What side effects are associated with this type of intervention?

Common treatments for Tennis Elbow include physical therapy, NSAIDs, corticosteroid injections, and PRP injections. Physical therapy generally has minimal side effects, primarily muscle soreness. NSAIDs can cause gastrointestinal issues, ulcers, and kidney problems with long-term use. Corticosteroid injections may lead to temporary pain at the injection site, skin thinning, and potential weakening of tendons with repeated use. PRP injections can cause pain, bleeding, tenderness, swelling, and bruising at the injection site. For embolization treatments like the Embozene trial, potential side effects include pain, bruising, and risk of infection at the catheter insertion site, as well as possible damage to surrounding tissues due to reduced blood flow.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for Tennis Elbow that utilize embolization to decrease blood flow to the area of pain, such as the investigational use of Embozene. Traditional FDA-approved treatments for Tennis Elbow typically include non-surgical options like nonsteroidal anti-inflammatory drugs (NSAIDs), physical therapy, and corticosteroid injections. In more severe cases, surgical interventions may be considered.

What other types of research exist?

Promising alternatives to Embozene for Tennis Elbow treatment include: 1) Botulinum toxin injections, which have shown efficacy in reducing pain and improving function in limb tremor and other musculoskeletal conditions. 2) Genicular nerve block, which has been effective in managing pain in knee osteoarthritis and could be adapted for elbow pain. 3) Topical treatments such as menthol, which have demonstrated rapid symptomatic improvement in neuropathic pain and could be explored for localized elbow pain relief.

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Embolization Agent

Artery Embolization for Tennis Elbow

N/A

Recruiting

Led By siddharth padia, M.D.

Research Sponsored by Siddharth Padia, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of lateral epicondylitis based on history and physical exam

Age ≥ 18 years and less than 80 years

Must not have

Active Infection or malignancy

Chronic renal insufficiency (serum creatinine >2 mg/dL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for tennis elbow that aims to reduce pain. It targets patients who haven't responded to other treatments. The goal is to see if this method is safe and effective.

Who is the study for?

This trial is for adults aged 18-79 with moderate to severe tennis elbow pain that hasn't improved after at least 6 months of treatments like NSAIDs, physical therapy, or steroid injections. Participants must be able to consent and have a life expectancy over a year. It's not for those with chronic kidney issues, contrast agent allergies unmanageable by steroids, bleeding problems, mild pain, infections/malignancy in the elbow area or previous surgery on the affected elbow.

What is being tested?

The study tests if blocking blood flow to painful areas of the elbow using Embozene particles can safely and effectively treat tennis elbow. This procedure involves injecting these tiny spheres into an artery leading to the painful region in order to reduce blood supply and alleviate pain.

What are the potential side effects?

Potential side effects may include discomfort at injection site, allergic reactions to materials used (if allergy management fails), complications from reduced blood flow such as tissue damage around the treated area, and general risks associated with embolization procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with tennis elbow.

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I am between 18 and 79 years old.

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I have moderate to severe elbow pain during physical activity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active infection or another type of cancer.

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My kidney function is low (creatinine >2 mg/dL).

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I have had surgery on my elbow before.

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I am allergic to iodine-based dyes and steroids don't help.

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I have a bleeding disorder that cannot be corrected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hand

Secondary study objectives

Change in imaging

Change in symptoms as assessed by the QuickDASH scores.

Change in symptoms as assessed by the patient-rates tennis elbow evaluation (PRTEE) scores.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Elbow Artery Embolization (EAE)Experimental Treatment1 Intervention

Patients will undergo EAE with Embozene microspheres (75 micron). The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the patient's pain.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Tennis Elbow include physical therapy, corticosteroid injections, and nonsteroidal anti-inflammatory drugs (NSAIDs). Physical therapy aims to strengthen the muscles and improve flexibility, reducing strain on the tendon. Corticosteroid injections reduce inflammation and pain by suppressing the immune response. NSAIDs also reduce inflammation and pain but through inhibition of cyclooxygenase enzymes. The investigational treatment with Embozene involves embolization, which decreases blood flow to the painful area, potentially reducing pain by limiting the inflammatory response and subsequent tissue damage. This matters for Tennis Elbow patients as it offers a targeted approach to pain management, potentially providing relief when other treatments are ineffective.