Neuroinflammation as a Predictor of Chronicity in Whiplash
NCT ID: NCT04940923
Last Updated: 2022-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
147 participants
OBSERVATIONAL
2021-06-01
2024-04-30
Brief Summary
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Work from the investigators' laboratory suggests that nerves may be inflamed. In this study, the contribution of nerve inflammation to symptoms early following whiplash will be established. It will determine whether clinical tests are able to identify those patients with inflamed nerves. It will also determine whether the presence of nerve inflammation can be used to identify patients who develop chronic pain. The study will recruit 115 patients within one month following a whiplash injury and thirty-two healthy volunteers. Participants will undergo a clinical assessment. A blood sample will be taken to look for inflammatory proteins and magnetic resonance imaging will be used to identify nerve inflammation in the neck and wrist. Questionnaires to establish neck disability, pain quality and psychological distress will be completed. MRI findings will be compared to healthy controls. At six-months, patients will be asked to repeat the questionnaires, which will be used to identify those patients who have recovered. Twenty-five recovered and twenty-five non-recovered patients will undergo a repeat MRI and clinical assessment. Although patients on this study will not directly benefit, the findings will help with early diagnosis and could refocus treatment to reduce chronic pain.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
Patients within 4 weeks of a whiplash injury.
MRI
T2 weighted and DTI MRI images of brachial plexus and wrist. Quantitative sensory tests include warm and cold detection and pain thresholds, paradoxical heat sensation, mechanical detection thresholds, mechanical pain sensation and thresholds, wind up ratios, vibration thresholds and pressure pain thresholds.
Clinical tests include standard neurological tests and test for heightened nerve mechanosensitivity.
Blood serum to analyse inflammatory proteins. Questionnaires include neck disability index, painDETECT, PTSD8, pain catastrophising scale, eq-5D-5L, DASS 42 and global perceived recovery
Healthy controls
Age and gender matched healthy controls
MRI
T2 weighted and DTI MRI images of brachial plexus and wrist. Quantitative sensory tests include warm and cold detection and pain thresholds, paradoxical heat sensation, mechanical detection thresholds, mechanical pain sensation and thresholds, wind up ratios, vibration thresholds and pressure pain thresholds.
Clinical tests include standard neurological tests and test for heightened nerve mechanosensitivity.
Blood serum to analyse inflammatory proteins. Questionnaires include neck disability index, painDETECT, PTSD8, pain catastrophising scale, eq-5D-5L, DASS 42 and global perceived recovery
Interventions
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MRI
T2 weighted and DTI MRI images of brachial plexus and wrist. Quantitative sensory tests include warm and cold detection and pain thresholds, paradoxical heat sensation, mechanical detection thresholds, mechanical pain sensation and thresholds, wind up ratios, vibration thresholds and pressure pain thresholds.
Clinical tests include standard neurological tests and test for heightened nerve mechanosensitivity.
Blood serum to analyse inflammatory proteins. Questionnaires include neck disability index, painDETECT, PTSD8, pain catastrophising scale, eq-5D-5L, DASS 42 and global perceived recovery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Male and female patients with chronic whiplash associated disorder that meet the Quebec Task Force Classification of whiplash grade II
2. Within approximately four weeks of their whiplash injury
3. Age 18-60
4. Participants capable of giving informed consent
Healthy Volunteers:
1. Free of neck or upper limb pain
2. No history of a whiplash injury or of neck or arm pain lasting \>3 months or any recent cervical or upper limb trauma requiring medical treatment.
3. Age 18-60
4. Participants capable of giving informed consent
Exclusion Criteria
1. Diagnosis of whiplash grade I (neck complaints without physical signs), III (obvious neurological signs) or IV (fracture or dislocation)
2. Experienced concussion or loss of consciousness as a result of the accident
3. Previous history of whiplash
4. Previous history of neck pain or headaches that required treatment
All participants (patients and healthy volunteers):
5. Unsuitability to undergo MRI (assessed with the MRI screening questionnaire)
6. Pregnant
7. History of inflammatory disease (e.g. autoimmune diseases, rheumatoid arthritis), neuropathy, diabetes, cancer or non-medically controlled hypertension
8. Current ongoing steroid treatment
9. Participants with an inadequate understanding of English will also be excluded
18 Years
60 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
University of Sussex
OTHER
Responsible Party
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Principal Investigators
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Andrew Dilley, PhD
Role: PRINCIPAL_INVESTIGATOR
Brighton and Sussex Medical School
Locations
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Brighton and Sussex Medical School
Brighton, East Sussex, United Kingdom
Oxford Neuroscience, University of Oxford
Oxford, Oxfordshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Ridehalgh C, Fundaun J, Bremner S, Cercignani M, Koushesh S, Schmid AB, Dilley A. Temporal development of peripheral neuroinflammation in whiplash-associated disorder grade II and its role in chronicity. Pain. 2025 Oct 10. doi: 10.1097/j.pain.0000000000003816. Online ahead of print.
Ridehalgh C, Fundaun J, Bremner S, Cercignani M, Koushesh S, Young R, Novak A, Greening J, Schmid AB, Dilley A. Evidence for peripheral neuroinflammation after acute whiplash. Pain. 2025 Oct 1;166(10):2285-2299. doi: 10.1097/j.pain.0000000000003560. Epub 2025 Mar 4.
Ridehalgh C, Fundaun J, Bremner S, Cercignani M, Young R, Trivedy C, Novak A, Greening J, Schmid A, Dilley A. Does peripheral neuroinflammation predict chronicity following whiplash injury? Protocol for a prospective cohort study. BMJ Open. 2022 Dec 15;12(12):e066021. doi: 10.1136/bmjopen-2022-066021.
Other Identifiers
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278291/ 070 DIL
Identifier Type: -
Identifier Source: org_study_id
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