跳至主要内容
临床试验/NCT04956510
NCT04956510已完成不适用

Investigation of Individuals With Osteoarthritis in Terms of ICF Components Based of ICF Comprehensive Core Set for Osteoarthritis and Quality of Life

Pamukkale University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年11月1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
100
试验地点
1
主要终点
Nottingham Health Profile (NHP):

研究概览

简要总结

Osteoarthritis (OA) is a common degenerative disease associated with functional impairments, activity limitations, participation restrictions, as well as poor quality life. Therefore, the comprehensive assessment is important to determine how complex problems affect patients with OA. The first aim of this study was to link and allocate items of The Western Ontario and McMaster Universities (WOMAC) OA index with ICF Comprehensive Core Set for osteoarthritis. The second aim was to examine the relationship between the quality of life and each ICF component's scores determined based on clinical data of WOMAC in OA.

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

入选标准

  • diagnosed with OA according to American College of Rheumatology clinical criteria for OA of the knee or hip;[14,15]
  • being in the age range 18-65; and
  • absence of other diseases affecting functions and daily life (orthopedic, neurological, cardiovascular, metabolic disease and lung pathology).

排除标准

  • comorbidity affecting lower extremity and functions (patellofemoral pain syndrome, rheumatoid arthritis, ligament tear, meniscus);
  • previous lower extremity surgery;
  • Intra-articular steroid or hyaluronic acid injection in the last three months
  • cognitive impairments;
  • pregnancy; and
  • illiteracy.

结局指标

主要结局

Nottingham Health Profile (NHP):

时间窗: 15 min

NHP is a widely used measure of perceived distress of patients in physical, emotional and social domains. It consists of 38 items which are physical mobility (8 items), pain (8 items), sleep (5 items), emotional reactions (9 items), social isolation (5 items) and energy level (3 items). Questions have "yes" or "no" answers. Higher score indicates greater distress

The Western Ontario and McMaster Universities (WOMAC) OA Index:

时间窗: 15 min

The WOMAC Index is a self-administered, disease-specific questionnaire consisting of 24 items which are widely used in the evaluation of hip and knee OA. It consists of 24 items: pain (5 items), stiffness (2 items), and physical function (17 items). High score indicates worse pain, stiffness, and functional limitations.

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

Elif Gur Kabul

MSc, PT, Research Assistant

Pamukkale University

研究点 (1)

Loading locations...

相似试验

Osteoarthritis in Terms of ICF Components | 临床试验