Transcatheter Arterial Embolization for Elbow and Foot Plantar Pain

Not Applicable

Recruiting

• Conditions: Epicondylitis, Lateral; Embolization; Elbow Tendinitis; Elbow Tendinopathy; Plantar Fascitis; Epicondylitis of the Elbow
• Interventions: Device: Transcatheter Arterial Embolization

• Registration Number: NCT06523114
• Lead Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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.

Study Timeline

• Study Start: 2022-04-18
• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-26
• Last Update Submitted: 2024-07-27
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lateral epicondylitis and plantar fascitis group	Transcatheter Arterial Embolization	Among patients with lateral epicondylitis or plantar fascitis, pain refractory to at least 6 months of physician directed conservative therapy

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Pain (VAS) Score	1,3,6,12 month	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1,3,6,12 month	Compare the safety of TAE by recording adverse events at 1 month, 3 months, 6 months, and 12 months post intervention

Trial Locations

Locations (1)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of