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临床试验/NCT05047367
NCT05047367已完成不适用

The Relationship of Psychological Factors and Sleep Quality With the Severity of Carpal Tunnel Syndrome

Cumhuriyet University1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2021年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
1
主要终点
The correlation between severity of Carpal Tunnel Syndrome and pain intensity

研究概览

简要总结

The most common entrapment neuropathy symptoms, the diagnosis of CTS, is determined by examination findings and by means of the results of electro-diagnostic test. With an increase in disease severity, trap neuropathy, whose symptoms are more pronounced at night, negatively affects the daily life of the person. Deterioration in sleep quality may cause depression and anxiety. Conflicting results have been found in the studies related to these findings. However, no study was found in which daytime sleepiness was evaluated in terms of CTS. The investigators aim in this study is to evaluate the relationship between CTS severity and depression, anxiety, sleep quality and daytime sleepiness.

详细描述

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy with an incidence of 2.7-4%. CTS, resulting from compression of the median nerve in the wrist, clinically progresses with tingling, numbness matching the nerve trace, and motor deficit in the presence of progressive nerve damage. Accordingly, the incidence of neuropathic pain is increasing. In addition to these symptoms mentioned, electro-diagnostic tests are used for diagnostic purposes and to determine the severity of nerve compression, and as a result, there are different types of classification, but most commonly CTS is classified as mild, moderate and severe. This classification is of great importance for the regulation of the follow-up and treatment protocol and making the association of existing complaints with the disease. Studies have shown that approximately 80% of CTS patients wake up at night due to numbness in the hand, resulting in deterioration in sleep quality. Impairment of sleep quality may cause increased sympathetic nervous system activity and awakening of physical and psychological stressors. Deterioration in sleep quality may cause depression and anxiety. Conflicting results have been found in the studies related to these findings. However, no study was found in which daytime sleepiness was evaluated in terms of CTS. The investigators aim in this study is to evaluate the relationship between CTS severity and depression, anxiety, sleep quality and daytime sleepiness. This study;149 patients with a diagnosis of CTS were prospectively included in the study. Electro-diagnostic test results were used to determine the severity of the disease. In this context, Boston CTS rating scale was used to evaluate the functional and symptomatic effects, Pittsburgh sleep quality scale and Epworth sleepiness scale were used to evaluate sleep quality and daytime sleepiness, and pain DETECT questionnaire was used to evaluate pain type.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-75 years diagnosed with CTS.
  • Patients who were mentally able to respond to the assessment questionnaires were also included

排除标准

  • Clinical diagnosis of cervical radiculopathy/plexopathy findings
  • Pregnancy
  • Diabetes mellitus
  • thyroid diseases
  • amyloidosis
  • collagen tissue diseases
  • Obstructive sleep apnea
  • History of the upper extremity trauma

结局指标

主要结局

The correlation between severity of Carpal Tunnel Syndrome and pain intensity

时间窗: study completion,an average of six months

Visual Analog Scale will be used for pain intensity.It is scored between 0-10. =: no pain 10: defined as the most severe pain

The correlation between severity of Carpal Tunnel Syndrome and neuropathic pain

时间窗: study completion,an average of six months

PainDETECT Questionnaire will be used for neuropathic pain evaluation.The questionnaire score ranges from 0-35 points, and a score of 19 and above indicates the presence of neuropathic pain.

The correlation between severity of Carpal Tunnel Syndrome and psychological evaluation

时间窗: study completion,an average of six months

Beck Depression Scale, Beck Anxiety Scale will be used for psychological evaluation. ≤9 points are classified as normal,10-16 points as mild depression,17-29 points as moderate depression, and 30-63 points as severe depression.Beck Anxiety Scale will be used in anxiety interrogation. ≤9 points are classified as normal, 10-18 points as mild anxiety, 19-29 points as moderate anxiety, and 30-63 points as severe anxiety.

Severity of Carpal Tunnel Syndrome

时间窗: study completion,an average of six months

Electromyography evaluation of patients

The correlation between severity of Carpal Tunnel Syndrome and sleep quality

时间窗: study completion,an average of six months

Pittsburgh Sleep Quality Scale will be used for sleep quality. Those who score ˃5 have poor sleep quality, and those who score ≤5 have "good sleep quality"

The correlation between severity of Carpal Tunnel Syndrome and sleepiness

时间窗: study completion,an average of six months

Epworth Sleepiness Scale will be used for sleepiness. It is scored between 0-28. As the total score increases, sleepiness increases.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emel Güler

Asst Prof

Cumhuriyet University

研究点 (1)

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