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

NCT01601912 | Completed

• 1 other identifier: WFWG-22
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Whiplash Injuries

Keywords

Whiplash Injuries; Chronic Pain; Exercise; Cognition

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

Atomoxetine NRI

We will modulate endogenous adrenergic pain inhibitory mechanisms by using a selective norepinephrine reuptake inhibitor (NRI).

Drug: Atomoxetine

Citalopram SSRI

We will modulate serotonergic pain inhibitory mechanisms by using a selective serotonin reuptake inhibitor (SSRI)

Drug: Citalopram

Interventions

Atomoxetine DRUG

40 mg, 1 application

Also known as: Strattera (Eli Lilly Nederland B.V)

Atomoxetine NRI

Citalopram DRUG

20 mg, 1 application

Also known as: Citalopram Sandoz (Sandoz N.V.)

Citalopram SSRI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

WAD patients: primary care clinic \& community sample Healthy people: community sample

You may qualify if:

• 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
• years of age and with Dutch as their native language will be able to participate

You may not qualify if:

• 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.
• 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
• \< 18years \> 65 years
• pregnant or until 1 year postnatal (for women)
• use of anti-depressive, anti-epileptic and pain medication.

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

Related Publications (2)

• 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.

  PMID: 22277322 BACKGROUND

• 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.

  PMID: 28934789 DERIVED

MeSH Terms

Conditions

Whiplash Injuries; Chronic Pain; Motor Activity

Interventions

Atomoxetine Hydrochloride; Citalopram

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jo Nijs, PhD

  Vrije Universiteit Brussel

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 18, 2012
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

BE (1)