Cross-cultural Adaptation of the 'Cold Intolerance Severity Score' (CISS) to the Dutch Language.

Hand Injuries Clinical Trial

— Ciss-DLV  

Official title:

Ciss-DLV-Cross-cultural Adaptation of the 'Cold Intolerance Severity Score' (CISS) to the Dutch Language.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05925907
• Other study ID #: PANAMA-10267
• Status: Recruiting
• Start date: December 12, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: December 2023
• Source: Erasmus Medical Center
• Contact: Reinier Feitz, MD PhD
• Phone: 0303200556
• Email: info[@]handcentrum.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To report Cold intolerance by the CISS score in medicolegal patients.

Description:

Rationale Cold intolerance is an important finding in hand trauma patients, nerve injury, crush injury, degloving injury or amputation. Cold intolerance as a symptom is probably the least responsive to any known medical treatment.

Perhaps due to the fact that we have no control over it, the consequences for cold tolerance are seldom researched. patients involved in medicolegal claims report more pain and less function than controls. Medicolegal examinations for various indications offer a long-term outcome view for the symptoms of cold tolerance. Therefore, together with Handcentrum we want to translate, improve and test the current PROM for cold intolerance CISS

Objective To report Coldintolerance by the CISS score in medicolegal patients.

Study parameters / Endpoints A validated Dutch version of the CISS A report on 100 CISS scores in medicolegal patients Examine if a shorter version of the CISS questionnaire is feasible

Study design 2-3 independent forward translations (e.g. from English into Dutch) by native speakers of the target language (e.g. Dutch). One of the translators understands the concept, one translator has no knowledge of the concept that the questionnaire measures and no medical background.

The translators make a joint forward translation together with an independent person.

2-3 independent back-translations (e.g. from Dutch into English) by native speakers of the source language (e.g. English). Both translators have no knowledge of the concept the questionnaire measures and have no medical background. ... Read more

Burden and risk These questionnaires are mandatory anyway. So, no additional time for the patients needed. There is no risk involved. There is no alteration in the medical or clinical pathway.

Recruitment and consent automatically enrolment and permission via Medisoft software from HandC

Summary Translation and validation of a Dutch version of a PROM for cold intolerance

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• - Adult

• Traumatic hand injury

• Sufficient knowledge of the Dutch language (at least level B1)

Exclusion Criteria:

• - Definitive total hand amputation

Related Conditions & MeSH terms

• Hand Injuries

Locations

Country	Name	City	State
Netherlands	Erasmuc MC	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Handcentrum, Bilthoven, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of a Dutch language translation of standard cold intolerance form	Test and retest of a Dutch language model of the CISS score	1 year