Lateral EpicondylitisNCT07883876
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
A study testing methylprednisolone acetate and tenoxicam in people with Lateral Epicondylitis, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, comparative clinical study aims to compare the effectiveness of ultrasound-guided corticosteroid and tenoxicam injections in patients with lateral epicondylitis. A total of 72 participants will be randomized into two groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- methylprednisolone acetate and tenoxicam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- History of elbow pain lasting longer than 3 months
- Localized pain and tenderness on palpation over the lateral epicondyle on physical examination
- Failure to improve with non-invasive treatment, including at least 6 weeks of NSAID treatment and splint use
- Pain intensity of 5 or higher on the Visual Analog Scale (VAS)
- Voluntary participation in treatment
Who cannot join
- History of injection treatment for lateral epicondylitis
- Cervical radiculopathy
- Carpal tunnel syndrome
- History of elbow surgery
- History of trauma or fracture of the forearm
- Limitation of wrist extension due to traumatic hand injury
Show all 12Show fewer
- Skin infection in the lateral epicondyle region
- Active infection or systemic inflammatory disease
- Bleeding diathesis or anticoagulant use
- Pregnancy or breastfeeding
- Malignancy
- Medical conditions that constitute a contraindication to local injections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara
İrem Bilgiç, MD, +90 539 848 33 60, irembilgic.md@gmail.com
Gizem Suna Tuncer, MD
About this study
Official title: Comparison of the Effectiveness of Ultrasound-Guided NSAID and Corticosteroid Injections in Patients With Lateral Epicondylitis
This prospective, randomized, comparative clinical study aims to compare the effectiveness of ultrasound-guided corticosteroid and tenoxicam injections in patients with lateral epicondylitis. A total of 72 participants will be randomized into two groups. One group will receive an ultrasound-guided methylprednisolone injection and the other group will receive an ultrasound-guided tenoxicam injection. Participants will be evaluated at baseline and at 4 and 12 weeks after treatment. Clinical outcomes will include pain, upper extremity function, lateral epicondylitis-related disability, and grip strength. Ultrasonographic assessment, including tendon thickness and strain elastography, will also be performed to evaluate structural and mechanical changes in the common extensor tendon.
Read the detailed description
This prospective, randomized, assessor-blinded, parallel-group clinical study will include 72 patients diagnosed with lateral epicondylitis. The study aims to compare the effectiveness of ultrasound-guided methylprednisolone acetate and tenoxicam injections.
Eligible participants who provide written informed consent will be randomly assigned to two treatment groups (36 participants per group) using simple randomization based on computer-generated random numbers. The randomization sequence will be generated by an independent researcher who is not involved in the study.
The corticosteroid group will receive a single ultrasound-guided injection of methylprednisolone acetate (20 mg) mixed with 1 mL of 1% lidocaine. The tenoxicam group will receive a single ultrasound-guided injection of tenoxicam (10 mg) mixed with 1 mL of 1% lidocaine.
All injections will be performed under sterile conditions using real-time ultrasound guidance. The lateral epicondyle and common extensor tendon insertion will be targeted using an in-plane needle approach.
Both groups will receive a standardized home exercise program and appropriate bracing recommendations.
Clinical assessments will be performed at baseline and at 4 and 12 weeks after treatment. Pain intensity will be evaluated using the Visual Analog Scale (VAS), and upper extremity disability will be assessed using the QuickDASH and Patient-Rated Tennis Elbow Evaluation (PRTEE). Pain-free grip strength will be measured using a Jamar dynamometer. Ultrasonographic assessments will include common extensor tendon thickness and strain elastography measurements.
Due to the nature of the interventions, participants and treatment providers will not be blinded. However, outcome assessments will be performed by an assessor who is unaware of treatment allocation. This assessor-blinded design aims to minimize assessment bias.
- Conditions
- Lateral Epicondylitis
- Being tested
- methylprednisolone acetate, tenoxicam
- Keywords
- Tenoxicam, Corticosteroid Injection, Strain Elastography, Ultrasound-Guided Injection
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylprednisolone acetateDrug
A single ultrasound-guided injection of 0.5 mL methylprednisolone acetate (20 mg; 40 mg/mL injectable suspension), mixed with 1 mL of 1% lidocaine, will be administered to the common extensor tendon region at the lateral epicondyle.
tenoxicamDrug
A single ultrasound-guided injection of 1 mL tenoxicam solution (10 mg, prepared from a 20 mg/2 mL formulation), mixed with 1 mL of 1% lidocaine, will be administered to the common extensor tendon region at the lateral epicondyle.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid Injections Group | Active comparator | Participants in this arm will receive a single ultrasound-guided injection of 0.5 mL methylprednisolone acetate (20 mg, 40 mg/mL suspension) mixed with 1 mL of 1% lidocaine. Receives: Drug: methylprednisolone acetate |
| Tenoxicam Injection Group | Experimental | Participants in this arm will receive a single ultrasound-guided injection of 1 mL tenoxicam solution (10 mg, prepared at a concentration of 20 mg/2 mL) mixed with 1 mL of 1% lidocaine. Receives: Drug: tenoxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Activity-Related Pain Intensity (VAS) at 12 Weeks
Activity-related pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity during activity. The primary outcome will be the change in activity-related VAS score from baseline to 12 weeks after injection, calculated as the 12-week score minus the baseline score. Negative values indicate a reduction in activity-related pain.
Measured: Baseline and 12 weeks after injection
Secondary outcomes (5)
Change From Baseline in Upper Extremity Disability (QuickDASH) at 12 Weeks
Upper extremity disability and function will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Scores range from 0 (no disability) to 100 (most severe disability). The change in QuickDASH score will be calculated as the 12-week score minus the baseline score. Negative values indicate an improvement in upper extremity function.
Measured: Baseline and 12 weeks after injection
Change From Baseline in Lateral Epicondylitis-Related Pain and Disability (PRTEE) at 12 Weeks
Pain and functional disability related to lateral epicondylitis will be assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire. The total score ranges from 0 (no pain or disability) to 100 (maximum pain and disability). The change in PRTEE score will be calculated as the 12-week score minus the baseline score. Negative values indicate an improvement in pain and functional disability.
Measured: Baseline and 12 weeks after injection.
Change From Baseline in Pain-Free Grip Strength (Jamar Dynamometer) at 12 Weeks
Pain-free grip strength will be measured using a Jamar hand dynamometer and recorded in kilograms (kg). The maximum grip strength achieved without eliciting pain will be recorded. The change in pain-free grip strength will be calculated as the 12-week value minus the baseline value. Positive values indicate an improvement in pain-free grip strength.
Measured: Baseline and 12 weeks after injection
Change From Baseline in Common Extensor Tendon Thickness at 12 Weeks
Common extensor tendon thickness will be measured in millimeters (mm) using ultrasonography at the lateral epicondyle region. The change in tendon thickness will be calculated as the 12-week measurement minus the baseline measurement. Negative values indicate a reduction in tendon thickness.
Measured: Baseline and 12 weeks after injection
Change From Baseline in Common Extensor Tendon Strain Ratio at 12 Weeks
The mechanical properties of the common extensor tendon will be assessed using strain elastography. ROI 1 will be placed within the common extensor tendon, and ROI 2 within the subcutaneous fat tissue as the reference region. The strain ratio will be calculated as ROI 2 / ROI 1 (fat strain / tendon strain). Higher strain ratios indicate greater relative tendon stiffness. The change in strain ratio will be calculated as the 12-week value minus the baseline value.
Measured: Baseline and 12 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Özgür Ortancıl, MD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883876
- Sponsor's protocol ID
- AEŞH-EK-2026-060
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ultrasound-Guided NSAID and Corticosteroid Injections in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT07883876
- Acronym / sponsor ID
- AEŞH-EK-2026-060
- Conditions
- Lateral Epicondylitis
- Keywords
- Tenoxicam, Corticosteroid Injection, Strain Elastography, Ultrasound-Guided Injection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 Oct 2026 (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.
This prospective, randomized, comparative clinical study aims to compare the effectiveness of ultrasound-guided corticosteroid and tenoxicam injections in patients with lateral epicondylitis. A total of 72 participants will be randomized into two groups. One group will receive an ultrasound-guided methylprednisolone injection and the other group will receive an ultrasound-guided tenoxicam injection. Participants will be evaluated at baseline and at 4 and 12 weeks after treatment. Clinical outcomes will include pain, upper extremity function, lateral epicondylitis-related disability, and grip strength. Ultrasonographic assessment, including tendon thickness and strain elastography, will also be performed to evaluate structural and mechanical changes in the common extensor tendon.
Detailed description
This prospective, randomized, assessor-blinded, parallel-group clinical study will include 72 patients diagnosed with lateral epicondylitis. The study aims to compare the effectiveness of ultrasound-guided methylprednisolone acetate and tenoxicam injections.
Eligible participants who provide written informed consent will be randomly assigned to two treatment groups (36 participants per group) using simple randomization based on computer-generated random numbers. The randomization sequence will be generated by an independent researcher who is not involved in the study.
The corticosteroid group will receive a single ultrasound-guided injection of methylprednisolone acetate (20 mg) mixed with 1 mL of 1% lidocaine. The tenoxicam group will receive a single ultrasound-guided injection of tenoxicam (10 mg) mixed with 1 mL of 1% lidocaine.
All injections will be performed under sterile conditions using real-time ultrasound guidance. The lateral epicondyle and common extensor tendon insertion will be targeted using an in-plane needle approach.
Both groups will receive a standardized home exercise program and appropriate bracing recommendations.
Clinical assessments will be performed at baseline and at 4 and 12 weeks after treatment. Pain intensity will be evaluated using the Visual Analog Scale (VAS), and upper extremity disability will be assessed using the QuickDASH and Patient-Rated Tennis Elbow Evaluation (PRTEE). Pain-free grip strength will be measured using a Jamar dynamometer. Ultrasonographic assessments will include common extensor tendon thickness and strain elastography measurements.
Due to the nature of the interventions, participants and treatment providers will not be blinded. However, outcome assessments will be performed by an assessor who is unaware of treatment allocation. This assessor-blinded design aims to minimize assessment bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid Injections Group | Active comparator | Drug: methylprednisolone acetateParticipants in this arm will receive a single ultrasound-guided injection of 0.5 mL methylprednisolone acetate (20 mg, 40 mg/mL suspension) mixed with 1 mL of 1% lidocaine. |
| Tenoxicam Injection Group | Experimental | Drug: tenoxicamParticipants in this arm will receive a single ultrasound-guided injection of 1 mL tenoxicam solution (10 mg, prepared at a concentration of 20 mg/2 mL) mixed with 1 mL of 1% lidocaine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years
- History of elbow pain lasting longer than 3 months
- Localized pain and tenderness on palpation over the lateral epicondyle on physical examination
- Failure to improve with non-invasive treatment, including at least 6 weeks of NSAID treatment and splint use
- Pain intensity of 5 or higher on the Visual Analog Scale (VAS)
Key exclusion criteria (12 listed)
- History of injection treatment for lateral epicondylitis
- Cervical radiculopathy
- Carpal tunnel syndrome
- History of elbow surgery
- History of trauma or fracture of the forearm
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 |
|---|---|---|
| methylprednisolone acetateA single ultrasound-guided injection of 0.5 mL methylprednisolone acetate (20 mg; 40 mg/mL injectable suspension), mixed with 1 mL of 1% lidocaine, will be administered to the common extensor tendon region at the lateral epicondyle. | Drug | Corticosteroid Injections Group |
| tenoxicamA single ultrasound-guided injection of 1 mL tenoxicam solution (10 mg, prepared from a 20 mg/2 mL formulation), mixed with 1 mL of 1% lidocaine, will be administered to the common extensor tendon region at the lateral epicondyle. | Drug | Tenoxicam Injection Group |
Primary outcome
Change From Baseline in Activity-Related Pain Intensity (VAS) at 12 Weeks
Time frame: Baseline and 12 weeks after injection
Activity-related pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity during activity. The primary outcome will be the change in activity-related VAS score from baseline to 12 weeks after injection, calculated as the 12-week score minus the baseline score. Negative values indicate a reduction in activity-related pain.
5 secondary outcomes
Change From Baseline in Upper Extremity Disability (QuickDASH) at 12 Weeks
Time frame: Baseline and 12 weeks after injection
Change From Baseline in Lateral Epicondylitis-Related Pain and Disability (PRTEE) at 12 Weeks
Time frame: Baseline and 12 weeks after injection.
Change From Baseline in Pain-Free Grip Strength (Jamar Dynamometer) at 12 Weeks
Time frame: Baseline and 12 weeks after injection
Change From Baseline in Common Extensor Tendon Thickness at 12 Weeks
Time frame: Baseline and 12 weeks after injection
Change From Baseline in Common Extensor Tendon Strain Ratio at 12 Weeks
Time frame: Baseline and 12 weeks after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Lateral Epicondylitis
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruitingObservational study
Metabolic and Inflammatory Indices in Lateral Epicondylitis
Lateral Epicondylitis
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.
Özgür Ortancıl, MD principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylprednisolone acetate and tenoxicam in people with Lateral Epicondylitis, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 20 Oct 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İrem Bilgiç, MD (+90 539 848 33 60, irembilgic.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Activity-Related Pain Intensity (VAS) at 12 Weeks (time frame: Baseline 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 20 Oct 2026.