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临床试验/NCT05023603
NCT05023603已完成不适用

Social Determinants of Health and Cognitive Factors in Carpal Tunnel Syndrome

Hospital Clínico La Florida2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
2
主要终点
Disability in upper-limb

研究概览

简要总结

Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy, characterized by pain, tingling sensation and paresthesia in the territory of the median nerve, symptoms modulated by psychosocial factors (eg, catastrophic thinking, depression, anxiety).

The objective of the study is to determine those psychological and social components that influence the symptoms and function of patients with CTS.

An observational cross-sectional design will be performed in patients with CTS. The patients will be selected consecutively in two hospitals of the South East Metropolitan Health Service (Santiago, Chile). The study variables will include: Perception of pain using the Visual Analogue Scale (VAS), the extent of symptoms will be evaluated using the Katz diagram; Functional assessment using the abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH); Catastrophic thinking as a response to pain using the Pain Catastrophizing Scale (PCS), fear of movement using the Tampa Scale for Kinesiophobia (TSK-11), and emotional state was assessed using the Hospital Anxiety and Depression Scale (HADS). Both are valid and reliable measures used to evaluate the influence of psychosocial factors in patients with CTS. Individual subject factors including duration of symptoms, type of work (desk / non-desk), BMI, age, gender, educational level and economic income will be collected through an interview process.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years of age, moderate or severe CTS medical diagnosis, duration of symptoms for more than three months, acceptance to participate in the study.

排除标准

  • Inability to understand instructions, non-controlled mental health pathology, cognitive problems, and previous surgery in the upper limb.

结局指标

主要结局

Disability in upper-limb

时间窗: Baseline (0 weeks)

The Perception of patients of their disability in upper-limb evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH) Spanish version Outcome Measure is a 30-item scored 1-5 (referencia). The assigned values for all completed responses are simply summed and averaged. Scoring: The assigned values for all completed responses are simply summed and averaged and higher values represent a worse Disability in upper-limb

Pain evaluation

时间窗: Baseline (0 weeks)

Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.

Hand diagrams

时间窗: Baseline (0 weeks)

To define total area marked for pain and numbness. The areas of the hand are marked by the patient and the marked area is quantified in square centimeters.

次要结局

  • Lateral pinch strength(Baseline (0 weeks))
  • Pain Interference: Kinesiophobia(Baseline (0 weeks))
  • Pain Catastrophizing Scale (PCS)(Baseline (0 weeks))
  • Emotional status: Hospital Anxiety and Depression Scale (HAD).(Baseline (0 weeks))
  • Educational level(Baseline (0 weeks))
  • Socioeconomic status(Baseline (0 weeks))
  • Grip strength(Baseline (0 weeks))

研究者

发起方
Hospital Clínico La Florida
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodrigo Ignacio Nunez Cortes

Principal Investigator

Hospital Clínico La Florida

研究点 (2)

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