Transcatheter Arterial Embolization for Elbow and Foot Plantar Pain

NCT ID: NCT06523114

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2025-09-02

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Transcatheter Arterial Embolization

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongkook Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Woosun Choi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Woosun Choi, MD. Ph D.

Role: STUDY_DIRECTOR

Associate Professor

Locations

Chung-Ang University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2110-003-449

Identifier Type: -

Identifier Source: org_study_id