Embolization treatment for tennis elbow pain
Safety and Efficacy of Elbow Artery Embolization (EAE) for the Treatment of Lateral Epicondylitis
This study is testing a new procedure using tiny particles to help people with tennis elbow pain who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05325242 on ClinicalTrials.gov |
What this trial studies
This clinical research examines the safety and effectiveness of elbow artery embolization (EAE) using Embozene particles to treat pain from lateral epicondylitis, commonly known as tennis elbow. The study involves a single-center, prospective, single-arm design, enrolling 25 patients who have not responded to conservative treatments. Participants will undergo the embolization procedure to reduce blood flow to the painful area in the elbow, followed by regular follow-up visits for 24 months to assess pain relief and any adverse effects. The study aims to provide insights into a novel treatment approach for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with moderate to severe lateral elbow pain who have not found relief from conservative treatments.
Not a fit: Patients with mild elbow pain, chronic renal insufficiency, or those who have had prior elbow surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce elbow pain and improve quality of life for patients suffering from tennis elbow.
How similar studies have performed: While this approach is investigational, similar embolization techniques have shown promise in treating other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of lateral epicondylitis based on history and physical exam * Ability to provide informed consent * Life expectancy greater than 12 months * Moderate-severe lateral elbow pain as determined by visual analog scale \> 4 (based on average severity during physical activity) * Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection) for at least 6 months. Exclusion Criteria: * Mild elbow pain as determined by visual analog scale \< 4 * Chronic renal insufficiency (serum creatinine \>2 mg/dL) * Allergy to iodinated contrast agents that is not responsive to steroid management * Active Infection or malignancy * Prior elbow surgery in the subject elbow * Uncorrectable bleeding diathesis
Where this trial is running
Los Angeles, California
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Siddharth Padia, M.D. — University of California, Los Angeles
- Study coordinator: Aniket Joglekar
- Email: AJoglekar@mednet.ucla.edu
- Phone: 310-948-8026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.