Trial document
DRKS00008835
Trial Description
Title
The role of learning, stress and underlying brain circuits involving prefrontal-limbic interactions in the development of chronic back pain
Trial Acronym
LSCBP
URL of the Trial
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.
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.
Do you plan to share individual participant data with other researchers?
[---]*
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00008835
- 2015/06/29
- [---]*
- yes
- Approved
- 2014-548N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
Secondary IDs
- [---]*
Health Condition or Problem studied
- chronic back pain
- M54 - Dorsalgia
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
Characteristics
- Non-interventional
- Other
- Non-randomized controlled trial
- Open (masking not used)
- [---]*
- Other
- Other
- Parallel
- N/A
- N/A
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)
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
Countries of Recruitment
- Germany
Locations of Recruitment
- Doctor's Practice
Recruitment
- Planned
- 2015/07/01
- 160
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 60 Years
Additional Inclusion Criteria
subacute back pain, healthy individuals as control sample
Exclusion Criteria
chronic and current drug consume, neurological disorder, left handedness, pregnancy, metal in the body
Addresses
-
start of 1:1-Block address primary-sponsor
- Zentralinstitut für seelische Gesundheit Mannheim
- Ms.
- J5
- 68159 Mannheim
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Zentralinstitut für seelische Gesundheit Mannheim
- Ms. PD Dr. Rer. nat. Frauke Nees
- J5
- 68159 Mannheim
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0621-1703-6306
- [---]*
- frauke.nees at zi-mannheim.de
- http://www.zi-mannheim.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Zentralinstitut für seelische Gesundheit Mannheim, Institut für Neuropsychologie und Klinische Psychologie
- Ms. PD Dr. rer. nat. Frauke Nees
- J5
- 68159 Mannheim
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0621-1703-6306
- 0621-1703-6305
- frauke.nees at zi-mannheim.de
- http://www.zi-mannheim.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- http://www.dfg.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
Trial Publications, Results and other Documents
- [---]*