跳至主要内容
临床试验/NCT06591715
NCT06591715尚未招募不适用

Investigation of Biopsychosocial Characteristics of Individuals Diagnosed with Knee Osteoarthritis

Aysima Barlak1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire

研究概览

简要总结

Since pain and depression are observed together in rheumatic diseases, the concept of limitation caused by the disease and health-related quality of life becomes more determinant than radiological joint damage. Sleep problems observed in OA also increase the level of depression findings and difficulty in movement. The chronic nature of the disease includes issues such as pain, fatigue, sleep problems, loss of function, anxiety, depression, and social isolation, together as in other chronic diseases. This complex structure accompanies a picture in which inflammatory processes are triggered.

When the literature is examined, the necessity of evaluation and methods including all these biopsychosocial characteristics of chronic diseases with multifaceted symptoms is emphasized. On the other hand, although it is stated that the common goal of non-pharmacological treatments is to contribute to biopsychosocial improvement in the patient, it is emphasized that evaluations with biopsychosocial content are insufficient. This situation causes the need for scales that provide a holistic assessment of chronic diseases. When the literature, including individuals diagnosed with osteoarthritis, is analyzed, the inadequacy of the studies providing biopsychosocial evaluation draws attention.

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

  • Diagnosis of knee osteoarthritis according to ACR knee osteoarthritis diagnostic criteria
  • Being in stage 2 or 3 according to Kellgren-Lawrence radiological staging criteria
  • To be 18 years of age or older
  • Being a reader-writer
  • Having read and signed the informed consent

排除标准

  • History of major psychiatric illness
  • Having malignant disease
  • Having chronic infectious or other rheumatologic diseases
  • Serious knee trauma or surgical operation in the last 6 months
  • Having collagen tissue disease
  • History of peripheral vascular disease or neuropathy
  • Being in stage 4 according to Kellgren Lawrence radiologic staging criteria
  • To have received a physiotherapy program for the relevant knee in the last 3 months

结局指标

主要结局

Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire

时间窗: 3 mounths

The BETY Questionnaire was developed on rheumatic patients and was introduced to the literature as a standardized biopsychosocial measurement tool as a result of improving the definitions of recovery from patients with expert opinions and statistical analysis. Scoring of the scale is done using a 5-point Likert system, each item is scored between 0 and 4 points, and a high total score in the scale consisting of a total of 30 items indicates a high biopsychosocial impact.

次要结局

  • Health Asessement Questionnaire (HAQ)(3 mounths)
  • Hospital Anxiety Depression Scale (HADS)(3 mounths)
  • Short Form - 36(3 mounths)
  • WOMAC Osteoarthritis Index(3 mounths)
  • Pain Catastrophizing Scale(3 mounths)
  • Tampa Scale of Kinesiophobia(3 mounths)
  • Time Up and Go Test(3 mounths)
  • Stair Climb Test(3 mounths)
  • 30s Sit to Stand test(3 mounths)
  • 10 m Walk Tets(3 mounths)
  • 6 min Walk Test(3 mounths)
  • Muscle Strength(3 mounths)
  • Muscle Endurance(3 mounths)
  • Proprioception(3 mounths)

研究者

发起方
Aysima Barlak
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aysima Barlak

PT

Hacettepe University

研究点 (1)

Loading locations...

相似试验