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临床试验/NCT06946030
NCT06946030已完成不适用

The Relationship Between Ocular Pseudoexfoliation Syndrome and Carpal Tunnel Syndrome

Ankara Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
159
试验地点
1
主要终点
Electromyography (EMG)

研究概览

简要总结

This prospective, single-center case-control study aimed to investigate the association between pseudoexfoliation syndrome (PES) and carpal tunnel syndrome (CTS) using biochemical markers. A total of 159 participants aged 50-80 years were categorized into PES, CTS, and control groups. Diagnoses were confirmed by slit-lamp biomicroscopy for PES and electrophysiological evaluation (EMG) for CTS. Serum biomarkers, including homocysteine, methylmalonic acid, paraoxonase-1 (PON1), homocysteine thiolactonase (HTLase), and matrix metalloproteinases (MMP-2 and MMP-9), were measured. Group comparisons, diagnostic performance (ROC analysis), and independent associations (multinomial logistic regression) were evaluated. Comorbidities were recorded and analyzed in subgroup analyses.

详细描述

Pseudoexfoliation syndrome (PES) is a systemic disorder characterized by the accumulation of extracellular fibrillar material in ocular and extraocular tissues. It has been associated with extracellular matrix dysregulation, oxidative stress, and vascular dysfunction, and may involve systemic manifestations beyond the eye. Previous studies have suggested links between PES and several systemic conditions, including cardiovascular disease, metabolic disorders, and neurodegenerative processes.

Carpal tunnel syndrome (CTS), the most common entrapment neuropathy, results from compression of the median nerve at the wrist and is influenced by both local mechanical factors and systemic conditions such as obesity, diabetes mellitus, and metabolic syndrome. Emerging evidence suggests that metabolic and inflammatory mechanisms, including dyslipidemia and oxidative stress, may contribute to peripheral nerve dysfunction.

Although both PES and CTS have been associated with systemic and metabolic disturbances, the extent to which they share common pathophysiological mechanisms remains unclear. In particular, alterations in homocysteine metabolism, oxidative stress pathways, and extracellular matrix remodeling may represent overlapping biological processes.

This prospective, case-control study was designed to evaluate the association between PES and CTS by comparing three groups: patients with PES, patients with CTS, and control subjects. Serum biomarkers related to homocysteine metabolism (homocysteine, methylmalonic acid), enzymatic activity (paraoxonase-1 and homocysteine thiolactonase), and extracellular matrix turnover (MMP-2 and MMP-9) were analyzed. The study also aimed to assess the coexistence of PES and CTS and to explore potential shared systemic mechanisms underlying both conditions.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being between the ages of 50-80
  • Having been diagnosed with PES during routine eye examination

排除标准

  • History of major hand-wrist trauma or surgical intervention
  • Acromegaly
  • Presence of any structural abnormality in bone structure
  • Pregnancy
  • Rheumatoid arthritis
  • Connective tissue disease
  • Acromegaly
  • Thoracic outlet syndrome
  • Brachial plexopathy
  • Cervical disc herniation
  • Presence of cardiac pacemaker
  • Steroid users
  • Repetitive hand operations

研究组 & 干预措施

Pseudoexfoliation Group

Patients diagnosed with pseudoexfoliation syndrome (PES) during routine ophthalmological examination. All participants underwent electrophysiological evaluation (EMG) to assess the presence of CTS.

Control Group

The control group consisted of symptomatic individuals presenting to physical therapy outpatient clinics with complaints such as mechanical back, knee, or hip pain. Participants had no electrophysiological evidence of carpal tunnel syndrome (CTS) and were matched for age and sex. All individuals underwent electrophysiological evaluation (EMG).

Carpal Tunnel Syndrome Group

Patients with electrophysiologically confirmed carpal tunnel syndrome (CTS). All participants underwent nerve conduction studies (EMG), and only those meeting diagnostic criteria for CTS were included in this group. Clinical symptom severity was assessed using the Boston Carpal Tunnel Questionnaire.

结局指标

主要结局

Electromyography (EMG)

时间窗: up to 12 weeks

Electromyography (EMG) is an examination method that measures the electrical conduction function of nerves using linear electrical current at an intensity that will not cause excessive discomfort to the patient. For this purpose, low-intensity electrical current is applied to the fingers and skin areas over the nerves, and this current is collected and measured by computerized devices from another part of the nerve or skin. Thus, it is determined whether the nerve is functioning properly.

次要结局

  • Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)(up to 12 weeks)

研究者

发起方
Ankara Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadide Koca

Physical Medicine & Rehabilitation Specialist

Ankara Training and Research Hospital

研究点 (1)

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Pseudoexfoliation and Carpal Tunnel Study | 临床试验