Trial document



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  DRKS00008835

Trial Description

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Title

The role of learning, stress and underlying brain circuits involving prefrontal-limbic interactions in the development of chronic back pain

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Trial Acronym

LSCBP

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URL of the Trial

http://-

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Brief Summary in Lay Language

Previous research leds to the assumption that emotional learning may play a major role in the development of
chronic pain. However whether these learning processes really predict persistent pain is still not very well known and the role of stress in these processes is also not clear. This will be the target of the present study investigating patients with subacute and chronic back pain and healthy controls. Besides psychosocial factors, activation in specific brain regions will also be assessd.

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Brief Summary in Scientific Language

Previous research leds to the assumption that emotional learning may play a major role in the development of
chronic pain. While a number of
studies have shown that psychosocial factors predict persistent pain, little is known how these relate to altered
learning processes. Moreover, the changes in brain structure and function associated with learning mechanisms have not been examined in a longitudinal manner. Moreover, learning processes may interact with the experience of stress, which can alter pain processing and pain-related brain circuits.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00008835
  •   2015/06/29
  •   [---]*
  •   yes
  •   Approved
  •   2014-548N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   chronic back pain
  •   M54 -  Dorsalgia
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Interventions/Observational Groups

  •   Observational study: Patients (investigation once, partly twice) - patients with chronic back pain perform different tasks (conditioning) at two measurement time points, depending on specific values regarding back pain (worsening in comparison to measurement time point 1)
  •   Observational study: healthy controls perform different tasks (conditioning) at one measurement time point
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Questionnaires on pain (West Haven-Yale Multidimensional Pain Inventory), anxiety (State-Trait-Anxiety Inventory) and depression (Beck Depression Scale) and tasks (conditioning) will be obtained for each particiant at each measurement time point (measurement time points: 01.07.2015 - 30.06.2019)

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Secondary Outcome

Persons, in whom back pain gets worse, will be measured twice (1 year after the first measurement time point, 01.07.2016 - 30.06.2019) using the conditioning tasks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2015/07/01
  •   160
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

subacute back pain, healthy individuals as control sample

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Exclusion Criteria

chronic and current drug consume, neurological disorder, left handedness, pregnancy, metal in the body

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Addresses

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    • Zentralinstitut für seelische Gesundheit Mannheim
    • Ms. 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für seelische Gesundheit Mannheim
    • Ms.  PD Dr. Rer. nat.  Frauke  Nees 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für seelische Gesundheit Mannheim, Institut für Neuropsychologie und Klinische Psychologie
    • Ms.  PD Dr. rer. nat.  Frauke  Nees 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.