Transcatheter Arterial Embolization for Elbow and Foot Plantar Pain

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

Status: Completed

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

Treatments: Device: Transcatheter Arterial Embolization

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06523114

2110-003-449

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Lateral epicondylitis and plantar fascitis group

Experimental group

Description:

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

Treatment:

Device: Transcatheter Arterial Embolization