CompletedNot Applicable

Unraveling the Nature of Impaired Pain Inhibition in Patients With Chronic Whiplash-associated Disorders

Belgium59 participantsStarted 2013-02

Plain-language summary

The primary study aim is to unravel the nature of impaired pain inhibition during exercise in patients with chronic Whiplash-Associated Disorders (WAD). This will be ascertained by examining whether activation of serotonergic and/or noradrenergic descending pathways improves pain inhibition during exercise in these patients. In addition, it is aimed at examining whether activation of serotonergic and/or noradrenergic descending pathways prevents post-exertional malaise following submaximal exercise in chronic WAD patients. A secondary study aim comprises of examining the effect of an acute submaximal exercise with and without activation of serotonergic or noradrenergic descending pathways on chronic WAD patients' cognitive performance. Furthermore, the isolated effect of activated serotonergic and noradrenergic descending pathways on chronic WAD patients' cognitive performance will be studied.

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.

Inclusion Criteria for patients: * WAD grades I to III according to the Quebec Task Force criteria * experienced a whiplash trauma at least three months ago * with chronic pain as a result of a whiplash injury * 18-65 years of age and with Dutch as their native language will be able to participate Exclusion Criteria for patients: * other comorbidities or health issues that could explain the pain complaints * \< 18years \> 65 years * pregnant or until 1 year postnatal (for women) * use of anti-depressive, anti-epileptic and pain medication. Inclusion Criteria for healthy volunteers: * 18-65 years of age and with Dutch as their native language will be able to participate * having a sedentary job and doing \< 3 h moderate physical activity/week * being painfree without any chronic disease Exclusion Criteria for healthy volunteers: * \< 18years \> 65 years * pregnant or until 1 year postnatal (for women) * use of anti-depressive, anti-epileptic and pain medication.

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

Changes in pain inhibition

Timeframe: Baseline before and after the submaximal graded exercise= day 1 A & B, after first intervention before and after the submaximal graded exercise= day 8 A & B, after second intervention before and after the submaximal graded exercise = day 15 A & B

Changes in psychomotor vigilance and alertness

Changes in selective attention and executive function

Trial details

NCT IDNCT01601912

SponsorVrije Universiteit Brussel

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Whiplash Injuries trials