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.
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 ⑤ 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 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
Parallel
Transcatheter Arterial Micro- Embolization (TAME)
Procedure/SurgeryA one-time transcatheter arterial micro-embolization (TAME) procedure will be performed via radial artery access. After angiographic identification of abnormal neovascularity or hypervascular lesions associated with shoulder pain, target vessels will be superselected with a microcatheter and embolized using Nexsphere-F (gelatin-based bioresorbable embolic particles) until angiographic stasis or marked reduction of abnormal hyperemia is achieved, according to operator judgement.
Usual care (conservative management)
Other interventionUsual conservative management for shoulder pain provided as part of standard clinical care. Conservative treatments (e.g., physical therapy, analgesic medications, and/or intra-articular hyaluronic acid injection) may be provided based on clinical judgement and patient preference and are not mandated or standardized by the study protocol.
Visual Analog Scale (VAS) score
Change from baseline in shoulder pain severity assessed using the Visual Analog Scale (VAS) score, a 0-10 scale where 0 indicates no pain and 10 indicates the worst imaginable pain.
Visual Analog Scale (VAS) scores at early follow-up
Change from baseline in shoulder pain severity assessed using the Visual Analog Scale (VAS) scores, a 0-10 scale where 0 indicates no pain and 10 indicates the worst imaginable pain.
Shoulder joint range of motion (ROM)
Change from baseline in shoulder joint range of motion measured in degrees using a goniometer.
American Shoulder and Elbow Surgeons (ASES) score
Change from baseline in shoulder function assessed using the American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form, a 0-100 scale where higher scores indicate better shoulder function.
Single Assessment Numeric Evaluation (SANE)
Change from baseline in shoulder function assessed using the Single Assessment Numeric Evaluation (SANE), a 0-100 scale where 0 represents complete disability and 100 represents normal shoulder function.
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Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Lead sponsor
Next Biomedical Co., Ltd.
Collaborator
