Hand InjuriesCiss-DLVNCT05925907
Cross-cultural Adaptation of the 'Cold Intolerance Severity Score' (CISS) to the Dutch Language.
An observational study of Hand Injuries, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
To report Cold intolerance by the CISS score in medicolegal patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hand Injuries
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Dec 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Handsurgery patients and medicolegal patients
Who may be able to join
- - Adult
- Traumatic hand injury
- Sufficient knowledge of the Dutch language (at least level B1)
Who cannot join
- - Definitive total hand amputation
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmuc MC
Rotterdam, South Holland, 3015 GD
Reinier Feitz, MD PhD, +31302685471, r.feitz@erasmusmc.nl
About this study
Official title: Ciss-DLV-Cross-cultural Adaptation of the 'Cold Intolerance Severity Score' (CISS) to the Dutch Language.
To report Cold intolerance by the CISS score in medicolegal patients.
Read the detailed 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
- Conditions
- Hand Injuries
- Keywords
- CISS, handsurgery, crush, nerve injury , amputation, coldintolerance
- Medical subject headings
- Hand Injuries, Crisponi syndrome, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Handsurgery patients | patients recruited from trauma handsurgery outpatient clinic in an academic teaching hospital, level 1 trauma unit. | |
| Medicolegal patients | Medicolegal patients that are examined in order to asses their personal injury claim. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a Dutch language translation of standard cold intolerance form
Test and retest of a Dutch language model of the CISS score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start12 Dec 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Handcentrum, Bilthoven, The Netherlands
- Responsible party
- Principal investigator, Reinier Feitz, MD PhD, Erasmus Medical Center
- Investigators
- Reinier Feitz, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925907
- Sponsor's protocol ID
- PANAMA-10267
- Acronym
- Ciss-DLV
- Status last verified
- Dec 2023
- First submitted
- 13 Jun 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ciss-DLV-Cross-cultural Adaptation of the 'Cold Intolerance Severity Score' (CISS) to the Dutch Language.
- ClinicalTrials.gov ID
- NCT05925907
- Acronym / sponsor ID
- Ciss-DLV / PANAMA-10267
- Conditions
- Hand Injuries
- Keywords
- CISS, handsurgery, crush, nerve injury , amputation, coldintolerance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Handcentrum, Bilthoven, The Netherlands
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To report Cold intolerance by the CISS score in medicolegal patients.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Handsurgery patients | – | –patients recruited from trauma handsurgery outpatient clinic in an academic teaching hospital, level 1 trauma unit. |
| Medicolegal patients | – | –Medicolegal patients that are examined in order to asses their personal injury claim. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Handsurgery patients and medicolegal patients
Key inclusion criteria (3 listed)
- - Adult
- Traumatic hand injury
- Sufficient knowledge of the Dutch language (at least level B1)
Key exclusion criteria (1 listed)
- - Definitive total hand amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of a Dutch language translation of standard cold intolerance form
Time frame: 1 year
Test and retest of a Dutch language model of the CISS score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reinier Feitz, MD PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Injuries, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reinier Feitz, MD PhD (0303200556, info@handcentrum.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of a Dutch language translation of standard cold intolerance form (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.