"Investigation of the Correlation Between Ultrasonographic Parameters and Pain, Symptom Severity, Functionality, and Quality of Life in Healthy Individuals and Patients Diagnosed With Mild and Moderate Carpal Tunnel Syndrome: An Analytical Cross-Sectional Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 1. Median Nerve Cross-Sectional Area (CSA)
研究概览
简要总结
"This study aims to investigate ultrasonographic parameters of the median nerve in healthy individuals and patients with mild and moderate carpal tunnel syndrome (CTS).
Specifically, investigator will assess the cross-sectional area (CSA) at the proximal carpal tunnel and the wrist/forearm ratio (WFR), and determine their diagnostic thresholds.
İnvestigators will also evaluate correlations between these ultrasound measures and clinical and electrophysiological findings, including pain, symptom severity, functional status, and quality of life (Visual Analog Scale, Boston Carpal Tunnel Questionnaire, SF-36).
详细描述
A) STUDY RATİONALE:
The median nerve runs along the medial aspect of the arm, passes anterior to the elbow, continues between the two heads of the pronator teres muscle in the forearm, progresses toward the wrist, and traverses the carpal tunnel before entering the hand
The carpal tunnel is an anatomical structure formed by the carpal bones, comprising the proximal row (scaphoid, lunate, triquetrum, pisiform) and the distal row (trapezium, trapezoid, capitate, hamate). The roof of the tunnel is known as the flexor retinaculum, attaching laterally to the scaphoid and trapezium bones and medially to the hamate and pisiform bones.
The primary structures passing through the carpal tunnel include the four flexor digitorum superficialis tendons, four flexor digitorum profundus tendons, the flexor pollicis longus tendon, and the median nerve. The median nerve innervates the volar surface of the first three digits and the radial half of the fourth digit, including the nail beds of these fingers.
Median neuropathy is the most common peripheral neuropathy, and the most frequent site of entrapment is the carpal tunnel at the wrist. Mechanical compression of the nerve leads to local ischemia and demyelination of nerve fibers, resulting in paresthesia, pain, and motor dysfunction. Paresthesia is initially more pronounced at night and may later occur during the day. In advanced cases, motor functions may also be affected.
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
- •Participants aged 18-60 years who meet the eligibility criteria as either healthy controls or patients with carpal tunnel syndrome (CTS) are eligible for the study.
- •Healthy Participants:
- •Absence of any clinical symptoms related to CTS.
- •Normal evaluation according to electrophysiological criteria for CTS.
- •Participants with CTS:
- •Participants must have a diagnosis of mild or moderate CTS based on clinical findings and electrophysiological evaluation.
- •b.1) Clinical Findings/Symptoms: b.1.1) Symptoms:
- •(A)- Sensory symptoms in the 1st, 2nd, 3rd finger, or lateral half of the 4th finger, or in any combination of these.
- •(B)- Symptom relief with hand-shaking or squeezing movements.
- •(C)- Pain or paresthesia triggered by hand grip or forceful hand use.
- •(D)- Nocturnal paresthesia causing the patient to wake from sleep.
- •b.1.2) Diagnostic Tests/Signs:
- •Tinel's sign
- •Phalen test
- •Reverse Phalen test
- •Carpal tunnel compression test
- •Flick sign
- •Clinical CTS Diagnosis:
- •Symptoms must be present for at least three months and at least the presence of sensory symptoms (A) plus at least one of B, C, or D, together with at least one positive diagnostic test/sign, is required for clinical diagnosis.
- •b.2) Electrophysiological Evaluation:
- •Mild CTS: Median-ulnar sensory peak latency difference ≥ 0.4 ms in the 4th finger, and median sensory distal latency of the 2nd finger ≥ 2.8 ms, with conduction velocity < 50 m/s. Sensory nerve action potential (SNAP) ≥ 12 μV.
- •Moderate CTS: Median distal motor latency of the 2nd finger between 4 ms and 5.5 ms, with conduction velocity < 50 m/s. Compound muscle action potential (CMAP) ≥ 5 mV.
- •E) EXCLUSİON CRİTERİA:
- •For Participants Meeting Patient Criteria:
- •Participants diagnosed with mild or moderate CTS who meet any of the following criteria will be excluded:
- •History of physical therapy for carpal tunnel syndrome within the last 6 months.
- •History of injection into the carpal tunnel.
- •History of carpal tunnel release surgery.
- •Presence of thenar atrophy in the hand.
- •History of cardiac pacemaker implantation.
- •History of lymphedema in the studied extremity.
- •History of cervical radiculopathy.
- •Presence of tenosynovitis in the ipsilateral upper extremity.
- •Presence of another compressive neuropathy in the ipsilateral upper extremity.
- •History of peripheral polyneuropathy or comorbidities that may cause peripheral polyneuropathy (e.g., diabetes mellitus).
- •Presence of metabolic disease.
- •History of fracture in the hand, wrist, or forearm.
- •Active pregnancy.
- •Presence of open wounds on the wrist.
- •History of uncontrolled systemic disease (endocrinologic, cardiovascular, pulmonary, hematologic, hepatic, renal, active systemic inflammatory disease, and/or malignancy).
- •History of inflammatory rheumatic or autoimmune disease.
- •Distal motor latency of the median nerve > 5.5 ms on electrophysiological evaluation.
- •Age < 18 or > 60 years.
- •Cognitive or mental incapacity preventing understanding or completion of questionnaires.
- •Anatomical variations affecting ultrasonographic assessment of the median nerve (e.g., bifid median nerve, persistent median artery).
- •Anatomical variations affecting electrophysiological measurements (e.g., Martin-Gruber anastomosis).
- •For Healthy İndividual Participants:
- •Participants will be excluded if they meet any of the following criteria:
- •Age < 18 or > 60 years.
- •Cognitive or mental incapacity preventing understanding or completion of questionnaires.
- 另有 2 项未显示
排除标准
- 未提供
研究组 & 干预措施
Healthy Participants
Healthy Participants:
INCLUSION CRITERIA:
Absence of any clinical symptoms related to CTS.
Normal evaluation according to electrophysiological criteria for CTS.
EXCLUSION CRITERIA:
Participants will be excluded if they meet any of the following criteria:
Age < 18 or > 60 years.
Cognitive or mental incapacity preventing understanding or completion of questionnaires.
Presence of any clinical symptoms potentially related to CTS based on established clinical criteria.
Electrophysiological findings consistent with CTS, based on defined diagnostic thresholds.
干预措施: ultrasound (Diagnostic Test)
Mild CTS
Participants who receive a clinical CTS diagnosis based on the previously specified CTS clinical symptoms and findings, and who meet the EMG criteria outlined below, will be classified as having mild CTS.
Clinical CTS Diagnosis:
Symptoms must be present for at least three months and at least the presence of sensory symptoms (A) plus at least one of B, C, or D, together with at least one positive diagnostic test/sign, is required for clinical diagnosis.
b.2) Electrophysiological Evaluation:
Mild CTS: Median-ulnar sensory peak latency difference ≥ 0.4 ms in the 4th finger, and median sensory distal latency of the 2nd finger ≥ 2.8 ms, with conduction velocity < 50 m/s. Sensory nerve action potential (SNAP) ≥ 12 μV.
The inclusion and exclusion criteria required for mild and moderate CTS have been previously specified
干预措施: ultrasound (Diagnostic Test)
Moderate CTS
Participants who receive a clinical CTS diagnosis based on the previously specified CTS clinical symptoms and findings, and who meet the EMG criteria outlined below, will be classified as having moderate CTS.
Clinical CTS Diagnosis:
Symptoms must be present for at least three months and at least the presence of sensory symptoms (A) plus at least one of B, C, or D, together with at least one positive diagnostic test/sign, is required for clinical diagnosis.
b.2) Electrophysiological Evaluation:
Moderate CTS: Median distal motor latency of the 2nd finger between 4 ms and 5.5 ms, with conduction velocity < 50 m/s. Compound muscle action potential (CMAP) ≥ 5 mV.
The inclusion and exclusion criteria required for mild and moderate CTS have been previously specified
干预措施: ultrasound (Diagnostic Test)
结局指标
主要结局
1. Median Nerve Cross-Sectional Area (CSA)
时间窗: 17 July 2025- 30 December 2025
The cross-sectional area (mm²) of the median nerve will be measured using high-resolution ultrasonography at the carpal tunnel inlet (scaphoid-pisiform level). Measurements will be obtained in the transverse plane by tracing the inner border of the nerve. These values will be used to determine diagnostic cutoff thresholds differentiating healthy individuals from patients with mild or moderate carpal tunnel syndrome (CTS), as defined by clinical and electrodiagnostic findings. Unit of Measure: mm²
2. Wrist-to-Forearm Ratio (WFR)
时间窗: 17 July 2025-30 December 2025
The wrist-to-forearm ratio will be calculated by dividing the median nerve CSA measured at the carpal tunnel inlet by the CSA measured approximately 12 cm proximal to the distal wrist crease. The result will be reported as a unitless ratio. This parameter will be analyzed to establish diagnostic threshold values distinguishing healthy participants from CTS patients. Unit of Measure: Unitless ratio
次要结局
- 1. Pain Severity (Visual Analog Scale)(17 July 2025- 30 December 2025)
- 2. Symptom Severity and Functional Status (Boston Carpal Tunnel Questionnaire)(17 July 2025- 30 December 2025)
- 3. Quality of Life (Short Form-36)(17 July 2025- 30 December 2025)
研究者
Cem Can Yucel
Doctor
Istanbul University