G90.5 G90.6 R52.2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients following unilateral trauma to the upper or lower extremities (fracture or contusion, treated conservatively or surgically) at or distal to the elbow or knee. Median NRS in the last 24 hours = 6 (3-7 days after trauma or surgery). After 3-4 months and the clinical follow-up examination, the pain group is divided into a ‘CRPS/CPTLP’ group and a ‘pain recovery’ group. The diagnosis of CRPS is made based on internationally accepted diagnostic criteria. If the pain persists but the other clinical criteria are not met, a diagnosis of CPTLP can be made according to ICD11. All patients who do not meet either of these two diagnoses are assigned to the ‘pain recovery’ group.
Exclusion criteria
Exclusion criteria: Trauma-related complications (e.g. infection, perfusion deficits) Diagnosed severe somatic disease, other chronic pain disorders, other diseases of the peripheral or central nervous system, severe pre-existing psychiatric disorders, other autoimmune diseases, HIV/AIDS, use of immunosuppressive or immunomodulatory medication, persons incapable of giving consent, persons with no or insufficient knowledge of German, use of illegal drugs within the last six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the planned protocol so that the study can subsequently be expanded as ELECTRA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Single cell RNA profiles, T-cell receptor sequencing and the intensity of binding of excited IgGs, and the clinical characteristics post trauma (usually on a scale of 0-10 but also dichotomous) from the questionnaires used. | — |
Countries
Germany
Contacts
Universitätsklinikum Würzburg