An interventional study of Dual-Target Injection and Rotator Interval Injection in Adhesive Capsulitis, sponsored by National Taiwan University Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
Inclusion Criteria:
Inclusion Criteria for the Control Group:
Inclusion Criteria for the Disease Group (Adhesive Capsulitis):
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.
Exclusion Criteria:
Exclusion Criteria (for both Control and Disease Groups):
Procedure: Rotator Interval Injection
Procedure: Dual-Target Injection
Procedure: Posterior Recess Injection
An ultrasound-guided injection targeting both the rotator interval and the subdeltoid bursa.
An ultrasound-guided injection administered through the rotator interval approach.
An injection into the glenohumeral joint utilizing a posterior approach.
Change from Baseline in Shoulder Pain and Disability Index (SPADI) Total Score
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).
Time frame: Baseline, Week 6, and Week 12
Change from Baseline in Visual Analog Scale (VAS) for Pain
Visual Analogue Scale: 1. Minimum and Maximum Values: 0 to 10 (often measured as 0 to 100 millimeters) 2. Higher scores mean a worse outcome (0 represents no pain at all, while 10 or 100 represents the worst imaginable pain).
Time frame: Baseline, Week 6, and Week 12
Change from Baseline in Shoulder Range of Motion (ROM)
Time frame: Baseline, Week 6, and Week 12
Incidence of Treatment-Related Adverse Events
Time frame: Up to Week 12
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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National Taiwan University Hospital