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

Primary Purpose

Whiplash Injuries

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Modern pain neuroscience approach

Usual care physiotherapy

About this trial

This is an interventional basic science trial for Whiplash Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of rehabilitation sciences (Ghent University)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modern pain neuroscience approach

Usual care evidence-based physiotherapy

Arm Description

Behavioral: Modern pain neuroscience approach

Behavioral: Usual care evidence-based physiotherapy

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04077619

First Posted

August 22, 2019

Last Updated

November 14, 2022

Sponsor

University Ghent

Collaborators

Research Foundation Flanders

1. Study Identification

Unique Protocol Identification Number

NCT04077619

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

September 4, 2019 (Actual)

Primary Completion Date

October 1, 2022 (Actual)

Study Completion Date

October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Ghent

Collaborators

Research Foundation Flanders

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Whiplash Injuries

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Modern pain neuroscience approach

Arm Type

Experimental

Arm Description

Behavioral: Modern pain neuroscience approach

Arm Title

Usual care evidence-based physiotherapy

Arm Type

Active Comparator

Arm Description

Behavioral: Usual care evidence-based physiotherapy

Intervention Type

Behavioral

Intervention Name(s)

Modern pain neuroscience approach

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Usual care physiotherapy

Intervention Description

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 Outcome Measure Information:

Title

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

Description

change between baseline assessment and the follow-up assessment after 16 weeks (after end of treatment) will be examined

Time Frame

Baseline (pre-treatment) assessment and follow-up assessment after 16 weeks of therapy (end of treatment).

Title

structural MRI measures (i.e., grey and white matter)

Description

change between baseline assessment and the follow-up assessment after 16 weeks (after end of treatment) will be examined

Time Frame

Baseline (pre-treatment) assessment and follow-up assessment after 16 weeks of therapy (end of treatment).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mira Meeus, PhD

Organizational Affiliation

University Ghent

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Iris Coppieters, PhD

Organizational Affiliation

University Ghent

Official's Role

Study Director

Facility Information:

Facility Name

Department of rehabilitation sciences (Ghent University)

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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