Intra-articular Tenoxicam Versus Triamcinolone Acetonide in Knee Osteoarthritis Management

NCT ID: NCT07194135

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-03
• Study Completion Date: 2025-04-30

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tenoxicam Injection

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

Group Type: EXPERIMENTAL

Tenoxicam

Intervention Type: DRUG

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

Triamcinolone Acetonide Injection

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

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type: DRUG

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

Interventions

Tenoxicam

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

Intervention Type: DRUG

Triamcinolone Acetonide

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Hossam Mohamed Saad

Lecturer of Orthopedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha University Hospitals, Department of Orthopedics and Rheumatology

Banhā, Qalyubia Governorate, Egypt

Countries

Egypt

Other Identifiers

Rc 26-10-2024

Identifier Type: -

Identifier Source: org_study_id