WhiplashNCT04204525
Chronic Whiplash Associated Disorders: Disability, Pain (Beliefs), Central Sensitization and Brain Activity
An observational study of Whiplash, run by University Ghent at 1 site in Belgium.
Trial summary
This is a cross-sectional case-control study in which 70 patients with chronic whiplash associated disorders will be recruited and compared to 70 healthy pain-free controls. The primary research question is to determine differences is self-reported functional status, pain, health-related quality of life, psychological… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Whiplash
- What is being tested?
- Quantitative sensory testing
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 1 Jan 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with chronic whiplash associated disorders will be compared to healthy controls
Who may be able to join
None listed.
Who cannot join
- Neuropathic pain; being pregnant or having given birth in the preceding year; chronic fatigue syndrome, fibromyalgia, cardiovascular disorders, endocrinological disorders, rheumatic and psychiatric disorders, epilepsy, history of specific spinal surgery (i.e. surgery for spinal stenosis); history of neck or shoulder surgery in the past 3 years and loss of consciousness during/after the trauma.
- Healthy pain-free persons (n=70), male or female, aged between 18 and 65 years, will be recruited. The healthy pain-free persons will serve as a control group and should meet the following inclusion criteria: 1) no history of whiplash trauma, no pain experience with a mean pain intensity of more than 2 out of 10 on the visual analogue scale for more than 8 consecutive days in the preceding year in the neck-shoulder-arm region 2) painfree at the day of testing (vas < 2/10) 3) native dutch speaker and 4) refraining from non-opioid analgesics 48h before the assessments (experimental measures baseline), and refraining from caffeine, alcohol and nicotine 24h before the assessments (experimental measures baseline).
- being pregnant or having given birth in the preceding year; chronic fatigue syndrome, fibromyalgia, cardiovascular disorders, endocrinological or neurological disorders, rheumatic and psychiatric disorders, epilepsy, history of neck-shoulder surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evidence for Central Sensitization in Patients With Chronic Whiplash Associated Disorders Based on Self-reported Outcomes of Pain (Beliefs), Disability, Central Sensitization, Quantitative Sensory Testing, and Electro-encephalography.
This is a cross-sectional case-control study in which 70 patients with chronic whiplash associated disorders will be recruited and compared to 70 healthy pain-free controls. The primary research question is to determine differences is self-reported functional status, pain, health-related quality of life, psychological correlates, measures of central sensitization, quantitative sensory testing (QST) and quantitative scalp Electroencephalography (EEG) to measure various parameters of brain activation. The secondary research question is to determine whether relationships can be found between the self-reported outcomes on one hand and the QST and EEG on the other hand.
Read the detailed description
Chronic whiplash associated disorders (CWAD) are frequently occuring conditions with varying degrees of neck pain and disability. They occur usually as a consequence of a motor vehicle accident. Acute whiplash injury has an annual incidence of 200-300 per 100.000 and affects 83% of persons in a traffic collision. Up to 50% of WAD patients do not fully recover, and up to 25% continue to have moderate to severe pain-related disabilities. The consequent pain and disability give rise to substantial socioeconomic cost. In Europe, the annual cost of WAD was estimated to be 12 billion euro.
Chronic neck pain, as observed in CWAD, is often incompletely responsive to available therapies. Due to the current lack of knowledge concerning the underlying factors responsible for the maintenance of these chronic pain conditions, there is no consensus on dedicated and specific therapy approaches for CWAD, resulting in a treatment gap in this condition. The chronicity and severeness of the disorders has led to paradigm shifts in the reasoning about chronic pain from seeing it as a symptom towards as a disease. Neuroimaging has provided evidence that chronic pain is a multidimensional process affecting sensory and emotional processing based on an altered state of the central nervous system in the form of central sensitization (CS). This sensitization results from an increased responsiveness to a variety of stimuli and expresses itself in the form of hyperalgesia, allodynia, referred pain, and ultimately in chronic widespread pain. Changes in both structural and functional brain activity and connectivity over time contribute to an augmentation of pain perception, by an enhanced pain facilitation and defective inhibition of nociceptive signals. It remains however debated whether CS is present as a pathophysiological feature in CWAD.
In this project we hypothesize that CS is one of the main features of the pathophysiology of CWAD, and that relationships occur between QST and EEG on one hand, and self-reported pain, disability, quality of life, psychological correlates and central sensitization on the other hand.
Therefore, 70 patients with CWAD and 70 (gender and age) matched healthy controls will be invited to fill out questionnaires, perform a QST protocol and EEG measurements.
The questionnaires will be filled out online during the two weeks before the determined testing moment and will consist of the Neck Disability Index, the Short Form Health Survey-36 items, a 0-10 Numeric Rating Scale for pain, the Central Sensitization Inventory, the Dutch version of the Pain Catastrophizing Scale, the Impact of Event Scale revised, the Pain anxiety symptoms scale (PASS-20), the patient specific complaints questionnaire (PSK), the Dolour neuropathic 4 (DN4) and the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS). Dutch versions of all questionnaires will be used.
During the testing moment, a QST protocol will be combined with EEG assessment. Electrical detection and electrical pain thresholds will be determined with a constant current electrical stimulator (DS7A Digitimer). Determination of the electrical detection and electrical pain threshold with the electrical stimulator will be performed at the sural nerve of the dominant leg and at the median nerve of both arms. Endogenous pain facilitation will be assessed by a temporal summation paradigm by delivering 20 electrical stimuli at the intensity of the electrical pain threshold.
Endogenous pain inhibition will be assessed by a conditioned pain modulation paradigm with electrical stimulation as test stimulus and the cold pressor test (immersion of the hand up to the wrist in cold water of 12°C) as conditioning stimulus.
EEG measurements with be performed with scalp EEG (Eego Sports, Ant neuro) with 32 surface Sn electrodes in a headcap in referential montage following the standard 10-20 recording system. Participants will be seated in a comfortable chair in a quiet room.
A 5 minute resting state measurement will be performed with eyes closed, followed by EEG measurements during the condition pain modulation paradigm.
- Conditions
- Whiplash
- Being tested
- Quantitative sensory testing
- Keywords
- chronic whiplash associated disorders, central sensitization, electroencephalography, functionality, quality of life, cross-sectional
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative sensory testingDiagnostic test
Also called Electro-encephalography
Electrical detection and pain thresholds will be determined (at the sural nerve of the dominant leg and at the median nerve of both arms) with a constant current electrical stimulator.
Endogenous pain facilitation will be assessed by a temporal summation paradigm by delivering 20 electrical stimuli at the intensity of the electrical pain threshold.
Endogenous pain inhibition will be assessed by a conditioned pain modulation paradigm with electrical stimulation as test stimulus and the cold pressor test as conditioning stimulus.
EEG measurements with be performed with scalp EEG with 32 surface Sn electrodes in a headcap in referential montage following the standard 10-20 recording system.
A 5 minute resting state measurement will be performed with eyes closed, followed by EEG measurements during the condition pain modulation paradigm to assess the evoked-related potentials.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic whiplash associated disorders | Male or female, aged between 18 and 65 years. Inclusion: 1) whiplash trauma (at least three months old) and pain since at least 3 months, self-reported mild to severe pain-related disability (score of 5/50 or more on the neck disability index), classified as wad II or wad III on the modified Quebec task force scale; 2) not undertaking exercise 1 day before the experiment; 3) not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state); 4) native dutch speaker and 5) refraining from non-opioid analgesics 48h before the assessments, and refraining from caffeine, alcohol and nicotine 24h before the assessments Receives: Diagnostic Test: Quantitative sensory testing | |
| Healthy controls | Male or female, aged between 18 and 65 years. Inclusion: 1) no history of whiplash trauma, no pain with a mean pain intensity of more than 2/10 on the visual analogue scale for > 8 consecutive days in the preceding year in the neck-shoulder-arm region 2) painfree at the day of testing 3) native dutch speaker and 4) refraining from non-opioid analgesics 48h before the assessments, and refraining from caffeine, alcohol and nicotine 24h before the assessments. Receives: Diagnostic Test: Quantitative sensory testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported functional status or disability
The Dutch version of the Neck Disability Index (questionnaire)
Measured: Single assessment, within 2 weeks before test moment
Self-reported health-related quality of life
The Dutch version of the Short Form Health Survey-36 items (questionnaire)
Measured: Single assessment, within 2 weeks before test moment
Self-reported pain assessment
A 0-10 Numeric Rating Scale for pain (questionnaire). Patients fill out the Numeric Rating Scale (0 no pain - 10 worst pain imaginable) for their perceived neck pain.
Measured: Single assessment, at test moment
Self-reported central sensitization symptoms
The Dutch version of the Central Sensitization Inventory (questionnaire)
Measured: Single assessment, within 2 weeks before test moment
Electrical detection and electrical pain thresholds with a constant current electrical stimulator (DS7A Digitimer)
Determination of the electrical detection and electrical pain threshold with the electrical stimulator will be performed at the sural nerve of the dominant leg and at the median nerve of the arms.
Measured: Single assessment, during single test moment (duration: approximately 20min), date of test moment will be determined based on the availability of the subject.
Endogenous pain facilitation assessed by a temporal summation paradigm
Temporal summation of electrical pain will be assessed by delivering 20 electrical stimuli at the intensity of the electrical pain threshold.
Measured: Single assessment, during single test moment (duration: approximately 10min), date of test moment will be determined based on the availability of the subject.
Endogenous pain inhibition assessed by a conditioned pain modulation paradigm
Conditioned pain modulation will be tested with electrical stimulation as test stimulus and the cold pressor test (immersion the hand up to the wrist in cold water of 12°C) as conditioning stimulus.
Measured: Single assessment,during single test moment (duration: approximately 10min), date of test moment will be determined based on the availability of the subject.
Resting state brain activity
Quantitative Electroencephalography (QEEG) will be recorded from 32 Sn surface electrodes using an electrode cap during 5 minutes of sitting on a chair with eyes closed. Spectral power will be analyzed.
Measured: Single assessment, during single test moment (duration: approximately 5min), date of test moment will be determined based on the availability of the subject.
Event-related potentials
Quantitative Electroencephalography (QEEG) will be recorded from 32 Sn surface electrodes using an electrode cap during the conditioned pain modulation paradigm. Latency and amplitude of the event-related potentials will be calculated.
Measured: Single assessment, during single test moment (duration: approximately 20min), date of test moment will be determined based on the availability of the subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Jan 2020
- Primary completion31 Oct 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for WhiplashStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, University Hospital, Ghent, Universitair Ziekenhuis Brussel
- Responsible party
- Sponsor
- Investigators
- Iris Coppieters, Study director, University GhentJo Nijs, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204525
- Sponsor's protocol ID
- 2017/0850
- Status last verified
- Dec 2019
- First submitted
- 20 Nov 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pinheiro ES, de Queiros FC, Montoya P, Santos CL, do Nascimento MA, Ito CH, Silva M, Nunes Santos DB, Benevides S, Miranda JG, Sa KN, Baptista AF. Electroencephalographic Patterns in Chronic Pain: A Systematic Review of the Literature. PLoS One. 2016 Feb 25;11(2):e0149085. doi: 10.1371/journal.pone.0149085. eCollection 2016.
PubMed 26914356Van Oosterwijck J, Nijs J, Meeus M, Paul L. Evidence for central sensitization in chronic whiplash: a systematic literature review. Eur J Pain. 2013 Mar;17(3):299-312. doi: 10.1002/j.1532-2149.2012.00193.x. Epub 2012 Sep 25.
PubMed 23008191Lenoir D, Willaert W, Ickmans K, Bernaers L, Nijs J, Malfliet A, Danneels L, Leysen L, De Pauw R, Cagnie B, Coppieters I, Meeus M. Are Reports of Pain, Disability, Quality of Life, Psychological Factors, and Central Sensitization Related to Outcomes of Quantitative Sensory Testing in Patients Suffering From Chronic Whiplash Associated Disorders? Clin J Pain. 2021 Dec 22;38(3):159-172. doi: 10.1097/AJP.0000000000001013.
PubMed 34939972
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence for Central Sensitization in Patients With Chronic Whiplash Associated Disorders Based on Self-reported Outcomes of Pain (Beliefs), Disability, Central Sensitization, Quantitative Sensory Testing, and Electro-encephalography.
- ClinicalTrials.gov ID
- NCT04204525
- Acronym / sponsor ID
- 2017/0850
- Conditions
- Whiplash
- Keywords
- chronic whiplash associated disorders, central sensitization, electroencephalography, functionality, quality of life, cross-sectional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, University Hospital, Ghent, Universitair Ziekenhuis Brussel
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 19 Dec 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.
This is a cross-sectional case-control study in which 70 patients with chronic whiplash associated disorders will be recruited and compared to 70 healthy pain-free controls. The primary research question is to determine differences is self-reported functional status, pain, health-related quality of life, psychological correlates, measures of central sensitization, quantitative sensory testing (QST) and quantitative scalp Electroencephalography (EEG) to measure various parameters of brain activation. The secondary research question is to determine whether relationships can be found between the self-reported outcomes on one hand and the QST and EEG on the other hand.
Detailed description
Chronic whiplash associated disorders (CWAD) are frequently occuring conditions with varying degrees of neck pain and disability. They occur usually as a consequence of a motor vehicle accident. Acute whiplash injury has an annual incidence of 200-300 per 100.000 and affects 83% of persons in a traffic collision. Up to 50% of WAD patients do not fully recover, and up to 25% continue to have moderate to severe pain-related disabilities. The consequent pain and disability give rise to substantial socioeconomic cost. In Europe, the annual cost of WAD was estimated to be 12 billion euro.
Chronic neck pain, as observed in CWAD, is often incompletely responsive to available therapies. Due to the current lack of knowledge concerning the underlying factors responsible for the maintenance of these chronic pain conditions, there is no consensus on dedicated and specific therapy approaches for CWAD, resulting in a treatment gap in this condition. The chronicity and severeness of the disorders has led to paradigm shifts in the reasoning about chronic pain from seeing it as a symptom towards as a disease. Neuroimaging has provided evidence that chronic pain is a multidimensional process affecting sensory and emotional processing based on an altered state of the central nervous system in the form of central sensitization (CS). This sensitization results from an increased responsiveness to a variety of stimuli and expresses itself in the form of hyperalgesia, allodynia, referred pain, and ultimately in chronic widespread pain. Changes in both structural and functional brain activity and connectivity over time contribute to an augmentation of pain perception, by an enhanced pain facilitation and defective inhibition of nociceptive signals. It remains however debated whether CS is present as a pathophysiological feature in CWAD.
In this project we hypothesize that CS is one of the main features of the pathophysiology of CWAD, and that relationships occur between QST and EEG on one hand, and self-reported pain, disability, quality of life, psychological correlates and central sensitization on the other hand.
Therefore, 70 patients with CWAD and 70 (gender and age) matched healthy controls will be invited to fill out questionnaires, perform a QST protocol and EEG measurements.
The questionnaires will be filled out online during the two weeks before the determined testing moment and will consist of the Neck Disability Index, the Short Form Health Survey-36 items, a 0-10 Numeric Rating Scale for pain, the Central Sensitization Inventory, the Dutch version of the Pain Catastrophizing Scale, the Impact of Event Scale revised, the Pain anxiety symptoms scale (PASS-20), the patient specific complaints questionnaire (PSK), the Dolour neuropathic 4 (DN4) and the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS). Dutch versions of all questionnaires will be used.
During the testing moment, a QST protocol will be combined with EEG assessment. Electrical detection and electrical pain thresholds will be determined with a constant current electrical stimulator (DS7A Digitimer). Determination of the electrical detection and electrical pain threshold with the electrical stimulator will be performed at the sural nerve of the dominant leg and at the median nerve of both arms. Endogenous pain facilitation will be assessed by a temporal summation paradigm by delivering 20 electrical stimuli at the intensity of the electrical pain threshold.
Endogenous pain inhibition will be assessed by a conditioned pain modulation paradigm with electrical stimulation as test stimulus and the cold pressor test (immersion of the hand up to the wrist in cold water of 12°C) as conditioning stimulus.
EEG measurements with be performed with scalp EEG (Eego Sports, Ant neuro) with 32 surface Sn electrodes in a headcap in referential montage following the standard 10-20 recording system. Participants will be seated in a comfortable chair in a quiet room.
A 5 minute resting state measurement will be performed with eyes closed, followed by EEG measurements during the condition pain modulation paradigm.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic whiplash associated disorders | – | Diagnostic Test: Quantitative sensory testingMale or female, aged between 18 and 65 years. Inclusion: 1) whiplash trauma (at least three months old) and pain since at least 3 months, self-reported mild to severe pain-related disability (score of 5/50 or more on the neck disability index), classified as wad II or wad III on the modified Quebec task force scale; 2) not undertaking exercise 1 day before the experiment; 3) not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state); 4) native dutch speaker and 5) refraining from non-opioid analgesics 48h before the assessments, and refraining from caffeine, alcohol and nicotine 24h before the assessments |
| Healthy controls | – | Diagnostic Test: Quantitative sensory testingMale or female, aged between 18 and 65 years. Inclusion: 1) no history of whiplash trauma, no pain with a mean pain intensity of more than 2/10 on the visual analogue scale for > 8 consecutive days in the preceding year in the neck-shoulder-arm region 2) painfree at the day of testing 3) native dutch speaker and 4) refraining from non-opioid analgesics 48h before the assessments, and refraining from caffeine, alcohol and nicotine 24h before the assessments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic whiplash associated disorders will be compared to healthy controls
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Neuropathic pain; being pregnant or having given birth in the preceding year; chronic fatigue syndrome, fibromyalgia, cardiovascular disorders, endocrinological disorders, rheumatic and psychiatric disorders, epilepsy, history of specific spinal surgery (i.e. surgery for spinal stenosis); history of neck or shoulder surgery in the past 3 years and loss of consciousness during/after the trauma.
- Healthy pain-free persons (n=70), male or female, aged between 18 and 65 years, will be recruited. The healthy pain-free persons will serve as a control group and should meet the following inclusion criteria: 1) no history of whiplash trauma, no pain experience with a mean pain intensity of more than 2 out of 10 on the visual analogue scale for more than 8 consecutive days in the preceding year in the neck-shoulder-arm region 2) painfree at the day of testing (vas < 2/10) 3) native dutch speaker and 4) refraining from non-opioid analgesics 48h before the assessments (experimental measures baseline), and refraining from caffeine, alcohol and nicotine 24h before the assessments (experimental measures baseline).
- being pregnant or having given birth in the preceding year; chronic fatigue syndrome, fibromyalgia, cardiovascular disorders, endocrinological or neurological disorders, rheumatic and psychiatric disorders, epilepsy, history of neck-shoulder surgery.
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 |
|---|---|---|
| Quantitative sensory testingAlso: Electro-encephalographyElectrical detection and pain thresholds will be determined (at the sural nerve of the dominant leg and at the median nerve of both arms) with a constant current electrical stimulator. Endogenous pain facilitation will be assessed by a temporal summation paradigm by delivering 20 electrical stimuli at the intensity of the electrical pain threshold. Endogenous pain inhibition will be assessed by a conditioned pain modulation paradigm with electrical stimulation as test stimulus and the cold pressor test as conditioning stimulus. EEG measurements with be performed with scalp EEG with 32 surface Sn electrodes in a headcap in referential montage following the standard 10-20 recording system. A 5 minute resting state measurement will be performed with eyes closed, followed by EEG measurements during the condition pain modulation paradigm to assess the evoked-related potentials. | Diagnostic test | Healthy controls, Patients with chronic whiplash associated disorders |
Primary outcome
Self-reported functional status or disability
Time frame: Single assessment, within 2 weeks before test moment
The Dutch version of the Neck Disability Index (questionnaire)
Self-reported health-related quality of life
Time frame: Single assessment, within 2 weeks before test moment
The Dutch version of the Short Form Health Survey-36 items (questionnaire)
Self-reported pain assessment
Time frame: Single assessment, at test moment
A 0-10 Numeric Rating Scale for pain (questionnaire). Patients fill out the Numeric Rating Scale (0 no pain - 10 worst pain imaginable) for their perceived neck pain.
Self-reported central sensitization symptoms
Time frame: Single assessment, within 2 weeks before test moment
The Dutch version of the Central Sensitization Inventory (questionnaire)
Electrical detection and electrical pain thresholds with a constant current electrical stimulator (DS7A Digitimer)
Time frame: Single assessment, during single test moment (duration: approximately 20min), date of test moment will be determined based on the availability of the subject.
Determination of the electrical detection and electrical pain threshold with the electrical stimulator will be performed at the sural nerve of the dominant leg and at the median nerve of the arms.
Endogenous pain facilitation assessed by a temporal summation paradigm
Time frame: Single assessment, during single test moment (duration: approximately 10min), date of test moment will be determined based on the availability of the subject.
Temporal summation of electrical pain will be assessed by delivering 20 electrical stimuli at the intensity of the electrical pain threshold.
Endogenous pain inhibition assessed by a conditioned pain modulation paradigm
Time frame: Single assessment,during single test moment (duration: approximately 10min), date of test moment will be determined based on the availability of the subject.
Conditioned pain modulation will be tested with electrical stimulation as test stimulus and the cold pressor test (immersion the hand up to the wrist in cold water of 12°C) as conditioning stimulus.
Resting state brain activity
Time frame: Single assessment, during single test moment (duration: approximately 5min), date of test moment will be determined based on the availability of the subject.
Quantitative Electroencephalography (QEEG) will be recorded from 32 Sn surface electrodes using an electrode cap during 5 minutes of sitting on a chair with eyes closed. Spectral power will be analyzed.
Event-related potentials
Time frame: Single assessment, during single test moment (duration: approximately 20min), date of test moment will be determined based on the availability of the subject.
Quantitative Electroencephalography (QEEG) will be recorded from 32 Sn surface electrodes using an electrode cap during the conditioned pain modulation paradigm. Latency and amplitude of the event-related potentials will be calculated.
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 5 Aug 2021.
- Background: PubMed 26914356Pinheiro ES, de Queiros FC, Montoya P, Santos CL, do Nascimento MA, Ito CH, Silva M, Nunes Santos DB, Benevides S, Miranda JG, Sa KN, Baptista AF. Electroencephalographic Patterns in Chronic Pain: A Systematic Review of the Literature. PLoS One. 2016 Feb 25;11(2):e0149085. doi: 10.1371/journal.pone.0149085. eCollection 2016.
- Background: PubMed 23008191Van Oosterwijck J, Nijs J, Meeus M, Paul L. Evidence for central sensitization in chronic whiplash: a systematic literature review. Eur J Pain. 2013 Mar;17(3):299-312. doi: 10.1002/j.1532-2149.2012.00193.x. Epub 2012 Sep 25.
- Derived from this study: PubMed 34939972Lenoir D, Willaert W, Ickmans K, Bernaers L, Nijs J, Malfliet A, Danneels L, Leysen L, De Pauw R, Cagnie B, Coppieters I, Meeus M. Are Reports of Pain, Disability, Quality of Life, Psychological Factors, and Central Sensitization Related to Outcomes of Quantitative Sensory Testing in Patients Suffering From Chronic Whiplash Associated Disorders? Clin J Pain. 2021 Dec 22;38(3):159-172. doi: 10.1097/AJP.0000000000001013.
- Individual participant dataSharing planned: Undecided
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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.
Iris Coppieters study director
University Ghent
Jo Nijs principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Whiplash, 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 0 inclusion and 3 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 5 Aug 2021. 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?
Self-reported functional status or disability (time frame: Single assessment, within 2 weeks before test moment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04204525, which also lists 3 linked publications.
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 5 Aug 2021.