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临床试验/CTRI/2024/08/071790
CTRI/2024/08/071790已完成不适用

Assessment of the functional outcome of intra-articular steroid injection for knee osteoarthritis in non diabetics and controlled diabetics - An observational study.

All India Institute of Medical Sciences (AIIMS), Guwahati1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
To determine the responsiveness of intra articular steroid injections in knee osteoarthritic patients.

研究概览

简要总结

To observe the functional outcome following intra-articular steroid injection (IASI) at 2 weeks and 4 weeks in knee osteoarthritis in non-diabetics and controlled diabetics as evaluated by The Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Numeric Rate Scale (NRS).We hypothesized that functional outcome after IASI in knee osteoarthritic patients would be better in non- diabetics individuals as compared to diabetic individuals with less requirement of rescue analgesics.

研究设计

研究类型
Observational

入排标准

年龄范围
45.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Individuals (non-diabetics and controlled diabetics) 45 years of age or older with unilateral or bilateral symptomatic knee pain (NRS ≥4/10) on most days for the past more than 1 month and radiologically (X-ray) confirmed knee OA with Kellgren-Lawrence (KL) radiographic severity grade 2–3.

排除标准

  • Refusal to consent.
  • Patients (with or without diabetes) having HbA1c ≥ 7% at baseline IASI in the past 3 months History of any systemic inflammatory arthritis History of trauma, surgery or infection in the affected knee joint Overlying skin and soft tissue infection Uncontrolled bleeding diathesis Known case of cancer Clinically significant cognitive impairment Known allergy to triamcinolone acetonide or lignocaine.

结局指标

主要结局

To determine the responsiveness of intra articular steroid injections in knee osteoarthritic patients.

时间窗: baseline and at 2 weeks and 4 weeks.

次要结局

  • Observe CRP levels in each group(At 2 weeks and 4 weeks)
  • Quantify dose of rescue analgesic(At 2 weeks and 4 weeks)
  • Observe local or systemic complications(At 2 weeks and 4 weeks)

研究者

发起方
All India Institute of Medical Sciences (AIIMS), Guwahati
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sristi Kumari

All India Institute of Medical Sciences, Guwahati

研究点 (1)

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