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| Name | Class |
|---|---|
| Dongkook Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Compare the safety of TAE by recording adverse events at 1 month, 3 months, 6 months, and 12 months post intervention | 1,3,6,12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Woosun Choi, MD. Ph D. | Associate Professor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
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| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092464 | Elbow Injuries |
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| D001134 |
| Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |