רדאר קליני AI | ||
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הניסוי הקליני NCT07336849 (TAE-FROST) עבור Adhesive Capsulitis of the Shoulder, כתף קפואה, Shoulder Adhesive Capsulitis הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
Transcatheter Arterial Embolization Using Nexsphere-F for Chronic Shoulder Pain Refractory to Conservative Treatment (TAE-FROST) 44 אקראי תווית פתוחה
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...
הצג עודThis 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...
הצג עודA Single-center, Prospective, Open Label Randomized Clinical Trial to Evaluate the Efficacy and Safety of Transcatheter Arterial Embolization Using 'Nexsphere-F' in Patients With Adhesive Capsulitis of the Shoulder Joint Refractory to Conservative Treatment.
- TAE-FROST
- 2505-006-641
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיExperimental: Transcatheter arterial micro-embolization (TAME) 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 ...הצג עוד | Transcatheter Arterial Micro- Embolization (TAME) 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 ab...הצג עוד |
משווה פעילActive Comparator: Usual care (conservative management) 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 b...הצג עוד | Usual care (conservative management) 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. |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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. | Baseline and 6 months after the procedure |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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. | 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. | 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. | 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. | 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. | 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. | Baseline and 6 months after the procedure |
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 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
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
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
Chung-Ang University Hosptial, Chung-Ang University College of Medicine