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NCT Number: NCT07194135

Intra-articular Tenoxicam Versus Triamcinolone Acetonide in Knee Osteoarthritis Management

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospitals, Department of Orthopedics and Rheumatology

Banhā, Qalyubia Governorate, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Tenoxicam

Drug

Intra-articular administration of tenoxicam, 20 milligrams as a single injection, delivered through an anterolateral approach under aseptic technique.

Triamcinolone Acetonide

Drug

Intra-articular administration of triamcinolone acetonide, 40 milligrams as a single injection, delivered through an anterolateral approach under aseptic technique.

Primary outcomes

  1. Change in Knee Pain Intensity Measured by Visual Analog Scale

    Time frame: 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.

Secondary outcomes

  1. Change in Knee Function Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks after injection

    The Western Ontario and McMaster Universities Osteoarthritis Index evaluates pain, stiffness, and physical function in patients with knee osteoarthritis. Scores range from 0 to 96, with higher scores indicating worse symptoms. The outcome was defined as the change from baseline to follow-up.

  2. Change in Glycemic Control Measured by Glycated Hemoglobin (HbA1c)

    Time frame: Baseline and 1 month after injection

    Glycated hemoglobin (HbA1c) was measured to evaluate the effect of intra-articular injection on blood glucose control. The outcome was defined as the change in HbA1c percentage from baseline to one month after injection.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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