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Completed

NCT Number: NCT04077619

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of rehabilitation sciences (Ghent University)

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modern pain neuroscience approach

Behavioral

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

Behavioral

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.

Primary outcomes

  1. blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state

    Time frame: 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)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Research Foundation Flanders

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 4, 2019
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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