Actively Recruiting
Transcatheter Arterial Embolization Using Nexsphere-F for Chronic Shoulder Pain Refractory to Conservative Treatment
Led by Chung-Ang University Hosptial, Chung-Ang University College of Medicine · Updated on 2026-04-29
44
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
C
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Lead Sponsor
N
Next Biomedical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Evaluation of the efficacy and safety of transcatheter arterial embolization using 'Nexsphere-F' for pain relief in patients with adhesive capsulitis of the shoulder joint that does not respond to conservative treatment. This study aims to investigate the efficacy and safety of transcatheter arterial embolization using embolic agents in patients with adhesive capsulitis of the shoulder joint. This is a single-center, prospective, open-label, randomized clinical trial.
CONDITIONS
Official Title
Transcatheter Arterial Embolization Using Nexsphere-F for Chronic Shoulder Pain Refractory to Conservative Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have voluntarily signed a written informed consent form after receiving an explanation of the purpose, methods, and potential effects of the clinical trial
- Patients aged between 19 and 85 years
- Patients with pain persisting for more than 3 months in the affected area and with a history of receiving physical therapy, analgesics/anti-inflammatory medications, or local injection treatments
- Patients with a measured shoulder joint range of motion (ROM) of less than 90 degrees
- Patients who agree not to receive any conservative treatment other than those permitted in this clinical trial (physical therapy, medication [NSAIDs, opioid analgesics, acetaminophen], intra-articular injections such as hyaluronic acid)
- Patients who are willing to comply with the treatment and procedures of the clinical trial and participate in all follow-up evaluations through hospital visits or telephone surveys
You will not qualify if you...
- Patients with a history of surgery on the shoulder joint targeted for the clinical trial prior to screening
- Patients suspected of having a full-thickness rotator cuff tear
- Patients with bleeding disorders or coagulopathies (e.g., idiopathic thrombocytopenic purpura, hemophilia, disseminated intravascular coagulation)
- Patients with advanced atherosclerosis or vasospasm in the arm vessels, or those expected to have such conditions
- Patients with a known hypersensitivity to gelatin
- Patients with a known hypersensitivity to contrast media
- Patients who are pregnant or breastfeeding
- Patients with a localized infection at the pain site
- Patients deemed inappropriate for participation by the investigator due to ethical concerns or potential impact on the clinical trial results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chung-Ang Univerisity Hospital
Seoul, South Korea, 06973
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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