Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis

NCT07883876 | Not Yet Recruiting

• 1 other identifier: AEŞH-EK-2026-060
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis

Keywords

Tenoxicam; Corticosteroid Injection; Strain Elastography; Ultrasound-Guided Injection

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks after injection

Secondary Outcomes (5)

• Change From Baseline in Upper Extremity Disability (QuickDASH) at 12 Weeks

  Baseline and 12 weeks after injection

• Change From Baseline in Lateral Epicondylitis-Related Pain and Disability (PRTEE) at 12 Weeks

  Baseline and 12 weeks after injection.

• Change From Baseline in Pain-Free Grip Strength (Jamar Dynamometer) at 12 Weeks

  Baseline and 12 weeks after injection

• Change From Baseline in Common Extensor Tendon Thickness at 12 Weeks

  Baseline and 12 weeks after injection

• Change From Baseline in Common Extensor Tendon Strain Ratio at 12 Weeks

  Baseline and 12 weeks after injection

Study Arms (2)

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.

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.

Drug: tenoxicam

Interventions

methylprednisolone acetate DRUG

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.

Corticosteroid Injections Group

tenoxicam DRUG

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.

Tenoxicam Injection Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Methylprednisolone Acetate; tenoxicam

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Özgür Ortancıl, MD

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İrem Bilgiç, MD

CONTACT

+90 539 848 33 60; irembilgic.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 20, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 20, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)