Elbow TendinitisNCT06523114
Transcatheter Arterial Embolization for Elbow and Foot Plantar Pain
A study testing Transcatheter Arterial Embolization in people with Elbow Tendinitis and Elbow Tendinopathy, run by Chung-Ang University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Elbow Tendinitis, Elbow Tendinopathy, Epicondylitis of the Elbow
- What is being tested?
- Transcatheter Arterial Embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Apr 2022to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients are pregnant or breastfeeding
- Local infection in the painful area
- Patients have a bleeding disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcatheter Arterial Embolization for Relief of Chronic Musculoskeletal Elbow and Foot Plantar Pain Refractory to Conservative Treatment
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.
Read the 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.
- Conditions
- Elbow Tendinitis, Elbow Tendinopathy, Epicondylitis of the Elbow, Epicondylitis, Lateral, Plantar Fascitis, Embolization
- Being tested
- Transcatheter Arterial Embolization
- Medical subject headings
- Elbow Tendinopathy, Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Arterial EmbolizationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Transcatheter Arterial Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1,3,6,12 month
Secondary outcomes (1)
Adverse Events
Compare the safety of TAE by recording adverse events at 1 month, 3 months, 6 months, and 12 months post intervention
Measured: 1,3,6,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start18 Apr 2022
- Primary completion2 Sep 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dongkook Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Woosun Choi, Chung-Ang University Hospital
- Investigators
- Woosun Choi, MD. Ph D., Study director, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523114
- Sponsor's protocol ID
- 2110-003-449
- Status last verified
- Dec 2025
- First submitted
- 22 Jul 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Arterial Embolization for Relief of Chronic Musculoskeletal Elbow and Foot Plantar Pain Refractory to Conservative Treatment
- ClinicalTrials.gov ID
- NCT06523114
- Acronym / sponsor ID
- 2110-003-449
- Conditions
- Elbow Tendinitis, Elbow Tendinopathy, Epicondylitis of the Elbow, Epicondylitis, Lateral, Plantar Fascitis, Embolization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Collaborators
- Dongkook Pharmaceutical Co., Ltd.
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lateral epicondylitis and plantar fascitis group | Experimental | Device: Transcatheter Arterial EmbolizationAmong patients with lateral epicondylitis or plantar fascitis, pain refractory to at least 6 months of physician directed conservative therapy |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients are pregnant or breastfeeding
- Local infection in the painful area
- Patients have a bleeding disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Arterial EmbolizationAfter 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. | Device | Lateral epicondylitis and plantar fascitis group |
Primary outcome
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.
1 secondary outcome
Adverse Events
Time frame: 1,3,6,12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
Related trials for Elbow Tendinitis
RecruitingObservational study
Embo Registry; National Registry for Artery Embolization
Chronic Pain, Osteoarthritis, Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woosun Choi, MD. Ph D. study director
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Arterial Embolization in people with Elbow Tendinitis and Elbow Tendinopathy, run by Chung-Ang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale Pain (VAS) Score (time frame: 1,3,6,12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.