Transcatheter Arterial Embolization for Elbow and Foot Plantar Pain

NCT06523114 | Completed

• 1 other identifier: 2110-003-449
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Elbow Tendinitis; Elbow Tendinopathy; Epicondylitis of the Elbow; Epicondylitis, Lateral; Plantar Fascitis; Embolization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events

  1,3,6,12 month

Study Arms (1)

Lateral epicondylitis and plantar fascitis group

EXPERIMENTAL

Among patients with lateral epicondylitis or plantar fascitis, pain refractory to at least 6 months of physician directed conservative therapy

Device: Transcatheter Arterial Embolization

Interventions

Transcatheter Arterial Embolization DEVICE

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.

Lateral epicondylitis and plantar fascitis group

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dongkook Pharmaceutical Co., Ltd.: collaborator
• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

MeSH Terms

Conditions

Elbow Tendinopathy; Tennis Elbow

Condition Hierarchy (Ancestors)

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

Study Officials

• Woosun Choi, MD. Ph D.

  Associate Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: April 18, 2022
• Primary Completion: September 2, 2025
• Study Completion: September 2, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

KR (1)