Carpal Tunnel Syndrome (CTS)NCT07249177
Upper Extremity Functional Index in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome (CTS) and Upper Extremity Function, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the validity and reliability of the Upper Extremity Functional Index in patients with carpal tunnel syndrome. This cross-sectional study included 101 patients diagnosed with carpal tunnel syndrome at a university hospital. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS), Upper Extremity Function
- What is being tested?
- Questionnaire
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jun 2021to 18 Nov 2022
- How long will I take part?
- 2 Weeks
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included patients aged 18-65 years who were diagnosed with carpal tunnel syndrome after visiting the neurology outpatient clinic of a university hospital, who volunteered, who had no history of other trauma, disease, or surgery in the affected limb, and who had no communication difficulties. The patients were included before starting any conservative or surgical treatment programme.
Who may be able to join
- To be diagnosed with carpal tunnel syndrome, to be a volunteer, and to be between the ages of 18 and 65 years.
Who cannot join
- no history of other trauma, disease or surgery in the affected limb and difficulty communicating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of the Upper Extremity Functional Index in Patients With Carpal Tunnel Syndrome
The aim of this study was to investigate the validity and reliability of the Upper Extremity Functional Index in patients with carpal tunnel syndrome. This cross-sectional study included 101 patients diagnosed with carpal tunnel syndrome at a university hospital. Patients were administered the Upper Extremity Functional Index, Michigan Hand Outcomes Questionnaire, and Boston Carpal Tunnel Questionnaire surveys. Test-retest reliability, internal consistency, and construct validity of the Upper Extremity Fuctional Index were evaluated.
- Being tested
- Questionnaire
- Keywords
- psychometrics, carpal tunnel syndrome, outcome measures, upper extremity functional index
- 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.
QuestionnaireOther
The Upper Extremity Functional Index (at the first session and after 2 weeks), the Michigan Hand Outcomes Questionnaire and the Boston Carpal Tunnel Questionnaire were administered to patients using a face-to-face assessment method.
| Study group | Role | What they receive |
|---|---|---|
| Patients aged 18-65 years diagnosed with carpal tunnel syndrome. | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Functional Index
It is a 20-item scale scored using a 4-point Likert scale (0 = Extremely difficult/I cannot do it, 4 = I do not experience any difficulty). The patient scores between 0 and 80, and it is recommended that the total score be used in studies. A high score indicates that the patient has good upper extremity function.
Measured: The questionnaire was administered at baseline (after diagnosis of carpal tunnel syndrome) and 15 days after the baseline assessment.
Michigan Hand Outcomes Questionnaire
This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.
Measured: The questionnaire was administered at baseline (after diagnosis of carpal tunnel syndrome)
Boston Carpal Tunnel Questionnaire
It has been developed to assess the severity of symptoms and functional status in patients with carpal tunnel syndrome. The symptom severity scale consists of 11 questions, while the functional status scale consists of 8 questions. Each question is scored between 1 and 5. A higher symptom severity or functional status score indicates worse symptoms or functional impairment.
Measured: The questionnaire was administered at baseline (after diagnosis of carpal tunnel syndrome)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start28 Jun 2021
- Primary completion18 Nov 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 101 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, UMUT ERASLAN, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249177
- Sponsor's protocol ID
- E-60116787-020-28687
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aytar A, Yuruk ZO, Tuzun EH, Baltaci G, Karatas M, Eker L. The Upper Extremity Functional Index (UEFI): cross-cultural adaptation, reliability, and validity of the Turkish version. J Back Musculoskelet Rehabil. 2015;28(3):489-95. doi: 10.3233/BMR-140545.
PubMed 25322741Sousa RL, Moraes VY, Zobiole AF, Nakachima LR, Belloti JC. Diagnostic criteria and outcome measures in randomized clinical trials on carpal tunnel syndrome: a systematic review. Sao Paulo Med J. 2023 Apr 17;141(6):e2022086. doi: 10.1590/1516-3180.2022.0086.07022023. eCollection 2023.
PubMed 37075455
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Upper Extremity Functional Index in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07249177
- Acronym / sponsor ID
- E-60116787-020-28687
- Keywords
- psychometrics, carpal tunnel syndrome, outcome measures, upper extremity functional index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 25 Nov 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.
The aim of this study was to investigate the validity and reliability of the Upper Extremity Functional Index in patients with carpal tunnel syndrome. This cross-sectional study included 101 patients diagnosed with carpal tunnel syndrome at a university hospital. Patients were administered the Upper Extremity Functional Index, Michigan Hand Outcomes Questionnaire, and Boston Carpal Tunnel Questionnaire surveys. Test-retest reliability, internal consistency, and construct validity of the Upper Extremity Fuctional Index were evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 18-65 years diagnosed with carpal tunnel syndrome. | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included patients aged 18-65 years who were diagnosed with carpal tunnel syndrome after visiting the neurology outpatient clinic of a university hospital, who volunteered, who had no history of other trauma, disease, or surgery in the affected limb, and who had no communication difficulties. The patients were included before starting any conservative or surgical treatment programme.
Key inclusion criteria (1 listed)
- To be diagnosed with carpal tunnel syndrome, to be a volunteer, and to be between the ages of 18 and 65 years.
Key exclusion criteria (1 listed)
- no history of other trauma, disease or surgery in the affected limb and difficulty communicating
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 |
|---|---|---|
| QuestionnaireThe Upper Extremity Functional Index (at the first session and after 2 weeks), the Michigan Hand Outcomes Questionnaire and the Boston Carpal Tunnel Questionnaire were administered to patients using a face-to-face assessment method. | Other | Patients aged 18-65 years diagnosed with carpal tunnel syndrome. |
Primary outcome
Upper Extremity Functional Index
Time frame: The questionnaire was administered at baseline (after diagnosis of carpal tunnel syndrome) and 15 days after the baseline assessment.
It is a 20-item scale scored using a 4-point Likert scale (0 = Extremely difficult/I cannot do it, 4 = I do not experience any difficulty). The patient scores between 0 and 80, and it is recommended that the total score be used in studies. A high score indicates that the patient has good upper extremity function.
Michigan Hand Outcomes Questionnaire
Time frame: The questionnaire was administered at baseline (after diagnosis of carpal tunnel syndrome)
This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.
Boston Carpal Tunnel Questionnaire
Time frame: The questionnaire was administered at baseline (after diagnosis of carpal tunnel syndrome)
It has been developed to assess the severity of symptoms and functional status in patients with carpal tunnel syndrome. The symptom severity scale consists of 11 questions, while the functional status scale consists of 8 questions. Each question is scored between 1 and 5. A higher symptom severity or functional status score indicates worse symptoms or functional impairment.
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 25 Nov 2025.
- Background: PubMed 25322741Aytar A, Yuruk ZO, Tuzun EH, Baltaci G, Karatas M, Eker L. The Upper Extremity Functional Index (UEFI): cross-cultural adaptation, reliability, and validity of the Turkish version. J Back Musculoskelet Rehabil. 2015;28(3):489-95. doi: 10.3233/BMR-140545.
- Background: PubMed 37075455Sousa RL, Moraes VY, Zobiole AF, Nakachima LR, Belloti JC. Diagnostic criteria and outcome measures in randomized clinical trials on carpal tunnel syndrome: a systematic review. Sao Paulo Med J. 2023 Apr 17;141(6):e2022086. doi: 10.1590/1516-3180.2022.0086.07022023. eCollection 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.
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 (CTS) and Upper Extremity Function, run by Pamukkale 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 1 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: finished, as of the sponsor's last update on 25 Nov 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?
Upper Extremity Functional Index (time frame: The questionnaire was administered at baseline (after diagnosis of carpal tunnel syndrome) and 15 days after the baseline assessment.). The study lists 3 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 NCT07249177, which also lists 2 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 25 Nov 2025.