Visualization and Quantification of Cold Intolerance Following Peripheral Nerve Injuries of the Upper Extremity

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039325

Enrollment

160

Registered

2026-02-12

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Cold intolerance following peripheral nerve injury of the upper extremity

Interventions

Group 1: Observational arm: Patients with peripheral nerve injury of the upper extremity who have undergone nerve reconstruction within the past two years.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Peripheral nerve injury of the upper extremity - Nerve reconstruction within the past 2 years - First assessment no earlier than 3 months after trauma - Full capacity to provide informed consent - Inclusion independent of age and sex

Exclusion criteria

Exclusion criteria: - Pregnancy or breastfeeding - Diabetes mellitus - Peripheral polyneuropathy or other neurological disorders that may interfere with nerve regeneration - Inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the severity of cold intolerance after peripheral nerve injury of the upper extremity, assessed using the German version of the modified Cold Intolerance Symptom Severity Questionnaire (modCISS), and the thermographically measured reperfusion dynamics of the affected hand following a standardized cold stress test. The endpoint is assessed at study inclusion (no earlier than 3 months after trauma or reconstruction); in a subset of patients, additional follow-up assessments are performed at 3 and 6 months. Data are collected through self-administered completion of the modCISS questionnaire and complementary non-invasive infrared thermography of both hands under standardized conditions. The contralateral, clinically unaffected hand serves as an intra-individual reference.	—

Measure

Time frame

The primary endpoint is the severity of cold intolerance after peripheral nerve injury of the upper extremity, assessed using the German version of the modified Cold Intolerance Symptom Severity Questionnaire (modCISS), and the thermographically measured reperfusion dynamics of the affected hand following a standardized cold stress test. The endpoint is assessed at study inclusion (no earlier than 3 months after trauma or reconstruction); in a subset of patients, additional follow-up assessments are performed at 3 and 6 months. Data are collected through self-administered completion of the modCISS questionnaire and complementary non-invasive infrared thermography of both hands under standardized conditions. The contralateral, clinically unaffected hand serves as an intra-individual reference.

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Secondary

Measure	Time frame
Secondary endpoints include sensory function of the affected hand and patient-reported functional impairment following peripheral nerve injury of the upper extremity. These comprise two-point discrimination (sharp–dull discrimination), the Ten Test assessing subjective sensibility within the autonomous sensory territory of the reconstructed nerve, and patient-reported outcome measures (DASH, I-HaND, and modCISS). Secondary endpoints are assessed at study inclusion (no earlier than 3 months after trauma or reconstruction); in a subset of patients, additional follow-up assessments are performed at 3 and 6 months. Data are collected through standardized clinical sensory testing (sharp–dull discrimination and Ten Test) and through self-administered completion of the DASH, I-HaND, and modCISS questionnaires.	—

Measure

Time frame

Secondary endpoints include sensory function of the affected hand and patient-reported functional impairment following peripheral nerve injury of the upper extremity. These comprise two-point discrimination (sharp–dull discrimination), the Ten Test assessing subjective sensibility within the autonomous sensory territory of the reconstructed nerve, and patient-reported outcome measures (DASH, I-HaND, and modCISS). Secondary endpoints are assessed at study inclusion (no earlier than 3 months after trauma or reconstruction); in a subset of patients, additional follow-up assessments are performed at 3 and 6 months. Data are collected through standardized clinical sensory testing (sharp–dull discrimination and Ten Test) and through self-administered completion of the DASH, I-HaND, and modCISS questionnaires.

—

Countries

Germany

Contacts

Public ContactMarc Rüwe

Universitätsklinikum Regensburg; Abteilung für Plastische, Hand- und Wiederherstellungschirurgie

marc.ruewe@ukr.de094194414863

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026