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EarLy idEntification of chroniC posT-suRgical pAin patients by immunophenotyping

EarLy idEntification of chroniC posT-suRgical pAin patients by immunophenotyping - ELECTRA-F

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037273
Enrollment
700
Registered
2025-06-25
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G90.5 G90.6 R52.2

Interventions

Group 1: Screening for severe postoperative pain after extremity surgery or trauma Clinical follow-up for 3 months to determine whether chronic pain or CRPS develops or whether the pain resolves Blood

Sponsors

Unverstitätsklinikum Würzburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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

MeasureTime frame
Feasibility of the planned protocol so that the study can subsequently be expanded as ELECTRA.

Secondary

MeasureTime 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

Public ContactHeike Rittner

Universitätsklinikum Würzburg

schmerzmedizin@ukw.de+4993120130557

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026