Chronic pain F45.41
Conditions
Interventions
Group 1: Patients with chronic pain will be invited to participate in one MRI session and one experimental session with experimental expectation manipulation to induce placebo/nocebo effects using a h
Sponsors
Universitätsklinikum Essen, Klinik für Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - Written informed consent - German-speaking - Chronic pain with an indication for participation in the Interdisciplinary Multimodal Pain Therapy (IMPT) at the Essen Back Center, F45.41 (ICD-11 code chronic primary pain), diagnosis confirmed by a study physician - Actual participation in the IMPT at the Essen Back Center Patients at the Essen Back Pain Center predominantly have chronic back pain as their primary diagnosis, but may also report other types of pain as their primary complaint.
Exclusion criteria
Exclusion criteria: - Lack of legal capacity or inability to provide informed consent - Skin conditions (e.g., atopic dermatitis), skin damage (e.g., acute sunburn, scars), open wounds or skin inflammation, or eczema at the stimulation site (inner side of the left forearm) - Presence of an acute infection (e.g., influenza-like illness, diarrhea) - Pregnancy (self-report) or breastfeeding - Major surgical procedures under general anesthesia within the past 3 months - Alcohol consumption within 24 hours prior to study appointments - Color blindness or color vision deficiency - Impaired or uncorrected visual acuity that cannot be corrected with glasses or contact lenses - Prior participation in another study using a similar experimental paradigm - Severe manifest psychiatric disorders, such as schizophrenia, substance use disorders, severe depression, or anxiety disorders - Other acute severe medical conditions (e.g., cancer) - High-dose analgesic use (particularly opioids > 100mg morphine equivalent per day) - Drug use (e.g., cannabis, amphetamines, opioid misuse) - Participation in medication-related studies within the past 3 months that could interfere with the current study - Participation in other experimental or clinical studies during the study period For the MRI part only: - Contraindications for MRI scanning, including: Pacemakers, cochlear implants, neurostimulators, or other magnetizable materials in the body - MRI-incompatible metallic foreign bodies on or in the participant, particularly non-removable piercings, dental implants, braces, large tattoos, or osteosynthesis material (e.g., bone screws) - Claustrophobia - Severe obesity (incompatibility with the MRI scanner)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Primary outcomes in the experimental paradigm: - Magnitude of experimentally-induced placebo and nocebo effects (difference in ratings of perceived pain intensity between experimental conditions in the test phase) - Magnitude of subjective expectation (difference in ratings of expected pain intensity between experimental conditions in the test phase) 2)Primary outcomes for the clinical treatment: - Pain intensity and pain-related disability 3 months after a standardized two- or three-week interdisciplinary multimodal pain therapy (IMPT) (von Korff et al., 1992, part of the German Pain Questionnaire, Petzke et al., 2021) The study will investigate how the primary outcomes of the experimental paradigm modulate the primary outcomes for the clinical treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Secondary outcomes in the experimental paradigm: - Magnitude of experimentally-induced placebo and nocebo effects (difference in ratings of perceived pain intensity between experimental conditions in the conditioning phase) - Magnitude of subjective expectation (difference in ratings of expected pain intensity between experimental conditions in the conditioning phase) 2) Secondary outcomes for the clinical treatment : - Weekly assessments of pain intensity and pain-related disability (von Korff, part of the German Pain Questionnaire) up to 12 weeks after the start of IMPT - Treatment expectations, treatment effects and side effects: Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE), weekly assessments up to 12 weeks after the start of IMPT as well as 3 months after IMPT - Quality of Life/Well-being: Marburg Questionnaire on Habitual Well-being (FW7) 3 months after IMPT - Pain-related Self Efficacy: Pain-related Self Efficacy Questionnaire (FESS) 3 months after IMPT - Attitudes towards own body: Body Mind Inventory (BMI) 3 months after IMPT - Depression, Anxiety, Stress: The Depression, Anxiety, and Stress Scale (DASS) 3 months after IMPT Exploratory clinical outcomes: - Pain intensity and pain-related disability (von Korff) directly after, 6 and 12 months after IMPT - Treatment expectations, treatment effects and side effects (GEEE) 6 and 12 months after IMPT - Quality of Life/Well-being (FW7) directly after, 6 and 12 months after the IMPT - Fear-induced avoidance behavior: Fear Avoidance Belief Questionnaire (FABQ-D) and Avoidance-Endurance Fast-Screen (AE-FS) directly after as well as 3, 6, 12 months after IMPT - Depression, Anxiety, Stress (DASS) directly after, 6 and 12 months after the IMPT - Pain-related Self Efficacy (FESS) directly after IMPT - Attitudes towards own body (BMI) directly after IMPT --> Please note that the questionnaires used to assess the clinical secondary a | — |
Countries
Germany
Contacts
Public ContactKatharina Schmidt
Universitätsklinikum Essen
Outcome results
None listed