Turkish Adaptation of the CTS-6 Evaluation Tool: A Validation and Reliability Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorIstanbul University

About this trial

The purpose of this study is to develop the Turkish version of the CTS-6 Evaluation Tool and to comprehensively assess its validity and reliability in the Turkish population. The CTS-6 Evaluation Tool is a widely used and reliable instrument for the assessment of diagnosis and symptom severity in patients with carpal tunnel syndrome.

In this study, the CTS-6 will undergo translation and cultural adaptation to ensure linguistic and cultural appropriateness for the Turkish population. The goal is to produce a valid, reliable, and practical tool that can be used efficiently in clinical settings. The adapted version is intended to be applicable across multiple medical specialties involved in the diagnosis and management of carpal tunnel syndrome in Turkey. The results are expected to provide a trustworthy Turkish version of the CTS-6 suitable for both clinical practice and research purposes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy Control Group

Group Presenting with CTS-like Symptoms

Group Diagnosed with CTS Based on Defined Criteria

Tinel Sign

Disqualifiers

None

Trial population

C) STUDY POPULATİON AND PARTİCİPANT GROUPS: This cross-sectional study will include participants aged 18-60 years who present to the Physical Medicine and Rehabilitation Outpatient Clinics at Istanbul University, Istanbul Faculty of Medicine, Esnaf Hospital, between March 1, 2026 and July 1, 2026. Three separate groups will be formed from participants who do not meet the predefined exclusion criteria: (1) a control group of healthy individuals with no clinical or electrophysiological pathology, (2) a group presenting with CTS-like symptoms but considered normal based on electrophysiological evaluation, and (3) a group diagnosed with CTS according to clinical and electrophysiological criteria. Accounting for potential dropouts, 42 participants per group will be recruited, for a total of 126 participants. All participants will receive detailed written and verbal information about the study's objectives, duration, and procedures, and written informed consent will be obtained.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • CTS-6 Evaluation Tool

    Diagnostic test

    In this study, we aim to develop the Turkish version of the CTS-6 Evaluation Tool and to evaluate the validity and reliability of this version.

Treatment groups

126 Participants
are divided into 3 treatment groups
Group A: Healthy Control Group1 intervention
Group B: Group Presenting with CTS-like Symptoms1 intervention
Group C: Group Diagnosed with CTS Based on Defined Criteria1 intervention

Trial outcomes

Primary outcomes

1

Validity and Reliability Metrics of the Turkish Version of the CTS-6 Evaluation Tool

Validity and reliability will be reported using: * Cronbach's alpha and McDonald's omega coefficients for internal consistency * Intraclass correlation coefficient (ICC\[3,1\]) with 95% confidence intervals for test-retest reliability * Spearman correlation coefficient between test and retest scores * Bland-Altman limits of agreement for repeated measurements * Exploratory factor analysis results including Kaiser-Meyer-Olkin statistic, Bartlett's test of sphericity, factor loadings, eigenvalues greater than 1, and percentage of total variance explained All metrics will be calculated based on CTS-6 total scores (range: 0-26).

Time frame
Between March 1, 2026, and July 1, 2026

Secondary outcomes

1

Differences in CTS-6 Total Scores Among Predefined Clinical Groups

CTS-6 total scores will be reported separately for: * Group Diagnosed with CTS Based on Defined Criteria * Group Presenting with CTS-like Symptoms * Healthy Control Group Between-group differences in CTS-6 total scores will be reported.

Time frame
Between March 1, 2026, and July 1, 2026
2

Correlation Between CTS-6 Total Scores and Boston Carpal Tunnel Questionnaire (BCTQ) Scores

Spearman correlation coefficients between CTS-6 total scores and BCTQ symptom severity and functional status subscale scores will be reported.

Time frame
Between March 1, 2026, and July 1, 2026
3

Correlation Between CTS-6 Total Scores and Electrodiagnostic Parameters

Correlation coefficients between CTS-6 total scores and electrodiagnostic parameters, including distal motor latency and sensory conduction velocity of the median nerve, will be reported.

Time frame
Between March 1, 2026, and July 1, 2026

Other outcomes

Sponsors and contacts

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