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

NCT04204525 | Completed

• 1 other identifier: 2017/0850
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Whiplash

Keywords

chronic whiplash associated disorders; central sensitization; electroencephalography; functionality; quality of life; cross-sectional

Outcome Measures

Primary Outcomes (9)

• Self-reported functional status or disability

  The Dutch version of the Neck Disability Index (questionnaire)

  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)

  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.

  Single assessment, at test moment

• Self-reported central sensitization symptoms

  The Dutch version of the Central Sensitization Inventory (questionnaire)

  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.

  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.

  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.

  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.

  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.

  Single assessment, during single test moment (duration: approximately 20min), date of test moment will be determined based on the availability of the subject.

Study Arms (2)

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

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.

Diagnostic Test: Quantitative sensory testing

Interventions

Quantitative sensory testing DIAGNOSTIC_TEST

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.

Also known as: Electro-encephalography

Healthy controls; Patients with chronic whiplash associated disorders

Eligibility Criteria

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

Study Population

Patients with chronic whiplash associated disorders will be compared to healthy controls

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Ghent: lead
• Research Foundation Flanders: collaborator
• University Hospital, Ghent: collaborator
• Universitair Ziekenhuis Brussel: collaborator

Study Sites (1)

Ghent university

Ghent, Belgium

Location

Related Publications (3)

• 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.

  PMID: 26914356 BACKGROUND

• Van 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.

  PMID: 23008191 BACKGROUND

• Lenoir 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.

  PMID: 34939972 DERIVED

MeSH Terms

Conditions

Whiplash Injuries

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries

Study Officials

• Iris Coppieters

  University Ghent

  STUDY DIRECTOR

• Jo Nijs

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: December 19, 2019
• Study Start: January 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: January 1, 2021
• Last Updated: August 5, 2021

Record last verified: 2019-12

Locations

BE (1)