Pain/ Pain system/ Pain modulation
Conditions
Interventions
Group 1: PREP with CE before and after ipsilateral verum and sham matrix stimulation
Group 2: PREP with CE before and after contralateral verum and sham matrix stimulation
Sponsors
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum gGmbH
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Sufficient knowledge of German
Exclusion criteria
Exclusion criteria: - Lack of informed consent - Average pain intensity in the last 4 weeks > 2 (NRS 0-10) - current pain intensity > 0 (NRS 0-10) - Insufficient knowledge of German or other communication problems - Treatment with topical local anaesthetics in the last 6 weeks - Treatment with topical capsaicin in the last 6 months - Epilepsy treated with anticonvulsants (carbamazepine, gabapentin, oxcarbazepine, pregabalin, valproate, etc.) - Psychiatric diseases (e.g. severe depression, bipolar disorder, anxiety disorder) treated with antidepressants with proven effect on neuropathic pain (tricyclic AD, e.g. amitriptyline; SNRI, e.g. duloxetine, venlafaxine; SSRI, e.g. citalopram) - Psychiatric illness (e.g. severe depression, bipolar disorder, anxiety disorder) treated with anticonvulsants - other severe systemic or focal CNS affection (e.g. stroke, spinal cord lesion, syringomyelia) - other central or peripheral neurological diseases (e.g. Parkinson's disease, polyneuropathy, multiple sclerosis, dementia, neuropathies, radiculopathies or nerve lesions, migraine) - peripheral arterial occlusive disease (up to stage Fontaine I) - Severe cognitive or psychiatric impairment - Serious internal diseases - diabetes mellitus - substance abuse - pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of PREP-induced pain after verum matrix stimulation: Pain-induced potentials (PREP) will be measured in each participant at four different time points: before and after verum matrix stimulation and before and after sham matrix stimulation. At each time point, PREP-induced pain is measured using the numerical rating scale (NRS, 0-10). The primary endpoint of the study is defined as a significant reduction in PREP-induced pain specifically attributable to verum matrix stimulation, as demonstrated by a repeated measures analysis of variance (ANOVA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Decrease of PREP amplitude after verum matrix stimulation: PREP are recorded in the electroencephalogram using suitable software (Brain Vision Recorder) and analysed offline. The amplitudes are determined as predefined peak-to-peak amplitudes at each of the four measurement times. Analogue to the calculations of PREP-induced pain, the secondary endpoint is defined as a significant reduction in PREP amplitudes specifically attributable to verum matrix stimulation, as demonstrated by a repeated measures analysis of variance (ANOVA). | — |
Countries
Germany
Contacts
Public ContactÖzüm Özgül
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum gGmbH
Outcome results
None listed