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临床试验/NCT03378440
NCT03378440已完成不适用

Psychosocial Predictors of Poor Outcomes After a Knee Arthroplasty: Prospective Observational Study.

University of Barcelona1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2018年12月17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
115
试验地点
1
主要终点
Disability / Limitations

研究概览

简要总结

The purpose of this study is to explore the association between the psychosocial variables: pain catastrophizing, fear of movement, coping skills, pain attitudes, anxiety and depression with postoperative outcomes (pain, health functioning, physical performance, and quality of life) after a knee arthroplasty (KA). The prevalence of KA has increased dramatically during the last two decades, its popularity can be attributed to its evident success regarding pain improvement, deformity correction and disability reduction in knee osteoarthritis subjects. However, only a third of the patients report no functional problems after surgery, the 20% of them are unsatisfied with its functional skills and around a 20% are experiencing pain, high disability degrees and a significant quality of life reduction. This results cannot be fully explained by mechanical processes, surgical procedures or surgery variations, but seems to be related to other psychological aspects. Chronic pain subjects often develop maladaptive thoughts and behaviours (i.e. pain catastrophism, kinesiophobia, activity avoidance) which contribute to make the subject suffer physically as well as emotionally, and affect on the intensity and persistency of pain.

This study is a single centre, prospective observational study of subjects undergoing primary KA. The study is designed and aimed to examine the relationship between postoperative psychosocial factors and the development of post-operative persistent pain and disability.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Disability / Limitations

时间窗: Change from baseline to 1, 3 and 6 months after surgical intervention

Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (Spanish version) will be used to assess patient´s physical function. This questionnaire can be completed in less than 5 minutes. It's a widely used, reliable, valid and responsive measure of outcome in people with osteoarthritis of the hip or knee.

Self-reported Pain

时间窗: Change from baseline to 1, 3 and 6 months after surgical intervention

Participants will be asked to rate their pain at resting, walking and flexing their knee on a horizontal 100-mm Visual Analogue Scale (VAS). The horizontal line anchors will be "no pain" and "worst imaginable pain". The VAS is a valid and reliable instrument compared with other pain rating scales, and has been well established in clinical practice and research for measuring pain levels in arthritis populations.

次要结局

  • Self-reported Quality of life(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Range of Motion(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Kinesiophobia(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Pain Attitudes(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Walking Speed(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Depression and anxiety(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Function(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Pain Catastrophism(1 week, 1 month, 3 months and 6 months after surgical intervention)

研究者

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

Marc Terradas Monllor

Marc Terradas-Monllor, PhD Student

University of Barcelona

研究点 (1)

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