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

NCT07420049 | Completed

• 1 other identifier: E-29624016-050.99-3618681
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome (CTS); Median Nerve Entrapment; Peripheral Nerve Disease; Reliability and Validity; Cross-cultural Adaptation; Diagnostic Tool; TURKISH VALIDITY AND RELIABILITY STUDY OF CTS-6 EVALUATİON TOOL; Peripheral Nerve Disorder

Keywords

CTS-6 Evaluation Tool; CTS-6; Cross-cultural adaptation; Carpal Tunnel Syndrome; median nerve entrapment; reliability and validity; Diagnostic Tool; Peripheral nerve disease; Peripheral nerve disorders; Turkish version; Turkish Validity and Reliability Study of CTS-6 Evaluation Tool

Outcome Measures

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).

  Between March 1, 2026, and July 1, 2026

Secondary Outcomes (3)

• Differences in CTS-6 Total Scores Among Predefined Clinical Groups

  Between March 1, 2026, and July 1, 2026

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

  Between March 1, 2026, and July 1, 2026

• Correlation Between CTS-6 Total Scores and Electrodiagnostic Parameters

  Between March 1, 2026, and July 1, 2026

Study Arms (3)

Healthy Control Group

Participants in this group will have no clinical symptoms consistent with CTS based on specified clinical criteria and will be considered normal according to the defined electrophysiological criteria. The inclusion and exclusion criteria for this group were previously defined. The clinical and electrophysiological criteria for CTS relevant to our study were previously described.

Diagnostic Test: CTS-6 Evaluation Tool

Group Presenting with CTS-like Symptoms

Participants in this group may exhibit symptoms similar to clinically defined CTS; however, electrophysiological evaluations will show normal findings according to the defined criteria. The inclusion and exclusion criteria for this group were previously defined. The clinical and electrophysiological criteria for CTS relevant to our study were previously described.

Diagnostic Test: CTS-6 Evaluation Tool

Group Diagnosed with CTS Based on Defined Criteria

Participants in this group meet the clinical diagnostic criteria for CTS and additionally fulfill electrophysiological evaluation criteria for mild, moderate, or severe CTS. The inclusion and exclusion criteria for this group were previously defined. The clinical and electrophysiological criteria for CTS relevant to our study were previously described.

Diagnostic Test: CTS-6 Evaluation Tool

Interventions

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.

Group Diagnosed with CTS Based on Defined Criteria; Group Presenting with CTS-like Symptoms; Healthy Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Participants aged 18-60 years will be categorized into three groups:
• Healthy Control Group
• Group Presenting with CTS-like Symptoms
• Group Diagnosed with CTS Based on Defined Criteria
• a) Healthy Control Group: Participants in this group will have no clinical symptoms consistent with CTS based on specified clinical criteria and will be considered normal according to the defined electrophysiological criteria.
• b) Group Presenting with CTS-like Symptoms: Participants in this group may exhibit symptoms similar to clinically defined CTS; however, electrophysiological evaluations will show normal findings according to the defined criteria.
• b.1) Clinical Findings / Symptoms:
• b.1.1) Symptoms:
• (A) Sensory symptoms in any of the 1st, 2nd, 3rd, or the radial part of the 4th finger
• (B) Symptoms alleviated by shaking, squeezing, or other hand movements
• (C) Pain or paresthesia associated with gripping or hand use
• (D) Nocturnal paresthesia causing awakening from sleep
• b.1.2) Diagnostic Tests / Signs:
• Tinel Sign
• Phalen Test

You may not qualify if:

• a) Participants Diagnosed with CTS Based on Defined Criteria:
• History of cardiac pacemaker
• History of lymphedema in the affected extremity
• History of cervical radiculopathy
• Presence of ipsilateral upper extremity tenosynovitis
• Presence of another compressive neuropathy in the ipsilateral upper extremity
• History of peripheral polyneuropathy
• Presence of metabolic disease
• History of fracture in the hand, wrist, or forearm
• Current pregnancy
• Open wound on the wrist
• Uncontrolled medical conditions (including endocrinological, cardiovascular, pulmonary, hematological, hepatic, renal, active systemic inflammatory disease, and/or malignancy)
• History of inflammatory rheumatologic or autoimmune disease
• Age \<18 years or \>60 years
• Trauma to the wrist or median nerve within the last 3 months

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul Unıversity, Istanbul Medicine Faculty, Esnaf Hospital

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy; Peripheral Nervous System Diseases; Neuritis

Condition Hierarchy (Ancestors)

Mononeuropathies; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Sina Arman (Esmailzadeh)

  Istanbul Unıversity Istanbul Medicine Faculty

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 19, 2026
• Study Start: March 1, 2026
• Primary Completion: July 29, 2026
• Study Completion: July 29, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-02

Locations

TU (1)