CompletedNot Applicable

Chronic Whiplash Associated Disorders: Disability, Pain (Beliefs), Central Sensitization and Brain Activity

Belgium120 participantsStarted 2020-01-01

Plain-language 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 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Patients with chronic WAD (n=70), male or female, aged between 18 and 65 years, will be recruited. The patients should meet the following inclusion criteria: 1) a whiplash trauma which is at least three months old and causes pain since at least 3 months, with self-reported mild to severe pain-related disability, established by a score of 5 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; 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. Exclusion criteria: 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) …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Self-reported functional status or disability

Timeframe: Single assessment, within 2 weeks before test moment

Self-reported health-related quality of life

Timeframe: Single assessment, within 2 weeks before test moment

Self-reported pain assessment

Timeframe: Single assessment, at test moment

Self-reported central sensitization symptoms

Timeframe: Single assessment, within 2 weeks before test moment

Electrical detection and electrical pain thresholds with a constant current electrical stimulator (DS7A Digitimer)

Timeframe: 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

Timeframe: Single assessment, during single test moment (duration: approximately 10min), date of test moment will be determined based on the availability of the subject.

Trial details

NCT IDNCT04204525

SponsorUniversity Ghent

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-10-31

View on ClinicalTrials.gov More Whiplash trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Self-reported functional status or disability

Timeframe: Single assessment, within 2 weeks before test moment

Self-reported health-related quality of life

Timeframe: Single assessment, within 2 weeks before test moment

Self-reported pain assessment

Timeframe: Single assessment, at test moment

Self-reported central sensitization symptoms

Timeframe: Single assessment, within 2 weeks before test moment

Electrical detection and electrical pain thresholds with a constant current electrical stimulator (DS7A Digitimer)

Timeframe: 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

Timeframe: Single assessment, during single test moment (duration: approximately 10min), date of test moment will be determined based on the availability of the subject.