Lateral Epicondylitis
Conditions
Keywords
Tenoxicam, Corticosteroid Injection, Strain Elastography, Ultrasound-Guided Injection
Brief 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. 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.
Interventions
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.
DRUGtenoxicam
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.
Sponsors
Ankara Etlik City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Activity-Related Pain Intensity (VAS) at 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Upper Extremity Disability (QuickDASH) at 12 Weeks | Baseline and 12 weeks after injection | 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. |
| Change From Baseline in Lateral Epicondylitis-Related Pain and Disability (PRTEE) at 12 Weeks | Baseline and 12 weeks after injection. | 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. |
| Change From Baseline in Pain-Free Grip Strength (Jamar Dynamometer) at 12 Weeks | Baseline and 12 weeks after injection | 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. |
| Change From Baseline in Common Extensor Tendon Thickness at 12 Weeks | Baseline and 12 weeks after injection | 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. |
| Change From Baseline in Common Extensor Tendon Strain Ratio at 12 Weeks | Baseline and 12 weeks after injection | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTİrem Bilgiç, MD
PRINCIPAL_INVESTIGATORÖzgür Ortancıl, MD
Ankara Etlik City Hospital
Outcome results
None listed