Carpal Tunnel SyndromeNCT05916456
Hand10 Questionnaire in Individuals With Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Hand10 questionnaire, Boston Carpal Tunnel Syndrome Questionnaire and Arm Shoulder Questionnaire for patients with carpal tunnel syndrome and Hand Deficiencies Questionnaire (DASH) will be applied one week apart to investigate the validity of the questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- The Hand10 Questionnaire, DASH Questionnaire and Boston carpal tunnel syndrome questionnaire
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 1 Jun 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our study will be conducted with individuals between the ages of 18-70 who have been diagnosed with CTS.
Who may be able to join
- Patients who volunteer for treatment
- 18-70 years old patients
- With patients diagnosed with CTS
Who cannot join
- -Patients who have had surgery on the wrist area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Validity and Reliability of the Hand10 Questionnaire in Individuals With Carpal Tunnel Syndrome
Hand10 questionnaire, Boston Carpal Tunnel Syndrome Questionnaire and Arm Shoulder Questionnaire for patients with carpal tunnel syndrome and Hand Deficiencies Questionnaire (DASH) will be applied one week apart to investigate the validity of the questionnaire.
Test-retest reliability and internal consistency will be determined using Intraclass Correlation Coefficient analysis and Cronbach alpha, respectively. The validity of Hand10 in individuals with CST will be determined using the Pearson Correlation Coefficient analysis, the Arm, Shoulder, and Hand Disability Questionnaire and the Boston Carpal Tunnel Syndrome Questionnaire.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- The Hand10 Questionnaire, DASH Questionnaire, Boston carpal tunnel syndrome questionnaire
- Keywords
- carpal tunnel syndrome, DASH questionnaire, Boston carpal tunnel syndrome questionnaire, HAND10 questionnaire, validity and reliability
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Hand10 QuestionnaireDiagnostic test
The Hand10 Questionnaire is a questionnaire consisting of 10 short questions used in the evaluation of upper extremity diseases. These questions are easy to understand and illustrated questions. Unlike other questionnaires, thanks to these features, it can be used in adults as well as in the elderly and children. Tore et al. In their study, the internal consistency of Hand10 was evaluated with Cronbach's alpha value according to statistical results and found it to be 0.919. According to these results, it has been determined that Hand10 is a reliable and valid assessment tool for patients with upper extremity disorders in the Turkish population.
DASH QuestionnaireDiagnostic test
DASH Questionnaire is one of the widely used questionnaires consisting of 30 items. There are five options for each answer. While getting answers ranging from 1 to 5; 1 means no symptoms and 5 means very severe symptoms. The total DASH score ranges from 0 to 100; 0 means no injury and 100 means serious injury. Contrary to the Hand10 questionnaire, DASH was not suitable for assessing upper extremity disorders in patients over 65 years of age.
Boston carpal tunnel syndrome questionnaireDiagnostic test
Boston carpal tunnel syndrome questionnaire (BKTSA) will be used to evaluate the functionality level and symptom severity of the patients. In this questionnaire, which consists of 2 parts: symptom severity and functional capacity, the average score for each part will be calculated by dividing the total score obtained by the number of questions. An increased score indicates decreased functional capacity and increased symptom severity.
What is being measured
The primary outcome is the main question the study is designed to answer.
The validity and reliability of the Hand10 questionnaire to individuals with carpal tunnel scan included
Patients diagnosed with Carpal tunnel by the doctor
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Jul 2023
- Primary completion1 Aug 2023
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Torun, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916456
- Sponsor's protocol ID
- HasanKU''
- Status last verified
- Oct 2024
- First submitted
- 7 Jun 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Validity and Reliability of the Hand10 Questionnaire in Individuals With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05916456
- Acronym / sponsor ID
- HasanKU''
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, DASH questionnaire, Boston carpal tunnel syndrome questionnaire, HAND10 questionnaire, validity and reliability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 23 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.
Hand10 questionnaire, Boston Carpal Tunnel Syndrome Questionnaire and Arm Shoulder Questionnaire for patients with carpal tunnel syndrome and Hand Deficiencies Questionnaire (DASH) will be applied one week apart to investigate the validity of the questionnaire.
Test-retest reliability and internal consistency will be determined using Intraclass Correlation Coefficient analysis and Cronbach alpha, respectively. The validity of Hand10 in individuals with CST will be determined using the Pearson Correlation Coefficient analysis, the Arm, Shoulder, and Hand Disability Questionnaire and the Boston Carpal Tunnel Syndrome Questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our study will be conducted with individuals between the ages of 18-70 who have been diagnosed with CTS.
Key inclusion criteria (3 listed)
- Patients who volunteer for treatment
- 18-70 years old patients
- With patients diagnosed with CTS
Key exclusion criteria (1 listed)
- -Patients who have had surgery on the wrist area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Hand10 QuestionnaireThe Hand10 Questionnaire is a questionnaire consisting of 10 short questions used in the evaluation of upper extremity diseases. These questions are easy to understand and illustrated questions. Unlike other questionnaires, thanks to these features, it can be used in adults as well as in the elderly and children. Tore et al. In their study, the internal consistency of Hand10 was evaluated with Cronbach's alpha value according to statistical results and found it to be 0.919. According to these results, it has been determined that Hand10 is a reliable and valid assessment tool for patients with upper extremity disorders in the Turkish population. | Diagnostic test | – |
| DASH QuestionnaireDASH Questionnaire is one of the widely used questionnaires consisting of 30 items. There are five options for each answer. While getting answers ranging from 1 to 5; 1 means no symptoms and 5 means very severe symptoms. The total DASH score ranges from 0 to 100; 0 means no injury and 100 means serious injury. Contrary to the Hand10 questionnaire, DASH was not suitable for assessing upper extremity disorders in patients over 65 years of age. | Diagnostic test | – |
| Boston carpal tunnel syndrome questionnaireBoston carpal tunnel syndrome questionnaire (BKTSA) will be used to evaluate the functionality level and symptom severity of the patients. In this questionnaire, which consists of 2 parts: symptom severity and functional capacity, the average score for each part will be calculated by dividing the total score obtained by the number of questions. An increased score indicates decreased functional capacity and increased symptom severity. | Diagnostic test | – |
Primary outcome
The validity and reliability of the Hand10 questionnaire to individuals with carpal tunnel scan included
Time frame: 3 month
Patients diagnosed with Carpal tunnel by the doctor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Carpal Tunnel Syndrome, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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 27 Dec 2024. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The validity and reliability of the Hand10 questionnaire to individuals with carpal tunnel scan included (time frame: 3 month). 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 27 Dec 2024.