Thumb OsteoarthritisNCT04627259
Validity And Reliability of the Turkish Version of the Thumb Disability Examination
An observational study of Thumb Osteoarthritis and Thumb Injury, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Purpose of the study is the validity and reliability of the Turkish version of The Thumb Disability Examination (TDX) so that it would be used as an assessment tool for Turkish thumb patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thumb Osteoarthritis, Thumb Injury, Thumb Fracture
- What is being tested?
- Thumb Disability Examination
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2018to 10 Jul 2021
- How long will I take part?
- 3 Years
- 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: Voluntary patients who applied to Hacettepe University, Faculty of Physiotherapy and Rehabilitation, Hand Surgery and Rehabilitation Unit within the last 6 months, with a history of TMC OA, De Quervain, trigger finger, fracture involving the thumb bones, ligament and tendon injuries, will be included in the study.
Who may be able to join
- able to speak, read, understand and write in Turkish
- having thumb pain
- being over the age of 18
Who cannot join
- mental disorders
- cognitive limitations
- able not to speak, read, understand and write in Turkish
- out of age 18-80 years old.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Physiotherapy and Rehabilitation Faculty, Hand Surgery Rehabilitation Unit
Altındağ, Ankara, 06100
About this study
Purpose of the study is the validity and reliability of the Turkish version of The Thumb Disability Examination (TDX) so that it would be used as an assessment tool for Turkish thumb patients.
Read the detailed description
The hand can be used as a very useful instrument that can perform very complex manipulations that require force and precision. In addition, it is specialized for touch and feeling, and it has a great role in perceiving the environment. The most important part that adds functionality to the hand is the thumb. It contributes more than other fingers during thumb grip activities. However, due to many factors such as inflammatory and neurological causes, orthopedic problems such as tendon and ligament injuries, the thumb joints may be loaded above normal. Mechanical stresses over time cause thumb pain and functional disabilities in daily life activities. Symptoms, muscle strength, normal joint movements, and functional conditions of the patients are objectively evaluated in the clinic by various methods. Patient-based questionnaires, such as The Disabilities of the Arm, Shoulder and Hand (DASH) and Michigan Hand Outcome Questionnaire, can evaluate the independence levels and performances of the patients in daily living activities. However, these questionnaires are used in all upper extremity pathologies, and there is no Turkish scale that evaluates only the function of the thumb, pain and patient satisfaction. During the clinical evaluations of patients with thumb complaints, a scale with a higher sensitivity than the DASH questionnaire, with a validity and reliability study that informs us of their performance and pain from the patients' perspective, is needed. Therefore The Thumb Disability Examination (TDX) was created by selecting the items that are suitable for the thumb from the DASH and Michigan Hand Outcome (MHQ) questionnaires. In this study, cultural adaptation of TDX to Turkish cultural will be done. In this process, the questionnaires will be translated from English to Turkish by two different people. A single Turkish translation will be created from these translations. This Turkish survey will be translated into English by two native speakers of English but who speak Turkish very well, and the English questionnaire will be compared with the original survey. In our study, the Turkish version and reliability (internal consistency, test and retest reliability) of the TDX will be evaluated. Voluntary patients who have been diagnosed in the study and applied to Hacettepe University, Faculty of Physiotherapy and Rehabilitation, Hand Surgery Rehabilitation Unit within the last 6 months will be included. Detailed information about the study to be carried out will be given to the patients face to face and if they accept, the informed consent form will be signed. DASH, SF-36, TDX, Beck Depression and Beck Anxiety, Michigan Hand Outcome Questionnaires, pain, normal joint motion, grip strength assessments will be done to patients twice, 3 days apart.The data obtained as a result of the study will help to identify the problems in patients with thumb pain and to show the effectiveness of the treatments from the patient's perspective. We considered that adding the Turkish adaptation of this questionnaire to the literature by making validity and reliability studies will contribute to clinical evaluations. The data obtained as a result of the study will help to identify the problems in patients with thumb complaints and to show the effectiveness of the treatments from the patient's perspective.
- Conditions
- Thumb Osteoarthritis, Thumb Injury, Thumb Fracture, Thumb Laceration
- Being tested
- Thumb Disability Examination
- Keywords
- thumb, thumb pain, thumb function, questionnaire, examination, validation, cultural adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thumb Disability ExaminationOther
Turkish Version of Thumb Disability Examination. The Turkish Version of Thumb Disability Examination consists of 20 questions related with thumb pain and functionality.
| Study group | Role | What they receive |
|---|---|---|
| patient | patients with thumb pain or functional problems Receives: Other: Thumb Disability Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thumb Disability Examination (TDX)
TDX is a 20-question survey divided into 3 sections. It can be calculated as a whole or for each section alone. All scoring is done on a 0-100 scale, with 0 being the least and 100 the most disability.
Measured: Baseline- 3 days later
Visüel Analog Scale- Pain
The severity of the pain felt by individuals during the activity that they have difficulty will be evaluated using the Visual Analogue Scale (VAS).
Measured: Baseline
Secondary outcomes (1)
The Disabilities of the Arm, Shoulder and Hand (DASH)
DASH contains 30 items related to symptoms and activities of daily living. The total score is 100 and higher scores indicate more disability.
Measured: Baseline- 3 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start10 Dec 2018
- Primary completion10 Jun 2021 (estimated)
- Study completion10 Jul 2021 (estimated)
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 Thumb OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feray Karademir, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627259
- Sponsor's protocol ID
- GO 18/205
- Status last verified
- Apr 2021
- First submitted
- 9 Nov 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Noback PC, Lombardi JM, Seetharaman M, Lee DH, Strauch RJ, Rosenwasser MP. Development and Validation of a Disease-Specific Questionnaire for Basal Joint Arthritis. J Wrist Surg. 2017 May;6(2):126-133. doi: 10.1055/s-0036-1593612. Epub 2016 Oct 14.
PubMed 28428914Düger T, Yakut E, Öksüz Ç, et al. Kol, Omuz, El Sorunları (Disabilities of the Arm, Shoulder and Hand-DASH) Anketi Türkçe uyarlamasının güvenirliği ve geçerliği. Fizyoter Rehabil. 2006;17:99-107.
Oksuz C, Akel BS, Oskay D, Leblebicioglu G, Hayran KM. Cross-cultural adaptation, validation, and reliability process of the Michigan Hand Outcomes Questionnaire in a Turkish population. J Hand Surg Am. 2011 Mar;36(3):486-92. doi: 10.1016/j.jhsa.2010.11.016. Epub 2011 Feb 4.
PubMed 21295925
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity And Reliability of the Turkish Version of the Thumb Disability Examination
- ClinicalTrials.gov ID
- NCT04627259
- Acronym / sponsor ID
- GO 18/205
- Conditions
- Thumb Osteoarthritis, Thumb Injury, Thumb Fracture, Thumb Laceration
- Keywords
- thumb, thumb pain, thumb function, questionnaire, examination, validation, cultural adaptation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 10 Jun 2021 (estimated)
- Study completion
- 10 Jul 2021 (estimated)
- First posted
- 13 Nov 2020 (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.
Purpose of the study is the validity and reliability of the Turkish version of The Thumb Disability Examination (TDX) so that it would be used as an assessment tool for Turkish thumb patients.
Detailed description
The hand can be used as a very useful instrument that can perform very complex manipulations that require force and precision. In addition, it is specialized for touch and feeling, and it has a great role in perceiving the environment. The most important part that adds functionality to the hand is the thumb. It contributes more than other fingers during thumb grip activities. However, due to many factors such as inflammatory and neurological causes, orthopedic problems such as tendon and ligament injuries, the thumb joints may be loaded above normal. Mechanical stresses over time cause thumb pain and functional disabilities in daily life activities. Symptoms, muscle strength, normal joint movements, and functional conditions of the patients are objectively evaluated in the clinic by various methods. Patient-based questionnaires, such as The Disabilities of the Arm, Shoulder and Hand (DASH) and Michigan Hand Outcome Questionnaire, can evaluate the independence levels and performances of the patients in daily living activities. However, these questionnaires are used in all upper extremity pathologies, and there is no Turkish scale that evaluates only the function of the thumb, pain and patient satisfaction. During the clinical evaluations of patients with thumb complaints, a scale with a higher sensitivity than the DASH questionnaire, with a validity and reliability study that informs us of their performance and pain from the patients' perspective, is needed. Therefore The Thumb Disability Examination (TDX) was created by selecting the items that are suitable for the thumb from the DASH and Michigan Hand Outcome (MHQ) questionnaires. In this study, cultural adaptation of TDX to Turkish cultural will be done. In this process, the questionnaires will be translated from English to Turkish by two different people. A single Turkish translation will be created from these translations. This Turkish survey will be translated into English by two native speakers of English but who speak Turkish very well, and the English questionnaire will be compared with the original survey. In our study, the Turkish version and reliability (internal consistency, test and retest reliability) of the TDX will be evaluated. Voluntary patients who have been diagnosed in the study and applied to Hacettepe University, Faculty of Physiotherapy and Rehabilitation, Hand Surgery Rehabilitation Unit within the last 6 months will be included. Detailed information about the study to be carried out will be given to the patients face to face and if they accept, the informed consent form will be signed. DASH, SF-36, TDX, Beck Depression and Beck Anxiety, Michigan Hand Outcome Questionnaires, pain, normal joint motion, grip strength assessments will be done to patients twice, 3 days apart.The data obtained as a result of the study will help to identify the problems in patients with thumb pain and to show the effectiveness of the treatments from the patient's perspective. We considered that adding the Turkish adaptation of this questionnaire to the literature by making validity and reliability studies will contribute to clinical evaluations. The data obtained as a result of the study will help to identify the problems in patients with thumb complaints and to show the effectiveness of the treatments from the patient's perspective.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: Thumb Disability Examinationpatients with thumb pain or functional problems |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Voluntary patients who applied to Hacettepe University, Faculty of Physiotherapy and Rehabilitation, Hand Surgery and Rehabilitation Unit within the last 6 months, with a history of TMC OA, De Quervain, trigger finger, fracture involving the thumb bones, ligament and tendon injuries, will be included in the study.
Key inclusion criteria (3 listed)
- able to speak, read, understand and write in Turkish
- having thumb pain
- being over the age of 18
Key exclusion criteria (4 listed)
- mental disorders
- cognitive limitations
- able not to speak, read, understand and write in Turkish
- out of age 18-80 years old.
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 |
|---|---|---|
| Thumb Disability ExaminationTurkish Version of Thumb Disability Examination. The Turkish Version of Thumb Disability Examination consists of 20 questions related with thumb pain and functionality. | Other | patient |
Primary outcome
Thumb Disability Examination (TDX)
Time frame: Baseline- 3 days later
TDX is a 20-question survey divided into 3 sections. It can be calculated as a whole or for each section alone. All scoring is done on a 0-100 scale, with 0 being the least and 100 the most disability.
Visüel Analog Scale- Pain
Time frame: Baseline
The severity of the pain felt by individuals during the activity that they have difficulty will be evaluated using the Visual Analogue Scale (VAS).
1 secondary outcome
The Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: Baseline- 3 days later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 28428914Noback PC, Lombardi JM, Seetharaman M, Lee DH, Strauch RJ, Rosenwasser MP. Development and Validation of a Disease-Specific Questionnaire for Basal Joint Arthritis. J Wrist Surg. 2017 May;6(2):126-133. doi: 10.1055/s-0036-1593612. Epub 2016 Oct 14.
- BackgroundDüger T, Yakut E, Öksüz Ç, et al. Kol, Omuz, El Sorunları (Disabilities of the Arm, Shoulder and Hand-DASH) Anketi Türkçe uyarlamasının güvenirliği ve geçerliği. Fizyoter Rehabil. 2006;17:99-107.
- Background: PubMed 21295925Oksuz C, Akel BS, Oskay D, Leblebicioglu G, Hayran KM. Cross-cultural adaptation, validation, and reliability process of the Michigan Hand Outcomes Questionnaire in a Turkish population. J Hand Surg Am. 2011 Mar;36(3):486-92. doi: 10.1016/j.jhsa.2010.11.016. Epub 2011 Feb 4.
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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 Thumb Osteoarthritis and Thumb Injury, run by Hacettepe 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 4 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 Apr 2021. 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?
Thumb Disability Examination (TDX) (time frame: Baseline- 3 days later). The study lists 2 primary outcomes in all. 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 NCT04627259, 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 27 Apr 2021.