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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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.
Chung-Ang Univerisity Hospital
Seoul, South Korea
RECRUITINGVisual 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
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