ICD11: Chronic Secondary Pain (including osteoarthritis FA00-FA0Z, peripheral neuropathic pain MG30.5). ICD11: Post-COVID condition (RA02) F32 F33 M79.7 G90.5
Conditions
Interventions
Group 1: 4 groups of patients: unipolar depression, chronic primary pain, chronic secondary pain, post-COVID syndrome
Study duration 8 days.
Day 1 (on-site appointment):
- structured clinical-psycholo
Sponsors
Zentralinstitut für Seelische Gesundheit
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: *Sufficient German language skills *Ability to understand the study protocol and give informed consent *Willingness to use the Ambulatory Assessment devices (smartphone, sensors). *For patient group Depression additionally: fulfillment of DSM-5 criteria for unipolar depression, stable antidepressant medication for at least 2 weeks *For patient group chronic primary pain additionally: according to ICD-11 criteria; at least moderate pain for at least 3 months without specific pathology *For patient group Chronic Secondary Pain additionally: according to ICD-11 criteria; at least moderately severe pain for at least 3 months and co-diagnosis of peripheral nerve damage or other specific pathology
Exclusion criteria
Exclusion criteria: *Contraindications to MRI scans (including but not limited to claustrophobia, pacemakers, cochlear implants, metal objects in head or body, intracranial vascular clips, large tattoos on head and neck, etc.) or brain/head abnormalities precluding MRI participation *Current substance dependence or abuse *For women of childbearing age additionally: presence of pregnancy, breastfeeding an infant. *For subjects with depression additionally: psychotic disorder (also earlier) *For healthy control subjects additionally: use of drugs or medication acting in the cortico-thalamostriatal system or in the somatosensory system; presence of a psychiatric disorder; presence of depression in 1st degree blood relatives; pain or headache within the last 3 months or significant somatic disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasticity in neuronal networks that relates dysfunctional emotional-cognitive processes to pain. This parameter is recorded during the two MRI measurements on the two on-site appointments (day 1 and day 8 of the study) and evaluated using standard MRI-specific analysis methods, including statistical analysis of the activation and connectivity patterns in the brain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dimensional and group differences in: - Measures of plastic changes in pain processing (processes of pain amplification, pain suppression, pain-induced inhibition and perceptual distortions of painful stimuli). These measures are collected on study days 1 and 8 on site using established neurophysiological tests. - Measures of ambulatory assessment, collected on study days 2 to 8 using the study smartphone - Measures of total allostatic load, operationalized as heart rate variability and cortisol level, these data are collected on study day 2 using saliva samples and on study days 2 and 3 using a chest sensor | — |
Countries
Germany
Outcome results
None listed