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.
383 studies on the registry are indexed under Bursitis; 111 are open to participants now.
This study's planned enrollment of 192 is above the median of 44 across 346 interventional studies indexed under Bursitis.
Browse Bursitis studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
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):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Start is estimated for Aug 2026; primary completion for Jul 2029, 35 months later.
Of 217 non-industry interventional studies with no phase under Bursitis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's planned 35 months is above that.
Counting every sponsor, half of 217 studies reached it within 10 months; a quarter within 5 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Taiwan University Hospital →