Trapeziometacarpal ArthrosisNCT06993532
Validity, and Reliability of the Turkish Version of the Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire
An observational study of Trapeziometacarpal Arthrosis, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
To our knowledge, a Turkish version of the TASD questionnaire, frequently used for assessing TMC arthrosis worldwide, does not currently exist. Therefore, proper translation and cross-cultural adaptation of the tool are necessary for non-English speaking patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trapeziometacarpal Arthrosis
- What is being tested?
- Validity and Reliability
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 16 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosis of Trapeziometacarpal arthrosis with individuals
Who may be able to join
- Patients aged 18 years or older,
- Diagnosis of Trapeziometacarpal arthrosis
Who cannot join
- Surgery on the thumb and/or hand/wrist,
- Acute trauma to the thumb,
- Cognitive problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gaziantep University
Gaziantep
About this study
Official title: Cross-Cultural Adaptation, Validity, and Reliability of the Turkish Version of the Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire
To our knowledge, a Turkish version of the TASD questionnaire, frequently used for assessing TMC arthrosis worldwide, does not currently exist. Therefore, proper translation and cross-cultural adaptation of the tool are necessary for non-English speaking patients. This study aimed to develop the Turkish version of the TASD questionnaire, and to demonstrate its reliability and validity for use in patients with TMC arthrosis.
Read the detailed description
The original TASD was translated into Turkish independently by a physiotherapist with expertise in hand research and proficiency in English, a healthcare professional, and English teacher with no healthcare background. Demographic data were collected, followed by administration of the TASD questionnaire, the Thumb Disability Examination (TDX) questionnaire, the Visual Analogue Scale (VAS) for pain assessment, and hand grip and pinch strength measurements using the Jamar® Hydraulic Hand Dynamometer and Jamar Hydraulic Pinch Gauge to assess thumb function and muscle strength. The questionnaires were administered twice, with a 7-day interval, during which no medical or rehabilitation intervention was provided that could alter the clinical condition of the patients.
- Conditions
- Trapeziometacarpal Arthrosis
- Being tested
- Validity and Reliability
- Keywords
- Trapeziometacarpal arthrosis, cross-cultural adaptation, Turkish version, reliability, validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validity and ReliabilityOther
The TASD questionnaire, the Thumb Disability Examination (TDX) questionnaire, the Visual Analogue Scale (VAS) for pain, as well as hand grip and pinch strength measurements using the Jamar® Hydraulic Hand Dynamometer and Jamar Hydraulic Pinch Gauge Dynamometer were employed to assess thumb function and muscle strength. The questionnaires were administered twice, with a 7-day interval, during which no medical or rehabilitation intervention was made that could alter the clinical condition of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Trapeziometacarpal arthrosis group | Patients aged 18 years or older, with a diagnosis of TMC arthrosis were included in the study. Receives: Other: Validity and Reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire
The TASD was developed by Becker et al. to evaluate symptom intensity, disability severity, and treatment effectiveness in individuals with TMC arthrosis
Measured: 7 days
Secondary outcomes (3)
Thumb Disability Examination Questionnaire
The TDX consists of 20 items organized into three subcategories, evaluating limitations in ADLs, pain severity, and patient satisfaction with thumb function
Measured: 7 days
Power Grip Strength and Pinch Strength
Power grip strength (PGS) and pinch strength (PS) were measured using the Jamar® Hydraulic Hand Dynamometer and Jamar® Hydraulic Pinch Gauge, respectively.
Measured: 7 days
Visual Analogue Scale
Pain intensity was assessed by asking the patient to rate their current pain on a 10 cm scale (0, no pain, 10, intolerable pain)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Mar 2025
- Primary completion16 Mar 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trapeziometacarpal ArthrosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim ERGEN, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993532
- Sponsor's protocol ID
- 2023/346
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: a decision has not been made yet.
Publications
Becker SJ, Teunis T, Ring D, Vranceanu AM. The Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire: Development and Preliminary Validation. Hand (N Y). 2016 Jun;11(2):197-205. doi: 10.1177/1558944715627239. Epub 2016 Feb 3.
PubMed 27390563Karademir F, Ayhan Kuru Ç, Yakut Y (2022) Cross-Cultural Adaptation, Reliability and Validity of the Turkish Version of the Thumb Disability Examination (TDX) Questionnaire . IFSSH, IFSHT, FESSH Combined Congress (pp.548). London, Canada.
de Souza Almeida VA, Fernandes CH, Meireles LM, Faloppa F, Ejnisman B, Cohen M. Translation and cross-cultural adaptation of "Trapeziometacarpal Arthrosis Symptoms and Disability-TASD" into Brazilian Portuguese. Adv Rheumatol. 2021 Oct 9;61(1):61. doi: 10.1186/s42358-021-00218-z.
PubMed 34627390
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Adaptation, Validity, and Reliability of the Turkish Version of the Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire
- ClinicalTrials.gov ID
- NCT06993532
- Acronym / sponsor ID
- 2023/346
- Conditions
- Trapeziometacarpal Arthrosis
- Keywords
- Trapeziometacarpal arthrosis, cross-cultural adaptation, Turkish version, reliability, validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 29 May 2025 (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 our knowledge, a Turkish version of the TASD questionnaire, frequently used for assessing TMC arthrosis worldwide, does not currently exist. Therefore, proper translation and cross-cultural adaptation of the tool are necessary for non-English speaking patients. This study aimed to develop the Turkish version of the TASD questionnaire, and to demonstrate its reliability and validity for use in patients with TMC arthrosis.
Detailed description
The original TASD was translated into Turkish independently by a physiotherapist with expertise in hand research and proficiency in English, a healthcare professional, and English teacher with no healthcare background. Demographic data were collected, followed by administration of the TASD questionnaire, the Thumb Disability Examination (TDX) questionnaire, the Visual Analogue Scale (VAS) for pain assessment, and hand grip and pinch strength measurements using the Jamar® Hydraulic Hand Dynamometer and Jamar Hydraulic Pinch Gauge to assess thumb function and muscle strength. The questionnaires were administered twice, with a 7-day interval, during which no medical or rehabilitation intervention was provided that could alter the clinical condition of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trapeziometacarpal arthrosis group | – | Other: Validity and ReliabilityPatients aged 18 years or older, with a diagnosis of TMC arthrosis were included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of Trapeziometacarpal arthrosis with individuals
Key inclusion criteria (2 listed)
- Patients aged 18 years or older,
- Diagnosis of Trapeziometacarpal arthrosis
Key exclusion criteria (3 listed)
- Surgery on the thumb and/or hand/wrist,
- Acute trauma to the thumb,
- Cognitive problems
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 |
|---|---|---|
| Validity and ReliabilityThe TASD questionnaire, the Thumb Disability Examination (TDX) questionnaire, the Visual Analogue Scale (VAS) for pain, as well as hand grip and pinch strength measurements using the Jamar® Hydraulic Hand Dynamometer and Jamar Hydraulic Pinch Gauge Dynamometer were employed to assess thumb function and muscle strength. The questionnaires were administered twice, with a 7-day interval, during which no medical or rehabilitation intervention was made that could alter the clinical condition of the patients. | Other | Trapeziometacarpal arthrosis group |
Primary outcome
Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire
Time frame: 7 days
The TASD was developed by Becker et al. to evaluate symptom intensity, disability severity, and treatment effectiveness in individuals with TMC arthrosis
3 secondary outcomes
Thumb Disability Examination Questionnaire
Time frame: 7 days
Power Grip Strength and Pinch Strength
Time frame: 7 days
Visual Analogue Scale
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Results publication: PubMed 27390563Becker SJ, Teunis T, Ring D, Vranceanu AM. The Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire: Development and Preliminary Validation. Hand (N Y). 2016 Jun;11(2):197-205. doi: 10.1177/1558944715627239. Epub 2016 Feb 3.
- Results publicationKarademir F, Ayhan Kuru Ç, Yakut Y (2022) Cross-Cultural Adaptation, Reliability and Validity of the Turkish Version of the Thumb Disability Examination (TDX) Questionnaire . IFSSH, IFSHT, FESSH Combined Congress (pp.548). London, Canada.
- Results publication: PubMed 34627390de Souza Almeida VA, Fernandes CH, Meireles LM, Faloppa F, Ejnisman B, Cohen M. Translation and cross-cultural adaptation of "Trapeziometacarpal Arthrosis Symptoms and Disability-TASD" into Brazilian Portuguese. Adv Rheumatol. 2021 Oct 9;61(1):61. doi: 10.1186/s42358-021-00218-z.
- Individual participant dataSharing planned: No. a decision has not been made yet.
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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 Trapeziometacarpal Arthrosis, run by University of Gaziantep 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 29 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06993532, which also lists 3 linked publications.
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 29 May 2025.