Elbow Tendinitis, Elbow Tendinopathy, Embolization, Epicondylitis, Lateral, Epicondylitis of the Elbow, Plantar Fascitis
Conditions
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.
Interventions
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.
Sponsors
Dongkook Pharmaceutical Co., Ltd.
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed