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临床试验/NCT02276105
NCT02276105已完成不适用

Investigation of Psychometric Properties of the EuroQoL EQ-5D-5L in Patients With Carpal Tunnel Syndrome

Schulthess Klinik1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Quality of life measured with the EQ5D

研究概览

简要总结

The purpose of this study is to determine how appropriate and practically is the EQ-5D questionnaire in use on patients with carpal tunnel syndrome undergoing surgery along the change of quality of life.

详细描述

Carpal Tunnel Syndrome (CTS) is one of the most indications in hand surgery. To rate surgery's outcome, hand-specific instruments like the Michigan Hand Questionnaire (MHQ) are used as well as questionnaires which refers to the quality of life (QOL). In clinical daily grind, the SF-12 or the EQ-5D are common instruments to gain information about the patient's QOL. At the time, there is no current evidence available while using standardized questionnaires like the EQ-5D to capture the change in QOL in patients with CTS undergoing surgery. It would be interesting to assert that the investigation offers results about the patient's QOL and its change. Therefore, the aim of the study is to investigate the psychometric properties of the EQ-5D on patients with CTS undergoing surgery.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18 years
  • diagnosed CTS
  • planned surgical decompression of the carpal tunnel
  • signed informed consent

排除标准

  • additional simultaneously performed hand surgery of the affected limb
  • recurrent surgery on the already involved hand
  • the other hand is already included in the study
  • disease, which do not allow appropriated analysis of data like central-neurological, psychiatric or metabolic disease
  • legal incompetence

结局指标

主要结局

Quality of life measured with the EQ5D

时间窗: from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up)

次要结局

  • Quality of life measured with the SF 12(from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up))
  • Hand function measured with the MHQ(from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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