Intra-articular Tenoxicam Versus Triamcinolone Acetonide in Knee Osteoarthritis Management

NCT07194135 | Completed

• 1 other identifier: Rc 26-10-2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Knee Osteoarthritis; Intra-articular Injection; Tenoxicam; Non-Steroidal Anti-Inflammatory Drugs; Triamcinolone Acetonide; Corticosteroid Injections; Pain Management

Outcome Measures

Primary Outcomes (1)

• Change in Knee Pain Intensity Measured by Visual Analog Scale

  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.

  Baseline, 2 weeks, 6 weeks, and 12 weeks after injection

Secondary Outcomes (2)

• 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

Study Arms (2)

Tenoxicam Injection

EXPERIMENTAL

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

Drug: Tenoxicam

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.

Drug: Triamcinolone Acetonide

Interventions

Tenoxicam DRUG

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

Tenoxicam Injection

Triamcinolone Acetonide DRUG

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

Triamcinolone Acetonide Injection

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospitals, Department of Orthopedics and Rheumatology

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia

Interventions

tenoxicam; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label trial. Participants and investigators were aware of treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Orthopedic Surgery

Model Details: Participants were randomly assigned in a 1:1 ratio to receive either intra-articular tenoxicam or intra-articular triamcinolone acetonide.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 26, 2025
• Study Start: November 3, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting documents will be available beginning 6 months after publication of the primary manuscript and for a period of 5 years thereafter.
• Access Criteria: Qualified researchers affiliated with an academic or healthcare institution may request access by submitting a brief proposal (study aims, analysis plan, and list of requested variables) and institutional ethics approval or exemption. Access will be granted upon execution of a Data Use Agreement that prohibits re-identification, redistribution, and use beyond the approved proposal. Data will be shared via secure, password-protected transfer or a controlled-access repository designated by the sponsor.

Locations

EG (1)