Turkish Adaptation of the CTS-6 Evaluation Tool: A Validation and Reliability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Validity and Reliability Metrics of the Turkish Version of the CTS-6 Evaluation Tool
研究概览
简要总结
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.
详细描述
A) STUDY RATİONALE:
The most common peripheral neuropathy is median nerve neuropathy, and the most frequent site of entrapment of the median nerve is the carpal tunnel at the wrist.
Local ischemia caused by mechanical compression of the nerve leads to demyelination of the nerve fibers, resulting in paresthesia, pain, and motor dysfunction. Paresthesias are initially more pronounced at night and later become noticeable during the day. In advanced cases, motor functions may be affected.
Carpal tunnel syndrome (CTS) is more common in women, but the male-to-female ratio varies between studies.
It is most commonly seen in individuals aged 50-54. The etiology and pathophysiology of CTS are multifactorial. Its etiology may include idiopathic causes (most common), anatomical causes, genetics, trauma, obesity, space-occupying lesions in the wrist, connective tissue diseases, hypermobility, metabolic and endocrine diseases, pregnancy, lactation, and menopause.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1) INCLUSION CRITERIA:
- •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:
- •Phalen Test
- •Reverse Phalen Test
- •Carpal Tunnel Compression Test
- •A clinical diagnosis of CTS will require symptoms persisting for at least three months, with at least one of the B, C, or D symptoms in addition to symptom A, plus at least one positive diagnostic test or sign.
- •b.2) Electrophysiological Evaluation:
- •b.2.1) Mild CTS:
- •Median-to-ulnar sensory distal latency difference ≥ 0.4 ms at the 4th finger
- •Median nerve sensory distal latency ≥ 2.8 ms at the 2nd finger
- •Median nerve conduction velocity < 50 m/s
- •Sensory nerve action potential ≥ 12 µV
- •b.2.2) Moderate CTS:
- •Median nerve distal motor latency at Abductor Pollicis Brevis (APB) 4 ms ≤ x < 6.5 ms
- •Median nerve conduction velocity < 50 m/s
- •Compound Muscle Action Potential (CMAP) ≥ 5 mV
- •b.2.3) Severe CTS:
- •Median nerve distal motor latency at APB ≥ 6.5 ms
- •Median nerve conduction velocity < 50 m/s and/or CMAP < 5 mV
- •c) 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.
排除标准
- •2.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
- •Received any injection in the wrist
- •Undergone any surgical procedure on the wrist
- •Mental or cognitive incapacity preventing understanding or completion of questionnaires
- •2.b) Participants Presenting with CTS-like Symptoms:
- •Mental or cognitive incapacity preventing understanding or completion of questionnaires
- •Age <18 years or >60 years
- •CTS diagnosis confirmed based on clinical and electrophysiological criteria
- •2.c) Healthy Control Group Participants:
- •Mental or cognitive incapacity preventing understanding or completion of questionnaires
- •Age <18 years or >60 years
- •Presence of any clinical symptoms potentially related to CTS based on defined clinical criteria
- •Electrophysiological findings consistent with CTS
研究组 & 干预措施
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.
干预措施: CTS-6 Evaluation Tool (Diagnostic Test)
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.
干预措施: CTS-6 Evaluation Tool (Diagnostic Test)
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.
干预措施: CTS-6 Evaluation Tool (Diagnostic Test)
结局指标
主要结局
Validity and Reliability Metrics of the Turkish Version of the CTS-6 Evaluation Tool
时间窗: Between March 1, 2026, and July 1, 2026
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).
次要结局
- 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)
研究者
Cem Can Yucel
Resident Physician
Istanbul University