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临床试验/NCT07599059
NCT07599059Enrolling By Invitation不适用

Artificial Intelligence-Assisted Dynamic Imaging Analysis and Predictive Modeling of Ultrasound-Guided Capsular Distension Therapy for Adhesive Capsulitis

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2026年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
192
试验地点
1
主要终点
Change from Baseline in Shoulder Pain and Disability Index (SPADI) Total Score

研究概览

简要总结

This study aims to integrate artificial intelligence with ultrasound imaging to investigate the dynamic biomechanical characteristics of adhesive capsulitis and to compare the therapeutic effectiveness of three ultrasound-guided hydrodilatation techniques: rotator interval injection, dual-target injection, and posterior glenohumeral injection. In the observational phase, healthy participants and patients with adhesive capsulitis will undergo static and dynamic ultrasound evaluations to quantify subacromial motion and the minimal vertical acromiohumeral distance (mvAHD) during shoulder abduction. A Faster R-CNN model will automatically identify the acromion and greater tuberosity to extract motion trajectories and frequency-based features.

In the randomized clinical trial phase, patients will be assigned to one of the three hydrodilatation techniques to compare improvements in pain, function, and range of motion at 6 and 12 weeks. All participants will subsequently enter a one-year follow-up to document recurrence, defined as the need for repeat intervention. Clinical characteristics, static sonographic parameters, dynamic motion metrics, and short-term treatment responses will be incorporated into machine-learning models to predict long-term outcomes, including recurrence risk. Eligible patients who decline randomization may consent to join a parallel observational cohort. They will receive standard-of-care treatment (conservative or interventional) based on their preference, and undergo the exact same baseline, Week 6, and Week 12 clinical and ultrasound assessments as the randomized trial participants.

The ultimate goal is to establish an AI-assisted predictive framework that enables individualized risk stratification, early identification of poor responders, and optimization of injection strategies. This model is expected to improve clinical decision-making, enhance treatment precision, and contribute to higher-quality patient care.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria for the Control Group:
  • Age-matched adults (≥ 18 years old) with no symptoms of adhesive capsulitis.
  • Age distribution matched with that of the disease group.
  • Inclusion Criteria for the Disease Group (Adhesive Capsulitis):
  • Shoulder stiffness persisting for more than one month.
  • Restriction of passive range of motion by more than 30° in at least two of the three directions (forward flexion, abduction, and external rotation) compared to the contralateral side, with imaging findings consistent with the diagnostic features of primary adhesive capsulitis.

排除标准

  • Exclusion Criteria (for both Control and Disease Groups):
  • Systemic rheumatic disease (like rheumatoid arthritis and ankylosing spondylitis).
  • History of malignancy.
  • Previous major trauma, surgeries, or recent injection therapy on the affected shoulder.
  • Suprascapular nerve block within the previous three months.
  • Inability to clearly understand or express personal willingness due to central nervous system injury.

研究组 & 干预措施

Posterior Recess Injection

Experimental

干预措施: Posterior Recess Injection (Procedure)

Rotator Interval Injection

Experimental

干预措施: Rotator Interval Injection (Procedure)

结局指标

主要结局

Change from Baseline in Shoulder Pain and Disability Index (SPADI) Total Score

时间窗: Baseline, Week 6, and Week 12

Shoulder Pain and Disability Index: 1. Minimum and Maximum Values: 0 to 100 2. Higher scores mean a worse outcome (indicating more severe shoulder pain and a higher degree of disability).

次要结局

  • Change from Baseline in Visual Analog Scale (VAS) for Pain(Baseline, Week 6, and Week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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