Sonographic Examination of Median Nerve Variations and Characteristics Observed in Healthy and Carpal Tunnel Syndrome Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Visual Analog Scale(VAS)
研究概览
简要总结
The aim of the study is to evaluate the prevalence of bifid median nerve in patients diagnosed with carpal tunnel syndrome (CTS) and whether it has a higher prevalence in CTS patients than in asymptomatic individuals, and to evaluate the characteristics of the bifid median nerve found and whether median nerve variations are predisposing factors in the development of CTS.
详细描述
Patients diagnosed with carpal tunnel syndrome electrophysiologically who applied to Etlik City Hospital physical therapy outpatient clinic will be included in the study.There are no sensitive groups.The research period was determined as 1 year.The sample size was done using G Power 3.1.9.4 statistical power analysis program for Windows.Based on the study conducted by Walker FO et al., the number of patients that would provide a significant difference (with a margin of error of 5% Type 1 and 20% Type 2, a study power of 80% and a confidence interval of 95%) was found to be 129 patients in total.Demographic and clinical characteristics of patients who meet the inclusion criteria and fill out the "Informed Consent Forum" will be recorded.General pain of the patients will be evaluated with the Visual Analogue Scale (Global Pain), symptom severity and functional status will be evaluated with the Boston Carpal Tunnel Questionnaire, and hand grip strength measurement will be evaluated with a dynamometer.The patient hand diagram will be marked according to the patient's sensory symptoms.Median nerve cross-sectional area will be measured at the pisiform level with ultrasound, and distal motor latency and sensory nerve conduction velocity will be measured with EMG and recorded.Median nerve stiffness will be evaluated by real-time elastography.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having typical Carpal Tunnel Sydnrome symptoms lasting longer than 3 months
- •Carpal tunnel syndrome diagnosed with EMG
- •Being a male/female >18 years of age
排除标准
- •History of polyneuropathy, brachial plexopathy, thoracic outlet syndrome, or surgery in the wrist area
- •Presence of inflammatory arthritis, hypothyroidism, pregnancy, rheumatological disorders, diabetes mellitus
- •Presence of peripheral vascular disease
结局指标
主要结局
Visual Analog Scale(VAS)
时间窗: This evaluation will be made and recorded at the beginning
The VAS used for pain assessment consists of a line drawn in the form of a ruler,and numbers from 0 to 10(with 0 as ''no pain'' and 10 as ''unbearable pain'') were asked to score.
次要结局
- Boston Carpal Tunnel Questionnaire(This evaluation will be made and recorded at the beginning.)
- Dynamometer(This evaluation will be made and recorded at the beginning.)
- Real-time elastography.(This evaluation will be made and recorded at the beginning.)
- Ultrasound(This evaluation will be made and recorded at the beginning.)
研究者
Yunus Burak Bayır
Yunus Burak Bayır, Principal İnvestigator
Ankara Etlik City Hospital