study ID Numbers:
  • B143201630602
  • G001419N
First Posted:
Sep 4, 2019
Last Update Posted:
Dec 6, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2021