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OpenTrials
Completed

NCT Number: NCT06523114

Transcatheter Arterial Embolization for Elbow and Foot Plantar Pain

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.

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Key information

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung-Ang University Hospital

Seoul, 06973, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Visual Analog Scale Pain (VAS) Score

    Time frame: 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 outcomes

  1. Adverse Events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chung-Ang University Hospital

Other

Collaborators

  • Dongkook Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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