Trial document

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DRKS-ID: 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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Organizational Data

DRKS-ID: DRKS00008835
Date of Registration in DRKS: 2015/06/29
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 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

Free text: chronic back pain
ICD10: M54 - Dorsalgia

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Interventions/Observational Groups

Arm 1: 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)
Arm 2: Observational study: healthy controls perform different tasks (conditioning) at one measurement time point

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Other
Allocation: Non-randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Other
Purpose: Other
Assignment: Parallel
Phase: N/A
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

Doctor's Practice Mannheim

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Recruitment

Planned/Actual: Planned
(Anticipated or Actual) Date of First Enrollment: 2015/07/01
Target Sample Size: 160
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Zentralinstitut für seelische Gesundheit Mannheim
- Ms.
- J5
- 68159 Mannheim
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Zentralinstitut für seelische Gesundheit Mannheim
- Ms. PD Dr. Rer. nat. Frauke Nees
- J5
- 68159 Mannheim
- Germany
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- Telephone: 0621-1703-6306
- Fax: [---]*
- E-mail: frauke.nees at zi-mannheim.de
- URL: http://www.zi-mannheim.de
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Contact for Public Queries
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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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- Telephone: 0621-1703-6306
- Fax: 0621-1703-6305
- E-mail: frauke.nees at zi-mannheim.de
- URL: http://www.zi-mannheim.de
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.dfg.de
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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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.