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临床试验/NCT05742776
NCT05742776招募中不适用

The Relationship Between Ultrasonographic Findings and Sleep Quality in Patients With Carpal Tunnel Syndrome

Afyonkarahisar Health Sciences University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年2月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

The aim of our study is to determine the relationship between disease severity and sleep quality in CTS patients and to compare the findings with healthy controls.

详细描述

Carpal tunnel syndrome is the most common form of entrapment neuropathies. Anatomically, the roof of the carpal tunnel consists of carpal bones, it is located under the transverse carpal ligament, and there are 9 tendon packs of the forearm flexors and the median nerve. Clinically, sensory (paresthesia and hypoesthesia), motor deficits and pain occur in the distribution of the median nerve secondary to mechanical compression and local ischemia.

With the increase in the severity of the disease, entrapment neuropathy, whose symptoms are more pronounced at night, negatively affects the daily life of the person. Waking up at night due to paresthesia is one of the diagnostic criteria for carpal tunnel syndrome. However, the mechanism linking CTS with insomnia is unclear.

The aim of our study is to determine the relationship between disease severity and sleep quality in CTS patients.

研究设计

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

入排标准

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

入选标准

  • Patients diagnosed with CTS according to the criteria of the American Academy of Neurology

排除标准

  • Patients with radiculopathy, brachial plexopathy, thoracic outlet syndrome and traumatic nerve injury that may affect the median nerve
  • History of Carpal tunnel surgery
  • Pregnancy
  • Malignancy
  • Thyroid diseases
  • Amyloidosis
  • Systemic lupus erythematosus, Rheumatoid arthritis, Systemic sclerosis, Gout, Dermatomyositis, Polymyositis
  • Obstructive sleep apnea

研究组 & 干预措施

Patient Group

CTS Patients

干预措施: Assessment of Sleep Quality (Other)

Control Group

Healthy Individuals

干预措施: Assessment of Sleep Quality (Other)

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: 2023.02-2023.05

Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.

次要结局

  • Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)(2023.02-2023.05)
  • Electrophysiological Evaluation(2023.02-2023.05)
  • Cross-sectional area of the Median Nerve (CSA)(2023.02-2023.05)
  • Hand and Finger Grip Strength Assessment(2023.02-2023.05)
  • Pittsburgh Sleep Quality Index (PSQI)(2023.02-2023.05)

研究者

发起方
Afyonkarahisar Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuran Eyvaz

Principal Investigator

Afyonkarahisar Health Sciences University

研究点 (1)

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