Carpal Tunnel SyndromeNCT05263128
Turkish Version of the Hand20 Questionnaire With Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by Hasan Kalyoncu University.
Trial summary
The questionnaire will be investigated by administering the Hand-20 questionnaire and the Boston Carpal Tunnel Syndrome Questionnaire to patients with carpal tunnel syndrome, one week apart. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Investigation of the validity of the Hand-20 Questionnaire in individuals with carpal tunnel syndrome
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Dec 2024
- How long will I take part?
- 7 Days
- 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 25 to 60 years
- All sexes
- Adult
Study population: Individuals diagnosed with carpal tunnel syndrome
Who may be able to join
- Patients aged 25-60 years
- Patients diagnosed with carpal tunnel
- Patients who volunteered for treatment
Who cannot join
- Patients who do not agree to volunteer
- Patients who have undergone surgery from the wrist region
About this study
Official title: Validity Study of the Turkish Version of the Hand20 Questionnaire With Carpal Tunnel Syndrome
The questionnaire will be investigated by administering the Hand-20 questionnaire and the Boston Carpal Tunnel Syndrome Questionnaire to patients with carpal tunnel syndrome, one week apart.
Read the detailed description
Questionnaires, which are used to express the perception of difficulty and hand functionality during daily living activities of individuals with carpal tunnel syndrome, and most importantly, which are easy to administer, should be preferred in order to plan a patient-specific treatment program with these results. Self-administered questionnaires showing the physical dimension of recovery are effective and sensitive to change.
Hand20 is a short, easy-to-understand and visual questionnaire used to evaluate disorders caused by upper extremity pathologies, developed by Suzuki et al. in 2010 and proven to be valid in upper extremity diseases by Töre et al. In this questionnaire consisting of 20 questions, the answer to each question is graded between 0 and 10 (0: No restrictions, 10: Impossible). The best score is 0, the worst score is 100.
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, a separate average score will be calculated for each part by dividing the total score obtained by the number of questions. An increased score indicates decreased functional capacity and increased symptom severity.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Investigation of the validity of the Hand-20 Questionnaire in individuals with carpal tunnel syndrome
- Keywords
- Carpal tunnel syndrome
- 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.
Investigation of the validity of the Hand-20 Questionnaire in individuals with carpal tunnel syndromeOther
To investigate the validity and reliability of the Hand-20 questionnaire used in individuals with upper extremity disease by comparing it with the Boston carpal tunnel syndrome questionnaire in individuals with carpal tunnel syndrome in Turkey
| Study group | Role | What they receive |
|---|---|---|
| Boston carpal tunnel syndrome questionnaire | Not described Receives: Other: Investigation of the validity of the Hand-20 Questionnaire in individuals with carpal tunnel syndrome | |
| Hand-20 questionnaire | Not described Receives: Other: Investigation of the validity of the Hand-20 Questionnaire in individuals with carpal tunnel syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the Validity of the Hand-20 Questionnaire in Individuals with Carpal Tunnel Syndrome
Measured: 1 week apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Aug 2022
- Primary completion1 May 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Why it stopped: The research was left unfinished and was not continued.
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
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Torun, Hasan Kalyoncu University
- Investigators
- Aysenur Tuncer, PhD, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263128
- Sponsor's protocol ID
- Hasan Kalyoncu Universty
- Status last verified
- Sep 2023
- First submitted
- 21 Feb 2022
- Last updated
- 18 Apr 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 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity Study of the Turkish Version of the Hand20 Questionnaire With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05263128
- Acronym / sponsor ID
- Hasan Kalyoncu Universty
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The research was left unfinished and was not continued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Mar 2022 (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.
The questionnaire will be investigated by administering the Hand-20 questionnaire and the Boston Carpal Tunnel Syndrome Questionnaire to patients with carpal tunnel syndrome, one week apart.
Detailed description
Questionnaires, which are used to express the perception of difficulty and hand functionality during daily living activities of individuals with carpal tunnel syndrome, and most importantly, which are easy to administer, should be preferred in order to plan a patient-specific treatment program with these results. Self-administered questionnaires showing the physical dimension of recovery are effective and sensitive to change.
Hand20 is a short, easy-to-understand and visual questionnaire used to evaluate disorders caused by upper extremity pathologies, developed by Suzuki et al. in 2010 and proven to be valid in upper extremity diseases by Töre et al. In this questionnaire consisting of 20 questions, the answer to each question is graded between 0 and 10 (0: No restrictions, 10: Impossible). The best score is 0, the worst score is 100.
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, a separate average score will be calculated for each part by dividing the total score obtained by the number of questions. An increased score indicates decreased functional capacity and increased symptom severity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boston carpal tunnel syndrome questionnaire | – | Other: Investigation of the validity of the Hand-20 Questionnaire in individuals with carpal tunnel syndrome |
| Hand-20 questionnaire | – | Other: Investigation of the validity of the Hand-20 Questionnaire in individuals with carpal tunnel syndrome |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Individuals diagnosed with carpal tunnel syndrome
Key inclusion criteria (3 listed)
- Patients aged 25-60 years
- Patients diagnosed with carpal tunnel
- Patients who volunteered for treatment
Key exclusion criteria (2 listed)
- Patients who do not agree to volunteer
- Patients who have undergone surgery from the wrist region
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 |
|---|---|---|
| Investigation of the validity of the Hand-20 Questionnaire in individuals with carpal tunnel syndromeTo investigate the validity and reliability of the Hand-20 questionnaire used in individuals with upper extremity disease by comparing it with the Boston carpal tunnel syndrome questionnaire in individuals with carpal tunnel syndrome in Turkey | Other | Boston carpal tunnel syndrome questionnaire, Hand-20 questionnaire |
Primary outcome
Investigation of the Validity of the Hand-20 Questionnaire in Individuals with Carpal Tunnel Syndrome
Time frame: 1 week apart
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
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Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
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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.
Aysenur Tuncer, PhD study director
Hasan Kalyoncu University
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Hasan Kalyoncu University.
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 2 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: withdrawn, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Investigation of the Validity of the Hand-20 Questionnaire in Individuals with Carpal Tunnel Syndrome (time frame: 1 week apart). 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 18 Apr 2024.