The role of learning, stress and underlying brain circuits involving prefrontal-limbic interactions in the development of chronic back pain
Organizational Data
- DRKS-ID:
- DRKS00008835
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2015-06-29
- Last update in DRKS:
- 2023-02-06
- Registration type:
- Prospective
Acronym/abbreviation of the study
LSCBP
URL of the study
No Entry
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.
Health condition or problem studied
- Free text:
- chronic back pain
- ICD10:
- M54 - Dorsalgia
- Healthy volunteers:
- No Entry
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
Endpoints
- 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
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Doctor's practice Mannheim
Recruitment period and number of participants
- Planned study start date:
- 2015-07-01
- Actual study start date:
- 2015-07-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 160
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 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
Primary Sponsor
- Address:
- Zentralinstitut für seelische Gesundheit MannheimJ568159 MannheimGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Zentralinstitut für seelische Gesundheit MannheimPD Dr. Rer. nat. Frauke NeesJ568159 MannheimGermany
- Telephone:
- 0621-1703-6306
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.zi-mannheim.de
Contact for Public Queries
- Address:
- Zentralinstitut für seelische Gesundheit Mannheim, Institut für Neuropsychologie und Klinische PsychologiePD Dr. rer. nat. Frauke NeesJ568159 MannheimGermany
- Telephone:
- 0621-1703-6306
- Fax:
- 0621-1703-6305
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.zi-mannheim.de
Principal Investigator
- Address:
- Zentralinstitut für seelische Gesundheit MannheimPD Dr. Rer. nat. Frauke NeesJ568159 MannheimGermany
- Telephone:
- 0621-1703-6306
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.zi-mannheim.de
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.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Ethics Committee
Address Ethics Committee
- Address:
- Medizinische Ethik-Kommission II Medizinischen Fakultät Mannheim, Forschungsgebäude, Haus 42 - Ebene 3Theodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49-621-38371770
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-08-04
- Ethics committee number:
- 2014-548N-MA
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-10-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Nees F, Ruttorf M, Fuchs X, Rance M, Beyer N. Brain-behaviour correlates of habitual motivation in chronic back pain. Sci Rep. 2020 Jul 6;10(1):11090. doi: 10.1038/s41598-020-67386-8. PMID: 32632166; PMCID: PMC7338353.
- Nees F, Ruttorf M, Fuchs X, Rance M, Beyer N. Volumetric brain correlates of approach-avoidance behavior and their relation to chronic back pain. Brain Imaging Behav. 2020 Oct;14(5):1758-1768. doi: 10.1007/s11682-019-00110-x. PMID: 31065925.
- Nees F, Löffler M, Usai K, Flor H. Hypothalamic-pituitary-adrenal axis feedback sensitivity in different states of back pain. Psychoneuroendocrinology. 2019 Mar;101:60-66. doi: 10.1016/j.psyneuen.2018.10.026. Epub 2018 Oct 26. PMID: 30414593.
- Nees F, Usai K, Löffler M, Flor H. The evaluation and brain representation of pleasant touch in chronic and subacute back pain. Neurobiol Pain. 2018 Oct 29;5:100025. doi: 10.1016/j.ynpai.2018.10.002. PMID: 31194113; PMCID: PMC6550103.
- Kandić M, Moliadze V, Andoh J, Flor H, Nees F. Brain Circuits Involved in the Development of Chronic Musculoskeletal Pain: Evidence From Non-invasive Brain Stimulation. Front Neurol. 2021 Aug 31;12:732034. doi: 10.3389/fneur.2021.732034. PMID: 34531819; PMCID: PMC8438114.
- Löffler M, Levine SM, Usai K, Desch S, Kandić M, Nees F, Flor H. Corticostriatal circuits in the transition to chronic back pain: The predictive role of reward learning. Cell Rep Med. 2022 Jul 19;3(7):100677. doi: 10.1016/j.xcrm.2022.100677. Epub 2022 Jul 6. PMID: 35798001; PMCID: PMC9381385.
- Nees F, Ditzen B, Flor H. When shared pain is not half the pain: enhanced central nervous system processing and verbal reports of pain in the presence of a solicitous spouse. Pain. 2022 Sep 1;163(9):e1006-e1012. doi: 10.1097/j.pain.0000000000002559. Epub 2021 Dec 15. PMID: 35027517; PMCID: PMC9393802.
- Löffler M, Schneider P, Schuh-Hofer S, Kamping S, Usai K, Treede RD, Nees F, Flor H. Stress-induced hyperalgesia instead of analgesia in patients with chronic musculoskeletal pain. Neurobiol Pain. 2022 Dec 6;13:100110. doi: 10.1016/j.ynpai.2022.100110. PMID: 36561877; PMCID: PMC9764253.
- Date of first publication of study results:
- 2018-10-29
- DRKS entry published for the first time with results:
- 2023-02-06
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry