Trial document




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  DRKS00012791

Trial Description

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Title

Number sense: Functional and structural cerebral consequences of chronic inflammatory pain

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In 2004 Apkarian was the first to describe a reduction of neuronal cells in the prefrontal cortex and thalamus in patients with chronic back pain. Similar changes have subsequently been reported in other chronic pain syndromes involving different brain regions such as the parietal and the insular cortices.
The parietal cortex is especially interesting as it facilitates mental number representation that is needed for mathematical operations in man. Dehaene coined the phrase ‘number sense’ for this task. In pain medicine an intact number sense is important for the accurate assessment of pain intensities using scales.
A study by Ruscheweyh suggests patients with joint pain are especially prone to changes in the parietal cortex. It can therefore be hypothesized number sense is altered in inflammatory-rheumatic diseases due to a reduction in gray matter density.
Furthermore, the autonomic nervous system is also frequently altered in chronic inflammatory joint diseases. For instance, patients with rheumatoid arthritis often display an increased sympathetic activity. It is hence feasible to suggest that a change in number sense due to a reduction in gray matter density in the parietal cortex is associated with an increased activity of the sympathetic nervous system in patients with rheumatic-inflammatory pain. As a consequence of this increased sympathetic activity the insular cortex might also show an altered activity profile.
The aim of the study is to evaluate if number sense is altered in patients with painful chronic inflammatory joint disease compared to healthy controls and if the number sense changes are associated with functional and morphological changes in the brain, especially in the parietal and insular cortices.


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Brief Summary in Scientific Language

In 2004 Apkarian was the first to describe a reduction of gray matter density in the prefrontal cortex and thalamus in patients with chronic back pain. Similar changes have subsequently been reported in other chronic pain syndromes involving different brain regions such as the parietal and the insular cortices.
The parietal cortex is especially interesting as it facilitates mental number representation that is needed for mathematical operations in man. Dehaene coined the phrase ‘number sense’ for this task. In pain medicine an intact number sense is important for the accurate assessment of pain intensities using scales.
A study by Ruscheweyh suggests patients with joint pain are especially prone to changes in the parietal cortex. It can therefore be hypothesized number sense is altered in inflammatory-rheumatic diseases due to a reduction in gray matter density.
Furthermore, the autonomic nervous system is also frequently altered in chronic inflammatory joint diseases. For instance, patients with rheumatoid arthritis often display an increased sympathetic activity. It is hence feasible to suggest that a change in number sense due to a reduction in gray matter density in the parietal cortex is associated with an increased activity of the sympathetic nervous system in patients with rheumatic-inflammatory pain. As a consequence of this increased sympathetic activity the insular cortex might also show an altered activity profile.

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Organizational Data

  •   DRKS00012791
  •   2017/07/28
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  •   yes
  •   Approved
  •   2017-059, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

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Health Condition or Problem studied

  •   M06.9 -  Rheumatoid arthritis, unspecified
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Interventions/Observational Groups

  •   chronic pain patients
    Tests: neuro-psychological tests, number sense tests, ECG, pulseoxymetry, MRI and fMRI

  •   healthy controls
    Tests: neuro-psychological tests, number sense tests, ECG, pulseoxymetry, MRI and fMRI
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

a) Clinical: Comparison of number sense between Groups employing numberline tasks
b) Cerebral functional: characterization of brain activity patterns after stimulation of number sense using fMRI
c) Anatomical: Measurement of gray matter density using MRI and voxel-based morphometry

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Secondary Outcome

a) Clinical: comparison of heart rate variability between Groups employing ECG analysis
b) Cerebral functional: characterization of activity patterns in autonomic brain regions (insular cortex) using fMRI

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/08/17
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

All: 18 years of age or older, fluid in German, right handedness,
Pain group: chronic-rheumatic joint disease; more than 6 months of pain
Controls: no pain

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Exclusion Criteria

Refusal to participate, missing consent, MRI contraindicated, Body weight: >130kg, Age: >75 years, inability to lie flat and still, pregnancy, alcohol and/ or drug abuse (present or in history), known dyscalculia, idiopathic back pain, neurological disease (dementia, epilepsy, migraine, strong recurrent headaches, Parkinson’s disease, multiple sclerosis, myasthenia gravis, meningitis, neurodegenerative disease, head or cerebral trauma, cerebro-vascular disease, , stroke, severe asthma, severe COPD, heart failure (>NHHA II), history of heart surgery, peripheral vascular disease, implanted pacemaker or Defibrillator, kidney failure, dialysis, chronic liver disease (hepatitis, liver failure), cancer (present or in history), acute infectious disease (HIV, tuberculosis), decompensated thyroid disease, history of psychiatric disease (schizophrenia, major depression, borderline personality disorder)

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Addresses

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    • Universitätsklinikum für Anästhesiologie, Intensiv-, Notfallmedizin und SchmerztherapieKlinikum Oldenburg AöR
    • Mr.  Dr  Carsten  Bantel 
    • Rahel Strauss Strasse 10
    • 26133  Oldenburg
    • Germany
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    • Universitätsklinik für Psychiatrie und Psychotherapie, Carl von Ossietzky Universität Oldenburg, Campus Karl-Jaspers Klinik
    • Mr.  Dr  Peter  Sörös 
    • Hermann-Ehlers-Straße 7
    • 26160  Bad Zwischenahn
    • Germany
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    • Universitätsklinikum für Anästhesiologie, Intensiv-, Notfallmedizin und SchmerztherapieKlinikum Oldenburg AöR
    • Mr.  Dr  Carsten  Bantel 
    • Rahel Strauss Strasse 10
    • 26133  Oldenburg
    • Germany
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    • AG Biologische Psychologie, Institut für Psychologie, Fakultät 6,Carl von Ossietzky Universität Oldenburg
    • Ms.  BSc  Melanie  Spindler 
    • Ammerländer Heerstraße 114-118
    • 26111  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum für Anästhesiologie, Intensiv-, Notfallmedizin und SchmerztherapieKlinikum Oldenburg AöR
    • Rahel.Straus-Straße 10
    • 26133  Oldenburg
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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