跳至主要内容
临床试验/CTRI/2025/02/081419
CTRI/2025/02/081419尚未招募不适用

Development, Validation and Implementation of Pain education module in patients with chronic knee osteoarthritis: A mixed method study.

未提供1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Numerical Pain Rating Scale (NPRS)

研究概览

简要总结

Osteoarthritis (OA) is the most prevalent type of musculoskeletal disorder globally and is also the leading cause of chronic pain and disability in adults.Pain is the main symptom of Osteoarthritis of knee, whether it is uni-compartmental, bi-compartmental or tri-compartmental which has debilitating effects on activities, function and in general on the overall Quality of Life of patients.

In this sense, the pain in knee OA (uni-compartmental, bi-compartmental or tri-compartmental) fits well with the biopsychosocial model, of the ICF, which reflects the influence of biological, psychological and social factors in the individual’s symptoms and suffering. The management of pain in knee OA should take all these factors into consideration. The purpose of doing this study is to develop, validate and implement a Pain education module for patients with chronic knee osteoarthritis. The developed module will be in the form of multimedia content whicch will be used educate the patients with chronic knee osteoarthritis.

The core idea behind the development of a Pain education module for patient with knee osteoarthritis, is that to the best of our knowledge no module in any form is available only for knee osteoarthritis. And more so for the Asian or specifically for the Indian population. As the lifestyle of Indians is different as compared to the western countries, as also, the cultural differences, religion has an important impact on pain.

We want to assess the effectiveness of the pain education module along with standardised physiotherapy care on pain, catastrophisation, kinesiophobia, knee function and beliefs regarding knee osteoarthrtis in patients with chronic knee osteoathritis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • Patients diagnosed with Tibio-femoral or patellofemoral arthritis
  • Patients with symptoms lasting for at least 3 months.
  • Patients fitting in the American College of Rheumatology criteria for knee osteoarthritis.
  • Patients with grade 1 to 3 of kellgren lawrece scale of radiological severity of knee osteoarthritis.

排除标准

  • Patients with any recent trauma or fractures or soft tissue injuries
  • Patients with other rheumatological, infectious or systemic conditions giving rise to Knee pain.
  • Patients with past history of knee surgeries.
  • Patients with any known cognitive deficits or neurological disorders.
  • Patients having a pain score of more than or equal to 8 on 10 on Numerical Pain Rating Scale.
  • Patients who are referred for total knee replacement.

结局指标

主要结局

Numerical Pain Rating Scale (NPRS)

时间窗: 0 weeks and 6 weeks

次要结局

  • Pain Catastrophizing Scale(0 weeks and 6 weeks)
  • Tampa scale of Kinesiophobia(0 weeks and 6 weeks)
  • Knee Osteoarthritis Outcome score (KOOS)(0 weeks and 6 weeks)
  • Timed-up-go test(0 weeks and 6 weeks)
  • Knee Osteoarthritis Fears and Beliefs Questionnaire (KOFBeQ)(0 weeks and 6 weeks)
  • Pain algometry(0 weeks and 6 weeks)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Chhaya V Verma

P.T. School and Centre TNMC and BYL Nair Hospital, Mumbai

研究点 (1)

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