Adhesive Capsulitis
Conditions
Keywords
Adhesive Capsulitis, Artificial Intelligence, Dynamic Ultrasound, Subacromial Motion, Vertical Acromiohumeral Distance
Brief summary
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.
Interventions
PROCEDUREDual-Target Injection
An ultrasound-guided injection targeting both the rotator interval and the subdeltoid bursa.
PROCEDURERotator Interval Injection
An ultrasound-guided injection administered through the rotator interval approach.
PROCEDUREPosterior Recess Injection
An injection into the glenohumeral joint utilizing a posterior approach.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria for the Control Group: 1. Age-matched adults (≥ 18 years old) with no symptoms of adhesive capsulitis. 2. Age distribution matched with that of the disease group. * Inclusion Criteria for the Disease Group (Adhesive Capsulitis): 1. Shoulder stiffness persisting for more than one month. 2. 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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Shoulder Pain and Disability Index (SPADI) Total Score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Visual Analog Scale (VAS) for Pain | Baseline, Week 6, and Week 12 | 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). |
| Change from Baseline in Shoulder Range of Motion (ROM) | Baseline, Week 6, and Week 12 | — |
| Incidence of Treatment-Related Adverse Events | Up to Week 12 | — |
Countries
Taiwan
Outcome results
None listed