An interventional study of Transcatheter Arterial Micro- Embolization (TAME) and Usual care (conservative management) in Adhesive Capsulitis of the Shoulder, Frozen Shoulder and Shoulder Adhesive Capsulitis, sponsored by Chung-Ang University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Chung-Ang University Hospital · Not applicable, Interventional, and Treatment
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.
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.
Pain levels will be assessed via outpatient visits or telephone interviews at baseline (pre-procedure), and at 1 week, 1 month, 3 months, and 6 months post-procedure. During outpatient visits, the Visual Analog Scale (VAS), American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE) score, shoulder range of motion (ROM), and the patient's subjective satisfaction (satisfied or not) will be recorded. Magnetic resonance imaging (MRI) of the shoulder joint will be performed both before the procedure and at 6 months post-procedure in both the control and intervention groups for comparative evaluation.
383 studies on the registry are indexed under Bursitis; 111 are open to participants now.
This study's planned enrollment of 44 is close to the median of 44 across 346 interventional studies indexed under Bursitis.
Browse Bursitis studies →Chung-Ang University Hospital is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
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Patients who have voluntarily signed a written 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)
Exclusion Criteria:
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 to gelatin
⑥ Patients with a known hypersensitivity to contrast media
⑦ Patients who are pregnant or breastfeeding
⑧ Patients with a localized infection at the pain site
⑨ Patients deemed inappropriate for participation by the investigator due to ethical concerns or potential impact on the clinical trial results
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the experimental group will undergo a one-time transcatheter arterial micro-embolization (TAME) procedure using Nexsphere-F. Usual conservative management for shoulder pain (e.g., physical therapy, analgesic medications, and/or intra-articular hyaluronic acid injection) may be provided as part of standard clinical care based on clinical judgement and patient preference and is not mandated by the study protocol.
Procedure: Transcatheter Arterial Micro- Embolization (TAME)
Participants assigned to the control group will not undergo transcatheter arterial micro-embolization (TAME) and will receive usual conservative management for shoulder pain 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 by the study protocol.
Other: Usual care (conservative management)
A 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 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.
Time frame: Baseline and 6 months after the procedure
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.
Time frame: Baseline, 1 week, 1 month, and 3 months after the procedure
Shoulder joint range of motion (ROM)
Change from baseline in shoulder joint range of motion measured in degrees using a goniometer.
Time frame: Baseline, and at 1 week, 1 month, 3 months, and 6 months after the procedure
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.
Time frame: Baseline and 6 months after the procedure
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.
Time frame: Baseline and 6 months after the procedure
Patient satisfaction with treatment
Patient satisfaction with treatment assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
Time frame: 6 months after the procedure
Structural changes of the shoulder joint assessed by magnetic resonance imaging (MRI)
Structural changes of the shoulder joint assessed by magnetic resonance imaging (MRI), including the presence and severity of synovitis, capsular thickening, bone marrow edema, and tendon pathology, evaluated by qualitative and semi-quantitative radiologic assessment.
Time frame: Baseline and 6 months after the procedure
Started Sep 2025 (actual). Primary completion is estimated for Aug 2027, 23 months after the start.
Of 217 non-industry interventional studies with no phase under Bursitis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's planned 23 months is above that.
Counting every sponsor, half of 217 studies reached it within 10 months; a quarter within 5 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
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Chung-Ang University Hospital