Osteoarthritis, KneeNCT07194135
Intra-articular Tenoxicam Versus Triamcinolone Acetonide in Knee Osteoarthritis Management
A study testing Tenoxicam and Triamcinolone Acetonide in people with Osteoarthritis, Knee, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Tenoxicam and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Nov 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Benha University Hospitals, Department of Orthopedics and Rheumatology
Banhā, Qalyubia Governorate, 13511
About this study
Official title: Comparison of Intra-articular Tenoxicam and Triamcinolone Acetonide in the Management of Knee Osteoarthritis: A Randomized Prospective Study
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.
Read more
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
- Being tested
- Tenoxicam, Triamcinolone Acetonide
- Keywords
- Knee Osteoarthritis, Intra-articular Injection, Tenoxicam, Non-Steroidal Anti-Inflammatory Drugs, Triamcinolone Acetonide, Corticosteroid Injections, Pain Management
- Medical subject headings
- Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenoxicamDrug
Intra-articular administration of tenoxicam, 20 milligrams as a single injection, delivered through an anterolateral approach under aseptic technique.
Triamcinolone AcetonideDrug
Intra-articular administration of triamcinolone acetonide, 40 milligrams as a single injection, delivered through an anterolateral approach under aseptic technique.
| Study group | Role | What they receive |
|---|---|---|
| Tenoxicam Injection | Experimental | Participants received a single intra-articular injection of tenoxicam 20 milligrams, administered aseptically through an anterolateral approach to the knee joint. Receives: 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. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline, 2 weeks, 6 weeks, and 12 weeks after injection
Change in Glycemic Control Measured by Glycated Hemoglobin (HbA1c)
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.
Measured: Baseline and 1 month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start3 Nov 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to receive either intra-articular tenoxicam or intra-articular triamcinolone acetonide.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194135
- Sponsor's protocol ID
- Rc 26-10-2024
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in the article will be shared, including baseline characteristics, treatment allocation, outcome measures (visual analog scale for pain, Western Ontario and McMaster Universities Osteoarthritis Index, glycated hemoglobin), and adverse event data. A data dictionary defining each variable will be provided. No directly identifying information will be included.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intra-articular Tenoxicam and Triamcinolone Acetonide in the Management of Knee Osteoarthritis: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT07194135
- Acronym / sponsor ID
- Rc 26-10-2024
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee Osteoarthritis, Intra-articular Injection, Tenoxicam, Non-Steroidal Anti-Inflammatory Drugs, Triamcinolone Acetonide, Corticosteroid Injections, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 3 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to receive either intra-articular tenoxicam or intra-articular triamcinolone acetonide.
| Arm | Type | Receives |
|---|---|---|
| Tenoxicam Injection | Experimental | Drug: TenoxicamParticipants received a single intra-articular injection of tenoxicam 20 milligrams, administered aseptically through an anterolateral approach to the knee joint. |
| Triamcinolone Acetonide Injection | Active comparator | Drug: Triamcinolone AcetonideParticipants received a single intra-articular injection of triamcinolone acetonide 40 milligrams, administered aseptically through an anterolateral approach to the knee joint. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenoxicamIntra-articular administration of tenoxicam, 20 milligrams as a single injection, delivered through an anterolateral approach under aseptic technique. | Drug | Tenoxicam Injection |
| Triamcinolone AcetonideIntra-articular administration of triamcinolone acetonide, 40 milligrams as a single injection, delivered through an anterolateral approach under aseptic technique. | Drug | Triamcinolone Acetonide Injection |
Primary outcome
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.
2 secondary outcomes
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
Change in Glycemic Control Measured by Glycated Hemoglobin (HbA1c)
Time frame: Baseline and 1 month after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in the article will be shared, including baseline characteristics, treatment allocation, outcome measures (visual analog scale for pain, Western Ontario and McMaster Universities Osteoarthritis Index, glycated hemoglobin), and adverse event data. A data dictionary defining each variable will be provided. No directly identifying information will be included.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenoxicam and Triamcinolone Acetonide in people with Osteoarthritis, Knee, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Pain Intensity Measured by Visual Analog Scale (time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.