跳至主要内容
临床试验/CTRI/2022/10/046322
CTRI/2022/10/046322已完成不适用

To explore movement evoked pain in weight-bearing and non-weight-bearing activities in patients with chronic knee osteoarthritis

Manipal College of Health Professions, Manipal Academy of Higher Education1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
1
主要终点
2) Numeric Pain Rating Scale (NPRS) score in non-weight-bearing activities

研究概览

简要总结

After CTRI approval has been obtained, the participants will be screened based on the inclusion and exclusion criteria. They will be included in the study after giving their informed consent. Demographic details and knee osteoarthritis characteristics will be recorded, after which Knee Injury and Osteoarthritis Outcome Score (KOOS) and Michigan Body Map (MBM) will be administered. The participants will be asked to perform weight-bearing and non-weight-bearing activities, during which the movement evoked pain and its sensitivity will be recorded using the 11-point Numeric Rating Scale (NPRS). Quantitative sensory tests (QST)- temporal summation and pain pressure threshold will be assessed and the results will be recorded. Data will be analyzed statistically and the results will be reported.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •Chronic knee osteoarthritis (more than 3 months)
  • •Conservatively managed or pre-operative knee osteoarthritis cases
  • •Pain severity of more than 3 out of 10 on the Numeric Pain Rating Scale (NPRS)
  • •Radiologically (Kellgren Lawrence grade of more than 0) or clinically (ACR criteria) diagnosed knee osteoarthritis
  • •Can read and understand English and/or Kannada
  • •Cognitively sound.

排除标准

  • •Known case of neurological disorder (e.g., peripheral neuropathy, stroke, GBS, multiple sclerosis, spinal cord lesion, cognitive impairment)
  • •Known case of systemic disorder (e.g., rheumatoid arthritis, SLE, fibromyalgia)
  • •Skin lesion at assessment site
  • •Pain for more than 3 months in areas other than the knee (e.g., chronic low back pain).

结局指标

主要结局

2) Numeric Pain Rating Scale (NPRS) score in non-weight-bearing activities

时间窗: One time assessment at the time of recruitment

3) Percentage change in pain severity in weight-bearing activities

时间窗: One time assessment at the time of recruitment

4) Percentage change in pain severity in non-weight-bearing activities

时间窗: One time assessment at the time of recruitment

1) Numeric Pain Rating Scale (NPRS) score in weight-bearing activities

时间窗: One time assessment at the time of recruitment

次要结局

  • 1. Wind-up ratio(2. Pain pressure threshold)

研究者

发起方
Manipal College of Health Professions, Manipal Academy of Higher Education
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验