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临床试验/NCT07194135
NCT07194135已完成不适用

Comparison of Intra-articular Tenoxicam and Triamcinolone Acetonide in the Management of Knee Osteoarthritis: A Randomized Prospective Study

Benha University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in Knee Pain Intensity Measured by Visual Analog Scale

研究概览

简要总结

Knee osteoarthritis is a very common joint condition that leads to pain, stiffness, and difficulty with daily activities, particularly in middle-aged and older adults. Many patients do not get adequate relief from oral pain medications, non-steroidal anti-inflammatory drugs, or physical therapy. Because of this, injections directly into the knee joint are often used.

Corticosteroid medicines, such as triamcinolone acetonide, are among the most frequently used intra-articular injections. They provide strong and rapid anti-inflammatory effects, but their benefits often wear off after only a few weeks. In addition, corticosteroids may cause unwanted systemic effects such as temporary increases in blood sugar, which can be especially concerning for patients with diabetes.

Non-steroidal anti-inflammatory drugs are another group of medicines that can relieve pain and inflammation. Tenoxicam is a long-acting medicine from this group. When given directly into the knee joint, tenoxicam may provide local pain relief for a longer duration, while reducing the amount of drug that circulates in the body. This may lower the risk of side effects compared with oral treatment or repeated corticosteroid injections.

This clinical study was designed to compare the effects of a single intra-articular injection of tenoxicam with a single intra-articular injection of triamcinolone acetonide in patients who have symptomatic knee osteoarthritis. The primary aim was to determine which treatment provides better improvement in knee pain, measured using a visual analog scale. Secondary aims included evaluating knee function using the Western Ontario and McMaster Universities Osteoarthritis Index, monitoring blood sugar control using glycated hemoglobin testing, and assessing the safety of each treatment by recording any local or general adverse events.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

This was an open-label trial. Participants and investigators were aware of treatment allocation.

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 45 to 75 years
  • Radiographically confirmed knee osteoarthritis (Kellgren-Lawrence grade II-III)
  • Persistent knee pain for at least 3 months despite oral non-steroidal anti-inflammatory drugs
  • Ability to provide informed consent

排除标准

  • Prior intra-articular injection within the past 6 months
  • Inflammatory arthritis (e.g., rheumatoid arthritis, gout)
  • Advanced knee osteoarthritis (Kellgren-Lawrence grade IV)
  • Active joint or systemic infection
  • Bleeding disorder or anticoagulant use contraindicating injection
  • Uncontrolled diabetes mellitus
  • Known hypersensitivity to tenoxicam or triamcinolone acetonide

研究组 & 干预措施

Tenoxicam Injection

Experimental

Participants received a single intra-articular injection of tenoxicam 20 milligrams, administered aseptically through an anterolateral approach to the knee joint.

干预措施: Tenoxicam (Drug)

Triamcinolone Acetonide Injection

Active Comparator

Participants received a single intra-articular injection of triamcinolone acetonide 40 milligrams, administered aseptically through an anterolateral approach to the knee joint.

干预措施: Triamcinolone Acetonide (Drug)

结局指标

主要结局

Change in Knee Pain Intensity Measured by Visual Analog Scale

时间窗: Baseline, 2 weeks, 6 weeks, and 12 weeks after injection

Pain intensity in the affected knee was assessed using a visual analog scale (0 to 100 millimeters), where 0 represents no pain and 100 represents the worst imaginable pain. The outcome was defined as the change from baseline score to follow-up assessments.

次要结局

  • Change in Knee Function Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline, 2 weeks, 6 weeks, and 12 weeks after injection)
  • Change in Glycemic Control Measured by Glycated Hemoglobin (HbA1c)(Baseline and 1 month after injection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hossam Mohamed Saad

Lecturer of Orthopedic Surgery

Benha University

研究点 (1)

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