Transcatheter Arterial Embolization for Elbow and Foot Plantar Pain

Transcatheter Arterial Embolization for Relief of Chronic Musculoskeletal Elbow and Foot Plantar Pain Refractory to Conservative Treatment

This is a prospective single arm study in which patients with moderate to severe chronic elbow or foot plantar pain, in the setting of lateral epicondylitis or plantar fascitis refractory to conservative treatment, will be enrolled.

The primary aim of this study is to estimate the effectiveness and safety of transcatheter arterial embolization (TAE) for changes in elbow or plantar pain with 6 and 12-month follow-up.

Study Overview

• Status: Completed
• Conditions: Elbow Tendinitis; Elbow Tendinopathy; Plantar Fascitis; Epicondylitis, Lateral; Epicondylitis of the Elbow; Embolization
• Intervention / Treatment: Device: Transcatheter Arterial Embolization

Detailed Description

This is a prospective single arm, single center study at Chung-Ang University Hospital. Patients with moderate to severe elbow or foot pain, and pain refractory to at least 6 months of physician directed conservative therapy (oral analgesic, physical therapy or local injection treatment) will be eligible for enrollment.

Transcatheter arterial embolization (TAE) is performed after receiving informed consent, and imipenem is used as an embolic material to embolize the target lesion. After the procedure, evaluate the VAS score and limitation of range of motion (LOM) of the joint area.

Follow-up at 1, 3, 6 and 12 months after embolization, and changes of VAS score and LOM are checked.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 06973
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who voluntarily signed a written consent form after receiving an explanation of the purpose, method, and effects of this clinical trial
• Patients who have had pain in the relevant area for more than 6 months and have a history of receiving physical therapy, analgesic anti-inflammatory medication, or local injection treatment
• Patients in whom hypervascularization was confirmed in the relevant area through imaging results (US, CT, MRI) evaluating the cause of pain.

Exclusion Criteria:

• Patients are pregnant or breastfeeding
• Local infection in the painful area
• Patients have a bleeding disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lateral epicondylitis and plantar fascitis group; Among patients with lateral epicondylitis or plantar fascitis, pain refractory to at least 6 months of physician directed conservative therapy	Device: Transcatheter Arterial Embolization; After accessing the common femoral artery or radial artery, embolization is performed using embolic material after confirming abnormal blood vessel abnormalities, lesion hypervascularity, and lesion enhancement findings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale Pain (VAS) Score	At 1 week, 1 month, 3 months, 6 months, and 12 months after the procedure, the degree of pain (visual analog scale pain, 10 points for maximum pain, 0 points for no pain) is assessed through an outpatient visit or by phone.	1,3,6,12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Compare the safety of TAE by recording adverse events at 1 month, 3 months, 6 months, and 12 months post intervention	1,3,6,12 month

Collaborators and Investigators

• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• Collaborators: Dongkook Pharmaceutical Co., Ltd.
• Investigators: Study Director: Woosun Choi, MD. Ph D., Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): September 2, 2025
• Study Completion (Actual): September 2, 2025

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 2110-003-449

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No