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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04204525
Other study ID # 2017/0850
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date January 1, 2021

Study information

Verified date December 2019
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Quantitative sensory testing
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.

Locations

Country Name City State
Belgium Ghent university Ghent

Sponsors (4)

Lead Sponsor Collaborator
University Ghent Research Foundation Flanders, Universitair Ziekenhuis Brussel, University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

Pinheiro ES, de Queirós FC, Montoya P, Santos CL, do Nascimento MA, Ito CH, Silva M, Nunes Santos DB, Benevides S, Miranda JG, Sá 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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported functional status or disability The Dutch version of the Neck Disability Index (questionnaire) Single assessment, within 2 weeks before test moment
Primary 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
Primary 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
Primary Self-reported central sensitization symptoms The Dutch version of the Central Sensitization Inventory (questionnaire) Single assessment, within 2 weeks before test moment
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
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