Whiplash InjuriesNCT04077619
Shifting Away From Pain: a Neurocognitive Approach in Treatment of Whiplash
A study testing Modern pain neuroscience approach in people with Whiplash Injuries, run by University Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Whiplash Injuries
- What is being tested?
- Modern pain neuroscience approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Sep 2019to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Neuropathic pain
- Being pregnant or having given birth in the preceding year
- Chronic fatigue syndrome
- Fibromyalgia
- Cardiovascular disorders
- Epilepsy
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of rehabilitation sciences (Ghent University)
Ghent, 9000
About this study
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
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.
Read the 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.
- Conditions
- Whiplash Injuries
- Being tested
- Modern pain neuroscience approach, Usual care physiotherapy
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modern pain neuroscience approachBehavioural
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 physiotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Modern pain neuroscience approach | Experimental | Behavioral: Modern pain neuroscience approach Receives: Behavioral: Modern pain neuroscience approach |
| Usual care evidence-based physiotherapy | Active comparator | Behavioral: Usual care evidence-based physiotherapy Receives: Behavioral: Usual care physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline (pre-treatment) assessment and follow-up assessment after 16 weeks of therapy (end of treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start4 Sep 2019
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash InjuriesStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Mira Meeus, PhD, Principal investigator, University GhentIris Coppieters, PhD, Study director, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077619
- Sponsor's protocol ID
- B143201630602
- Other IDs
- G001419N
- Status last verified
- Nov 2022
- First submitted
- 22 Aug 2019
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04077619
- Acronym / sponsor ID
- B143201630602
- Conditions
- Whiplash Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Modern pain neuroscience approach | Experimental | Behavioral: Modern pain neuroscience approachBehavioral: Modern pain neuroscience approach |
| Usual care evidence-based physiotherapy | Active comparator | Behavioral: Usual care physiotherapyBehavioral: Usual care evidence-based physiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (17 listed)
- Neuropathic pain
- Being pregnant or having given birth in the preceding year
- Chronic fatigue syndrome
- Fibromyalgia
- Cardiovascular disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modern pain neuroscience approachModern 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. | Behavioural | Modern pain neuroscience approach |
| Usual care physiotherapyUsual 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. | Behavioural | Usual care evidence-based physiotherapy |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
Related trials for Whiplash Injuries
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Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
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Virtual Reality Rehabilitation in Neck Pain Subjects
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Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mira Meeus, PhD principal investigator
University Ghent
Iris Coppieters, PhD study director
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modern pain neuroscience approach in people with Whiplash Injuries, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.