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临床试验/CTRI/2025/10/095770
CTRI/2025/10/095770尚未招募不适用

Prevalence of Pain Associated Psychological Distress among Individuals with Osteoarthritis of Knee

Shalini R2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2025年10月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
164
试验地点
2
主要终点
1. OSPRO-YF (17item) will be used to screen pain associated

研究概览

简要总结

The study is a cross-sectional investigation aiming to determine the prevalence of pain-associated psychological distress among adults with Osteoarthritis of the Knee. The minimum samples to recruit is 164 subjects through convenience sampling in Bangalore Urban, including Ramaiah Hospitals and community settings, between August 2025 and July 2026. Eligible participants must be aged 45 to 85 years, have pain for more than 3 months, be diagnosed with Osteoarthritis of the Knee (ACR criteria or K-L grade 1-4), and report a pain intensity of greater or equal 4/10 on the NPRS. Key outcome measures include the OSPRO-YF (17-item) questionnaire to screen for psychological distress, the WOMAC index for knee disability, the NPRS for pain intensity, and the IPAQ-SF for physical activity level. The results will be analyzed using descriptive statistics to calculate prevalence and confidence intervals, and to examine correlations between pain, OA severity, age, and functional disability.

研究设计

研究类型
Observational

入排标准

年龄范围
45.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • pain persisting more than 3months with intensity of greater of equal to 4/10 on NPRS scale.
  • Patients diagnosed with osteoarthritis of knee by the ACR (American College of Rheumatology) criteria OR with radiological findings using Kellgren-Lawrence grade 1-4.

排除标准

  • Patients receiving active treatment for a psychological condition
  • Acute knee injuries (fractures, ligament tears).

结局指标

主要结局

1. OSPRO-YF (17item) will be used to screen pain associated

时间窗: 8 minutes

psychological distress

时间窗: 8 minutes

次要结局

  • 1. WOMAC will be used to assess knee disability(2. NPRS will be used to assess pain intensity)

研究者

发起方
Shalini R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shalini R

Ramaiah college of physiotherapy

研究点 (2)

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