跳至主要内容
临床试验/NCT05949489
NCT05949489招募中不适用

Associations Between Psychological Factors, Pain Sensitivity, and Physical Function in Knee Osteoarthritis: a One-year Follow up Study

Ahram Canadian University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Change in Physical Function from Baseline to 1 year (WOMAC)

研究概览

简要总结

This study aims to determine if baseline measures of psychology and pain sensitivity can predict changes in physical function at 1 year in patients with knee osteoarthritis.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Physician diagnosis of knee OA based on clinical and radiographic ACR criteria
  • Pain in or around the knee on most days of the past month
  • Aged 40 years or above
  • Ambulatory with or without walking aid

排除标准

  • Inflammatory arthritis (rheumatoid arthritis, lupus, etc.)
  • Recent knee injury or surgery (past 3 months)
  • Severe comorbidity likely to prevent study completion (dementia, terminal illness)
  • inability to comply with study procedures or follow up

结局指标

主要结局

Change in Physical Function from Baseline to 1 year (WOMAC)

时间窗: Change from baseline at 1 year

Assessed using the WOMAC physical function subscale (0-68 scale, higher = worse function)

次要结局

  • Kinesiophobia(Change from baseline at 1 year)
  • Pain Catastrophizing Scale(Change from baseline at 1 year)
  • Change in Sleep Quality from Baseline to 1 year (Pittsburgh Sleep Quality Index)(Change from baseline at 1 year)
  • Change in Pain Self-efficacy from Baseline to 1 year (Pain Self-Efficacy Questionnaire)(Change from baseline at 1 year)

研究者

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

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Ahram Canadian University

研究点 (1)

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Psychological and Pain Factors in Knee Osteoarthritis | 临床试验