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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00008835
Date of registration:	29/06/2015
Prospective Registration:	Yes
Primary sponsor:	Zentralinstitut für seelische Gesundheit Mannheim
Public title:	The role of learning, stress and underlying brain circuits involving prefrontal-limbic interactions in the development of chronic back pain
Scientific title:	The role of learning, stress and underlying brain circuits involving prefrontal-limbic interactions in the development of chronic back pain - LSCBP
Date of first enrolment:	01/07/2015
Target sample size:	160
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00008835
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
Phase:

Countries of recruitment
Germany

Contacts

Name:	Frauke Nees
Address:	J5 68159 Mannheim Germany
Telephone:	0621-1703-6306
Email:	frauke.nees@zi-mannheim.de
Affiliation:	Zentralinstitut für seelische Gesundheit Mannheim

Name:	Frauke Nees
Address:	J5 68159 Mannheim Germany
Telephone:	0621-1703-6306
Email:	frauke.nees@zi-mannheim.de
Affiliation:	Zentralinstitut für seelische Gesundheit Mannheim, Institut für Neuropsychologie und Klinische Psychologie

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dorsalgia

chronic back pain
M54

Intervention(s)

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

Primary Outcome(s)

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(s)

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

Secondary ID(s)

Source(s) of Monetary Support

Deutsche Forschungsgemeinschaft

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 14/10/2014
Contact:

ethikkommission-ii@medma.uni-heidelberg.de

Medizinische Ethik-Kommission II Medizinischen Fakultät Mannheim, Forschungsgebäude, Haus 42 - Ebene 3

+49-621-38371770

ethikkommission-ii@medma.uni-heidelberg.de

Results

Results available:	Yes
Date Posted:	06/02/2023
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00008835#studyResults

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