A 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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental: 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 the study protocol.
干预措施: Transcatheter Arterial Micro- Embolization (TAME) (Procedure)
Active 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 by the study protocol.
干预措施: Usual care (conservative management) (Other)
结局指标
主要结局
Visual Analog Scale (VAS) score
时间窗: Baseline and 6 months after the procedure
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.
次要结局
- Visual Analog Scale (VAS) scores at early follow-up(Baseline, 1 week, 1 month, and 3 months after the procedure)
- Structural changes of the shoulder joint assessed by magnetic resonance imaging (MRI)(Baseline and 6 months after the procedure)
- Shoulder joint range of motion (ROM)(Baseline, and at 1 week, 1 month, 3 months, and 6 months after the procedure)
- Single Assessment Numeric Evaluation (SANE)(Baseline and 6 months after the procedure)
- American Shoulder and Elbow Surgeons (ASES) score(Baseline and 6 months after the procedure)
- Patient satisfaction with treatment(6 months after the procedure)
研究者
Woosun Choi
Associate Professor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine