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

NCT04077619 | Completed DMC

• 2 other identifiers: B143201630602G001419N
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash Injuries

Outcome Measures

Primary Outcomes (2)

• 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).

Study Arms (2)

Modern pain neuroscience approach

EXPERIMENTAL

Behavioral: Modern pain neuroscience approach

Behavioral: Modern pain neuroscience approach

Usual care evidence-based physiotherapy

ACTIVE COMPARATOR

Behavioral: Usual care evidence-based physiotherapy

Behavioral: Usual care physiotherapy

Interventions

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.

Modern pain neuroscience approach

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.

Usual care evidence-based physiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• a history of a chronic pain syndrome

Sponsors & Collaborators

• University Ghent: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

Department of rehabilitation sciences (Ghent University)

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Whiplash Injuries

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries

Study Officials

• Mira Meeus, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

• Iris Coppieters, PhD

  University Ghent

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: September 4, 2019
• Study Start: September 4, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

BE (1)