NCT01601912|Completed
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Sponsor study identifier
observational
59
1 country
1
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 14, 2012
Actual (reported)May 18, 2012
Actual (reported)February 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 2013
Actual (reported)December 2013
Actual (reported)Changes in pain inhibition
To investigate pain inhibition, a combination of temporal en spatial summation will be used on the example of Cathcart et al. (2009). Temporal summation is applied by using an analogue Wagner pressure algometer and spatial summation is induced by causing ischemic pain with an inflatable cuff.
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
To investigate cognitive function we used the Psychomotor Vigilance Task (PVT) which is a 10-minute test.
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 selective attention and executive function
The Stroop task is used to assess selective attention and executive function
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
Change in scores on the Neck Disability Index questionnaire
Baseline = day 1, after the first intervention = day 8, after the second intervention = day 15
Change in scores on the Brief Pain Inventory questionnaire
Baseline = day 1, after the first intervention = day 8, after the second intervention = day 15
Changes in the scores on the Whiplash Associated Disorders Symptom list
Day 1 pre and post submaximal graded exercise and 24h after exercise = day 1 A,B&C, day 8 pre and post submaximal graded exercise & 24h after exercise = day 8 A,B&C, day 15 pre and post submaximal graded exercise & 24h after exercise = day 15 A,B&C
We will modulate endogenous adrenergic pain inhibitory mechanisms by using a selective norepinephrine reuptake inhibitor (NRI).
We will modulate serotonergic pain inhibitory mechanisms by using a selective serotonin reuptake inhibitor (SSRI)
40 mg, 1 application
20 mg, 1 application
WAD patients: primary care clinic \& community sample Healthy people: community sample
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, 1090, Belgium
Van Oosterwijck J, Nijs J, Meeus M, Van Loo M, Paul L. Lack of endogenous pain inhibition during exercise in people with chronic whiplash associated disorders: an experimental study. J Pain. 2012 Mar;13(3):242-54. doi: 10.1016/j.jpain.2011.11.006. Epub 2012 Jan 24.
Ickmans K, Malfliet A, De Kooning M, Goudman L, Hubloue I, Schmitz T, Goubert D, Aguilar-Ferrandiz ME. Lack of Gender and Age Differences in Pain Measurements Following Exercise in People with Chronic Whiplash-Associated Disorders. Pain Physician. 2017 Sep;20(6):E829-E840.
Jo Nijs, PhD
Vrije Universiteit Brussel
59 participants (actual enrollment reported by the registry).
First Submitted
May 14, 2012
First Posted
May 18, 2012
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Effectiveness of an Educational Video Following Acute Whiplash Trauma
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Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
January 14, 2014
Record last verified: 2014-01
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